FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)

KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Abacavir Sulphate 600 mg and J05AR02964T1001XX Yes A* Antiretroviral combination therapy of HIV infection in adults ADULTS & ADOLESCENT (> 12 years of
Lamivudine 300 mg Tablet and adolescents from 12 years of age with the following age): Recommended dose is one tablet
criteria: once daily. Not to be used in adults or
i)Patients unsuitable or failed other HAART treatment adolescents weigh less than 40kg.
ii)Patients who are at high risk of renal impairment iii)Patients CHILDREN : Not recommended
with osteoporosis or at high risk of bone loss
Acarbose 50 mg Tablet A10BF01000T1001XX No A/KK Only for treatment of: Initially 50 mg daily, increase to 3 times
i) Non insulin dependent diabetes mellitus (NIDDM) when diet daily up to 100 mg 3 times daily. Max
therapy is insufficient; 200 mg 3 times daily
ii) Non insulin dependent diabetes mellitus (NIDDM) in
combination with existing conventional oral therapy where
glycaemic control is inadequate.
Restriction: i) As second/third line treatment of diabetes type
2, with HBA1c < 8%. ii) For patient who have postprandial
hyperglycemia when treated with combination of available
oral anti-diabetic/insulin. iii) The use of acarbose should be
reviewed 6 months after initiation and stopped if HBA1c
reduction is less than 0.5%.

Acetazolamide 250 mg Tablet S01EC01000T1001XX Yes B Reduction of intraocular pressure in open-angle glaucoma, 250mg 1-4 times a day, the dosage being
secondary glaucoma and peri-operatively in angle-closure titrated according to patient response
glaucoma
Acetazolamide 500 mg Injection S01EC01000P4001XX Yes B Reduction of intra-ocular pressure in open-angle glaucoma, Adult : 250-1000mg per 24hours, usually
secondary glaucoma and peri-operatively in angle-closure in divided doses for amounts over
glaucoma 250mg daily
Acetylcysteine 200 mg/ml Injection V03AB23520P3001XX Yes A* Antidote for paracetamol poisoning Diluted with dextrose 5% and infused IV.
Initial, 150 mg/kg IV in 200 ml over 60
minutes, then 50 mg/kg IV in 500 ml
over 4 hours, followed by 100 mg/kg IV
in 1000 ml over 16 hours. Total dose:
300mg/kg in 20 hour
Acetylsalicylic Acid 100 mg, Glycine 45 B01AC06259T1001XX No B Prevention of myocardial infarct, stroke, vascular occlusion 1 tablet daily
mg Tablet and deep vein thrombosis. Transient ischaemic attacks

Acetylsalicylic Acid 300 mg Soluble N02BA01000T4001XX Yes C Mild to moderate pain 300 - 900 mg every 4 - 6 hours as
Tablet required. Max 4 g daily. Use in children
not recommended
Acitretin 10 mg Capsule D05BB02000C1001XX Yes A* i) Severe form of psoriasis including erythrodermic psoriasis ADULT: initially 25-30 mg daily for 2-4
and local or generalized pustular psoriasis. weeks, then adjusted according to
ii) Severe disorders of keratinization, such as -congenital response, usually within range 25-50 mg
ichthyosis -pityriasis rubra pilaris -Darier's disease -other daily for further 6-8 weeks (max: 75 mg
disorders of keratinization which may be resistant to other daily). In disorders of keratinization,
therapies maintenance therapy of less than
20mg/day and should not exceed
50mg/day CHILD: 0.5mg/kg daily
occasionally up to 1 mg/kg daily to a
max. 35 mg daily for limited periods

Acitretin 25 mg Capsule D05BB02000C1002XX Yes A* i) Severe form of psoriasis including erythrodermic psoriasis ADULT: initially 25-30 mg daily for 2-4
and local or generalized pustular psoriasis. weeks, then adjusted according to
ii) Severe disorders of keratinization, such as -congenital response, usually within range 25-50 mg
ichthyosis -pityriasis rubra pilaris -Darier's disease -other daily for further 6-8 weeks (max: 75 mg
disorders of keratinization which may be resistant to other daily). In disorders of keratinization,
therapies maintenance therapy of less than
20mg/day and should not exceed
50mg/day CHILD: 0.5mg/kg daily
occasionally up to 1 mg/kg daily to a
max. 35 mg daily for limited periods

Acriflavine 0.1% Lotion D08AA03000L6001XX Yes C+ Infected skin, lesions, cuts, abrasions, wounds and burns. Apply undiluted three times daily to the
affected part .
Actinomycin D (Dactinomycin) 500 L01DA01110P4001XX Yes A i) For solid tumours; i) ADULT: 500 mcg IV daily for max of 5
mcg/ml Injection ii) Gestational trophoblastic disease days. CHILD: 1.5 mg/m2 once every 3
weeks (if weight less than 10 kg, 50
mcg/kg) ii) 500 mcg IV on Days 2, 4, 6, 8,
10, repeat every 7 - 10 days or 500 mcg
IV bolus on Days 1 and 2, repeat every
15 days
Acyclovir 200 mg Tablet J05AB01000T1001XX Yes A/KK i) Mucocutaneous Herpes Simplex infection in i) ADULT: initially 400 mg 5 times daily
immunocompromised and AIDS patients ii) Primary and for 7 - 14 days. CHILD less than 2 years:
recurrent Varicella Zoster infection in immunocompromised 200 mg 4 times daily, CHILD more than 2
and AIDS patients iii) Severe Kaposi Varicella Eruption (Eczema years: 400 mg 4 times daily ii), iii) and iv)
herpeticum) iv) Severe primary HSV infections (eg. Neonatal ADULT: 200 - 400 mg 4 times daily.
herpes, encephalitis, eczema herpeticum, genital herpes, CHILD: less than 2 years, half adult dose;
gingival stomatitis, vaginal delivery with maternal vulva more than 2 years, adult dose v) ADULT:
herpes) v) Severe and complicated varicella infection (eg. 800 mg 5 times daily for 7 days vi)
Encephalitis, purpura fulminans) vi) Severe zoster infection in ADULT: 20 mg/kg (maximum: 800 mg)
paediatrics (eg. Encephalitis, purpura fulminans, four times daily for 5 days, CHILD 6
immunocompromised patients and facial, sacral and motor years: 800 mg four times daily. CHILD
zoster) less than 2 years; 400mg 4 times daily,
more than 2 years; 800mg 4 times daily

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Acyclovir 200 mg/5 ml Suspension J05AB01000L8001XX Yes A* i) Mucocutaneous Herpes Simplex infection in i) ADULT: initially 400 mg 5 times daily
immunocompromised and AIDS patients ii) Primary and for 7 - 14 days. CHILD less than 2 years:
recurrent Varicella Zoster infection in immunocompromised 200 mg 4 times daily, CHILD more than 2
and AIDS patients iii) Severe Kaposi Varicella Eruption (Eczema years: 400 mg 4 times daily ii), iii) and iv)
herpeticum) iv) Severe primary HSV infections (eg. Neonatal ADULT: 200 - 400 mg 4 times daily.
herpes, encephalitis, eczema herpeticum, genital herpes, CHILD : less than 2 years, half adult dose;
gingival stomatitis, vaginal delivery with maternal vulva more than 2 years, adult dose. v) ADULT:
herpes) v) Severe and complicated varicella infection (eg. 800 mg 5 times daily for 7 days vi)
Encephalitis, purpura fulminans) vi) Severe zoster infection in ADULT: 20 mg/kg (maximum: 800 mg)
paediatrics (eg.Encephalitis, purpura fulminans, four times daily for 5 days, CHILD 6
immunocompromised patients and facial, sacral and motor years: 800 mg four times daily. CHILD:
zoster) less than 2 years; 400mg 4 times daily,
more than 2 years; 800 mg 4 times daily

Acyclovir 250 mg Injection J05AB01000P4001XX Yes A* Treatment and prophylaxis of herpes simplex in ADULT: 5 mg/kg by IV infusion 8 hourly
immunocompromised, severe initial genital herpes and for 5 days, doubled to 10mg/kg every 8
Varicella -Zoster hourly in varicella-zoster in the
immunocompromised and in simplex
encephalitis (usually given for at least 10
days in encephalitis; possibly for 14 - 21
days). NEONATE & INFANT up to 3
months with disseminated herpes
simplex: 20mg/kg every 8 hourly for 14
days (21 days in CNS involvement),
varicella-zoster 10-20mg/kg every 8
hourly usually for 7 days. CHILD, 3
months - 12 years: Herpes simplex or
Varicella Zoster: 250 mg/m2 8 hourly for
5 days, doubled to 500 mg/m2 8 hourly
for varicella-zoster in the
immunocompromised and in simplex
encephalitis (usually given for 10 days in
encephalitis)

Acyclovir 3% Eye Ointment S01AD03000G5101XX Yes A* Only for the treatment of herpes simplex keratitis Apply 1 cm 5 times daily. Continue for at
least 3 days after healing
Acyclovir 5% Cream D06BB03000G1001XX No A* Herpes simplex infections of the skin, including initial and Apply every 4 hours for 5 - 10 days
recurrent labial and genital herpes simplex infections

Acyclovir 800 mg Tablet J05AB01000T1002XX Yes A/KK i) Mucocutaneous Herpes Simplex infection in i) ADULT: initially 400 mg 5 times daily
immunocompromised and AIDS patients ii) Primary and for 7 - 14 days. CHILD less than 2 years:
recurrent Varicella Zoster infection in immunocompromised 200 mg 4 times daily, CHILD more than 2
and AIDS patients iii) Severe Kaposi Varicella Eruption (Eczema years: 400 mg 4 times daily ii), iii) and iv)
herpeticum) iv) Severe primary HSV infections (eg. Neonatal ADULT: 200 - 400 mg 4 times daily.
herpes, encephalitis, eczema herpeticum, genital herpes, CHILD: less than 2 years, half adult dose;
gingival stomatitis, vaginal delivery with maternal vulva more than 2 years, adult dose v) ADULT:
herpes) v) Severe and complicated varicella infection (eg. 800 mg 5 times daily for 7 days vi)
Encephalitis, purpura fulminans) vi) Severe zoster infection in ADULT: 20 mg/kg (maximum: 800 mg)
paediatrics (eg. Encephalitis, purpura fulminans, four times daily for 5 days, CHILD 6
immunocompromised patients and facial, sacral and motor years: 800 mg four times daily. CHILD
zoster) less than 2 years; 400mg 4 times daily,
more than 2 years; 800mg 4 times daily

Adalimumab 40 mg Injection L04AB04000P5001XX No A* i) Third line treatment of: - Severe rheumatoid arthritis - i)Severe rheumatoid arthritis, Psoriatic
Psoriatic arthritis - Ankylosing spondylitis after failure of arthritis, Ankylosing spondylitis :
conventional DMARDs or other biologics ii)Treatment of adults Subcutaneous 40 mg every other week
with moderate to severe chronic plaque psoriasis who have ii)Chronic plaque psoriasis : Initial, 80 mg
not responded to, have contraindication or are unable to SC, followed by 40 mg SC every other
tolerate phototherapy and/or systemic therapies including week starting one week after the initial
acitretin, methotreaxate and cyclosporine iii) Crohn's Disease dose iii) & iv) Crohn?s disease &
a) For treatment of moderately to severely active Crohn?s Ulcerative colitis: 160mg at week 0 (dose
Disease in adult patients who have inadequate response to can be administered as four injections in
conventional therapy b) For treatment of moderately to one day or as two injections per day for
severely active Crohn?s Disease in adult patients who have lost two consecutive days) and 80mg at week
response to or are intolerant to infliximab iv) Ulcerative Colitis - 2. After induction treatment, the
For treatment of moderately to severely active ulcerative recommended maintenance dose is
colitis in adult patients who have had an inadequate response 40mg every other week via
to conventional therapy including corticosteroids and 6- subcutaneous injection.
mercaptopurine or azathioprine, or who are intolerant to or
have medical contraindications for such therapies

Adapalene 0.1% Cream D10AD03000G1001XX Yes A* Acne vulgaris where comedones, papules and pustules Apply once daily to the affected areas
predominate in those sensitive to benzoyl peroxide or topical after washing at bedtime
tretinoin [third line treatment]
Adapalene 0.1% Gel D10AD03000G3001XX Yes A/KK Acne vulgaris where comedones, papules and pustules Apply once daily to the affected areas
predominate in those sensitive to benzoyl peroxide or topical after washing at bedtime
tretinoin [third line treatment]
Adefovir Dipivoxil 10 mg Tablet J05AF08000T1001XX No A* i) Treatment of chronic HBeAg positive and HBeAg negative Adult (18-65 years): 10mg Once Daily
hepatitis B infection in adults with compensated liver function Renal Dose Adjustment : 10mg every
(lamivudine should be tried first) ii) Lamivudine-resistant 48hours (30-49ml/min); 10mg every
chronic hepatitis B virus infection with either compensated or 72hours (10-29ml/min); 10mg every 7
decompensated hepatitis function (only by hepatologist and days (Hemodialysis)
gastroenterologist for approved indications)

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Adenosine 3 mg/ml Injection C01EB10000P3001XX No B Rapid conversion of paroxysmal supraventricular tachycardia ADULT: Initially: 3 mg given as a rapid IV
to sinus rhythm bolus (over 2 seconds). Second dose: If
the first dose does not result in
elimination of the supraventricular
tachycardia with in 1 or 2 minutes, 6 mg
should be given also as a rapid IV bolus.
Third dose: If the second dose does not
result in elimination of the
supraventicular tachycardia with in 1-2
minutes, 12 mg should be given also as a
rapid IV bolus

Adrenaline Acid (Epinephrine) Tartrate 1 C01CA24123P3001XX Yes B Cardiopulmonary resuscitation 1 mg by intravenous injection repeated
mg/ml Injection every 3-5 minutes according to response

Aflibercept 40mg/ml solution vial for S01LA05000P3001XX No A* i) Treatment of neovascular (wet) age-related macular i) The recommended dose is 2mg
injection degeneration (wet AMD). ii) Visual impairment due to diabetic aflibercept, equivalent to 0.05mL (50 μL)
macular edema (DME). Prescribing restriction: a) Treatment of given as intra-vitreal injection.
naive patients with vision equal or poorer than 20/50; b) Aflibercept treatment is initiated with
Patients with poor response to treatment with ranibizumab. one injection per month for three
consecutive doses, followed by one
injection every two months. ii) 2 mg
aflibercept (equivalent to 50 microliters)
administered by intravitreal injection
monthly for the first 5 consecutive
doses, followed by one injection every 2
months. There is no requirement for
monitoring between injections.

Agomelatine 25 mg Tablet N06AX22000T1001XX No A* Major depression The recommended dose is 25mg once
daily at bedtime, maybe increased to
50mg once daily at bedtime.

Albendazole 200 mg Tablet P02CA03000T1001XX Yes C+ i) Single or mixed infestations of intestinal parasites ii) i)Child 12-24months: 200mg as a single
Strongyloides infection dose ii) Adult & Child above 2 years:
400mg as a single dose for 3 consecutive
days; Child 12 - 24months: 200mg as a
single dose for 3 consecutive days

Albendazole 200 mg/5 ml Suspension P02CA03000L8001XX Yes C+ i) Single or mixed infestations of intestinal parasites ii) i)Child 12-24months: 200mg as a single
Strongyloides infection dose ii) Adult & Child above 2 years:
400mg as a single dose for 3 consecutive
days; Child 12 - 24months: 200mg as a
single dose for 3 consecutive days

Alcohol 70% Solution D08AX08000L9901XX Yes C+ Use as antiseptic and disinfectant Apply to the skin undiluted or when
needed
Alendronate Sodium 70 mg and M05BB03972T1002XX No A* Osteoporosis in postmenopausal women with a history of 1 tablet once weekly [70mg/5600 IU].
Cholecalciferol 5600 IU Tablet vertebral fracture and whom oestrogen replacement therapy Patient should receive supplemental
is contraindicated. Review treatment after 2 years and if there calcium or vitamin D, if dietary vitamin D
is positive response, treatment may be continued up to 5 inadequate. The tablet should be taken
years and then re-evaluate. Treatment should be stopped if at least half and hour before the first
there is no positive response after 5 years. Otherwise, patient food, beverage, or medication of the day
needs to be given drug holiday for 1 to 2 years and then with plain water only. To facilitate
continue treatment shall the benefit outweigh the risk. delivery to stomach and thus reduce the
potential for esophageal irritation, it
should only be swallowed upon arising
for the day with a full glass of water and
patient should not lie down for at least
30 minutes and until after their first food
of the day.

Alendronate Sodium 70 mg Tablet M05BA04520T1001XX No A* Osteoporosis in postmenopausal women with a history of 70 mg once weekly. Swallow the tablet
vertebral fracture and whom oestrogen replacement therapy whole with a full glass of plain water
is contraindicated. Review treatment after 2 years and if there only on an empty stomach at least 30
is positive response, treatment may be continued up to 5 minutes before breakfast (and any other
years and then re-evaluate. Treatment should be stopped if oral medication); stand or sit upright for
there is no positive response after 5 years. Otherwise, patient at least 30 minutes and do not lie down
needs to be given drug holiday for 1 to 2 years and then until after eating breakfast
continue treatment shall the benefit outweigh the risk.

Alfacalcidol 0.25 mcg Capsule A11CC03000C1001XX No A/KK i) Renal osteodystrophy in patients on haemodialysis ii) Initial dose ADULT and CHILD above 20kg
Hypoparathyroidism and pseudohypoparathyroidism iii) body weight : 1 mcg daily; CHILD under
Adjunct to the management of tertiary hyperparathyroidism 20kg body weight : 0.05 mcg/kg/day.
iv) Rickets and osteomalacia v) Osteoporosis Maintenance dose : 0.25 mcg to 2 mcg
daily
Alfacalcidol 1 mcg Capsule A11CC03000C1002XX No A/KK i) Renal osteodystrophy in patients on haemodialysis ii) Initial dose ADULT and CHILD above 20kg
Hypoparathyroidism and pseudohypoparathyroidism iii) body weight : 1 mcg daily; CHILD under
Adjunct to the management of tertiary hyperparathyroidism 20kg body weight : 0.05 mcg/kg/day.
iv) Rickets and osteomalacia v) Osteoporosis Maintenance dose : 0.25 mcg to 2 mcg
daily
Alfacalcidol 2 mcg/ml Drops A11CC03000D5001XX No A* i) Renal osteodystrophy in patients on haemodialysis ii) NEONATES : 0.1 mcg/kg/day
Hypoparathyroidism and pseudohypoparathyroidism iii)
Adjunct to the management of tertiary hyperparathyroidism
iv) Rickets and osteomalacia v) Osteoporosis

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Alfacalcidol 2 mcg/ml Injection A11CC03000P3001XX No A* Treatment of: i) Renal osteodystrophy in patients on Adult: Initially, 1 mcg daily.
haemodialysis ii) Hypoparathyroidism and Maintenance: 0.25-1 mcg daily. Child:
pseudohypoparathyroidism iii) Adjunct to the management of Premature infants and neonates: 0.05-
tertiary hyperparathyroidism iv) Rickets and osteomalacia v) 0.1 mcg/kg daily; <20 kg: 0.05 mcg/kg
Osteoporosis daily. Elderly: 0.5 mcg daily.

Alfentanil HCl 0.5 mg/ml Injection N01AH02110P3001XX No A* For use as short acting narcotic analgesic in short procedures Initial dose: 20 - 40 mcg/kg.
and day-care surgical procedures Supplemental dose: 15 mcg/kg or
infusion 0.5 - 1.0 mcg/kg/min
Alfuzosin HCl 10 mg Tablet G04CA01110T1001XX No A* Treatment of functional symptoms related with benign 10 mg once a day pre bed
prostatic hypertrophy (BPH)
Alglucosidase alfa 5 mg/ml Injection A16AB07000P4001XX No A* Infantile-onset Pompe disease 20 mg/kg of body weight administered
once every 2 weeks as an intravenous
infusion. Monitoring It is suggested that
patients be monitored periodically for
IgG antibody formation. Patients who
experience Infusion-associated reactions
suggestive of hypersensitivity may be
tested for IgE antibodies to alglucosidase
alfa. Treated patients who experience a
decrease in benefit despite continued
treatment with Alglucosidase Alfa, in
whom antibodies are suspected to play a
role, may be tested for neutralization of
enzyme uptake or activity.

Alkaline Nasal Douche R01A000999L5001XX No B To remove nasal plug To be diluted with an equal volume of
warm water before use
Allopurinol 100 mg Tablet M04AA01000T1002XX Yes A/KK i) Frequent and disabling attacks of gouty arthritis (3 or more Initial dose : 100-300 mg daily.
attacks/year). ii) Clinical or radiographic signs of erosive gouty Maintenance : 300-600 mg daily.
arthritis. iii) The presence of tophaceous deposits. iii) Urate Maximum: 900 mg daily
nephropathy. iv) Urate nephrolithiasis. v) Impending cytotoxic
chemotherapy or radiotherapy for lymphoma or leukaemia

Allopurinol 300 mg Tablet M04AA01000T1001XX Yes A/KK i) Frequent and disabling attacks of gouty arthritis (3 or more Initial dose : 100-300 mg daily.
attacks/year). ii) Clinical or radiographic signs of erosive gouty Maintenance : 300-600 mg daily.
arthritis. iii) The presence of tophaceous deposits. iii) Urate Maximum: 900 mg daily
nephropathy. iv) Urate nephrolithiasis. v) Impending cytotoxic
chemotherapy or radiotherapy for lymphoma or leukaemia

All-Trans Retinoic Acid 10 mg Capsule L01XX14000C1001XX No A* Acute promyelocytic leukaemia Induction: 45 mg/m2 daily for 30 - 90
days. Maintenance: 45 mg/m2 daily for 2
weeks every 3 months. Renal/or hepatic
insufficiency: 25mg/m2 daily for 30-90
days. Refer to protocols
Alprazolam 0.25 mg Tablet N05BA12000T1001XX No A/KK Anxiety disorders 0.25 - 0.5 mg 3 times daily (elderly or
delibitated 0.25 mg 2-3 times daily),
increased if necessary to a total dose of
3 mg/day. Not recommended for
children
Alprazolam 0.5 mg Tablet N05BA12000T1002XX No A Anxiety disorders 0.25 - 0.5 mg 3 times daily (elderly or
delibitated 0.25 mg 2-3 times daily),
increased if necessary to a total dose of
3 mg/day. Not recommended for
children
Alprazolam 1 mg Tablet N05BA12000T1003XX No A Anxiety disorders 0.25 - 0.5 mg 3 times daily (elderly or
delibitated 0.25 mg 2-3 times daily),
increased if necessary to a total dose of
3 mg/day. Not recommended for
children
Alprostadil 500 mcg/ml Injection C01EA01000P3001XX No A* For treatment of congenital heart diseases which are ductus 0.05 - 0.1 mcg/kg/min by continuous IV
arteriosus dependent infusion, then decreased to lowest
effective dose
Alteplase 50 mg per vial Injection B01AD02000P4001XX No A* Thrombolytic treatment of acute ischaemic stroke. 0.9 mg/kg (maximum of 90 mg) infused
over 60 minutes with 10% of the total
dose administered as an initial
intravenous bolus. Treatment must be
started as early as possible within 4.5
hours after onset of stroke symptoms
and after exclusion of intracranial
haemorrhage by appropriate imaging
technique.
Amantadine HCl 100 mg Capsule N04BB01110C1001XX No B Parkinson's disease Initial dose: 100 mg daily and is
increased to 100 mg twice daily (not
later than 4 p.m.) after a week. Elderly
over 65 years: less than 100 mg or 100
mg at intervals of more than 1 day

Amikacin 125 mg/ml Injection J01GB06183P3003XX No A Infections due to susceptible organisms ADULT: (IM or IV): 15 mg/kg/day 8 - 12
hourly for 7 - 10 days. Maximum: 1.5
g/day. CHILD: 15 mg/kg/day 8 - 12
hourly. Maximum: 1.5 g/day. Neonates:
Initial loading dose of 10 mg/kg followed
by 7.5 mg/kg/day 12 hourly. Maximum
15mg/kg/day

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Amikacin 250mg/ml Injection J01GB06183P3002XX No A Infections due to susceptible organisms ADULT: (IM or IV): 15 mg/kg/day 8 - 12
hourly for 7 - 10 days. Maximum: 1.5
g/day. CHILD: 15 mg/kg/day 8 - 12
hourly. Maximum: 1.5 g/day. Neonates:
Initial loading dose of 10 mg/kg followed
by 7.5 mg/kg/day 12 hourly. Maximum
15mg/kg/day
Amiloride HCl 5 mg & C03EA01900T1001XX No B i) Diuretic as an adjunct to the management of oedematous i) Initially 1 - 2 tab daily adjusted
Hydrochlorothiazide 50 mg Tablet states ii) Hypertension according to response. Max : 4 tabs
daily. ii) 1 -2 tabs daily as a single or
divided dose
Amino Acids Injection B05BA01910P3001XX No A Source of amino acids in patients needing IV nutrition Dose to be individualised. ADULT usually
500-2000 ml by IV. ADULT usual
requirement for amino acid: 1-2
g/kg/day
Amino Acids with Electrolytes Injection B05BA10910P3002XX No A Source of amino acids and electrolytes in patients needing IV Dose to be individualised. ADULT usual
nutrition requirement for amino acid 1-2 g/kg/day

Amino Acids with Glucose with B05BA10910P3003XX No A Source of amino acids, carbohydrate and electrolytes in Dose to be individualised. ADULT usual
Electrolytes Injection patients needing IV nutrition requirement for amino acid 1-2
g/kg/day, carbohydrate 4-6 g/kg/day
Amino Acids, Glucose and Lipid with B05BA10910P3001XX No A Source of amino acids, carbohydrate, lipid and electrolytes in Dose to be individualised. ADULT: 500 -
Electrolytes Injection patients needing IV nutrition 2000 ml daily given by IV. ADULT usual
requirement for amino acid 1-2 g/kg/
day, carbohydrate 4-6 g/kg/day, lipid 2-3
g/kg/day
Aminophylline 25 mg/ml Injection R03DA05000P3001XX Yes B Reversible airways obstruction, acute severe brochospasm Adult: Loading dose: 5 mg/kg (ideal body
weight) or 250-500 mg (25 mg/ml) by
slow inj or infusion over 20-30 min.
Maintenance infusion dose: 0.5
mg/kg/hr. Max rate: 25 mg/min. Child:
Loading dose: same as adult dose.
Maintenance dose: 6 mth-9 yr: 1
mg/kg/hr and 10-16 yr: 0.8 mg/kg/hr.

Amiodarone 200 mg Tablet C01BD01110T1001XX Yes A* Arrhythmias 200 mg 3 times daily for 1 week, then
reduced to 200 mg twice daily for
another week. Maintenance dose,
usually 200 mg daily or the minimum
required to control the arrhythmia
Amiodarone 50 mg/ml Injection C01BD01110P3001XX Yes A* Arrhythmias when other drugs are contraindicated or Initial infusion of 5mg/kg via large
ineffective venous access over 20-120 minutes with
ECG monitoring; subsequent infusion
given if necessary according to response
up to a maximum of 1.2 g in 24 hours

Amisulpride 100 mg Tablet N05AL05000T1001XX No A* Treatment of psychoses, particularly acute or chronic Predominantly negative episodes: 50-
schizophrenia disorders characterized by positive 300 mg once daily adjusted according to
symptoms(e.g. delusion, hallucinations, thought disorders) the patient?s response. Mixed episodes
and/or negative symptoms(e.g. blunted emotions, emotional with positive and negative symptoms:
and social withdrawal) including when the negative symptoms 400-800 mg/day in 2 divided doses
predominate adjusted according to the patient?s
response. Should be taken on an empty
stomach (Preferably taken before meals)

Amisulpride 400 mg Tablet N05AL05000T1002XX No A* Treatment of psychoses, particularly acute or chronic Predominantly negative episodes: 50-
schizophrenia disorders characterized by positive 300 mg once daily adjusted according to
symptoms(e.g. delusion, hallucinations, thought disorders) the patient?s response. Mixed episodes
and/or negative symptoms(e.g. blunted emotions, emotional with positive and negative symptoms:
and social withdrawal) including when the negative symptoms 400-800 mg/day in 2 divided doses
predominate adjusted according to the patient?s
response. Should be taken on an empty
stomach (Preferably taken before meals)

Amitriptyline HCl 25 mg Tablet N06AA09110T1001XX Yes B Depression Initially 25mg 3 times a day.
Maintenance: 25-100mg daily in divided
doses. Hospitalized patient: 100mg/day
&gradually increase to 200-300mg/day.
ADOLESCENT and ELDERLY: initially 20-
30mg/day in divided doses w/ gradual
increments. CHILD under 16 years are
not recommended

Amlodipine 10 mg and Valsartan 160 mg C09DB01935T1003XX No A/KK Essential hypertension in patients whose blood pressure is not Doses range from amlodipine besylate 5
Tablet adequately controlled by monotherapy mg/valsartan 160 mg to amlodipine
besylate 10 mg/valsartan 320 mg
ORALLY once daily, with dose titration
occurring every 1 to 2 weeks if
necessary. MAX amlodipine besylate 10
mg/valsartan 320 mg
Amlodipine 10 mg Tablet C08CA01000T1002XX Yes B Hypertension 5 mg once daily. Max: 10 mg once daily

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Amlodipine 5 mg and Valsartan 160 mg C09DB01935T1002XX No A/KK Essential hypertension in patients whose blood pressure is not Doses range from amlodipine besylate 5
Tablet adequately controlled by monotherapy mg/valsartan 160 mg to amlodipine
besylate 10 mg/valsartan 320 mg
ORALLY once daily, with dose titration
occurring every 1 to 2 weeks if
necessary. MAX amlodipine besylate 10
mg/valsartan 320 mg
Amlodipine 5 mg Tablet C08CA01000T1001XX Yes B Hypertension 5 mg once daily. Max: 10 mg once daily

Ammonium Bicarbonate, Tincture R05CA04900L2101XX Yes C Cough Adults, the elderly and children over 12
Ipecac, etc Mixture years: 10- 20ml, repeated after 4 hours if
required. Not more than 4 doses to be
taken in any 24 hours.
Amorolfine 5 % Nail Lacquer D01AE16110L5001XX No A* Fungal nail infections Apply to affected nail once or sometimes
twice a week after filling and cleansing,
allow to dry, treat finger nail for 6
months, toe nail for 9 - 12 months
(review at intervals of 3 months)

Amoxicillin & Clavulanate 228 mg/5 ml J01CR02961F2102XX No A/KK Infections caused by susceptible organisms Mild to Moderate infection:
Syrup 25mg/kg/day (based on Amoxicillin
dose) in 2 divided dose. Severe infection:
45mg/kg/day (based on Amoxicillin
dose) in 2 divided dose
Amoxicillin 1 g & Clavulanate 200 mg J01CR02961P4002XX No A Infections caused by susceptible organisms. Respiratory tract, CHILD less than 3 months: 30mg/kg 12
Injection skin, soft tissue, GUT infection, septicaemia, peritonitis, post- hourly. 3 months - 12 years: 30mg/kg 6 -
operative infection & osteomyelitis 8 hourly. ADULT: 1.2 g by IV or
intermittent infusion 6 - 8 hourly

Amoxicillin 250 mg Capsule J01CA04012C1001XX Yes B Infections caused by susceptible strains of gram positive and ADULT: 250 - 500 mg 3 times daily.
gram negative organisms CHILD: 20 - 40 mg/kg/day in divided
doses 8 hourly
Amoxicillin 500 mg & Clavulanate 125 J01CR02961T1002XX No A/KK Infections due to beta-lactamase producing strain where ADULT & CHILD more than 12 years:
mg Tablet amoxicillin alone is not appropriate. Respiratory tract, skin, Mild to moderate infections: 625 mg
soft tissue, GUT infection, septicaemia, peritonitis, post- twice daily.
operative infection & osteomyelitis
Amoxicillin 500 mg and Clavulanate 100 J01CR02961P4001XX No A Infections caused by susceptible organisms. Respiratory tract, CHILD less than 3 months: 30mg/kg 12
mg Injection skin, soft tissue, GUT infection, septicaemia, peritonitis, post- hourly. 3 months - 12 years: 30 mg/kg 6 -
operative infection and osteomyelitis 8 hourly. ADULT: 1.2 g by IV or
intermittent infusion 6 - 8 hourly

Amoxicillin 500 mg Capsule J01CA04012C1002XX Yes B Infections caused by susceptible strains of gram positive and ADULT: 250 - 500 mg 3 times daily.
gram negative organisms CHILD: 20 - 40 mg/kg/day in divided
doses 8 hourly
Amoxicillin Trihydrate 125 mg/5 ml J01CA04012F1001XX Yes B Infections caused by susceptible strains of gram positive and CHILD less than 10 years: 125 - 250 mg 8
Syrup gram negative organisms hourly. CHILD less than 20 kg: 20 - 40
mg/kg/day in 3 - 4 divided doses

Amphotericin B 0.15% Eye Drops S01A000801D2002XX No A Fungal infection of the cornea 1 drop hourly or 2 hourly
Amphotericin B 0.25% Eye Drops S01A000801D2003XX No A Fungal infection of the cornea 1 drop hourly or 2 hourly
Amphotericin B 50 mg Injection J02AA01801P4001XX No A Systemic fungal infections ADULT: 0.25 mg/kg/day by IV infusion,
gradually increase if tolerated to 1
mg/kg/day. Maximum in severe cases:
1.5 mg/kg daily or on alternate days. For
neonates, lower doses are
recommended
Ampicillin Sodium & Sulbactam Sodium J01CR01961F2101XX No A Treatment of susceptible bacterial infections ADULT: (1-) 2-6g daily CHILDREN: (25-)
250 mg/5 ml Suspension 50-100mg/kg daily PREMATURE AND
NEWBORNS: 25-50mg/kg daily
Ampicillin Sodium & Sulbactam Sodium J01CR01961T1001XX No A/KK Treatment of susceptible bacterial infections ADULT: 375-750mg twice daily
375 mg Tablet CHILDREN AND INFANTS: 25-
50mg/kg/day in 2 divided doses, if ≥
30kg use an adult dose
Ampicillin Sodium 1g & Sulbactam J01CR01961P4002XX No A Treatment of susceptible bacterial infections ADULT: 1.5 - 12 g/day in divided doses 6 -
Sodium 500mg Injection 8 hourly. Maximum: 4 g Sulbactam.
CHILD: 150-300 mg/kg/day 6 - 8 hourly.
Prophylaxis of surgical infections: 1.5 - 3
g at induction of anaesthesia. May be
repeated 6 - 8 hourly. NEONATES: First
week of life, 75mg/kg/day in divided
doses every 12 hour

Ampicillin Sodium 500 mg & Sulbactam J01CR01961P4001XX No A Treatment of susceptible bacterial infections ADULT: 1.5 - 12 g/day in divided doses 6 -
Sodium 250 mg Injection 8 hourly. Maximum: 4 g Sulbactam per
day. CHILD: 150-300mg/kg/day 6 - 8
hourly. Prophylaxis: 1.5 -3 g at induction
of anaesthesia. May be repeated 6 - 8
hourly

Ampicillin Sodium 500 mg Injection J01CA01520P4001XX Yes B Treatment of susceptible bacterial infections (non beta- 250 - 500 mg IM/IV every 4 - 6 hours.
lactamase-producing organisms); meningitis Maximum: 400 mg/kg/day. Meningitis: 2
g 6 hourly. CHILD: 150 mg/kg/daily IV in
divided doses. Usual children dose less
than 10 years, half adult dose

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Ampicillin Trihydrate 125 mg/5 ml J01CA01012F2101XX Yes B Treatment of susceptible bacterial infections (non beta- CHILD: 50 - 100 mg/kg/day 4 times daily.
Suspension lactamase-producing organisms) Under 1 year: 62.5 - 125 mg 4 times
daily, 1 - 10 years: 125 - 250 mg 4 times
daily
Anastrozole 1 mg Tablet L02BG03000T1001XX No A* Treatment of hormone responsive metastatic or locally 1 mg daily
advanced breast cancer after failure of tamoxifen
Anidulafungin 100mg Injection J02AX06000P3001XX No A* Treatment of invasive candidiasis, including candidemia in Loading dose of 200 mg on day 1, then
adults when intolerance or resistance to Amphotericin B or 100 mg once daily thereafter for at least
Fluconazole 14 days after the last positive culture.

Antazoline HCl, Tetrahydrozoline HCl and S01GA52110D2001XX No A/KK Hay fever, conjunctivitis, allergic conjunctivitis, vernal ADULT : Instill 1 drop, 3 - 4 times daily,
Benzalkonium Cloride Eye Drops keratoconjunctivitis and eczematosa into the lower eyelid. CHILD 2 - 12 years :
Instill 1 drop daily or twice daily

Anti RhD Gamma Globulin 300 mcg/2 ml J06BB01000P3001XX Yes B Prevention of Rh(D) sensitisation to Rh(D)-negative woman: i) i) Antepartum prophylaxis: The
Injection (150 mcg = 750 IU) Pregnancy/delivery of Rh(D)-positive infant ii) recommended dose is a single dose of
Abortion/threatened abortion, ectopic pregnancy or 300mcg administered by IV or IM
hydatidiform mole iii) Transplacental haemorrhage resulting injection ii) Postpartum prophylaxis:
from antepartum haemorrhage, amniocentesis, chorionic 300mcg should be administered as soon
biopsy or obstetric manipulative procedures e.g. external as possible after delivery and no later
version or abdominal trauma than 72 hours thereafter, by IV or IM
route. If the 72-hour limit is exceeded,
anti-Rh(D) immunoglobulin must be
administered anyway.

Antilymphocyte/Antithymocyte L04AA03000P3001XX No A* i) To be used when conventional anti-rejection therapy is not 10 - 30 mg/kg body weight daily. Slow IV
Immunoglobulin (from Horse) Injection successful ii) Treatment of aplastic anaemia not responding to infusion (over at least 4 hours) diluted in
oxymethalone after 3 months, in which there is persistent 250 - 500 ml Normal Saline. For Graft
pancytopenia with repeated attacks of septicaemia and versus host disease treatment:40
bleeding. iii) Severe aplastic anaemia with the following mg/kg/day
parameters: a) Granulocyte less than 0.5x109/L b) Platelet less
than 20x109/L c) Reticulocyte less than 20x109/L iv) As a
conditioning regime prior to transplant. v) Graft-versus-host
disease treatment

Antirabies Immunoglobulin Injection J06BB05000P3001XX Yes B Treatment of rabies, post-exposure Human rabies immunoglobulin: 20 iu/kg;
half by IM and half by infiltration around
the wound. Equine rabies
immunoglobulin: 40iu/kg of body weigth
in adults and children. Note: Please refer
to package insert for recommendations
by the manufacturer.

Antithymocyte Immunoglobulin (from L04AA04000P3001XX No A* i)Prophylaxis of acute graft rejection ii)Treatment of acute i)1.0 - 1.5 mg/kg/day for 2 - 9 days after
rabbit) Injection graft rejection iii)Prophylaxis of acute and chronic graft versus transplantation of a kidney, pancreas or
host disease iv)Treatment of steroid-resistant, acute graft liver, for 2 - 5 days after heart
versus host disease v)Treatment of aplastic anemia transplantation ii)1.5 mg/kg/day for 3 -
14 days iii)2.5 - 5.0 mg/kg/day for 4 days
iv)2.5 - 5.0 mg/kg/day for 5 days v)2.5 -
3.5 mg/kg/day for 5 days

Antivenene Cobra Injection J06AA03000P3002XX Yes B Treatment of patients who exhibit manifestations of systemic Initial dose of 100ml of reconstituted
envenoming following a bite by Cobra (Naja kaouthia). antivenene given by slow intravenous
infusion (2ml/min). Subsequent dose can
be given every 12 hours according to the
clinical symptoms. As product may differ
from batches and manufacturer, it is
strongly recommended to refer to the
product insert on dosing
recommendation.

Antivenene Pit Viper Injection J06AA03000P3001XX Yes B Treatment of patients who exhibit manifestations of systemic Initial dose of 30ml of reconstituted
envenoming following a bite by Malayan Pit Viper antivenene given by slow intravenous
(Calloselasma rhodostoma). infusion (2ml/min). Subsequent dose can
be given every 6 hours according to the
clinical symptoms. As product may differ
from batches and manufacturer, it is
strongly recommended to refer to the
product insert on dosing
recommendation.

Antivenene Serum (Sea snake) 1000 J06AA03000P3003XX Yes B Treatment of patients who exhibit manifestations of systemic 1000 units by IV infusion over 1/2 to 1
units Injection envenoming following a bite by sea snake. hour. In severe cases 3000 -10000 units
may be required
Antivenene Serum Snake Polyvalent J06AA03000P3004XX Yes B Treatment of patients who exhibit manifestations of systemic Recommended initial dose is 20ml by
Injection envenoming following a bite by Indian Cobra (Naja intravenous infusion. The injection
naja),Common Krait (Bungarus caeruleus), Russell's Viper should be given very slowly as 5 minutes
(Daboia russelli) and Saw-scaled Viper (Echis carinatus). by direct slow intravenous route or
1hour by infusion. If symptoms
continue, further doses are administered
as required until symptoms completely
disappear.

FUKKM BIL. 3/2017 (DISEMBER 2017) 7/146

 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Apixaban 2.5mg film coated tablet. B01AF02000T3201XX No A* Prevention of stroke and systemic embolism in adult patients 5 mg taken orally twice daily. Dose
with non-valvular atrial fibrillation (NVAF), with one or more reduction: 2.5mg taken orally twice daily
risk factors, such as prior stroke or transient ischaemic attack in NVAF patients with at least two of the
(TIA); age ≥ 75 years; hypertension; diabetes mellitus; following characteristics: age ≥80 years
symptomatic heart failure (NYHA Class ≥ II). Restriction: Only old, body weight≤60kg, or serum
for renal patients. creatinine≥1.5mg/dL (133micromole/L).

Apixaban 5mg film coated tablet. B01AF02000T3202XX No A* Prevention of stroke and systemic embolism in adult patients 5 mg taken orally twice daily. Dose
with non-valvular atrial fibrillation (NVAF), with one or more reduction: 2.5mg taken orally twice daily
risk factors, such as prior stroke or transient ischaemic attack in NVAF patients with at least two of the
(TIA); age ≥ 75 years; hypertension; diabetes mellitus; following characteristics: age ≥80 years
symptomatic heart failure (NYHA Class ≥ II). Restriction: Only old, body weight≤60kg, or serum
for renal patients. creatinine≥1.5mg/dL (133micromole/L).

Aprepitant 125 mg Capsule A04AD12000C1002XX No A* In combination with other antiemetic agents for prevention of 125 mg 1 hour prior to chemotherapy on
delayed nausea and vomiting associated with initial and repeat Day 1. To be given as part of a 3-day
course of highly emetogenic chemotherapy regimen that includes a corticosteroid
and a 5-HT3 antagonist

Aprepitant 80 mg Capsule A04AD12000C1001XX No A* In combination with other antiemetic agents for prevention of 80 mg once daily in the morning on Days
delayed nausea and vomitting associated with initial and 2 and Day 3. To be given as part of a 3-
repeat course of highly emetogenic chemotherapy day regimen that includes a
corticosteroid & a 5-HT3 antagonist

Aprotinin 10,000 KIU/ml Injection B02AB01000P3001XX No A* Only for Open Heart Surgery (extracorporeal circulation) All patients should receive a 1 ml IV test
dose at least 10 minutes prior to loading
dose. Initially 2 million KIU bolus
followed by 2 million KIU in heart-lung
machine followed by a slow infusion of
500,000 KIU/hr until end of surgery.
CHILD: 20,000 KIU/kg/day

Aqueous Cream D02AX00000G1001XX Yes C+ Dry skin As a soap or apply to the skin as an
emollient cream
Aripiprazole 10mg Tablet N05AX12000T1001XX No A* i) Treatment of acute episodes of schizophrenia and for Schizophrenia: 10 or 15 mg/day.
maintenance of clinical improvement during continuation Maintenance dose: 15 mg/day. Bipolar
therapy. ii) Treatment of acute manic episodes associated with mania: Starting dose: 15 or 30 mg/day.
bipolar I disorder Dose adjustment should occur at
intervals of not less than 24 hour

Aripiprazole 15mg Tablet N05AX12000T1002XX No A* i) Treatment of acute episodes of schizophrenia and for Schizophrenia: 10 or 15 mg/day.
maintenance of clinical improvement during continuation Maintenance dose: 15 mg/day. Bipolar
therapy. ii) Treatment of acute manic episodes associated with mania: Starting dose: 15 or 30 mg/day.
bipolar I disorder Dose adjustment should occur at
intervals of not less than 24 hour

Arsenic Trioxide 1 mg/ml Injection L01XX27550P3001XX No A* Relapsed acute promyelocytic leukaemia (APML). To be Induction : 0.15 mg/kg/day IV until bone
prescribed by consultant haematologist only marrow remission. Total induction dose
≤ 60 doses. Consolidation : 0.15
mg/kg/day IV for 25 doses in 5 weeks (5
days per week, followed by 2 days
interruption; treatment should begin 3-6
weeks after completion of induction
therapy).

Artemether 20mg + Lumefantrine 120mg P01BE52981T1001XX No B Acute uncomplicated falciparum malaria ADULT and CHILD over 12 years weighing
Tablet over 35 kg : 4 tablets as a single dose at
the time of initial diagnosis, again 4
tablets after 8 hours and then 4 tablets
twice daily (morning and evening) on
each of the following two days (total
course comprises 24 tablets). INFANT
and CHILD weighing 5 kg to less than 35
kg : A 6 dose regimen with 1 to 3 tablets
per dose, depending on bodyweight

Artesunate 100 mg and Mefloquine HCI P01BF02000T1002XX No A Treatment of acute uncomplicated Plasmodium Weight 5-8kg, Age 6-11 months, Dose:
220 mg Tablet falciparummalaria, resulting either from P. falciparum mono- One tablet 25/55mg OD x 3 days Weight
infection or mixed infection with P. vivax. : 9-17kg, Age 1-6 years, Dose : Two
tablet 25/55mg OD x 3 days Weight :18-
29kg, Age 7-12 years, Dose :One tablet
100/220mg OD x 3 days Weight ≥30kg,
Age ≥13 years, Dose:Two tablet
100/220mg OD x 3 days

Artesunate 25 mg and Mefloquine HCI P01BF02000T1001XX No A Treatment of acute uncomplicated Plasmodium Weight 5-8kg, Age 6-11 months, Dose:
55 mg Tablet falciparummalaria, resulting either from P. falciparum mono- One tablet 25/55mg OD x 3 days Weight
infection or mixed infection with P. vivax. : 9-17kg, Age 1-6 years, Dose : Two
tablet 25/55mg OD x 3 days Weight :18-
29kg, Age 7-12 years, Dose :One tablet
100/220mg OD x 3 days Weight ≥30kg,
Age ≥13 years, Dose:Two tablet
100/220mg OD x 3 days

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Artesunate 60 mg Injection P01BE03000P3001XX Yes A Treatment of severe malaria caused by Plasmodium 2.4mg of artesunate/kg body weight, by
falciparum in adults and children intravenous (IV) or intramuscular (IM)
injection, at 0, 12 and 24 hours, then
once daily until oral treatment can be
substituted. For adults and children with
severe malaria or who are unable to
tolerate oral medicines, artesunate 2.4
mg/kg body weight IV or IM given on
admission (time = 0), then at 12 hrs and
24 hrs, then once a day for 5-7 days is
the recommended treatment.

Artificial tears/eye lubricant ophthalmic S01KA02000G32XXXX Yes B Symptomatic relief of severe dry eye conditions and as lens Instill 1-2 drops in affected eye(s) as
gel lubricant during ophthalmic diagnostic procedures needed. Refer to product information
leaflet.
Artificial tears/eye lubricant ophthalmic S01XA20900G51XXXX No A Keeping the eye lubricated and comfortable during the night Apply a small amount into the eye. Refer
ointment product information leaflet.
Artificial tears/eye lubricant ophthalmic S01XA20000D20XXXX Yes B Tear deficiency, ophthalmic lubricant; for relief of dry eyes 1 - 2 drops several times a day. Refer to
solution and eye irritation product information leaflet.
Ascorbic Acid 100 mg Tablet A11GA01000T1002XX Yes C+ Vitamin C deficiency ADULT: 100-250 mg once or twice daily
CHILD: 100 mg three times daily for one
week followed by 100mg daily until
symptoms abate.
Ascorbic Acid 500 mg Tablet A11GA01000T1003XX Yes C+ Vitamin C deficiency ADULT: 100-250 mg once or twice daily
CHILD: 100 mg three times daily for one
week followed by 100mg daily until
symptoms abate.
Ascorbic Acid 500 mg/2 ml Injection A11GA01000P3001XX No B For prevention and treatment of scurvy Therapeutic: Not less than 250 mg daily
in divided doses
Asenapine 10mg Sublingual Tablet N05AH05253T7002XX No A* For second or third line treatment in adult for: i) Schizophrenia i) Schizophrenia: - Acute treatment in
ii) Bipolar Disorder - Monotherapy: Acute treatment of manic adults: Recommended starting and
or mixed episodes associated with Bipolar I disorder. - target dose of asenapine is 5mg given
Adjunctive therapy: As adjunctive therapy with either lithium twice daily. - Maintenance dose: 5mg
or valproate for the acute treatment of manic or mixed twice daily. ii) Bipolar Disorder: -
episodes associated with Bipolar I Disorder. Monotherapy: 10mg twice daily.
Adjunctive therapy: 5mg twice daily with
lithium or valproate. Dose can be
increased to 10mg twice daily based on
clinical response.
Asenapine 5mg Sublingual Tablet N05AH05253T7001XX No A* For second or third line treatment in adult for: i) Schizophrenia i) Schizophrenia: - Acute treatment in
ii) Bipolar Disorder - Monotherapy: Acute treatment of manic adults: Recommended starting and
or mixed episodes associated with Bipolar I disorder. - target dose of asenapine is 5mg given
Adjunctive therapy: As adjunctive therapy with either lithium twice daily. - Maintenance dose: 5mg
or valproate for the acute treatment of manic or mixed twice daily. ii) Bipolar Disorder: -
episodes associated with Bipolar I Disorder. Monotherapy: 10mg twice daily.
Adjunctive therapy: 5mg twice daily with
lithium or valproate. Dose can be
increased to 10mg twice daily based on
clinical response.
Atenolol 100 mg Tablet C07AB03000T1002XX Yes B Hypertension, angina pectoris, myocardial infarction and Hypertension and arrythmias; 50 - 100
arrhythmias mg daily, Angina; 100 mg daily,
Myocardial infarction; individualised
Atenolol 50 mg Tablet C07AB03000T1001XX Yes B Hypertension, angina pectoris, myocardial infarction and Hypertension and arrythmias; 50 - 100
arrhythmias mg daily, Angina; 100 mg daily,
Myocardial infarction; individualised
Atomoxetine HCl 10 mg Capsule N06BA09110C1001XX No A* Attention deficit hyperactivity disorder (ADHD) in children 6 CHILD and ADOLESCENTS up to 70 kg:
years and older who do not respond to methylphenidate or Initially 0.5 mg/kg/day for at least 7
who have intolerable effects or have tics. Diagnosis should be days, then increased according to
made according to DSM IV criteria or the guidelines in ICD-10 response. Maintenance: 1.2 mg/kg/day.
ADULTS and ADOLESCENTS more than 70
kg: Initially 40 mg/day for at least 7 days
then increased according to response.
Maintenance: 80 mg/day. Max 100 mg/
day

Atomoxetine HCl 18 mg Capsule N06BA09110C1002XX No A* Attention deficit hyperactivity disorder (ADHD) in children 6 CHILD and ADOLESCENTS up to 70 kg:
years and older who do not respond to methylphenidate or Initially 0.5 mg/kg/day for at least 7
who have intolerable effects or have tics. Diagnosis should be days, then increased according to
made according to DSM IV criteria or the guidelines in ICD-10 response. Maintenance: 1.2 mg/kg/day.
ADULTS and ADOLESCENTS more than 70
kg: Initially 40 mg/day for at least 7 days
then increased according to response.
Maintenance: 80 mg/day. Max 100 mg/
day

Atomoxetine HCl 25 mg Capsule N06BA09110C1003XX No A* Attention deficit hyperactivity disorder (ADHD) in children 6 CHILD and ADOLESCENTS up to 70 kg:
years and older who do not respond to methylphenidate or Initially 0.5 mg/kg/day for at least 7
who have intolerable effects or have tics. Diagnosis should be days, then increased according to
made according to DSM IV criteria or the guidelines in ICD-10 response. Maintenance: 1.2 mg/kg/day.
ADULTS and ADOLESCENTS more than 70
kg: Initially 40 mg/day for at least 7 days
then increased according to response.
Maintenance: 80 mg/day. Max 100 mg/
day

FUKKM BIL. 3/2017 (DISEMBER 2017) 9/146

 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Atomoxetine HCl 40 mg Capsule N06BA09110C1004XX No A* Attention deficit hyperactivity disorder (ADHD) in children 6 CHILD and ADOLESCENTS up to 70 kg:
years and older who do not respond to methylphenidate or Initially 0.5 mg/kg/day for at least 7
who have intolerable effects or have tics. Diagnosis should be days, then increased according to
made according to DSM IV criteria or the guidelines in ICD-10 response. Maintenance: 1.2 mg/kg/day.
ADULTS and ADOLESCENTS more than 70
kg: Initially 40 mg/day for at least 7 days
then increased according to response.
Maintenance: 80 mg/day. Max 100 mg/
day

Atomoxetine HCl 60mg Capsule N06BA09110C1005XX No A* Attention deficit hyperactivity disorder (ADHD) in children 6 CHILD and ADOLESCENTS up to 70 kg:
years and older who do not respond to methylphenidate or Initially 0.5 mg/kg/day for at least 7
who have intolerable effects or have tics. Diagnosis should be days, then increased according to
made according to DSM IV criteria or the guidelines in ICD-10 response. Maintenance: 1.2 mg/kg/day.
ADULTS and ADOLESCENTS more than 70
kg: Initially 40 mg/day for at least 7 days
then increased according to response.
Maintenance: 80 mg/day. Max 100 mg/
day

Atorvastatin 20 mg Tablet C10AA05000T1002XX Yes A/KK Hypercholesterolaemia and coronary heart disease intolerant 10 mg once daily. Maximum: 80 mg daily
or not responsive to other forms of therapy
Atorvastatin 40 mg Tablet C10AA05000T1001XX Yes A/KK Hypercholesterolaemia and coronary heart disease intolerant 10 mg once daily. Maximum: 80 mg daily
or not responsive to other forms of therapy
Atorvastatin 80 mg Tablet C10AA05000T1004XX Yes A/KK Hypercholesterolaemia and coronary heart disease intolerant 10 mg once daily. Maximum: 80 mg daily
or not responsive to other forms of therapy
Atosiban 7.5 mg/ml Injection G02CX01122P3001XX No A* To delay imminent preterm birth in pregnant women with Initial intravenous bolus dose of 6.75mg
i)Regular uterine contractions of at least 30 seconds duration (using 7.5mg/ml solution for injection).
at a rate of ≥ 4 per 30 minutes ii) A cervical dilation of 1 to 3 Immediately followed by a continuous
cm (0 - 3 nulliparas) and effacement of ≥ 50% iii) Age ≥ 18 high dose infusion (loading infusion 300
years iv) A gestational age from 28 until 33 completed weeks mcg/min using 7.5mg/ml concentrate
v) A normal foetal heart rate. for solution for infusion) during three
hours, followed by lower infusion of
100mcg/min up to 45 hours. Duration of
treatment should not exceed 48 hours.
Total dose given during a full course
should not exceed 330mg of the active
substance.

Atracurium Besylate 10 mg /ml in 2.5 ml M03AC04197P3001XX No A* Muscle relaxant in general anaesthesia, Endotracheal Adult & childn >2 mth 0.3-0.6 mg/kg IV.
Injection intubation, Aid controlled ventilation. Endotracheal intubation dose: 0.5-0.6
mg/kg. Supplementary dose: 0.1-0.2
mg/kg as required. Continuous infusion
rates of 0.3-0.6 mg/kg/hr to maintain
neuromuscular block during long
surgical procedure.
Atracurium Besylate 10 mg /ml in 5 ml M03AC04197P3002XX No A* Muscle relaxant in general anaesthesia, Endotracheal Adult & childn >2 mth 0.3-0.6 mg/kg IV.
Injection intubation, Aid controlled ventilation. Endotracheal intubation dose: 0.5-0.6
mg/kg. Supplementary dose: 0.1-0.2
mg/kg as required. Continuous infusion
rates of 0.3-0.6 mg/kg/hr to maintain
neuromuscular block during long
surgical procedure.
Atropine Sulphate 0.3%, Cocaine HCl S01F000183P3001XX No A Subconjunctival injection to dilate pupils resistant to topical 1 - 2 drops
1.7%, Adrenaline Acid Tartrate 0.03% mydriatics
Mydriatic Injection
Atropine Sulphate 1% Eye Drops S01FA01183D2001XX Yes B Determination of refraction, strabismus, iritis and iridocyclitis, PREOPERATIVE MYDRIASIS : one drop of
after extra or intracapsular extraction of lens a 1% solution supplemented with one
drop of 2.5 or 10% phenylephrine prior
to surgery. ANTERIOR UVEITIS or
POSTOPERATIVE MYDRIASIS : one drop
of a 1% or 2% solution up to 3 times a
day
Atropine Sulphate 1mg/ml Injection A03BA01183P3001XX Yes B i) Reduce vagal inhibition,salivary and bronchiol secretion in i) Adult: 300-600 mcg IM/SC 30-60
anaesthesia ii) Reversal of excessive bradycardia iii) Reversal of minutes before anaesthesia.
effect of competitive muscle relaxants iv) Overdosage with Alternatively, 300-600 mcg IV
other compounds having muscarinic action v) immediately before induction of
Organophosphate poisoning anaesthesia. Child: >20 kg: 300-600 mcg;
12-16 kg: 300 mcg; 7-9 kg: 200 mcg; >3
kg: 100 mcg. Doses to be given via IM/SC
admin 30-60 minutes before
anaesthesia.ii) Adult: 500 mcg every 3-5
minutes. Total: 3 mg. Max Dosage: 0.04
mg/kg body weight.iii) Adult 0.6-1.2 mg
before or with anticholinesterase iv)
Adult: 0.6-1 mg IV/IM/SC, repeated
every 2 hr. v) Adult: 2 mg IV/IM, every
10-30 minutes until muscarinic effects
disappear or atropine toxicity appears. In
severe cases, dose can be given as often
as every 5 minutes. In moderate to
severe poisoning, a state of
atropinisation is maintained for at least 2
days and continued for as long as
symptoms are present. Child: 20 mcg/kg
given every 5-10 minutes.

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Azacitidine Powder for suspension for L01BC07000P4001XX No A* First line therapy for intermediate-2 and high risk MDS, Recommended starting dose for the first
injection 100mg/vial CMMOL with 10-29% blasts with no transplant option and treatment cycle, for all patients
elderly AML with 20-30% blasts and multilineage dysplasia. regardless of baseline haematology
laboratory values, is 75mg/m2 of body
surface area. Injected subcutaneously.
Daily for 7 days, followed by a rest
period of 21 days (28 day treatment
cycle)
Azathioprine 50 mg Tablet L04AX01000T1001XX Yes A i) Prophylaxis of rejection in organ and tissue transplant ii) i) Adult: 1-5 mg/kg/day. Adjust dose
Auto-immune diseases iii) Rheumatoid arthritis according to clinical response and
haematological tolerance. Dose may also
be given via IV administration. ii) Adult:
1-3 mg/kg/day. Discontinue treatment if
there is no improvement after 12 week.
iii) Adult: Initially, 1 mg/kg/day given in 1-
2 divided doses for 6-8 week, may
increase by 0.5 mg/kg every 4 week until
response or up to 2.5 mg/kg/day.
Maintenance: Reduce dose gradually to
achieve the lowest effective dose.

Azelaic Acid 20% Cream D10AX03000G1001XX No A* Acne vulgaris Apply twice daily (sensitive skin, once
daily for 1st week). Treatment should
not exceed 6 months
Azithromycin 200 mg/5 ml Granules J01FA10011F1001XX No A* Treatment of complicated respiratory tract infections not CHILD 36 - 45 kg: 400 mg, 26 - 35 kg:
responding to standard macrolides 300mg, 15 - 25 kg 200 mg, less than 15
kg: 10 mg/kg. To be taken daily for 3
days or to be taken as a single dose on
day 1, then half the daily dose on days 2 -
5
Azithromycin 250 mg Tablet J01FA10011T1001XX No A* Category of prescriber A/KK is only approved for indication (i): i) 1 g as a single dose; ii) 500 mg daily for
(i) Adult treatment of uncomplicated genital infections due to 3 days; iii) 1 g weekly
Chlamydia trichomatis or susceptible Neisseria gonorrhoea.
The following indication is still under category of prescriber
A*: (ii) Treatment of complicated respiratory tract infection
not responding to standard macrolides; (iii) Prophylaxis
against Mycobacterium avium complex in patients with
advanced HIV.

Azithromycin 500 mg Injection J01FA10011P4001XX No A* Only for treatment of severe atypical pneumonia 500 mg IV as a single daily dose for a
minimum of two days followed by 500
mg oral dose as a single daily dose to
complete a 7 - 10 days course

Bacampicillin 400 mg Tablet J01CA06000T1001XX No B Infections caused by ampicillin-sensitive gram positive& gram ADULT: 400 mg twice daily. Severe
negative microorganisms infection: 800 mg twice daily. CHILD
more than 25 kg: 12.5 - 25 mg/kg 12
hourly
Baclofen 10 mg Tablet M03BX01000T1001XX No B Spasticity of the skeletal muscle ADULT: 5 mg 3 times daily. Max: 80 mg
daily. CHILD: 0.75 - 2 mg/kg daily (more
than 10 years, maximum: 2.5 mg/kg
daily)
Balanced Salt Solution B05CB10907L5001XX No A For irrigation during ocular surgery Irrigate as directed
Balanced Salt Solution PLUS (fortified B05CB10905L5001XX No A For irrigation during intraocular surgery especially in patients Irrigate as directed
with sodium bicarbonate, glucose & with poor cornea endothelium and poorly controlled diabetes
glutathione)
Barium Sulphate Suspension V08BA01183L8001XX Yes B For x-ray examination of the alimentary tract: i) Oesophagus ii) i) Up to 150 ml of a 50% - 200%
Stomach and duodenum iii) Colon suspension orally ii) Up to 300 ml of a
30% - 200% suspension orally iii) Up to 2
litre of a 30% - 200% suspension orally

Basiliximab 20 mg Injection L04AC02000P3001XX No A* Prophylaxis of acute organ rejection in de novo renal ADULT & CHILD 2 years and above & 35
transplantation. kg or more:20 mg /dose. 2 years or more
but less than 35kg:10 mg/dose. First
dose given within 2 hours before start of
transplantation and second dose 4th day
after transplant

BCG 81 mg/3 ml L03AX03000P3001XX No A* Superficial bladder cancer 81 mg intravesically once weekly for 6
weeks, followed by treatments at 3, 6,
12, 18, and 24 months after initial
treatment
BCG Vaccine Freeze-Dried Injection J07AN01000P4001XX Yes C+ For the prevention of tuberculosis 0.1 ml by intradermal injection. INFANT
under 12 months: 0.05 ml
Beclomethasone Dipropionate 100 R03BA01133A2101XX Yes B Prophylaxis of asthma especially if not fully controlled by Adults: The usual maintenance dose is
mcg/dose Inhaler bronchodilators one to two inhalations (200-400 mcg)
twice daily.If needed,the dose can be
increased up to 1600 mcg/day divided in
two to four doses : Children 6-12 years
old: One inhalation (200 mcg) two times
daily and dose may be increased up to
800 mcg/day in divided two to four
doses if necessary.

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Beclomethasone dipropionate 100mcg R03AK07986A2101XX No A/KK i) Regular treatment of asthma where use of a combination For asthma, the dosage is based on
and formoterol fumarate dihydrate product (inhaled corticosteroid and long-acting beta2 agonist) treatment approach: i) Maintenance
6mcg pressurized inhalation solution is appropriate in: a) Patients not adequately controlled with therapy (taken as regular maintenance
inhaled corticosteroids and "as needed" inhaled short-acting treatment with a separate as needed
beta2 agonist, or b) Patients already adequately controlled on rapid-acting bronchodilator): Dose
both inhaled corticosteroids and long-acting beta2-agonists. recommendations for adults 18 years
The following indication (COPD) is categorised as A* - To be and above: One or two inhalations twice
initiated by Consultant/ Specialists from disciplines related to daily. The maximum daily dose is 4
the listed indication only: ii) Symptomatic treatment of inhalations. ii) Maintenance and reliever
patients with severe COPD (FEV1 < 50% predicted normal) and therapy (taken as regular maintenance
a history of repeated exacerbation, who have significant treatment and as needed in response to
symptoms despite regular therapy with long-acting asthma symptoms): Dose
bronchodilators. recommendations for adults 18 years
and above: The recommended
maintenance dose is 1 inhalation twice
daily (one inhalation in the morning and
one inhalation in the evening). Patients
should take 1 additional inhalation as
needed in response to symptoms. If
symptoms persist after a few minutes,
an additional inhalation should be taken.
The maximum daily dose is 8 inhalations.
For COPD: 2 puffs two times a day.

Beclomethasone Dipropionate 200 R03BA01133A2102XX Yes A/KK Prophylaxis of asthma especially if not fully controlled by ADULT : 1 - 2 puff twice daily. May
mcg/dose Inhaler bronchodilators increase to 2 puff 2 - 4 times daily CHILD
: 1 puff twice daily. May increase to 1
puff 2 - 4 times daily
Beclomethasone Dipropionate 50 R01AD01133A4101XX Yes A/KK Prophylaxis and treatment of perennial and seasonal allergic ADULT and CHILD over 6 years : Apply
mcg/dose Nasal Spray rhinitis and vasomotor rhinitis 100 mcg (2 sprays) into each nostril
twice daily or 50 mcg (1 spray) into each
nostril 3 - 4 times/day. Maximum 400
mcg daily (8 sprays). When symptoms
controlled, reduce dose to 50 mcg (1
spray) into each nostril twice daily

Bendamustine Hydrochloride 100mg/vial L01AA09110P3302XX No A* Bendamustine is indicated for monotherapy in patients with Monotherapy for iNHL refractory to
powder for concentrate for solution for indolent B-cell non-Hodgkin?s lymphomas (iNHL) that has rituximab: 120mg/m2 body surface area
infusion progressed during or within six months of treatment with bendamustine hydrochloride on days 1
rituximab or a rituximab-containing regimen. and 2; every 3 weeks.

Bendamustine Hydrochloride 25mg/vial L01AA09110P3301XX No A* Bendamustine is indicated for monotherapy in patients with Monotherapy for iNHL refractory to
powder for concentrate for solution for indolent B-cell non-Hodgkin?s lymphomas (iNHL) that has rituximab: 120mg/m2 body surface area
infusion progressed during or within six months of treatment with bendamustine hydrochloride on days 1
rituximab or a rituximab-containing regimen. and 2; every 3 weeks.

Benzalkonium 0.01% - 0.02% Cream D08AJ01000G1001XX No B Prevention and treatment of nappy rash Wash and dry baby's bottom. Apply by
spreading the cream evenly paying
particular attention to the fold of the
skin, after every nappy change
Benzalkonium Chloride Disinfectant V07AV00100L9908XX No C Low level disinfectant suitable for general cleaning and Cleaning purposes: Dilute 1 in 10.
Solution disinfection of hard surface Disinfection, use undiluted
Benzathine Penicillin 2.4 MIU (1.8 g) J01CE08702P4001XX Yes B i) Treatment of mild to moderately severe infections due to i) ADULT: 1.2 mega units IM ii) For
Injection Penicillin G-sensitive organisms ii) Treatment of syphillis syphillis: 2.4 mega units weekly for 1 - 3
weeks
Benzhexol 2 mg Tablet N04AA01110T1001XX Yes B i) Parkinson's disease ii) Drug induced parkinsonism iii) ADULT: Initially 1 mg daily, increase
Dystonias gradually. Maintenance: 5 - 15 mg daily
in 3 - 4 divided doses. (Max 15mg/day)

Benzoic Acid Compound Half Strength D01AE12952G5001XX Yes C Tinea infections of the skin Apply sparingly to affected area once or
(Paed) Ointment twice daily
Benzoic Acid Compound Ointment D01AE12952G5002XX Yes C Tinea infections of thickened skin of palms and soles Apply sparingly to affected area once or
twice daily
Benzoin Compound Tincture D08AX00000L5001XX No C Infected skin, lesions, cuts, abrasions, wounds and burns Apply undiluted to the skin 1 or 2 times
daily. Duration of therapy, may be weeks
to months depending on the infection
being treated
Benzoyl Peroxide 10% Gel D10AE01241G3002XX Yes B Mild to moderate acne vulgaris Apply 1-2 times daily preferably after
washing with soap and water
Benzoyl Peroxide 5% Gel D10AE01241G3001XX Yes B Mild to moderate acne vulgaris Apply 1-2 times daily preferably after
washing with soap and water
Benzydamine HCl 0.15% Solution A01AD02110M2001XX No B For relief of painful condition of the oral cavity Used as a 30 seconds gargle or rinse,
undiluted. ADULT 15 ml. CHILD less 12
years 5-15 ml. Uninterrupted treatment
should not be more than 7 days

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Benzydamine Hydrochloride 3.0 mg/ml A01AD02110A4201XX No A* Temporary relief of painful conditions of the mouth and throat ADULTS and CHILDREN OVER 12 YEARS:
throat spray including tonsillitis, sore throat, radiation mucositis, aphthous 2-4 sprays (1-2mg) directly onto the
ulcers, pharyngitis, swelling, redness, inflammatory sore/inflamed area and swallow gently.
conditions, post-orosurgical and periodontal procedures. (For Repeat every 1 1/2 to 3 hours as
pediatric and otorhinolaringology use. Restrict to patients who necessary. CHILDREN 6-12 YEARS: 2
are not able to gargle) sprays (1mg) directly onto sore/
inflamed area and swallow gently.
Repeat every 11/2 to 3 hours as
necessary. CHILDREN UNDER 6 YEARS:
Not recommended. Uninterrupted
treatment should not exceed seven days,
unless under medical supervision

Benzyl Benzoate 12.5 % Emulsion (Child) P03AX01252L2001XX Yes C Scabies - for child 2-12 years old After bath, apply over the whole body,
neck down and leave on for 24 hours
then wash off. Reapply for another 24
hours, the first repeat application should
be within 5 days of the initial
application, a third application may be
required in some cases

Benzyl Benzoate 25 % Emulsion (Adult) P03AX01000L2002XX Yes C+ Scabies for adult and children more than 12 years old. After bath, apply over the whole body,
neck down and leave on for 24 hours
then wash off. Reapply for another 24
hours, the first repeat application should
be within 5 days of the initial
application, a third application may be
required in some cases.

Benzylpenicillin 1 mega unit (600 mg) J01CE01702P4001XX Yes B i) Infections caused by susceptible organisms ii) Infective i) Adult: 600mg - 3600mg (1 - 6 mega
Injection endocarditis units) daily, divided into 4 to 6 doses.
Higher doses (24 mega units) in divided
doses may be given in serious infections
such as meningitis. Child 1 month to 12
years old: 100mg/kg/day in 4 divided
doses, not exceeding 4g/day; Infants 1 -4
weeks: 75mg/kg/day in 3 divided doses;
Newborn Infants: 50mg/kg/day in 2
divided doses ii)7.2 to 12g (12 - 20 mega
units) maybe given daily in divided doses

Benzylpenicillin 10,000 units/ml Eye S01AA14702D2002XX No B Eye infection 1-2 drops every 15 minutes or
Drops accordingly to needs of the patient
Benzylpenicillin 2,500 units/ml (1.5 S01AA14702D2001XX No B Eye infection 1-2 drops every 15 minutes or
mg/ml) Eye Drops accordingly to needs of the patient
Benzylpenicillin 5 mega units (3 g) J01CE01702P4002XX Yes B i) Infections caused by susceptible organisms ii) Infective i) ADULT: 600 - 1200 mg IM 4 times
Injection endocarditis daily, increased if necessary in more
serious infections. CHILD: 50 - 100 mg/kg
body weight daily IV in 2 - 4 divided
doses ii) ADULT: 7.2 g daily by slow IV
infusion in 6 divided doses
Beractant Intratracheal Suspension (200 R07AA02000L8001XX Yes A* Treatment of newborn baby with birth weight of 700 g or 100 mg/kg (4 ml/kg) body weight
mg phospholipids in 8 ml vial) greater undergoing mechanical ventilation for respiratory intratracheally up to 4 doses in 1st 48 hr.
distress syndrome, whose heart rate and arterial oxygenation Doses should not be given more
are continuously monitored frequently than 6 hrly. To be
administered as soon as possible.
Betahistine Dihydrochloride 16 mg N07CA01110T1002XX No A/KK i) Meniere's Syndrome as defined by the following core Given in doses of 8 to 16 mg orally 3
Tablet symptoms: - Vertigo (with nausea/vomiting). - Hearing loss times daily (total 24 to 48 mg/day)
(Hardness of hearing). - Tinnitus (ringing in the ears) preferably with food. CHILD not
ii)Symptomatic treatment of vestibular vertigo recommended
Betahistine Dihydrochloride 24 mg N07CA01110T1003XX No A* i) Meniere's Syndrome as defined by the following core 24-48mg in divided doses daily
Tablet symptoms: - Vertigo (with nausea/vomiting). - Hearing loss
(Hardness of hearing). - Tinnitus (ringing in the ears)
ii)Symptomatic treatment of vestibular vertigo
Betahistine Dihydrochloride 8 mg Tablet N07CA01110T1001XX No A/KK i) Meniere's Syndrome as defined by the following core Given in doses of 8 to 16 mg orally 3
symptoms: - Vertigo (with nausea/vomiting). - Hearing loss times daily (total 24 to 48 mg/day)
(Hardness of hearing). - Tinnitus (ringing in the ears) preferably with food. CHILD not
ii)Symptomatic treatment of vestibular vertigo recommended
Betamethasone 0.5 mg Tablet H02AB01000T1001XX No A Suppression of inflammatory and allergic disorders, congenital 0.5 - 9 mg daily in divided doses. CHILD:
adrenal hyperplasia, cerebral oedema 0.5 - 7.5 mg/m2/day divided every 6 - 12
hours
Betamethasone 17-Valerate 0.01-0.05% D07AC01256G1001XX Yes B Eczemas, prurigo nodularis, limited psoriasis in appropriate in Apply sparingly to affected area 2 - 3
Cream sites times daily then reduced to once daily
when improvement occurs
Betamethasone 17-Valerate 0.01-0.05% D07AC01256G5001XX Yes B Eczema, prurigo nodularis, limited psoriasis in appropriate in Apply sparingly to affected area 2 - 3
Ointment sites times daily then reduced to once daily
when improvement occurs
Betamethasone 17-Valerate 0.1% Cream D07AC01256G1002XX Yes A Eczemas, prurigo nodularis, psoriasis (excluding widespread Apply sparingly to affected area 2 - 3
plaque psoriasis) times daily then reduced to once daily
when improvement occurs
Betamethasone 17-Valerate 0.1% D07AC01256G5002XX Yes A Eczema, prurigo nodularis, psoriasis (excluding widespread Apply sparingly to affected area 2-3
Ointment plaque psoriasis) times daily then reduced to once daily
when improvement occurs
Betamethasone Disodium Phoshate 0.1% S03BA03162D1001XX No B Non-infected inflammatory conditions Apply 2 - 3 drops every 2 - 3 hours,
Ear Drops reduce frequency when relief obtained

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Betamethasone Disodium Phoshate 0.5% S03BA03162D1002XX No B Non-infected inflammatory conditions Apply 2 - 3 drops every 2 - 3 hours,
Ear Drops reduce frequency when relief obtained

Betamethasone Disodium Phosphate S01BA06162D2001XX Yes A Non-infected inflammatory conditions of the eyes 1 - 2 drops every 1 - 2 hours until
0.1% Eye Drops controlled then reduce frequency
Betamethasone Disodium Phosphate S01BA06162G5101XX Yes A Non-infected inflammatory conditions of the eyes 2 - 4 times daily or at night when used
0.1% Eye Ointment with eye drops
Betamethasone Disodium Phosphate S03CA06991D1001XX No B Allergic dermatosis in the ear Apply 2 - 3 drops 3 - 4 times daily,
and Neomycin Sulphate 0.5% Ear Drops reduce frequency when relief obtained

Betamethasone Disodium Phosphate S01CA05991D2001XX No A Infected inflammatory conditions of the eyes 2 - 3 drops every 2 - 3 hours
and Neomycin Sulphate Eye Drops
Betamethasone Sodium Phosphate 4 H02AB01162P3001XX No B Pre-operative and in serious trauma or illness, shock, as Usual intravenous doses are up to 9
mg/ml Injection adjunctive therapy in rheumatoid disorders, ocular, mg/day of the sodium phosphate salt
dermatologic and respiratory allergic and inflammatory states only. CHILD: IM: 0.5 - 7.7 mg
base/m2/day divided every 6 - 12 hours.
ADOLESCENT and ADULT, IM: 0.6 - 9 mg
divided every 12 - 24 hours

Betaxolol 0.25% Eye Suspension S01ED02110D2001XX No A Chronic open-angle glaucoma, ocular hypertension One to two drops in the affected eye(s)
twice daily
Bicalutamide 50 mg Tablet L02BB03000T1001XX No A* Advanced prostate cancer in combination with LHRH analogue 50 mg once daily. (morning or evening),
therapy or surgical castration. with or without food. Take on the same
time each day. Adult: When used with
gonadorelin analogue: Usual dose: 50
mg once daily. May be started with or at
least 3 days before starting gonadorelin
analogue therapy.

Bimatoprost 0.01% ophthalmic solution S01EE03000D20-02XXX No A* Bimatoprost 0.01% ophthalmic solution is indicated for the One drop in the affected eye(s) once
reduction of elevated intraocular pressure in chronic open- daily, administered in the evening. The
angle glaucoma and ocular hypertension in adults (as dose should not exceed once daily, as
monotherapy or as adjunctive therapy to beta blockers). (for more frequent administration may
2nd line) lessen the intraocular pressure lowering
effect.
Bisacodyl 10 mg Suppository A06AB02000S2002XX No C i) Constipation ii) Bowel preparation for radiological i) ADULT and CHILD over 10 years: 10
procedures and surgery mg, CHILD less than 10 years 5 mg insert
rectally ii) ADULT 10-20 mg, CHILD over 4
years 5 mg the following morning before
procedures insert rectally

Bisacodyl 5 mg Suppository A06AB02000S2001XX No C i) Constipation ii) Bowel preparation for radiological i) ADULT and CHILD over 10 years: 10
procedures and surgery mg, CHILD less than 10 years 5 mg insert
rectally ii) ADULT 10-20 mg, CHILD over 4
years 5 mg the following morning before
procedures insert rectally

Bisacodyl 5 mg Tablet A06AB02000T1001XX Yes C i) Constipation ii) Bowel preparation for radiological i) ADULT and CHILD over 10 years 5-10
procedures and surgery mg, CHILD 4-10 years 5 mg. To be taken
at night for effect on the following
morning ii) ADULT 10-20 mg the night
before procedures, CHILD over 4 years 5
mg the night before procedures

Bismuth Subnitrate, Iodoform and Liquid R01AX30984G6001XX No B As a mild antiseptic for wounds and abscesses. Sterile gauze As directed for local application
Paraffin Paste impregnated with paste for packing cavities after
otorhinological surgery
Bisoprolol Fumarate 2.5 mg Tablet C07AB07000T1001XX No B Treatment of stable moderate to severe congestive cardiac 1.25 mg once daily to 5 - 10 mg daily
failure in addition to ACEI's and diuretics
Bisoprolol Fumarate 5 mg Tablet C07AB07000T1002XX No B Treatment of stable moderate to severe congestive cardiac 1.25 mg once daily to 5 - 10 mg daily
failure in addition to ACEI's and diuretics
Bleomycin HCl 15 mg Injection L01DC01110P4001XX Yes A Squamous cell carcinoma, germ cell tumours, lymphomas. 15 - 30 mg weekly in divided doses or 10 -
Routes: SC, IM, IV (either as bolus or as infusion over 24 20 mg/m2 once or twice weekly or 10
hours), intra-arterial, intra-pleural mg/m2 slow bolus in 15 minutes D1 and
D15. Total dosage:should not exceed 300
mg. CHILD: 10 - 15 mg/m2 over 6 hours
every 3 - 4 weeks

Boric Acid with Spirit 2% w/v Ear Drops S02AA03000D1001XX No C Perforated eardrum 3 drops instilled into affected ear 3 - 4
times daily
Bortezomib 3.5 mg Injection L01XX32000P3001XX No A* i) Treatment of multiple myeloma in patient who have 1.3 mg/ m2/dose given as IV bolus
received at least one prior therapy. ii) For use in combination injection twice weekly for two weeks
with conventional therapy for the treatment of previously (days 1, 4, 8, and 11) followed by a 10-
untreated multiple myeloma patients who are not eligible for day rest period (days 12-21). At least 3
haematopoietic stem cell transplantation. days should elapse between consecutive
doses of bortezomib
Bosentan 125 mg tablet C02KX01000T1001XX No A* For the treatment of pulmonary arterial hypertension (PAH) in Initially 62.5 mg bd for 4 weeks, then
patients with WHO Class III or IV symptoms, to improve increase to the maintenance dose of 125
exercise ability and decrease the rate of clinical worsening (To mg bd
be used by those who are trained and specialized in treating
and managing PAH)
Brimonidine Tartrate 0.15% Ophthalmic S01EA05123D2001XX No A* Lowering of intraocular pressure in patients with open-angle 1 drop in the affected eye(s) 3 times
glaucoma or ocular hypertension daily
Bromazepam 3 mg Tablet N05BA08000T1002XX No A Anxiety disorders Adult: Initially, 6-18 mg daily in divided
doses. Doses up to 60 mg daily have
been used. Elderly: Max initial dose: 3
mg daily

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Bromhexine HCl 4 mg/2 ml Injection R05CB02110P3001XX Yes A Secretolytic therapy in acute and chronic bronchopulmonary 4 to 8 mg SC, IM or IV 2 - 3 times daily
diseases associated with abnormal mucous secretion and (maximum 24mg/ day). Elderly: Max
impaired mucous transport initial dose: 3 mg daily.
Bromhexine HCl 4 mg/5 ml Elixir R05CB02110L1001XX Yes B Secretolytic therapy in acute and chronic bronchopulmonary 1) Adults :10 ml three times a day.Can
diseases associated with abnormal mucous secretion and increase up to 15 ml four times a day.
impaired mucous transport 2)Children 5 to 12 years : 5 ml four times
a day 3)Children 2 to 5 years: 5 ml two
times a day
Bromhexine HCl 8 mg Tablet R05CB02110T1001XX Yes B Secretolytic therapy in acute and chronic bronchopulmonary ADULT and CHILD more than 12 years : 8
diseases associated with abnormal mucous secretion and mg 3 times daily, 6 - 12 years : 4 mg 3
impaired mucous transport times daily, 2 - 6 years : 4 mg 2 times
daily
Bromocriptine Mesilate 10 mg Tablet G02CB01196T1003XX No A/KK i) Hypogonadism or Galactorrhoea ii) Acromegaly i) Initially 1 - 1.25 mg at bedtime
increased gradually, usual dose: 7.5 mg
daily in divided doses. Max 30 mg daily
ii) 1.25 - 2.5 mg at bedtime for 3 days
and may be increased by 1.25 - 2.5 mg
every 3 - 7 days up to 30 mg a day in
divided doses
Bromocriptine Mesilate 2.5 mg Tablet G02CB01196T1001XX No A/KK i) Hypogonadism or Galactorrhoea ii) Acromegaly i) Initially 1 - 1.25 mg at bedtime
increased gradually, usual dose: 7.5 mg
daily in divided doses. Max 30 mg daily
ii) 1.25 - 2.5 mg at bedtime for 3 days
and may be increased by 1.25 - 2.5 mg
every 3 - 7 days up to 30 mg a day in
divided doses
Bromocriptine Mesilate 5 mg Tablet G02CB01196T1002XX No A/KK i) Hypogonadism or Galactorrhoea ii) Acromegaly i) Initially 1 - 1.25 mg at bedtime
increased gradually, usual dose: 7.5 mg
daily in divided doses. Max 30 mg daily
ii) 1.25 - 2.5 mg at bedtime for 3 days
and may be increased by 1.25 - 2.5 mg
every 3 - 7 days up to 30 mg a day in
divided doses
Budesonide 1 mg/2 ml Nebuliser R03BA02000A3002XX Yes B Maintenance treatment of asthma as prophylactic therapy ADULT : Initially 1 - 2 mg twice daily.
Solution especially if not fully controlled by bronchodilators CHILD 3 months - 12 years of age : 500
mcg - 1 mg. Maintenance dose : half of
the above doses
Budesonide 100 mcg/dose Inhaler R03BA02000A2101XX Yes B Maintenance treatment of asthma as prophylactic therapy ADULT : 200 - 1600 mcg daily in 2 - 4
especially if not fully controlled by bronchodilators divided doses. Maintenance with twice
daily dosing. CHILD more than 7 years
200 - 800 mcg, 2 - 7 years 200 - 400 mcg.
To be taken orally in 2 - 4 divided doses

Budesonide 160 mcg and Formoterol 4.5 R03AKO7989A2101XX No A/KK i)Regular treatment of asthma where use of a combination Asthma Maintenance therapy Adult ≥18
mcg Inhalation (inhaled corticosteroid and long-acting beta2-agonist) is yr 160 mcg to 320 mcg bd. Some
appropriate:- - Patients not adequately controlled with inhaled patients may require up to a max of 640
corticosteroids and ?as needed? inhaled short-acting beta2- mcg bd. Adolescent 12-17 yr 160 mcg to
agonists. or - Patients already adequately controlled on both 320 mcg bd. Childn 6-11 yr 160 mcg bd,
inhaled corticosteroids and long- acting beta2-agonists. ii) <6 yr Not recommended. Maintenance &
Symptomatic treatment of patients with severe COPD (FEV1 relief Adult ≥18 yr 320 mcg/day either as
<50% predicted normal) and a history of repeated 160 mcg bd or 320 mcg either morning
exacerbations, who have significant symptoms despite regular or evening. For some patients a
therapy with long-acting bronchodilators. maintenance dose of 320 mcg bd may be
appropriate. Patients should take 160
mcg additional inhalation as needed in
response to symptoms. If symptoms
persist after a few minutes, an additional
inhalation should be taken. Not more
than 960 mcg should be taken on any
single occasion. A total daily dose of
more than 1280 mcg is not normally
needed, however a total daily dose of up
to 1920 mcg could be used for a limited
period. Patients using more than 1280
mcg daily should seek medical advice,
should be reassessed & their
maintenance therapy reconsidered.
Childn & adolescent <18 yr Not
recommended. COPD Adult ≥18 yr 320
Budesonide 200 mcg/dose Inhalation R03BA02000A2102XX Yes B Maintenance treatment of asthma as prophylactic therapy ADULT : 200 - 1600 mcg daily in 2 - 4
especially if not fully controlled by bronchodilators divided doses. Maintenance with twice
daily dosing. CHILD more than 7 years
200 - 800 mcg, 2 - 7 years 200 - 400 mcg.
To be taken orally in 2 - 4 divided doses

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Generic Name MDC NEML Category Indications Dosage

Budesonide 320 mcg and Formoterol 9 R03AK07989A2102XX No A/KK i) Regular treatment of asthma where use of a combination Asthma; Maintenance therapy: Adult
mcg Inhalation (inhaled corticosteroid and long-acting beta2-agonist) is ≥18 yr 160 mcg to 320 mcg bd. Some
appropriate:- - Patients not adequately controlled with inhaled patients may require up to a max of 640
corticosteroids and "as needed" inhaled short-acting beta2- mcg bd. Adolescent 12-17 yr 160 mcg to
agonists. or - Patients already adequately controlled on both 320 mcg bd. Children 6-11 yr 160 mcg
inhaled corticosteroids and long- acting beta2-agonists. ii) bd, <6 yr Not recommended.
Symptomatic treatment of patients with severe COPD (FEV1 Maintenance & relief: Adult ≥18 yr 320
<50% predicted normal) and a history of repeated mcg/day either as 160 mcg bd or 320
exacerbations, who have significant symptoms despite regular mcg either morning or evening. For
therapy with long-acting bronchodilators. some patients a maintenance dose of
320 mcg bd may be appropriate.
Patients should take 160 mcg additional
inhalation as needed in response to
symptoms. If symptoms persist after a
few minutes, an additional inhalation
should be taken. Not more than 960 mcg
should be taken on any single occasion.
A total daily dose of more than 1280
mcg is not normally needed, however a
total daily dose of up to 1920 mcg could
be used for a limited period. Patients
using more than 1280 mcg daily should
seek medical advice, should be
reassessed & their maintenance therapy
reconsidered. Children & adolescent less
than 18 yr: Not recommended. COPD;
Budesonide 500 mcg/2 ml Nebuliser R03BA02000A3001XX Yes B Maintenance treatment of asthma as prophylactic therapy ADULT : Initially 1 - 2 mg twice daily.
Solution especially if not fully controlled by bronchodilators CHILD 3 months - 12 years of age : 500
mcg - 1 mg. Maintenance dose : half of
the above doses
Budesonide 64mcg Nasal Spray R01AD05000A4103XX Yes A Seasonal allergic, perennial rhinitis and nasal polyposis ADULT and CHILD 6 years and older.
Rhinitis : 2 spray into each nostril once
daily in the morning or 1 spray into each
nostril twice daily. Nasal polyps : 2 spray
twice daily
Bumetanide 0.5 mg/ml Injection C03CA02000P3001XX No A* Oedema used in furosemide allergic patient IV injection: 1 - 2 mg repeated after 20
mins. IV infusion: 2 - 5 mg over 30 - 60
mins
Bumetanide 1 mg Tablet C03CA02000T1001XX No A* Oedema used in furosemide allergic patient 1 mg in the early evening. Up to 5 mg
daily in severe cases
Bupivacaine 0.125% Epidural Injection N01BB01110P3004XX Yes A Epidural analgesia for postoperative pain relief. Infuse at 6 - 15 ml/hour. Not to exceed 2
mg/kg in a single dose.
Bupivacaine 0.5 % Heavy Injection N01BB01110P3003XX Yes A Used for spinal anaesthesia ADULT: 2 - 4 ml. Not to exceed 2 mg/kg
in a single dose
Bupivacaine 0.5 % Injection N01BB01110P3002XX Yes B For peripheral sympathetic nerve and epidural (excluding Regional nerve block or epidural block:
caudal) anaesthesia and obstetrics anaesthesia 15 - 30 ml. Nerve block of finger or toe:
2 - 6 ml. Maximum: 2 mg/kg body
weight in any 4 hours period, equivalent
to 25 - 30 ml in adults of average weight

Bupivacaine 0.5 % with Adrenaline N01BB51975P3001XX Yes B Regional nerve block or epidural block. 10 - 40 ml (0.25 %) or maximum : 2
1:200,000 Injection mg/kg body weight in any 4 hours
period, equivalent to 25 - 30 ml of 0.5%
solution
Buprenorphine 10mcg/hr transdermal N02AE01110M7001XX No A* Treatment of non-malignant pain of moderate intensity when Once weekly transdermal patch/for
patch an opioid is necessary for obtaining adequate analgesia. Not hospital use only. Patient aged 18 years
suitable for the treatment of acute pain. Restrictions: For and over. Initial dose: 5 mcg/hr For
elderly patients or patients with comorbidities/difficult to elderly: Renal impairment. No special
swallow dose adjustments necessary in patients
with renal impairment Hepatic
impairment Patients with hepatic
insufficiency should be carefully
monitored during the treatment with
buprenorphine patch. Alternate therapy
should be considered. Patch should be
used with cautions in severe hepatic
impairment patient

Buprenorphine 5mcg/hr transdermal N02AE01110M7003XX No A* Treatment of non-malignant pain of moderate intensity when Once weekly transdermal patch/for
patch an opioid is necessary for obtaining adequate analgesia. Not hospital use only. Patient aged 18 years
suitable for the treatment of acute pain. Restrictions: For and over. Initial dose: 5 mcg/hr For
elderly patients or patients with comorbidities/difficult to elderly: Renal impairment. No special
swallow dose adjustments necessary in patients
with renal impairment Hepatic
impairment Patients with hepatic
insufficiency should be carefully
monitored during the treatment with
buprenorphine patch. Alternate therapy
should be considered. Patch should be
used with cautions in severe hepatic
impairment patient

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Generic Name MDC NEML Category Indications Dosage

Busulfan 2 mg Tablet L01AB01000T1001XX No A i) Chronic myeloid leukaemia (CML) and other i) ADULT: Initial: 2 - 4 mg daily.
myeloproliferative diseases ii) Haemopoietic stem cell Maintenance: 0.5 - 2 mg daily. Stop
transplant (HSCT)- refer to specific protocols when white blood cell less than 20 x
109/L. CHILD: 60 mcg/kg body weight
daily ii) CHILD: Induction 60 mcg/kg body
weight daily (maximum 4 mg) if
leucocytes more than 20,000/mm3 and
platelets more than 100,000/mm3.
Maintenance 10 - 30mcg/kg (maximum 2
mg daily)
Busulfan 6 mg/ml Injection L01AB01000P3001XX No A* For use in combination with cyclophosphamide as a 0.8 mg/kg of ideal body weight or actual
conditioning regimen prior to allogeneic hematopoietic stem body weight, whichever is lower via
cell transplantation (HSCT) for chronic myelogenous leukemia central venous catheter as a 2-hour
in selected cases with high risk of liver toxicity and intolerance infusion on the basis of every 6 hours for
to oral busulfan. To be prescribed by paediatric oncologist and 4 days, for a total of 16 doses. For obese
consultant haematologist trained in transplant only. or severely obese patients, IV Busulfan
should be administered based on
adjusted ideal body weight

Cabergoline 0.5 mg Tablet G02CB03000T1001XX No A* i) Treatment of hyperprolactinaemic disorders ii) Prevention of i)0.5mg per week given in 1 or 2 (one-
puerperal lactation and suppression of lactation in HIV helf of one 0.5mg tablet) doses per week
infected mothers only ii) HIV mothers only : Prevent lactation 2
tab first day after delivery. Interruption
of laction : 0.25mg 12 hourly for 2 days

Calamine Cream D04AX00000G1001XX Yes C+ Soothes and relieves nappy rashes, prickly heat, minor skin Apply to the affected area as required, 1-
irritations, insect bites and sunburn, Pruritic skin conditions. 3 times daily

Calamine Lotion D04AX00000L8001XX Yes C+ Soothes and relieves nappy rashes, prickly heat, minor skin Apply to the skin as required and allow
irritations, insect bites and sunburn, Pruritic skin conditions. to dry, 1-3 times daily

Calamine with 0.25 - 0.5% Menthol D04AX00952L6001XX No C Soothes and relieves nappy rashes, prickly heat, minor skin Apply to the skin as required and allow
Lotion irritations, insect bites and sunburn, Pruritic skin conditions. to dry, 1 - 3 times daily

Calamine with 0.5% Phenol Cream D04AX00952G1001XX No C For use as a mild astringent Apply to the affected area as required

Calamine with 2 - 6% Precipitated D04AX00952L6002XX No C Acne vulgaris Apply to the skin as required and allow
Sulphur Lotion to dry, 1 - 3 times daily
Calcipotriol 50 mcg/g Cream D05AX02000G1001XX No A* Only for the treatment of Psoriasis Vulgaris ADULT Apply to the affected skin lesions
twice daily. Maintenance therapy may
be achieved with less frequent
application. The weekly dose should not
exceed 100 g. CHILD over 6 years, apply
twice daily. 6-12 years maximum 50gm
weekly, over 12 years maximum 75gm
weekly
Calcipotriol 50 mcg/g Ointment D05AX02000G5001XX No A* Only for the treatment of Psoriasis Vulgaris ADULT Apply to the affected skin lesions
twice daily. Maintenance therapy may
be achieved with less frequent
application. The weekly dose should not
exceed 100 g. CHILD over 6 years, apply
twice daily. 6-12 years maximum 50gm
weekly, over 12 years maximum 75gm
weekly
Calcipotriol 50 mcg/ml Scalp Solution D05AX02000L9901XX No A* Only for the treatment of Psoriasis Vulgaris Apply to scalp twice daily. Maximum 60
mL weekly.
Calcipotriol Hydrate 50 mcg/g & D05AX52952G5001XX No A* Resistant plaque psoriasis Apply once daily up to 4 weeks with
Betamethasone Dipropionate 0.5 mg/g maximum weekly dose of 100g and
Ointment maximum treatment area 30% of body
surface
Calcipotriol monohydrate 50 mcg/g and D05AX52952G3001XX No A* Topical treatment of scalp and non-scalp plaque psoriasis Should be applied to affected areas once
Betamethasone dipropionate 0.5 mg/g vulgaris in adults daily. The recommended treatment
Gel period is 4 weeks for scalp areas and 8
weeks for non-scalp areas. The body
surface area treated with calcipotriol
containing products should not exceed
30% and maximum dose should not
exceed 15g or 100g/ week

Calcitonin (synthetic Salmon) 100 IU H05BA01000P3002XX No A* Acute hypercalcaemia 5-10 IU per kg body weight in 500mL
Injection physiological saline daily by i.v. infusion
over at least 6 hours or by slow i.v.
injection in 2-4 divided doses spread
over the day. Renal impairment: Dosage
adjustment needed.

Calcitonin (Synthetic Salmon) 50 IU H05BA01000P3001XX No A* Acute hypercalcaemia 5-10 IU per kg body weight in 500mL
Injection physiological saline daily by i.v. infusion
over at least 6 hours or by slow i.v.
injection in 2-4 divided doses spread
over the day. Renal impairment: Dosage
adjustment needed.

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Generic Name MDC NEML Category Indications Dosage

Calcitriol 0.25 mcg Capsule A11CC04000C1001XX No A/KK i)Established postmenopausal osteoporosis ii) Renal "i) 0.25 mcg 2 times daily ii) Initial dose
osteodystrophy in patients on haemodialysis 0.25 mcg. In patients with normal or
iii)Hypoparathyroidism and rickets iv)Secondary only slightly reduced serum calcium
hyperparathyroidism in renal failure levels, doses of 0.25 mcg every other day
is sufficient iii) 0.25 mcg/day given in the
morning iv) ADULT and CHILD 3 years
and older : Initially 0.25 mcg/ml. CHILD
less than 3 years : 10 to 15 ng/kg/day "

Calcitriol 1 mcg/ml Injection A11CC04000P3001XX No A* Management of hypocalcaemia and/or secondary Initially dose, depending on severity, 1
hyperparathyroidism in patients undergoing chronic renal mcg (0.02 mg/kg) to 2 mcg 3 times
dialysis weekly, approximately every other day

Calcitriol 2 mcg/ml Injection A11CC04000P3002XX No A* Management of hypocalcaemia and/or secondary Initially dose, depending on severity, 1
hyperparathyroidism in patients undergoing chronic renal mg (0.02 mg/kg) to 2 mg 3 times weekly,
dialysis approximately every other day

Calcium Carbonate 500 mg Capsule A12AA04121C1001XX No B To be used only for: i) Hyperphosphatemia (phosphate binder) a) Hyperphosphatemia: i) Stage 3 to 5
in chronic renal failure patients ii) Calcium supplementation chronic kidney disease, total dose of
elemental calcium from all sources (ie,
dietary and calcium-based phosphate
binder) not to exceed 2,000 mg/day ii)
Stage 5 chronic kidney disease, total
dose of elemental calcium from calcium-
based phosphate binder not to exceed
1,500 mg/day b) Calcium
supplementation 1,000-2,500mg
elemental calcium per day in divided
doses (500mg capsule contains 200mg
elemental calcium)

Calcium Carbonate 500 mg Tablet A12AA04121T1001XX No B To be used only for: a) Hyperphosphatemia (phosphate a) Hyperphosphatemia: i) Stage 3 to 5
binding activity) in patients with chronic renal failure b) chronic kidney disease, total dose
Calcium supplementation of†elemental†calcium from all sources
(ie, dietary and calcium-based phosphate
binder) not to exceed 2,000 mg/day ii)
Stage 5 chronic kidney disease, total
dose of†elemental†calcium from calcium-
based phosphate binder not to exceed
1,500 mg/day b) Calcium
supplementation 1,000-2,500mg
elemental calcium per day in divided
doses (500mg tablet contains 200mg
elemental calcium)

Calcium Chloride Dihydrate, Sodium B05BB01905P6002XX No A Replacement of extracellular fluid losses in the case of isotonic The maximum infusion rate depends on
Chloride, Magnesium Chloride dehydration, where acidosis is present or imminent. the needs of the patient in fluid
Hexahydrate, Sodium Acetate replacement and electrolytes, patient?s
Trihydrate,Potassium Chloride, and weight, clinical condition, and biological
Malic Acid Solution status. Adults, elderly,
adolescents:500ml-3L/24hr. Babies,
children: 20ml to 100ml/kg/24 hr.
Calcium Disodium Edetate 200 mg V03AB03999P3001XX No A Lead Poisoning IM (Lead encephalopathy): 1000
Injection mg/m(2)/day IM in divided equal doses 8
to 12 hours apart, for 5 days. Therapy is
interrupted for 2 to 4 days, and followed
by an additional 5-day course of therapy,
if indicated. Do not exceed the
recommended daily dosage. IV: 1000
mg/m(2)/day administered IV over 8 to
12 hours for 5 days. Therapy is
interrupted for 2 to 4 days, and followed
by an additional 5-day course of therapy,
if indicated.

Calcium Gluconate 10% Injection A12AA03000P3001XX Yes B i)Acute hypocalcaemia ii)Hypocalcaemic tetany iii)Cardiac i) 1-2 g (2.25-4.5 mmol). CHILD 50 mg/kg
resuscitation ii) ADULT 1g (2.2 mmol) by slow IV
injection followed by continuous
infusion of 4 g (8.8 mmol) daily iii) IV or
intracardiac injection, 10 ml

Calcium Lactate 300 mg Tablet A12AA05125T1001XX No C For prophylaxis of calcium deficiency and treatment of chronic ADULT 1-5 g daily in divided doses
hypocalcaemia
Calcium Polystyrene Sulphonate Powder V03AE01999F2101XX No A Hyperkalemia resulting from acute or chronic renal failure 15 - 30g daily in 2-3 divided doses. Each
dose should be suspended in 30 - 50ml
of water and administered orally

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Generic Name MDC NEML Category Indications Dosage

Calfactant 35mg/ml intratracheal R07AA02000L9104XXX No A* For the prevention of Respiratory Distress Syndrome (RDS) in 3mL/kg body weight at birth to be
suspension premature infants at high risk for RDS and for the treatment administered every 12 hours for total up
(“rescue”) of premature infants who develop RDS. Prophylaxis: to 3 doses. Should only be administered
Indicated for premature infants <29 weeks of gestational age intratracheally though an endotracheal
at significant risk for RDS. Should be administered as soon as tube. The dose is drawn into a syringe
possible, preferably within 30 minutes after birth. Treatment: from the single-use vial using a 20-gauge
Indicated for infants ≤72 hours of age with RDS (confirmed by or larger needle with care taken to avoid
clinical and radiologic findings) and requiring endotracheal excessive foaming. Administration is
intubation. made by instillation of the calfactant
suspension into the endotracheal tube.

Capecitabine 150 mg Tablet L01BC06000T1002XX No A* i) Metastatic breast cancer in elderly and poor performance i) & ii) 1250 mg/m2 twice daily (morning
status patients and refractory to taxanes. ii) Metastatic colon and evening) for 2 weeks, every 21 days.
cancer, first line in elderly and poor performance status iii) Recommended for a total of 24 weeks
patients. iii) Colon cancer, adjuvant therapy for stage III (8 cycles of 2 weeks of drug
(Duke's Stage C) following surgery. iv) First line treatment of administration and 1 week rest period.
patients with advanced gastric cancer in combination with a Iv) In combination with a platinum on
platinum-based regimen day 1, give capecitabine 1250 mg/m2
twice daily for 14 days. Repeated every 3
weeks for 8 cycles or optimum number
of cycles

Capecitabine 500 mg Tablet L01BC06000T1001XX No A* i)Metastatic breast cancer in elderly and poor performance i) & ii) 1250 mg/m2 twice daily (morning
status patients and refractory to taxanes ii) Metastatic colon and evening) for 2 weeks, every 21 days
cancer, first line in elderly and poor performance status iii) Recommended for a total of 24 weeks
patients iii) Colon cancer, adjuvant therapy for stage III (Duke's (8 cycles of 2 weeks of drug
Stage C) following surgery iv) First line treatment of patients administration and 1 week rest period iv)
with advanced gastric cancer in combination with a platinum- In combination with a platinum on day 1,
based regimen give capecitabine 1250 mg/m2 twice
daily for 14 days. Repeated every 3
weeks for 8 cycles or optimum number
of cycles

Captopril 25 mg Tablet C09AA01000T1002XX Yes B i) Hypertension ii) Congestive heart failure iii) Post-myocardial i) Initially 12.5 mg twice daily.
infarction iv) Diabetic nephropathy Maintenance: 25-50 mg 2 - 3 times daily,
may be increased to maximum 450
mg/day in divided doses ii) Initially 6.25 -
12.5 mg 3 times daily, increase after
several days to 25 - 50 mg 3 times daily
iii) Start 3 days after MI Initially 6.25 mg
daily, gradually increased to 37.5 mg
daily in divided doses. May increase
after several week to 150 mg/day in
divided doses if needed and tolerated
iv)75 - 100 mg daily in divided dose.

Carbachol 0.01% Intraocular Solution S01EB02100D2001XX No A For intraocular use for miosis during surgery Instill no more than 0.5 ml gently into
the anterior chamber
Carbamazepine 100 mg/5 ml (2% w/v) N03AF01000L9001XX Yes A Epilepsy ADULT: Initially, 100-200 mg once or
Syrup twice daily gradually increased by
increments of 100-200 mg every 2 week.
Maintenance: 0.8-1.2 g daily in divided
doses. CHILD: 10-15 years: 0.6-1 g daily;
5-10 years: 400-600 mg daily; 1-5 years:
200-400 mg daily; less than or equal to 1
year: 100-200 mg daily. Alternatively, 10-
20 mg/kg body weight daily in divided
doses. Max: Adult: 1.6 g daily

Carbamazepine 200 mg CR Tablet N03AF01000T5001XX Yes A Epilepsy ADULT: Initial, 200 mg twice daily for the
first week, may increase dosage by 200
mg/day at weekly intervals until optimal
response is obtained. Maximum 1.6
g/day. CHILD: usual maximum dosage
1000 mg/day in children 12-15 years of
age, 1200 mg/day in patients above 15
years of age

Carbamazepine 200 mg Tablet N03AF01000T1001XX Yes B i) Epilepsy ii) Trigeminal neuralgia i) ADULT: 100 - 200 mg 1 - 3 times daily
increased gradually to usual dose of 0.8 -
1.2 g daily in divided doses. CHILD: Up to
1 year: 100 - 200 mg daily; 1 - 5 yrs: 200 -
400 mg daily; 5 - 10 years: 400 - 600 mg
daily; 10 - 15 years: 0.6 - 1 g daily ii) The
initial dosage of 200 to 400mg should be
slowly raised daily until freedom from
pain is achieved (normally at 200mg 3 to
4 times daily). The dosage should then
be gradually reduced to the lowest
possible maintenance level. In elderly
patients, an initial dose of 100mg twice
daily is recommended.

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Carbamazepine 400 mg CR Tablet N03AF01000T5002XX Yes A Epilepsy ADULT: Initial, 200 mg twice daily for the
first week, may increase dosage by 200
mg/day at weekly intervals until optimal
response is obtained. Maximum 1.6
g/day. CHILD: usual maximum dosage
1000 mg/day in children 12-15 years of
age, 1200 mg/day in patients above 15
years of age

Carbamide (Urea) 10 % Cream D02AE01000G1001XX No B Contact irritant dermatitis, infantile eczemas, acute and Apply sparingly and rub into affected
chronic allergic eczemas, icthyosis, hyperkeratotic area 2 - 3 times daily and when required
after cleansing skin
Carbetocin 100 mcg/ ml Injection H01BB03000P2001XX No A* Prevention of uterine atony and postpartum hemorrhage A single IV dose of 100mcg (1ml) is
following elective cesarean section under epidural or spinal adminitered by bolus injection, slowly
anaesthesia over 1minute, only when delivery of the
infant has been completed by caesarean
section under epidural or spinal
anaesthesia, before or after delivery of
the placenta.

Carbimazole 5 mg Tablet H03BB01000T1001XX Yes B Hyperthyroidism ADULT: Initially, 10-60mg daily in divided
doses given 8 hourly. Maintenance: 5 to
20mg daily. CHILDREN > 6 years: Initially
15mg daily in divided doses. CHILDREN 1-
6 years: Initially 7.5mg daily in divided
doses

Carboplatin 150 mg Injection L01XA02000P4001XX Yes A* Adult solid tumours, paediatric tumours. Salvage therapy for 360 - 400 mg/m2 BSA, by IV infusion
lymphoma over 15 mins to 1 hour on Day 1 every 4
weeks. Alternatively, prescription may
be based on Area Under Curve (AUC)
calculations. CHILD: 500-600 mg/m2
over 1 hour once every 3 weeks. Salvage
regimes in lymphomas - refer to specific
protocols. Starting dose in renal
impairment, please refer to product
insert.

Carboplatin 450 mg Injection L01XA02000P4002XX Yes A* Adult solid tumours, paediatric tumours. Salvage therapy for 360 - 400 mg/m2 BSA, by IV infusion
lymphoma over 15 mins to 1 hour on Day 1 every 4
weeks. Alternatively, prescription may
be based on Area Under Curve (AUC)
calculations. CHILD: 500-600 mg/m2
over 1 hour once every 3 weeks. Salvage
regimes in lymphomas - refer to specific
protocols. Starting dose in renal
impairment, please refer to product
insert.

Carboprost Tromethamine 250 mcg G02AD04999P3001XX No A* Postpartum haemorrhage refractory to oxytocin Initially 250 mcg deep IM inj. The dose
Injection may be repeated at intervals of 15-90
min if necessary. Max total dose: 2 mg.

Cardioplegia solution containing B05XA16934P3001XX No A* For myocardial preservation(prevent myocardial damage) Dilute 20 ml to 1 L of Ringer solution
Potassium Chloride, Magnesium chloride during cardiac surgery (cooled to 2-8 ∞C prior to use). Ini al
& Procaine HCl Injection rapid instillation into aortic root at 300
ml/m≤ body surface area/min for 3
minutes. Should myocardial activity
persist or recur instill at 300ml/m≤ body
surface area/min for 2 minutes

Carvedilol 25 mg Tablet C07AG02000T1002XX No A/KK Treatment of stable moderate to severe congestive cardiac 3.125 mg twice daily for 2 weeks, then
failure in addition to ACEI's and diuretics 6.25 mg twice daily for 2 weeks, then
12.5 mg twice daily for 2 weeks then 25
mg twice daily (titrated up to the highest
tolerated level). Max: <85 kg: 25 mg bid;
>85 kg: 50 mg bid.
Carvedilol 6.25 mg Tablet C07AG02000T1001XX No A/KK Treatment of stable moderate to severe congestive cardiac 3.125 mg twice daily for 2 weeks, then
failure in addition to ACEI's and diuretics 6.25 mg twice daily for 2 weeks, then
12.5 mg twice daily for 2 weeks then 25
mg twice daily (titrated up to the highest
tolerated level). Max: <85 kg: 25 mg bid;
>85 kg: 50 mg bid.
Caspofungin Acetate 50 mg Injection J02AX04122P4001XX No A* i) Confirmed systemic fungal infection in patients who are i) Invasive aspergillosis & invasive
refractory or intolerant to other fungal therapies. ii) For candidiasis: ADULT: Initially, 70 mg
pediatric patient (12 month and older) for the following infused over 1 hour followed by
indications : a) Empirical therapy for presumed fungal subsequent doses of 50 mg/day.
infections in febrile, neutropenic patients b) Treatment of Oesophageal candidiasis: ADULT: 50 mg
invasive candidiasis, including candidemia and the following by slow IV infusion over approximately 1
Candida infections ; intra-abdominal abscesses, peritonitis and hour ii) For all indications, a loading dose
pleural space infections c) Treatment of esophageal of 70mg/m2 on D1 followed by
candidiasis d) Treatment of invasive Aspergillosis in patients maintenance dose of 50mg/m2 od.
who are refractory to or intolerant of others therapy (eg :
Amphotericin B)

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Caspofungin Acetate 70 mg Injection J02AX04122P4002XX No A* For adult and pediatric patient (12 month and older) for the i) Invasive aspergillosis & invasive
following indications: a) Treatment of invasive candidiasis, candidiasis: ADULT: Initially, 70 mg
including candidemia and the following Candida infections ; infused over 1 hour followed by
intra-abdominal abscesses, peritonitis and pleural space subsequent doses of 50 mg/day.
infections b) Treatment of invasive Aspergillosis in patients Oesophageal candidiasis: ADULT: 50 mg
who are refractory to or intolerant of others therapy (eg : by slow IV infusion over approximately 1
Amphotericin B) c) Treatment of esophageal candidiasis (need hour daily ii) Child (12months to 17
to follow the current indications) years) : For all indication) A single
70mg/m2 loading dose (not to exceed an
actual dose of 70mg) by slow IV infusion
over 1hour; followed by 50mg/m2 (not
to exceed an actual dose of 70mg)

Cefaclor 125 mg/5 ml Suspension J01DC04000F2101XX No A Infections caused by susceptible organisms including CHILD:>1 mth: 20 mg/kg daily in 3
Staphylococcus aureus and H. influenzae, treatment of divided doses, increased to 40 mg/kg
sinusitis and infections involving the respiratory tract, skin and daily if necessary, <1 yr: 62.5 mg tid, 1-5
skin structure, bone and joint, and urinary tract yr: 125 mg tid, >5 yr: 250 mg tid.
Maximum: 1 g daily
Cefaclor 375 mg MR Tablet J01DC04010T5001XX No A i) Adult pharyngitis, tonsillitis, skin& soft tissue infections ii) i) 375 mg twice daily ii) 375 mg or 500
Bronchitis iii) Pneumonia iv) Lower UTI mg twice daily iii) 750mg twice daily iv)
375mg twice daily or 500 mg once daily

Cefaclor 500 mg Capsule J01DC04000C1002XX No A Infections caused by susceptible organisms including ADULT: 250 mg 3 times daily for 10 days.
Staphylococcus aureus and H. influenzae, treatment of For severe infections, double the dosage.
sinusitis and infections involving the respiratory tract, skin and Maximum: 4 g daily. CHILD:>1 mth: 20
skin structure, bone and joint, and urinary tract mg/kg daily in 3 divided doses, increased
to 40 mg/kg daily if necessary, <1 yr:
62.5 mg tid, 1-5 yr: 125 mg tid, >5 yr:
250 mg tid . Maximum: 1 g daily

Cefazolin Sodium 1 g Injection J01DB04520P3001XX No A Infection caused by cefazolin-sensitive microorganism, ADULT: Uncomplicated infections: 500 -
infection of the respiratory tract, urogenital tract, skin and soft 1000 mg 2 - 3 times daily. Moderately
tissue, bile duct, bones and joint, endocarditis, systemic septic severe and severe infections: 500 - 1000
infection, peri-operative/ surgical prophylaxis mg 3 - 4 times daily. Severe life-
threatening infections: 1 - 1.5 g 4 times
daily. Rarely, dose up to 12 g daily.
CHILDREN >1 month: 25-50mg/kg/day in
3-4 divided dose

Cefepime 1 g Injection J01DE01110P4002XX No A* Febrile neutropenia, septicaemia, lower respiratory tract ADULT: 1 - 2 g twice daily for most
infection, urinary tract infection, skin and skin structure infections. For severe infections
infections, gynaecologic and intra-abdominal infections including febrile neutropenia: 2 g 3
times daily. CHILD:2 mth - 16 yr: ≤40 kg:
50 mg/kg every 8-12 hr for 7-10 days

Cefepime 500 mg Injection J01DE01110P4001XX No A* Febrile neutropenia, septicaemia, lower respiratory tract ADULT: 1 - 2 g twice daily for most
infection, urinary tract infection, skin and skin structure infections. For severe infections
infections, gynaecologic and intra-abdominal infections including febrile neutropenia: 2 g 3
times daily. CHILD: 2 mth - 16 yr: ≤40 kg:
50 mg/kg every 8-12 hr for 7-10 days

Cefoperazone Sodium 1 g Injection J01DD12520P4002XX No A Infections due to gram-negative bacteria ADULT: 1 - 2 g twice daily IM or IV. By IV,
adult dose may be doubled. Maximum:
16 g daily in divided doses. CHILD &
INFANT: 50 - 200 mg/kg/day in 2 - 4
divided doses. NEONATE less than 8
days: 50 - 200 mg/kg/day 12 hourly

Cefoperazone Sodium 2 g Injection J01DD12520P4003XX No A Infections due to gram-negative bacteria ADULT: 1 - 2 g twice daily IM or IV. By IV,
adult dose may be doubled. Maximum:
16 g daily in divided doses. CHILD &
INFANT: 50 - 200 mg/kg/day in 2 - 4
divided doses. NEONATE less than 8
days: 50 - 200 mg/kg/day 12 hourly

Cefoperazone Sodium 500 mg & J01DD62000P4001XX No A i) Treatment of infections due to multi-drug resistance ADULT: 1 - 2 g twice daily. In severe or
Sulbactam Sodium 500 mg Injection pathogens producing B-lactamase ii) Treatment of infections refractory infections the daily dosage of
caused by Acinetobacter species sulbactam/cefoperazone may be
increased up to 8g (4g cefopreazone
activity) CHILD: 40 - 80 mg/kg/day in 2 to
4 equally divided doses; in serious or
refractory infections, may increase to
160mg/kg/d in 2 - 4 equally divided
doses.

Cefoperazone Sodium 500 mg Injection J01DD12520P4001XX No A Infections due to gram-negative bacteria ADULT: 1 - 2 g twice daily IM or IV. By IV,
adult dose may be doubled. Maximum:
16 g daily in divided doses. CHILD &
INFANT: 50 - 200 mg/kg/day in 2 - 4
divided doses. NEONATE less than 8
days: 50 - 200 mg/kg/day 12 hourly

Cefotaxime 1 g Injection J01DD01520P4002XX Yes A Infections due to gram-negative bacteria ADULT: 1 g 12 hourly (up to 12 g/day in
severe cases). CHILD: 50 - 180 mg/kg/day
in 4 - 6 divided doses
Cefotaxime 500 mg Injection J01DD01520P4001XX Yes A Infections due to gram-negative bacteria ADULT: 1 g 12 hourly (up to 12 g/day in
severe cases). CHILD: 50 - 180 mg/kg/day
in 4 - 6 divided doses

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Ceftaroline Fosamil 600mg Powder for J01D102000P4001XX No A* Treatment of complicated skin and soft tissue infections 600mg administered every 12 hours by
concentrate for solution for infusion (cSSTI) in adults Restriction: Restricted for only complicated intravenous infusion over 60 minutes for
SSTI in patients who are unable to tolerate or not responding 5-14 days. Dose adjustment in renal
to vancomycin. impairment: - CrCl > 30 to ≤50 ml/min :
400mg (IV) every 12 hours (over 60
minutes) - CrCl ≥ 15 ≤ 30 ml/min: 300mg
(IV) every 2 hoours (over 60 minutes) -
CrCl < 30ml/min including
hemodialysis*: 200mg (IV) every 12
hours (over 60 minutes) * Ceftaroline is
hemodialyzable, thus should be
administered after hemodialysis.

Ceftazidime 1 g Injection J01DD02520P4003XX No A Severe gram negative bacterial infections ADULT: 1 g 8 hourly or 2 g 12 hourly. In
severe infections: 2 g 8 hourly. CHILD: 25
- 150 mg/kg/day in 2 - 3 divided doses

Ceftazidime 2 g Injection J01DD02520P4004XX No A Severe gram negative bacterial infections ADULT: 1 g 8 hourly or 2 g 12 hourly. In
severe infections: 2 g 8 hourly. CHILD: 25
- 150 mg/kg/day in 2 - 3 divided doses

Ceftazidime 250 mg Injection J01DD02520P4001XX No A Severe gram negative bacterial infections ADULT: 1 g 8 hourly or 2 g 12 hourly. In
severe infections: 2 g 8 hourly. CHILD: 25
- 150 mg/kg/day in 2 - 3 divided doses

Ceftazidime 500 mg Injection J01DD02520P4002XX No A Severe gram negative bacterial infections ADULT: 1 g 8 hourly or 2 g 12 hourly. In
severe infections: 2 g 8 hourly. CHILD: 25
- 150 mg/kg/day in 2 - 3 divided doses

Ceftriaxone 0.25 g Injection J01DD04520P4001XX Yes A/KK i) Gonorrhoea ii) Chancroid i) 250 mg by deep IM injection ii) single
IM injection 250 mg only. For severe
infection up to 100 mg/kg/day
Ceftriaxone 0.5 g Injection J01DD04520P4002XX Yes A Infections caused by susceptible organisms ADULT: 1 - 2 g once daily. Severe
infection: 4 g daily at 12 hour intervals.
INFANT & CHILD, 3 weeks - 12 years: 20 -
80 mg/kg body weight daily. CHILD with
body weight 50 kg or more: adult dose.
NEONATE up to 2 weeks: 20 - 50 mg/kg
body weight daily, not to exceed 50
mg/kg
Ceftriaxone 1g Injection J01DD04520P4003XX Yes A Infections caused by susceptible organisms ADULT: 1 - 2 g once daily. Severe
infection: 4 g daily at 12 hour intervals.
INFANT & CHILD, 3 weeks - 12 years: 20 -
80 mg/kg body weight daily. CHILD with
body weight 50 kg or more: adult dose.
NEONATE up to 2 weeks: 20 - 50 mg/kg
body weight daily, not to exceed 50
mg/kg
Cefuroxime Axetil 125 mg Tablet J01DC02233T1001XX No A/KK Upper and lower respiratory tract, genito-urinary tract, skin & ADULT: 250 mg twice daily ;UTI: 125 mg
soft tissue and urinary tract infections (UTI) twice daily. CHILD:30 mg/kg/day in 2
divided doses, up to 500 mg daily

Cefuroxime Axetil 125 mg/5 ml J01DC02233F2101XX No A Infections caused by susceptible organisms 30 mg/kg/day in 2 divided doses, up to
Suspension 500 mg daily.
Cefuroxime Axetil 250 mg Tablet J01DC02233T1002XX No A/KK Upper and lower respiratory tract, genito-urinary tract, skin & ADULT: 250 mg twice daily ;UTI: 125 mg
soft tissue and urinary tract infections (UTI) twice daily. CHILD:30 mg/kg/day in 2
divided doses, up to 500 mg daily

Cefuroxime Sodium 1.5 g Injection J01DC02520P4003XX No A Infections caused by susceptible organisms, surgical ADULT: 750 mg every 6 - 8 hours as IM
prophylaxis or IV. Severe infections: 1.5 g every 6 - 8
hours as IV. CHILD: 30 - 100 mg/kg/day
in 3 - 4 divided doses or 2-3 divided
doses in neonates. Surgical prophylaxis:
1.5 g IV
Cefuroxime Sodium 250 mg Injection J01DC02520P4001XX No A Infections caused by susceptible organisms, surgical ADULT: 750 mg every 6 - 8 hours as IM
prophylaxis or IV. Severe infections: 1.5 g every 6 - 8
hours as IV. CHILD: 30 - 100 mg/kg/day
in 3 - 4 divided doses or 2-3 divided
doses in neonates. Surgical prophylaxis:
1.5 g IV
Cefuroxime Sodium 750 mg Injection J01DC02520P4002XX No A Infections caused by susceptible organisms, surgical ADULT: 750 mg every 6 - 8 hours as IM
prophylaxis or IV. Severe infections: 1.5 g every 6 - 8
hours as IV. CHILD: 30 - 100 mg/kg/day
in 3 - 4 divided doses or 2-3 divided
doses in neonates. Surgical prophylaxis:
1.5 g IV

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Celecoxib 200 mg Capsule M01AH01000C1001XX No A i) Osteoarthritis ii) Rheumatoid Arthritis iii) Acute pain iv) i) ADULTS: 200 mg once daily. May
Ankylosing Spondylitis increase to 200 mg bid, if necessary.
CHILD not recommended ii) 100mg twice
daily, increased if necessary to 200 mg 2
times daily; CHILD not recommended iii)
400mg as a single dose on first day
followed by 200mg once daily on
subsequent days iv) Initial, 200 mg once
daily or 100 mg twice daily; if no effect
after 6 weeks, may increase to max. 400
mg daily in 1-2 divided doses. If no
response following 2 weeks of treatment
with 400 mg/day, consider
discontinuation and alternative
treatment

Celecoxib 400 mg Capsule M01AH01000C1002XX No A* i) Osteoarthritis ii) Rheumatoid Arthritis iii) Acute pain iv) i) ADULTS: 200 mg once daily. CHILD not
Ankylosing Spondylitis recommended ii) 100 mg twice daily,
increased if necessary to 200 mg 2 times
daily; CHILD not recommended iii) 400
mg as a single dose on first day followed
by 200 mg once daily on subsequent
days iv) Initial, 200 mg once daily or 100
mg twice daily; if no effect after 6 weeks,
may increase to max. 400 mg daily in 1-2
divided doses. If no response following 2
weeks of treatment with 400 mg/day,
consider discontinuation and alternative
treatment

Cephalexin Monohydrate 125 mg/5 ml J01DB01010F2101XX No B Respiratory tract infections, ear, nose and throat infections, CHILD: 25 - 100 mg/kg/day every 6
Syrup urinary tract infections, obstetric and gynaecologic infections hourly. Maximum: 4 g daily

Cephalexin Monohydrate 250 mg J01DB01010C1001XX No B i) Respiratory tract infection, urinary tract infection ii) i) 250 mg 6 hourly ii) 250 - 500 mg 6
Capsule Complicated, recurrent or chronic infections, bronchitis iii) hourly iii) 1 - 1.5 g 3 times daily or 4
Pneumonia times daily. Maximum: 6 g/day Child: 25-
100 mg/kg daily in divided doses. Max: 4
g daily.
Cephalexin Monohydrate 250 mg Tablet J01DB01010T1001XX No B i) Respiratory tract infection, urinary tract infection ii) i) 250 mg 6 hourly ii) 250 - 500 mg 6
Complicated, recurrent or chronic infections, bronchitis iii) hourly iii) 1 - 1.5 g 3 times daily or 4
Pneumonia times daily. Maximum: 6 g/day Child: 25-
100 mg/kg daily in divided doses. Max: 4
g daily.
Cephalexin Monohydrate 500 mg J01DB01010C1002XX No B i) Respiratory tract infection, urinary tract infection ii) i) 250 mg 6 hourly ii) 250 - 500 mg 6
Capsule Complicated, recurrent or chronic infections, bronchitis iii) hourly iii) 1 - 1.5 g 3 times daily or 4
Pneumonia times daily. Maximum: 6 g/day
Cephalexin Monohydrate 500 mg Tablet J01DB01010T1002XX No B i) Respiratory tract infection, urinary tract infection ii) i) 250 mg 6 hourly ii) 250 - 500 mg 6
Complicated, recurrent or chronic infections, bronchitis iii) hourly iii) 1 - 1.5 g 3 times daily or 4
Pneumonia times daily. Maximum: 6 g/day Child: 25-
100 mg/kg daily in divided doses. Max: 4
g daily.
Cetirizine HCl 10 mg Tablet R06AE07110T1001XX Yes A/KK Urticaria, allergic dermatoses (insect bites, atopic eczema), ADULT and CHILD over 6 years:10 mg
perennial rhinitis, allergic rhinitis daily or 5 mg twice daily. Child 2-6 years:
5 mg once daily or 2.5 mg twice daily

Cetrimide 1-2% Lotion. D08AJ04000L6001XX Yes C+ As shampoo and cleansing agent Apply to affected area
Cetrorelix 0.25 mg Injection H01CC02122P4001XX No A* Prevention of premature ovulation in patients undergoing a Given by SC 0.25 mg/day, given either in
controlled ovarian stimulation, followed by oocyte pick-up and the morning beginning on the day 5 or 6
assisted reproductive techniques of ovarian stimulation or in the evening
beginning on day 5, and continued until
ovulation induction

Cetuximab 5 mg/ml Solution for Infusion L01XC06000P5002XX No A* For neo-adjuvant treatment of KRAS wild type metastatic Administered once a week. The very first
colorectal cancer with the aim of liver resection with the dose is 400mg cetuximab per m2 body
following conditions: i) The primary colorectal tumour has surface area with a recommended
been resected or is potentially resected. ii)The metastatic infusion period of 120 minutes. All
disease is confined to the liver and is unresectable iii) The subsequent weekly doses are 250mg per
patient is fit enough to undergo surgery to resect the primary m2 body surface area each with a
colorectal tumour and to undergo liver surgery if the recommended infusion period of 60
metastases become resectable after treatment with minutes. The maximum infusion rate
cetuximab. iv)The treatment is limited to 16 weeks must not exceed 10mg/min.

Charcoal, Activated 250 mg Tablet A07BA01000T1001XX Yes C i) Diarrhoea and food poisoning ii) Reduce absorption of i) ADULT 0.5-1 g given 3-4 times daily.
drugs, plant, inorganic poison and chemicals in poisoning CHILD half adult dose. ii) Need to be
cases dissolved in liquid (slurry consistency).
ADULT and CHILD over 12 years: initial
30-100 g or 1-2 g/kg; repeat initial dose
as soon as possible or 20-50 g every 2-6
hours. CHILD over 1-12 years, 25-50 g or
1-2 g/kg; may repeat half the initial dose
every 2-6 hour as needed. CHILD to 1
year of age, 1 g/kg; may repeat half the
initial dose every 2-6 hours as needed.
For maximum efficacy administer within
1 hour after ingestion of toxic compound

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Charcoal, Activated 50 g Granules A07BA01000F1001XX Yes A Emergency treatment of acute oral poisoning and drug ADULT:Acute poisoning: 50 - 100g in
overdose suspension. Severe poisoning: 50 - 100g
as an initial dose followed by 20g every 4
- 6 hours. CHILDREN: 1g/kg/dose

Chloral Hydrate 200 mg/5 ml Mixture N05CC01010L2101XX No B Preoperative sedation ADULT : 0.5 - 1 g (max 2 g) with plenty of
water at bedtime. CHILD : Neonate: 30-
50 mg/kg; up to 100 mg/kg may be used
with respiratory monitoring. 1 mth-12
yr: 30-50 mg/kg (max: 1 g); up to 100
mg/kg (max: 2 g) may be used; 12-18 yr:
1-2 g. Doses to be taken 45-60 minutes
before procedure. May be given rectally
if oral route is not available.

Chlorambucil 2 mg Tablet L01AA02000T1001XX Yes A Low grade lymphoma, chronic lymphocytic leukaemia. Ovarian General : Initial :0.1 -0.2 mg/kg body
cancer weight daily for 4 - 8 weeks maintanance
: given either by reduced daily dosage or
intermittent course of treatment.
Chronic Lymphocytic Leukaemia: initial :
0.15mg/kg/day untill total leukocyte
count has fallen to 10,000peruL, then
resumed treatment untill 4 weeks after
the end of the first course then
continued at a dosage 0.1mg/kg/day.

Chloramphenicol 0.5% Eye Drops S01AA01000D2001XX Yes C Broad spectrum antibiotic in superficial eye infections Instill 1 drop of a 0.5% solution every 2
hr. Increase dosage interval upon
improvement. To continue treatment for
at least 48 hr after complete healing

Chloramphenicol 1% Eye Ointment S01AA01000G5101XX Yes C Treatment of ocular infections involving the conjunctiva ADULT and CHILD : Apply to the
and/or cornea caused by chloramphenicol susceptible conjunctiva, a thin strip (approximately 1
organisms cm) of ointment every 3 hours or more
frequently
Chloramphenicol 125 mg/5 ml J01BA01126L8001XX No B Typhoid fever, salmonella infections, meningitis, cholera, CHILD: 25 - 50 mg/kg/day in 4 divided
Suspension anaerobic and rickettsial infections doses. Severe infections, premature&
full-term infants less than 2 weeks:
25mg/kg/day in divided doses. Full-term
infants more than 2 weeks: up to
50mg/kg/day in divided doses

Chloramphenicol 250 mg Capsule J01BA01126C1001XX No B Treatment of typhoid, paratyphoid fevers, bronchopneumonia ADULT: 500 mg 4 times daily or 50
and enteric infection mg/kg/day in 4 divided doses. Maximum
dose: 4 g/day. CHILD: 25 - 100
mg/kg/day in 4 divided doses
Chloramphenicol 5% w/v Ear Drops S02AA01000D1001XX No C Acute otitis media, otitis externa with perforation Apply 2 - 3 drops into the ear 2 - 3 times
daily. Not to be used for long term

Chloramphenicol Sodium Succinate 1 g J01BA01520P4001XX No B Treatment of typhoid, paratyphoid fevers, bronchopneumonia Adult:50 to 100 mg/kg/day in 4 divided
Injection and enteric infection doses. Premature and full-term
neonates: 25 mg/kg/day in 4 divided
doses. Full-term infants >2 wk: 50
mg/kg/day in 4 divided doses. Children:
50-100 mg/kg/day in 4 divided doses

Chlorhexidine 1:200 in Alcohol with D08AC52137L9901XX Yes C+ To be used undiluted for hand and skin disinfections Pre-op surgical hand disinfection: Spread
Emollient (Hand Disinfectant). 5ml throughly over both hands and
forearms, rubbing vigorously. When dry
apply a further 5ml and repeat
procedure. Antiseptic hand disinfection
on the ward: Spread 3ml throughly over
the hands and wrist rubbing vigorously
until dry. Disinfection of patient's skin:
Prior to surgery, apply to a sterile swab
and rub thoroughly over the operation
site for a minimum of 2 mins

Chlorhexidine Gluconate 0.2 % R02AA05137M2001XX Yes C As a gargle Rinse mouth with 10 ml for about 1
Mouthwash minute twice daily
Chlorhexidine gluconate 1% cream D08AC02137G1001XX Yes C+ As a disinfectant cream. It can be used for disinfection or Clean the affected skin area and apply
lubricating during gynaecological and obstetric procedures or cream as required.
childbirth.
Chlorhexidine Gluconate 2% in Alcohol D08AC52137L9902XX No C Use as disinfectant in central venous catheter care bundle Skin Preparation:Use Chlorhexidine
70% Solution Gluconate 2% in Isopropyl Alcohol 70%
and allow to dry. Catheter acces:Apply to
catheter ports or hubs prior to accessing
the line for administering fluids or
injections
Chlorhexidine Gluconate 4% Scrub D08AC02137M9901XX Yes C+ Surgical hand scrub/disinfection, pre-op skin preparation Surgical hand disinfection: Apply 5ml to
clean hands and forearms for 1 min.
Rinse and repeat with another 5ml for a
further 2 mins and then rinse and dry.
General skin disinfection: Apply
appropriate quantity to wet area and
scrub for 1 min. Rinse thoroughly & dry

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Chlorhexidine Gluconate 5% Solution D08AC02137L9901XX Yes C+ i) Preoperative skin disinfection ii) Wounds or burns iii) i) & iii) 1 : 10 in 70 % Alcohol ii) 1 : 100
Emergency disinfection of instruments
Chlorinated Lime Powder V07AV00000F9901XX No C Antiseptic and disinfectants Not applicable
Chlorinated Lime Solution & Buffered D08A000999G9901XX No C Wound or ulcer Apply to affected areas undiluted as a
Acetate Solution cleansing agent
Chloroquine Phosphate 250 mg Tablet P01BA01162T1001XX Yes C Treatment of malaria - acute attack ADULT 600 mg base stat, 300 mg 6 - 8
(150 mg Chloroquine base) hours later and a further 300 mg on each
of 2 following days. CHILD 3 - 4 years :
150 mg base stat, 75 mg 6 hours later,
then 75 mg daily for 2 days. CHILD 5 - 8
years : 300 mg stat, 150 mg 6 hours
later, then 150 mg daily for 2 days

Chlorpheniramine Maleate 10 mg/ml R06AB04253P3001XX Yes B Allergic conditions 10 - 20 mg IM or SC, repeated if

Injection required. Not to exceed 40 mg in 24
hours. 10 - 20 mg over 1 minute by slow
IV
Chlorpheniramine Maleate 2 mg/5 ml R06AB04253L9001XX Yes C Symptomatic treatment of allergic conditions responsive to CHILD 2 - 5 years : 1 mg every 4 - 6 hours
Syrup antihistamine (maximum 6 mg daily) 6 - 12 years : 2 mg
every 4 - 6 hours (maximum 12 mg daily)

Chlorpheniramine Maleate 4 mg Tablet R06AB04253T1001XX Yes C Symptomatic treatment of allergic conditions responsive to ADULT : 4 mg every 4 - 6 hours.
antihistamines Maximum 24 mg daily. CHILD 2 - 5 years
: 1 mg every 4 - 6 hours (maximum 6 mg
daily) 6 - 12 years : 2 mg every 4 - 6
hours (maximum 12 mg daily)

Chlorpromazine HCl 100 mg Tablet N05AA01110T1002XX Yes B Psychosis mania and agitation ADULT : Initial dose - 25 mg 3 times daily
according to response up to 1 g daily.
PAEDIATRIC: Up to 5 years: 0.5 mg/kg
body weight every 4 - 6 hours (Maximum
40 mg daily). CHILD 6 - 12 years: A third
to half adult dose (Maximum 75 mg
daily)
Chlorpromazine HCl 25 mg Tablet N05AA01110T1001XX Yes B Psychosis mania and agitation ADULT : Initial dose - 25 mg 3 times daily
according to response up to 1 g daily.
PAEDIATRIC: Up to 5 years: 0.5 mg/kg
body weight every 4 - 6 hours (Maximum
40 mg daily). CHILD 6 - 12 years: A third
to half adult dose (Maximum 75 mg
daily)
Chlortetracycline 1% Eye Ointment S01AA02000G5101XX No B Eye infections requiring a broad spectrum antibiotic Apply thin strip (approximately 1 cm) to
the conjuctiva 2 to 4 hourly or more
frequently.
Chlortetracycline 1-3 % Cream D06AA02000G1001XX No B Bacterial skin infections Apply directly to affected area twice
daily as required for 1 - 2 weeks
Cholera Vaccine J07AE01000P3001XX Yes B Immunisation of cholera Prophylactic ADULT: First dose of 0.5 ml
SC/IM followed after 1 - 4 weeks by a
second dose of 1 ml. CHILD: 1 - 5 years:
0.1 ml (1st dose), 0.3 ml (2nd dose).
CHILD; 5 - 10 years: 0.3 ml (1st dose),
0.5ml (2nd dose). Booster: For optimum
long-term protection, a booster dose is
recommended for adults after 2 years.
Children 2-6 years should receive a
booster dose after 6 months.

Cholestyramine Resin 4 G C10AC01000M4001XX No A i) Hypercholesterolemia ii) Familial hypercholesterolemia - Hypercholesterolemia: Adjunct: initial, 4
heterozygous iii) Generalized atherosclerosis iv) Diarrhoea due g orally 1-2 times daily, maintenance, 8
to bile acid malabsorption v) Pruritus of skin associated with to 16 g in divided doses, max 24 g daily
partial biliary obstruction CHILD: 50 - 150 mg/ kg 6 - 8 hourly oral

Choline Salicylate 8.7%, Cetylkonium N02BA03900G3001XX No B For relief of the pain and discomfort in mouth ulcers and Apply to area 4 times daily
Chloride 0.01% Dental Gel sores, infant teething and denture irritation
Choriogonadotropin Alfa 250 mcg/0.5 ml G03GA01000P5001XX No A* i)Women undergoing superovulation prior to assisted 250 mcg 24-48 hour after the last
Injection in Prefilled Syringe reproductive techniques such as in-vitro fertilization (IVF) administration of an FSH or hMG
ii)Anovulatory or oligo-ovulatory women preparation, when optimal stimulation
of follicular growth is achieved.

Chorionic Gonadotrophin Human (HCG) G03GA01000P4001XX No A* i)Treatment of infertile women to induce ovulation ii) As a i) & ii)Induction of ovulation: 5000 -
5000 IU Injection luteal support in controlled ovarian hyperstimulation cycles 10,000 units one day following last dose
of menotropin. Up to 3 repeat injections
of 5000 units each may be given within
the following 9 days to prevent
insufficiency corpus luteum
Ciclesonide 160mcg Inhaler R03BA08000A2101XX No A* Prophylactic treatment of asthma in adults, adolescents and For adults and adolescents over 12 years
children over 6 years (follow current indication) Not meant for of age with mild to moderate asthma is
6 yo) 160 to 640mcg per day: severe asthma
dose may be increased to 1280mcg per
day.

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Ciclosporin 100 mg Capsule L04AD01000C1002XX Yes A* Only for: i) Patients in whom donor specific transplantation i & ii) Initially 12.5 - 15 mg/kg/day,
cannot be carried out and in young children to minimise side- beginning on the day before transplant.
effects of steroids ii) Follow-up cases of bone marrow Maintenance approx 12.5 mg/kg/day for
transplant iii) Patients with severe rheumatoid arthritis not 3 - 6 months before being tapered off to
responding to other second line drugs iv) Patients with zero by 1 year of transplantation iii) 3
idiopathic nephrotic syndrome who are steroid toxic or poor mg/kg/day in 2 divided doses for first 6
response to cyclophosphamide v) Severe aplastic anemia, pure weeks. May increased gradually to
red cell aplasia vi) Cases of recalcitrant psoriasis and atopic maximum 5 mg/kg. Treatment
eczema vii) Treatment of chronic ocular inflammatory withdrawn if no response after 3 months
disorders/uveitis iv) ADULT: 5 mg/kg/day in 2 divided
doses. CHILD: 6 mg/kg/day in 2 divided
doses. Patients with permitted levels of
kidney failure, the starting dose must
not more than 2.5 mg/kg/day v) 12
mg/kg/day. vi) 2.5 mg/kg/day in 2
divided doses increasing if there is no
improvement after 4 weeks by 0.5 -1
mg/kg/month up to maximum 5
mg/kg/day vii) 5 mg/kg/day in 2 divided
doses, may increase to 7 mg/kg/day in
resistant cases. Maintenance: Less than
5 mg/kg/day especially during remission

Ciclosporin 100 mg/ml Drink Solution L04AD01000L5002XX Yes A* Only for : i) Patients in whom donor specific transplantation i & ii) Initially 12.5 - 15 mg/kg/day,
cannot be carried out and in young children to minimise side- beginning on the day before transplant.
effects of steroids ii) Follow-up cases of bone marrow Maintenance approx 12.5 mg/kg/day for
transplant iii) Patients with severe Rheumatoid arthritis not 3 - 6 months before being tapered off to
responding to other second line drugs iv) Patients with zero by 1 year of transplantation iii) 3
idiopathic nephrotic syndrome who are steroid toxic or poor mg/kg/day in 2 divided doses for first 6
response to cyclophosphamide v) Severe aplastic anaemia, weeks. May increased gradually to
pure red cell aplasia vi) Cases of recalcitrant psoriasis and maximum 5 mg/kg. Treatment
atopic eczema withdrawn if no response after 3 months
iv) ADULT: 5 mg/kg/day in 2 divided
doses. CHILD: 6 mg/kg/day in 2 divided
doses. Patients with permitted levels of
kidney failure, the starting dose must
not more than 2.5 mg/kg/day v) 12
mg/kg/day vi) 2.5 mg/kg/day in 2 divided
doses increasing if there is no
improvement after 4 weeks by 0.5 -1
mg/kg/month up to maximum 5
mg/kg/day

Ciclosporin 25 mg Capsule L04AD01000C1001XX Yes A* Only for: i) Patients in whom donor specific transplantation i & ii) Initially 12.5 - 15 mg/kg/day,
cannot be carried out and in young children to minimise side- beginning on the day before transplant.
effects of steroids ii) Follow-up cases of bone marrow Maintenance approx 12.5 mg/kg/day for
transplant iii) Patients with severe rheumatoid arthritis not 3 - 6 months before being tapered off to
responding to other second line drugs iv) Patients with zero by 1 year of transplantation iii) 3
idiopathic nephrotic syndrome who are steroid toxic or poor mg/kg/day in 2 divided doses for first 6
response to cyclophosphamide v) Severe aplastic anemia, pure weeks. May increased gradually to
red cell aplasia vi) Cases of recalcitrant psoriasis and atopic maximum 5 mg/kg. Treatment
eczema vii) Treatment of chronic ocular inflammatory withdrawn if no response after 3 months
disorders/uveitis iv) ADULT: 5 mg/kg/day in 2 divided
doses. CHILD: 6 mg/kg/day in 2 divided
doses. Patients with permitted levels of
kidney failure, the starting dose must
not more than 2.5 mg/kg/day v) 12
mg/kg/day vi) 2.5 mg/kg/day in 2 divided
doses increasing if there is no
improvement after 4 weeks by 0.5 -1
mg/kg/month up to maximum 5
mg/kg/day vii) 5 mg/kg/day in 2 divided
doses, may increase to 7 mg/kg/day in
resistant cases. Maintenance: Less than
5 mg/kg/day especially during remission

Ciclosporin 50 mg/ml Injection L04AD01000P3001XX Yes A* i) Post bone marrow transplant ii) Solid organ transplant i) 3 - 5 mg/kg/day until tolerate orally ii)
2 - 3 mg/kg/day for recipients who are
unable to take orally

Cilostazol 100 mg Tablet B01AC00000T1002XX No A* Improvement of the maximal and pain-free walking distances 100 mg twice daily
in patients with intermittent claudication, who do not have
rest pain and who do not have evidence of peripheral tissue
necrosis.
Cimicifuga Racemosa Rhizome Extract 20 HG03WA5001T1001XX No A Traditionally used for the relief of hot flushes, sweating, 20 mg twice daily
mg Tablet restlessness associated with menopause

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Generic Name MDC NEML Category Indications Dosage

Cinacalcet Hydrochloride 25mg tablet H05BX01110T1001XX No A* Secondary hyperparathyroidism in patients undergoing The starting dose for adults is 25mg once
maintenance dialysis with hypercalcaemia. Restriction(s): For daily to be administered orally. Depends
treatment of refractory secondary hyperparathyroidism in on the serum parathyroid hormone
patients with end-stage renal disease (including those with (PTH) and calcium levels, the dose may
calciphylaxis) only in those: i) who have 'very uncontrolled' be adjusted within a range of 25-75mg
plasma levels of intact parathyroid hormone (defined as once daily. If no improvement in PTH,
greater than 85pmol/L [800 pg/mL] that are refractory to the dose may be increased up to 100 mg
standard therapy, and an adjusted serum calcium level at once daily. Dose can be increased by
upper limit of normal or high, despite appropriate adjustment 25mg at a time at intervals of at least 3
of phosphate binders including non-calcium based phosphate weeks. The safety of cinacalcet in low
binders. ii) in whom surgical parathyroidectomy is birth weight infants, newborns,
contraindicated in that the risks of surgery are considered to sucklings, infants and children has not
outweigh the benefits, or if there is likely to be a significant been established. Caution when
delay for surgery. Response to treatment should be monitored cinacalcet is administered to patients
regularly and treatment should be continued with dose aged 65 years or older. It is
escalation as appropriate. If a reduction in the plasma levels of recommended not to use cinacalcet in
intact parathyroid hormone of 30% or more is not seen within pregnant women or in women who may
4 months of treatment, then consideration should be given to possibly be pregnant. Cinacalcet should
stopping treatment. be avoided in nursing mothers.

Cinnarizine 25 mg Tablet N07CA02000T1001XX No B Vestibular disorders Adult: One tablet 3 times daily
Ciprofloxacin 100 mg/50 ml Injection J01MA02125P3001XX No A Treatment of infections due to susceptible bacterial strains ADULT: the dosage range is 100-400mg
twice daily Gonorrhoea: 100mg single
dose Upper and Lower Urinary Tract
Infection: 100mg bd Upper and Lower
Respiratory Tract Infection: 200mg bd-
400mg twice daily Cystic Fibrosis with
psuedomonal Lower RTI: 400mg bd
Others: 200-400mg bd inhalation
Anthrax: 400mg bd

Ciprofloxacin 200 mg/100 ml Injection J01MA02125P3002XX No A Treatment of infections due to susceptible bacterial strains Suggest to rephrase ADULT: the dosage
range is 100-400mg twice daily
Gonorrhoea: 100mg single dose Upper
and Lower Urinary Tract Infection:
100mg bd Upper and Lower Respiratory
Tract Infection: 200mg bd-400mg twice
daily Cystic Fibrosis with psuedomonal
Lower RTI: 400mg bd Others: 200-400mg
bd inhalation Anthrax: 400mg bd

Ciprofloxacin 250 mg Tablet J01MA02110T1001XX No A Treatment of infections due to susceptible bacterial strains ADULT: 125-750 mg twice daily. Acute
gonorrhoea: a single dose of 250 mg

Ciprofloxacin 500 mg Tablet J01MA02110T1002XX No A Treatment of infections due to susceptible bacterial strains ADULT: 125-750 mg twice daily. Acute
gonorrhoea: a single dose of 250 mg

Ciprofloxacin HCl 0.3% Ophthalmic S01AX13110D2001XX No A* Treatment of bacterial infections caused by susceptible strains i) 2 drops every 15 minutes for the first 6
Solution in i) corneal ulcers ii) bacterial conjunctivitis hours, then 2 drops every 30 minutes for
the rest of the first day. Second day : 2
drops every hour. Subsequent days (3rd -
14th day) : 2 drops every 4 hours.
Treatment may be continued after 14
days if corneal re-epithelialization has
not occured ii) 1 - 2 drops every 2 hours
into the conjunctival sac while awake for
2 days and 1-2 drops every 4 hours while
awake for the next 5 days

Cisatracurium Besylate 2 mg/ml Injection M03AC11197P3001XX No A* As an adjunct to general anaesthesia to facilitate endotracheal Administered as bolus intravenous
intubation, to provide skeletal muscle relaxation during injection. May be administered as
surgery and to facilitate mechanical ventilation. Restricted to infusion in ICU patients at a rate of
patients with lung problem such as asthma. 3mcg/kg/min. Adult dose: a) Induction:
0.15mg/kg over 5-10 secs, b)
Maintenance: 0.03 mg/kg. Children 2-12
years: a) Induction: 0.1 mg/kg over 5-10
secs, b) Maintenance: 0.02 mg/kg

Cisplatin 10 mg Injection L01XA01000P3001XX No A Germ cell tumours, ovarian tumours, adult solid tumours, Germ cell tumours: 20 mg/m2 daily for 5
lymphomas days every 3 weeks for 3 - 4 courses.
Ovarian tumours: 75 mg/m2 once every
3 weeks as part of combination therapy
with paclitaxel or 50-60mg/m2 IV once
every 3 weeks as a single agent. Baseline
creatinine clearance, pretreatment
hydration and forced diuresis are
mandatory. CHILD: 100mg/m2 over 6
hours once every 3 weeks. Lymphomas:
Refer to protocols CHILD: 100mg/m2
over 6 hours once every 3 weeks.
Lymphomas: Refer to protocols

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Generic Name MDC NEML Category Indications Dosage

Cisplatin 50 mg Injection L01XA01000P3002XX No A Germ cell tumours, ovarian tumours, adult solid tumours, Germ cell tumours: 20 mg/m2 daily for 5
lymphomas days every 3 weeks for 3 - 4 courses.
Ovarian tumours: 75 mg/m2 once every
3 weeks as part of combination therapy
or 100 mg/m2 IV once every 3 weeks as
a single agent. Baseline creatinine
clearance, pretreatment hydration and
forced diuresis are mandatory. CHILD:
100mg/m2 over 6 hours once every 3
weeks. Lymphomas: Refer to protocols
CHILD: 100mg/m2 over 6 hours once
every 3 weeks. Lymphomas: Refer to
protocols

Clarithromycin 125 mg/5 ml Granules J01FA09000F1001XX Yes A* Treatment of complicated respiratory tract infections not CHILD: 8 - 12 years: 30 - 40 kg 10 mL, 4 -
responding to standard macrolides 8 years: 20 - 29 kg 7.5 mL, 2 - 4 years: 12 -
19 kg 5 mL, 1 - 2 years: 8 - 11 kg 2.5 mL,
less than 8 kg: 7.5 mg/kg. To be given
twice daily. Maximum dose: 1g/day

Clarithromycin 250 mg Tablet J01FA09000T1001XX Yes A* Only for i) treatment of complicated respiratory tract infection i) 250 - 500 mg twice daily. Up to 6 - 14
not responding to standard macrolides ii) eradication of days ii) 500 mg twice daily with
Helicobacter pylori infection omeprazole & amoxicillin. Up to 2 weeks

Clarithromycin 500 mg Injection J01FA09000P3001XX No A* Only for treatment of complicated respiratory tract infection Susceptible infections Adult: 500 mg bid
not responding to standard macrolides for 2-5 days. Dose to be infused over 60
minutes in a 0.2% solution; revert to oral
therapy whenever possible. Child: 1 mth-
12 yr: 7.5 mg/kg every 12 hr. Dose to be
given via infusion into proximal vein.
Dosage Recommendation CrCl
(ml/min)<30 : Half the dosage or double
dosing interval

Clindamycin HCl 300 mg Capsule J01FF01110C1001XX No A* i) Skin and soft tissue infections, bone& joint infections ii) i) ADULT: 150 - 300 mg every 6 hours; up
Cerebral toxoplasmosis iii) Children less than 8 years to 450 mg every 6 hours in severe
old:Treatment and prophylaxis of malaria in combination with infections; Max: 1.8g/day CHILD: 3 - 6
quinine, as an alternative to doxycline mg/kg every 6 hours. Children weighing
<10 kg should receive at least 37.5 mg
every 8 hr. ii) 600 mg 6 hourly for 6
weeks iii) 10mg/kg twice a day, in
combination with quinine. The
combination to be given for 7 days

Clindamycin Phosphate 150 mg/ml J01FF01162P3001XX No A* i) Skin and soft tissue infections, bone & joint infections ii) i) ADULT: 0.6 - 2.7 g daily (in 2 - 4 divided
Injection Cerebral toxoplasmosis doses); up to 4.8 g daily; CHILD over 1
month, 20 - 40 mg/kg/day or 350
mg/m2/day in 3 - 4 divided doses ii)
1200 mg every 6 hours for 3 weeks
followed by 300 mg orally every 6 hours
for another 3 weeks

Clobazam 10 mg tablet N05BA09000T1001XX No A* As adjunctive therapy in patients with epilepsy not adequately The initial dose in adults and adolescents
stabilised with their basic medication. >15 yr should be low (5 to15mg daily), if
necessary, increased gradually to a
maximum daily dose of about 80mg.
Doses of up to 30mg may be taken as a
single dose in the evening. The initial
dose in children from 3 to15 yr is
normally 5mg. A maintenance dose of
0.3 to 1.0mg/kg body weight daily is
usually sufficient.

Clobetasol Propionate 0.05% Cream D07AD01133G1001XX Yes A Short term treatment only of more resistant dermatoses eg. Apply sparingly once or twice daily,
psoriasis, recalcitrant eczemas, lichen planus, discoid lupus changing to lower potency therapy as
erythematosus and other conditions which do not respond soon as condition is controlled. For mild
satisfactorily to less potent steroids to moderate use maximum for 2 weeks.
For moderate to severe maximum
duration 4 consecutive weeks. Max: 50
g/week
Clobetasol Propionate 0.05% Ointment D07AD01133G5001XX Yes A Short term treatment only of more resistant dermatoses eg. Apply sparingly once or twice daily,
psoriasis, recalcitrant eczemas, lichen planus, discoid lupus changing to lower potency therapy as
erythematosus and other conditions which do not respond soon as condition is controlled. For mild
satisfactorily to less potent steroids to moderate use maximum for 2 weeks.
For moderate to severe maximum
duration 4 consecutive weeks. Max:50
g/week
Clobetasone Butyrate 0.05% Cream D07AB01255G1001XX Yes A/KK Eczema and dermatitis of all types Apply up to four times daily until
condition improves, then reduce
frequency
Clobetasone Butyrate 0.05% Ointment D07AB01255G5001XX Yes A Eczema and dermatitis of all types Apply up to four times daily until
condition improves, then reduce
frequency
Clodronate 800 mg Tablet M05BA02011T1011XX No A* Treatment of hypercalcaemia due to malignancy 2 tablets in single or two divided doses

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Generic Name MDC NEML Category Indications Dosage

Clofazimine 100 mg Capsule J04BA01000C1002XX Yes B i) Previously untreated leprosy patients ii) Leprosy patients i) ADULT: 100 mg each other day or 50
resistant to sulphones iii) Suppression of lepra reactions mg daily with 100mg Dapsone & 300mg
once a month with 600mg rifampicin
under supervision. Maximum: 200
mg/day. CHILD: 10-14 yr: 50mg
clofazimine on alternate days with 50mg
dapsone & 150 mg clofazimine with 450
mg rifampicin once a month.Maximum:
100 mg/day. ii) 100 mg daily iii) 200-
300mg usually effective. Treatment with
minimum suppression dose continued
for at least 6 months

Clofazimine 50 mg Capsule J04BA01000C1001XX Yes B i) Previously untreated leprosy patients ii) Leprosy patients i) ADULT: 100 mg each other day or 50
resistant to sulphones iii) Suppression of lepra reactions mg daily with 100mg Dapsone & 300mg
once a month with 600mg rifampicin
under supervision. Maximum: 200
mg/day. CHILD: 10-14 yr: 50mg
clofazimine on alternate days with 50mg
dapsone & 150 mg clofazimine with 450
mg rifampicin once a month.Maximum:
100 mg/day. ii) 100 mg daily iii) 200-
300mg usually effective. Treatment with
minimum suppression dose continued
for at least 6 months

Clomiphene Citrate 50mg Tablet G03GB02136T1001XX Yes A Anovulatory infertility 50 mg daily from 2nd - 6th or 5th - 9th
day of menstrual cycle. Increase dose
gradually by increments of 50 mg if
there is no response until a dosage of
200 mg daily is achieved (starting as
early as 30 days afer the previous
course). Further treatment may not be
recommended if pregnancy has not
occurred after a total of 6 treatment
cycles.
Clomipramine HCI 25 mg Tablet N06AA04110T1001XX No A Depression, obsessive-compulsive disorder. Initially 10 mg daily, increased gradually
as necessary to 30 - 150 mg daily in
divided doses or as a single dose at
bedtime; max 250 mg daily. ELDERLY
initially 10 mg daily increased carefully
over approximately 10 days to 30 - 75
mg daily;Child: ≥10 yr: Initially, 25 mg
daily, increased gradually over 2 wk.
Max: 3 mg/kg/day or 100 mg daily,
whichever is smaller. Give in divided
doses. Once titrated, dose may be given
as a single dose at bedtime.

Clonazepam 0.5 mg Tablet N03AE01000T1001XX Yes B i) Epilepsy ii) Non-epileptic myoclonus i) & ii) ADULT: Initial dose should not
exceed 1.5mg/day divided into 3 doses,
may be increased in increments of
0.5mg every 3 days until seizures are
controlled. Maintenance dose: 3-
6mg/day. Maximum: 20mg/day. CHILD
up to 10 years: initial dose 0.01-0.03
mg/kg/day in 2-3 divided doses,
increased by no more than 0.25-0.5mg
every third day, maximum
0.2mg/kg/day. CHILD 10-16 years: initial
dose 1-1.5mg/day in 2-3 divided dose,
may be increased by 0.25-0.5mg every
third day until individual maintenance
dose of 3-6mg/day is reached.

Clonazepam 2 mg Tablet N03AE01000T1002XX Yes B i) Epilepsy ii) Non-epileptic myoclonus i) & ii) ADULT: Initial dose should not
exceed 1.5mg/day divided into 3 doses,
may be increased in increments of
0.5mg every 3 days until seizures are
controlled. Maintenance dose: 3-
6mg/day. Maximum: 20mg/day. CHILD
up to 10 years: initial dose 0.01-0.03
mg/kg/day in 2-3 divided doses,
increased by no more than 0.25-0.5mg
every third day, maximum
0.2mg/kg/day. CHILD 10-16 years: initial
dose 1-1.5mg/day in 2-3 divided dose,
may be increased by 0.25-0.5mg every
third day until individual maintenance
dose of 3-6mg/day is reached.

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Generic Name MDC NEML Category Indications Dosage

Clonidine HCl 0.025 mg Tablet N02CX02110T1001XX No A Rapid opiod detoxification combination use with naltrexone Rapid detoxification in 4-5 days (use with
naltrexone): 6 mcg/kg ORALLY divided in
3 doses 6 to 8 hours apart the first day,
increasing to 11 mcg/kg divided in 3
doses given day two, tapering to 0.6
mcg/kg the third day. Rapid opioid
detoxification for 7 days ( use with
naltrexone) : 0.1 to 0.2 mg every 4 hours
as needed
Clopidogrel 75 mg Tablet B01AC04192T1001XX No A* Prevention of myocardial infarct, stroke or established 75 mg once daily
peripheral arterial disease. As second/third line treatment in
patients who are sensitive to acetylsalicylic acid & intolerant
to ticlopidine
Clostridium Botulinum Toxin Type A 100 M03AX01000P4001XX No A* i) Focal dystonias ii) Hemifacial spasm iii) Spasticity including 20 - 200 units 3 months once
units cerebral palsy
Clostridium Botulinum Type A toxin M03AX01000P4003XX No A* i) Focal dystonias ii) Hemifacial spasm iii) Spasticity including Initially 20 U/kg divided between both
haemagglutinin complex 300 units/vial cerebral palsy calf muscles. May be titrated 10-30 U/kg
powder for injection up to max of not >1000 U/patient.
Should only be used in children > 2 years
of age. Repeat injections given not less
than 3 months from previous injection.

Clostridium botulinum Type A toxin M03AX01000P4002XX No A* i) Focal dystonias ii) Hemifacial spasm iii) Spasticity including Initially 20 U/kg divided between both
haemagglutinin complex 500U/vial cerebral palsy calf muscles. May be titrated 10-30 U/kg
powder for injection up to max of not >1000 U/patient.
Should only be used in children > 2 years
of age. Repeat injections given not less
than 3 months from previous injection.

Clotrimazole 1% Cream D01AC01000G1001XX Yes B Cutaneous candidiasis, Tinea corporis, Tinea cruris, Tinea pedis Rub in gently onto affected and
and Tinea versicolor surrounding skin 2 or 3 times daily
continuing for about 2 weeks beyond the
dissapearance of all symptoms
Clotrimazole 1% Ear Drop S02AA00000D1002XX No B Otomycosis; concomitant therapy with antibiotics and 4 to 5 drops 3 to 4 times daily
corticosteroid ear drops
Clotrimazole 1% Solution D01AC01000L6001XX Yes A Cutaneous candidiasis, tinea orporis, tinea cruris, tinea pedis Apply gently onto affected and
and tinea versicolor surrounding skin area 2 or 3 times daily
continuing for 2-4 weeks
Clotrimazole 500 mg Vaginal Tablet G01AF02000S1003XX Yes B Vaginal candidiasis 500 mg as a single one-time dose
Cloxacillin Sodium 125 mg/5 ml J01CF02520L8001XX Yes B Treatment of susceptible bacterial infections, notably Child: 50-100 mg/kg in divided doses
Suspension penicillinase-producing staphylococci every 6 hr
Cloxacillin Sodium 250 mg Capsule J01CF02520C1001XX Yes B Treatment of susceptible bacterial infections, notably ADULT: 250 - 500 mg every 6 hours.
penicillinase-producing staphylococci Child: 50-100 mg/kg in divided doses
every 6 hr.
Cloxacillin Sodium 250 mg Injection J01CF02520P4001XX Yes B Treatment of susceptible bacterial infections, notably ADULT: 250 to 500 mg every 6 hours
penicillinase-producing staphylococci infections depending on type and severity of
infection. CHILD less than 20 kg: 25 to 50
mg/kg/day in equally divided doses
every 6 hours
Cloxacillin Sodium 500 mg Capsule J01CF02520C1002XX Yes B Treatment of susceptible bacterial infections, notably ADULT: 250 - 500 mg every 6 hours.
penicillinase-producing staphylococci Child: 50-100 mg/kg in divided doses
every 6 hr.
Cloxacillin Sodium 500 mg Injection J01CF02520P4002XX Yes B Treatment of susceptible bacterial infections, notably ADULT: 250 to 500 mg every 6 hours
penicillinase-producing staphylococci infections depending on type and severity of
infection. CHILD less than 20 kg: 25 to 50
mg/kg/day in equally divided doses
every 6 hours
Clozapine 100 mg Tablet N05AH02000T1002XX No A Treatment of resistant schizophrenia Initial dose : 12.5 mg ( once or twice )
daily, increase slowly in steps of 25 - 50
mg up to 300 mg daily within 2 - 3
weeks. Maximum 900 mg/day
Clozapine 25 mg Tablet N05AH02000T1001XX No A Treatment of resistant schizophrenia Initial dose : 12.5 mg ( once or twice )
daily, increase slowly in steps of 25 - 50
mg up to 300 mg daily within 2 - 3
weeks. Maximum 900 mg/day
Coal Tar 1-9% Ointment D05AA00000G5001XX Yes B Dandruff, seborrhoeic dermatitis, atopic dermatitis, eczema Apply sparingly to the affected area 1-3
and psoriasis. Used as a mild astringent for the skin, as a times daily starting with low strength
soothing and protective application in eczema and as a preparations
protective to slight excoriation
Coal Tar 20% Solution D05AA00000L5201XX Yes B Dandruff, seborrhoeic dermatitis, atopic dermatitis, eczema Use 100 ml in a bath
and psoriasis
Coal Tar and Salicylic Acid (various D05AA00946G5002XX No B Dandruff, seborrhoeic dermatitis, atopic dermatitis, eczema Apply to the affected areas
concentrations) Ointment and psoriasis
Coal Tar with Salicylic Acid (various D05AA00000L5202XX No B Dandruff, seborrhoeic dermatitis, atopic dermatitis, eczema Apply to the affected areas or as in
concentrations) Solution and psoriasis product leaflet
Cocaine 10% Solution N01BC01110L5001XX No B To produce local anaesthesia or vasoconstriction during Maximum total dose recommended for
endoscopic nasal surgery, turbinectomy septoplasty, application to the nasal mucosa in
polypectomy etc healthy adult is 1.5 to 2 mg/kg of a 10%
cocaine solution
Cocois Co. Ointment D05AA00946G5001XX No B Scalp psoriasis and severe seborrhoeic dermatitis Rub a small amount into the scalp gently

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Generic Name MDC NEML Category Indications Dosage

Colchicine 0.5 mg Tablet M04AC01000T1001XX Yes B i) Acute gout and prophylaxis of recurrent gout. ii) i) Initial dose, 0.5-1.2 mg, then 0.5-0.6
Leucocytoclastic Vasculitis either cutaneous or systemic mg every hour until relief of pain is
involvement, Behcet's syndrome, Urticarial vasculitis, Systemic obtained or vomiting or diarrhoea occurs
sclerosis, Sweet's syndrome and severe recalcitrant aphthous (Maximum : 8 mg). The course should
stomatitis not be repeated within 3 days.
Prevention of attacks during initial
treatment with allopurinol or uricosuric
drugs: 0.5 mg 1-3 times daily. ii) 0.5 mg 1-
3 times daily depends on disease and
severity, up to a maximum of 3 mg/day

Colistimethate Sodium 1 million IU per J01XB01520P4001XX No A* Intravenous administration for the treatment of serious A minimum of 5 days treatment is
vial (Polymyxin E) infections caused by Gram negative bacteria, when more generally recommended. For the
commonly used systemic antibacterial agents may be treatment of respiratory exacerbations
contraindicated or may be ineffective because of bacterial in cystic fibrosis patients, treatment
resistance. should be continued up to 12 days.
Children and adults (including elderly):
Up to 60kg: 50,000 units/kg/day to a
maximum of 75,000 units/kg/day. The
total daily dose should be divided into
three doses given at approximately 8-
hour intervals. Over 60kg: 1-2 million
units three times a day. The maximum
dose is 6 million units in 24 hours. Renal
impairment: In moderate to severe renal
impairment, excretion of colistimethate
sodium is delayed. Therefore, the dose
and dose interval should be adjusted in
order to prevent accumulation.
Suggested Dosage Adjustment in Renal
Impairment (for over 60 kg body
weight): - Mild (CrCl 20-50 ml/min): 1-2
million units every 8 hr. - Moderate (CrCl
10-20 ml/min): 1 million units every 12-
18 hr. - Severe (CrCl <10 ml/min): 1
million units every 18-24 hr.
Colloidal Bismuth Subcitrate 120 mg A02BX05136T1001XX No A Eradication therapy for Helicobacter Pylori in combination 240 mg twice daily for 1-2 weeks
Tablet with antibiotics and antisecretory drugs
Compound Sodium Lactate (Hartmanns B05XA30125P6001XX Yes C Replacement of extracellular losses of fluid and electrolytes, as 100-1000 ml by IV or according to the
Solution) an alkaliniser agent needs of the patient
Conjugated estrogens 0.3 mg Tablet G03CA57000T1003XX No A i) Osteoporosis associated with oestrogen deficiency ii) Female i) 0.3 - 0.625 mg daily ii) 0.3- 1.25mg
hypoestrogenism iii) Vasomotor symptoms associated with daily for 3weeks, then off for 1 week iii)
oestrogen deficiency iv)atrophic vaginitis and urethritis & iv) 0.3mg-1.25mg daily

Conjugated Estrogens 0.625 mg & G03FA12295T1002XX No A Management of moderate to severe vasomotor symptoms 1 tablet daily
Medroxyprogesterone Acetate 2.5 mg associated with menopause, prevention and management of
Tablet postmenopausal osteoporosis, atropic vaginitis and atropic
urethritis in post menopausal woman with intact uterus

Conjugated Oestrogens 0.625 mg Tablet G03CA57000T1001XX No A i) Osteoporosis associated with oestrogen deficiency ii) Female i) 0.3 - 0.625 mg daily ii) 0.3- 1.25mg
hypoestrogenism iii) Vasomotor symptoms associated with daily for 3weeks, then off for 1 week iii)
oestrogen deficiency iv)atrophic vaginitis and urethritis & iv) 0.3mg-1.25mg daily

Conjugated Oestrogens 0.625 mg/g G03CA57000G1001XX No A Atrophic vaginitis and post menopausal atrophic urethritis Intravaginally or topically 0.5-2g daily
Cream depending on severity of condition.
Administration should be cyclic, with 3
weeks on conjugated estrogens and one
week off. Estrogens should be used for
the shortest duration possible when
treating atrophic vaginitis. Every 3 to 6
months attempts should be made to
taper or discontinue therapy and
conjugated estrogens should be titrated
to give the lowest possible dosage to
control symptoms

Continuous Ambulatory Peritoneal B05DB00908H2504XX Yes B For chronic renal diseases requiring dialysis and acute therapy- Dose depending on clinical cases
Dialysis (CAPD) Solution containing 2.3% resistance renal failure eg. prior to transfer to a dialysis centre
glucose (Calcium 1.75mmol/L) &
(Calcium 1.25mmol/L)
Continuous Ambulatory Peritoneal B05DB00908H2501XX Yes B For chronic renal diseases requiring dialysis and acute therapy- Dose depending on clinical cases
Dialysis Solution containing 1.5% resistance renal failure eg. prior to transfer to a dialysis centre
Dextrose
Continuous Ambulatory Peritoneal B05DB00908H2502XX Yes B For chronic renal diseases requiring dialysis and acute therapy- Dose depending on clinical cases
Dialysis Solution containing 2.5% resistance renal failure eg. prior to transfer to a dialysis centre
Dextrose
Continuous Ambulatory Peritoneal B05DB00908H2503XX Yes B For chronic renal diseases requiring dialysis and acute therapy- Dose depending on clinical cases
Dialysis Solution containing 4.25% resistance renal failure eg. prior to transfer to a dialysis centre
Dextrose
Copper 250 mm2 Intrauterine Device G02BA02000M9001XX Yes B Intrauterine contraception One unit intrauterine device to be
inserted into the uterine cavity on the
last day of the menstrual flow or in the
first days afterwards. It is advised that
the Multiload Cu 250 devices are
replaced every 3 years

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Copper 375 mm2 Intrauterine Device G02BA02000M9002XX Yes B Contraception One unit intrauterine device to be
inserted into the uterine cavity on the
last day of the menstrual flow or in the
first days afterwards. It is advised that
the Multiload Cu 375 devices are
replaced every 5 years
Copper Sulphate Crystal D08A000183F9901XX No C Wounds The tip of the crystal should be
moistened by dipping in water and
applied carefully to the lesion
Corifollitropin Alfa 100mcg/0.5ml G03GA09000P5001XX No A* Controlled Ovarian Stimulation (COS) in combination with a Women with Body Weight ≤60 kg: A
solution for injection GnRH antagonist for the development of multiple follicles in single dose of 100 mcg should be
woman participating in an Assisted Reproductive Technology administered. Women with Body Weight
(ART) program Restriction: As second line treatment >60 kg: A single dose of 150 mcg should
alternative to other recombinant FSH be administered. Details : Refer to
Product Information
Corifollitropin Alfa 150mcg/0.5ml G03GA09000P5002XX No A* Controlled Ovarian Stimulation (COS) in combination with a Women with Body Weight ≤60 kg: A
solution for injection GnRH antagonist for the development of multiple follicles in single dose of 100 mcg should be
woman participating in an Assisted Reproductive Technology administered. Women with Body Weight
(ART) program Restriction: As second line treatment >60 kg: A single dose of 150 mcg should
alternative to other recombinant FSH be administered. Details : Refer to
Product Information
Cortisone Acetate 5 mg Tablet H02AB10122T1002XX No B For salt losing congenital adrenal hyperplasia in newborn and 20-30 mg/m2 daily. Doses may be
paediatric patients divided with two-thirds in the morning
and one-third late in the afternoon

Crotamiton 10 % Cream P03A000000G1001XX Yes B i) Pruritus ii) Scabies iii) Insect bite reactions i) and iii) Massage into affected area
until the medication is completely
absorbed. Repeat as needed. Apply 2 or
3 times daily ii) Apply to the whole body
from below the chin. 2nd application is
applied 24 hr later. May need to use
once daily for up to 5 days.

Cyanocobalamin 0.1 mg Injection B03BA01000P3001XX Yes B i) Prophylaxis of anaemia ii) Uncomplicated pernicious i) Prophylaxis of anaemia: 250-1000 mcg
anaemia or Vitamin B12 malabsorption IM every month ii) Uncomplicated
pernicious anaemia or Vitamin B12
malabsorption: Initial 100 mcg daily for 5-
10 days followed by 100-200 mcg
monthly until complete remission is
achieved. Maintenance: up to 1000 mcg
monthly. CHILD 30-50 mcg daily for 2 or
more weeks (to a total dose of 1-5mg).
Maintenance: 100 mcg monthly to
sustain remission OR AS PRESCRIBED.

Cyanocobalamin 1 mg Injection B03BA01000P3002XX Yes B i) Prophylaxis of anaemia associated with Vitamin B12 i) Prophylaxis of anaemia: 250-1000 mcg
deficiency ii) Uncomplicated pernicious anaemia or Vitamin IM every month ii) Uncomplicated
B12 malabsorption pernicious anaemia or Vitamin B12
malabsorption: Initial 100 mcg daily for 5-
10 days followed by 100-200 mcg
monthly until complete remission is
achieved. Maintenance: up to 1000 mcg
monthly. CHILD 30-50 mcg daily for 2 or
more weeks (to a total dose of 1-5mg).
OR AS PRESCRIBED.

Cyanocobalamin 50 mcg Tablet B03BA01000T1002XX No B Vitamin B12 deficiency of dietary origin ADULT 50-150 mcg daily. CHILD 50-105
mcg daily in 1-3 divided doses
Cyclopentolate 0.2% with Phenylephrine S01GA55990D2001XX No A Dilating agent for premature babies 1 drop every 5 - 10 minutes; not
1% Eye Drops exceeding three times to produce rapid
mydriasis. Observe infants closely for at
least 30 minutes
Cyclopentolate 1% Eye Drops S01FA04000D2002XX Yes A Mydriasis and cycloplegia ADULT : 1 drop of solution in eye(s); may
repeat after 5-10 minutes if needed.
CHILD : 1 drop of solution in eye(s); may
repeat after 5-10 minutes if needed. Pre-
treatment on the day prior to
examination is usually not necessary. If
desirable, 1 or 2 drops may be instilled
the evening prior to examination.

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Cyclophosphamide 1 g Injection L01AA01000P4002XX Yes A i) Solid tumours (adult and paediatric), leukaemia, non- i) ADULT: 600 - 750 mg/m2 IV once
Hodgkin's lymphoma, multiple myeloma ii) Severe lupus every 3 weeks as part of combination
nephritis (Class III and IV) iii) Other systemic vasculitis iv) regime. CHILD: Dose variable depending
Systemic lupus erythematosus, rheumatoid arthritis, on disease and protocol. Range 600
polyarteritis nodosa, wegener granulomatosis v) Pemphigus mg/m2 to 2 g/m2 infusion over 1 hour
vulgaris to 6 hours (lower doses can be given as
bolus). Care with pre and post-hydration.
Mesna to be given with doses more than
1 g/m2. Higher doses are used in
haematopoetic stem cell transplant-refer
to specific protocols ii) 750 mg/m2 BSA
monthly for 18 months iii) 750 mg/m2
BSA monthly for 6 months. Dose can be
adjusted up to 1,000 mg/m2 BSA to
achieve adequate leucocyte suppression
iv) 500 - 1000 mg intravenously (Regime
varies according to indication). Starting
dose may be given fortnightly then at
monthly intervals followed by 3 monthly
intervals v) 500 mg infusion on the 2nd
day of the dexamethasone-
cyclophosphamide pulsed regime, the
cycle is repeated every 4 weeks up to 6
cycles or till remission followed by oral
cyclophosphamide
Cyclophosphamide 200 mg Injection L01AA01000P4001XX Yes A i) Solid tumours (adult and paediatric), leukaemia, non- i) ADULT: 600 - 750 mg/m2 IV once
Hodgkin's lymphoma, multiple myeloma ii) Severe lupus every 3 weeks as part of combination
nephritis (Class III and IV) iii) Other systemic vasculitis iv) regime. CHILD: Dose variable depending
Systemic lupus erythematosus, rheumatoid arthritis, on disease and protocol. Range 600
polyarteritis nodosa, wegener granulomatosis v) Pemphigus mg/m2 to 2 g/m2 infusion over 1 hour
vulgaris to 6 hours (lower doses can be given as
bolus). Care with pre and post-hydration.
Mesna to be given with doses more than
1 g/m2. Higher doses are used in
haematopoetic stem cell transplant-refer
to specific protocols ii) 750 mg/m2 BSA
monthly for 18 months iii) 750 mg/m2
BSA monthly for 6 months. Dose can be
adjusted up to 1,000 mg/m2 BSA to
achieve adequate leucocyte suppression
iv) 500 - 1000 mg intravenously (Regime
varies according to indication). Starting
dose may be given fortnightly then at
monthly intervals followed by 3 monthly
intervals v) 500 mg infusion on the 2nd
day of the dexamethasone-
cyclophosphamide pulsed regime, the
cycle is repeated every 4 weeks up to 6
cycles or till remission followed by oral
cyclophosphamide
Cyclophosphamide 50 mg Tablet L01AA01000T1001XX Yes A i) Solid tumours, leukaemia, lymphoma, autoimmune i) ADULT: 50 - 100 mg/day. Monitor full
disorders, autoimmune bullous diseases, connective tissue blood count (FBC), liver function, urine
disease, pyoderma gangrenosum ii) For severe lupus nephritis microscopy and renal function. CHILD,
(Class III & IV), systemic vasculitis and steroid up to 1 year: 10 - 20 mg daily, 1 - 5
resistant/dependent nephrotic syndrome iii) Systemic lupus years: 30 - 50 mg daily, 6 - 12 years: 50 -
erythematosus (SLE), rheumatoid arthritis, polyarteritis 100 mg daily ii) 2 mg/kg/day for 3 - 4
nodosa, wegener granulomatosis months iii) 1 - 1.5 mg/kg/day orally in
divided doses
Cycloserine 250 mg Capsule J04AB01000C1001XX Yes A* Multi-Drug Resistance Tuberculosis treatment failure. (For ADULT: Initial: 250 mg every 12 hours
respiratory physicians) for 14 days, then administer 0.5 - 1 g
daily in 2 divided doses for 18 - 24
months (maximum daily dose: 1 g).
CHILD: 2-12 yr: 5 mg/kg bid; 12-18 yr:
250 mg bid for 2 wk then adjusted to a
max dose of 1 g daily
Cyclosporine Ophthalmic Emulsion S01XA18000D2001XX No A* To increase tear production in patients whose tear production 1 drop twice a day in each eye
0.05% is presumed to be suppressed due to ocular inflammation approximately 12 hours apart.
associated with keratoconjunctivitis sicca. Increased tear
production was not seen in patients currently taking anti
inflammatory drugs or using punctal plugs.

Cyproterone Acetate 2 mg & G03HB01954T1001XX No A* Androgen dependent diseases in women 1 tablet daily for 21 days on the first day
Ethinyloestradiol 0.035 mg Tablet of the cycle, followed by 7 tab free days.
Starting on day 2 to 5 is allowed, but
during the first cycle a barrier method is
recommended for the first 7days of
tablet taking.
Cyproterone Acetate 50 mg Tablet G03HA01122T1001XX No A* Carcinoma of prostate i) After orchidectomy, 100 mg once daily
or twice daily ii) If used together with
LHRH agonists, the initial dose is 100 mg
twice daily for 5 to 7 days before the
start of LHRH agonist, then 100 mg twice
daily for 3 to 4 weeks together with the
LHRH agonist

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Cytarabine 1 g Injection L01BC01000P4004XX Yes A i) Central nervous system lymphoma ii) Meningeal leukemia iii) Standard doses 100 - 200 mg/m2 daily
Non Hodgkin's Lymphoma iv) High dose cytarabine as over 5 - 10 days. Higher doses for
conditioning to cytoreduce the disease before stem cell intensification/consolidation: 1000 -
transplant for relapsed or refractory leukemia v) As salvage for 3000 mg/m2 daily over 3 - 5 days
acute lymphocytic leukemia vi) As salvage for acute myeloid depending on specific protocols. CHILD:
leukemia vii) As palliative chemotherapy in elderly acute Dose variable depending on disease and
myeloid leukemia/ myelodysplastic syndrome protocol. Range from 100 mg/m2 to 3
g/m2 twice daily. May be given as SC, IV
bolus or infusion. Intrathecal dose: Less
than 1 year: 15 mg, 1 - 2 years: 20 mg, 2 -
3 years: 25 mg, more than 3 years: 30
mg. (ENSURE THAT PREPARATION IS
SUITABLE FOR INTRATHECAL USE)

Cytarabine 100 mg Injection L01BC01000P4002XX Yes A i) Central nervous system lymphoma ii) Meningeal leukemia iii) Standard doses 100 - 200 mg/m2 daily
Non Hodgkin's Lymphoma iv) High dose cytarabine as over 5 - 10 days. Higher doses for
conditioning to cytoreduce the disease before stem cell intensification/consolidation: 1000 -
transplant for relapsed or refractory leukemia v) As salvage for 3000 mg/m2 daily over 3 - 5 days
acute lymphocytic leukemia vi) As salvage for acute myeloid depending on specific protocols. CHILD:
leukemia vii) As palliative chemotherapy in elderly acute Dose variable depending on disease and
myeloid leukemia/ myelodysplastic syndrome protocol. Range from 100 mg/m2 to 3
g/m2 twice daily. May be given as SC, IV
bolus or infusion. Intrathecal dose: Less
than 1 year: 15 mg, 1 - 2 years: 20 mg, 2 -
3 years: 25 mg, more than 3 years: 30
mg. (ENSURE THAT PREPARATION IS
SUITABLE FOR INTRATHECAL USE)

Cytarabine 500 mg Injection L01BC01000P4003XX Yes A i) Central nervous system lymphoma ii) Meningeal leukemia iii) Standard doses 100 - 200 mg/m2 daily
Non Hodgkin's Lymphoma iv) High dose cytarabine as over 5 - 10 days. Higher doses for
conditioning to cytoreduce the disease before stem cell intensification/consolidation: 1000 -
transplant for relapsed or refractory leukemia v) As salvage for 3000 mg/m2 daily over 3 - 5 days
acute lymphocytic leukemia vi) As salvage for acute myeloid depending on specific protocols. CHILD:
leukemia vii) As palliative chemotherapy in elderly acute Dose variable depending on disease and
myeloid leukemia/ myelodysplastic syndrome protocol. Range from 100 mg/m2 to 3
g/m2 twice daily. May be given as SC, IV
bolus or infusion. Intrathecal dose: Less
than 1 year: 15 mg, 1 - 2 years: 20 mg, 2 -
3 years: 25 mg, more than 3 years: 30
mg. (ENSURE THAT PREPARATION IS
SUITABLE FOR INTRATHECAL USE)

Dabigatran Etexilate 110 mg Capsule B01AE07999C1002XX No A* i) Prevention of venous thromboembolic events in patients i) Following total knee replacement:
who have undergone total knee replacement or total hip Initially ADULT 110mg (ELDERLY, 75 mg)
replacement surgery. ii) Reduction of the risk of stroke and
within 1- 4 hours after surgery, then 220
systemic embolism in patients with non-valvular atrial mg (ELDERLY, 150 mg) once daily
fibrillation (AF). iii) Treatment of deep vein thrombosis (DVT)
thereafter for 6-10 days Following total
and pulmonary embolism (PE) and prevention of recurrent hip replacement: Initially ADULT 110 mg
DVT and PE in adults. (ELDERLY, 75 mg) within 1- 4 hours after
surgery, then 220 mg (ELDERLY, 150 mg)
once daily thereafter for 28-35 days ii)
Recommended daily dose is 300mg
taken orally as 150mg hard capsule twice
daily. Therapy should be continued
lifelong. iii) Recommended daily dose is
300mg taken as one 150mg capsule BD
following treatment with a parenteral
anticoagulant for at least 5 days. The
duration of therapy should be
individualized after careful assessment
of the treatment benefit against the risk
for bleeding. ii) & iii) For the following
groups, the recommended daily dose is
220 mg taken as one 110mg capsule
twice daily: - Patients aged 80 years or
above -Patients who receive
concomitant verapamil Special patient
population for renal impairment : Renal
Dabigatran Etexilate 75 mg Capsule B01AE07999C1001XX No A* Prevention of venous thromboembolic events in patients who Following total knee replacement:
have undergone total knee replacement or total hip Initially ADULT 110 mg (ELDERLY, 75 mg)
replacement surgery within 1- 4 hours after surgery, then 220
mg (ELDERLY, 150 mg) once daily
thereafter for 6-10 days Following total
hip replacement: Initially ADULT 110 mg
(ELDERLY, 75 mg) within 1- 4 hours after
surgery, then 220 mg (ELDERLY, 150 mg)
once daily thereafter for 28-35 days

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Dabigatran Etexilate150 mg Capsule B01AE07999C1003XX No A* i) Reduction of the risk of stroke and systemic embolism in i) Recommended daily dose is 300mg
patients with non-valvular atrial fibrillation (AF). ii) Treatment taken orally as 150mg hard capsule twice
of deep vein thrombosis (DVT) and pulmonary embolism (PE) daily. Therapy should be continued
and prevention of recurrent DVT and PE in adults. lifelong. ii) Recommended daily dose is
300mg taken as one 150mg capsule BD
following treatment with a parenteral
anticoagulant for at least 5 days. The
duration of therapy should be
individualized after careful assessment
of the treatment benefit against the risk
for bleeding. For the following groups,
the recommended daily dose is 220 mg
taken as one 110mg capsule twice daily: -
Patients aged 80 years or above -Patients
who receive concomitant verapamil
Special patient population for renal
impairment : Renal function should be
assessed by calculating the creatinine
clearance (CrCl) prior to initiation of
treatment with Dabigatran to exclude
patients for treatment with severe renal
impairment (i.e. CrCl < 30 ml/min).

Dacarbazine 100 mg Injection L01AX04000P4001XX Yes A* i) Malignant melanoma, sarcomas, neuroblastomas and other i) 250 mg/m2 for 5 days, may be
childhood solid tumours ii) Hodgkin's Disease repeated every 3 weeks ii) 375 mg/m2 IV
every 2 weeks
Danazol 100 mg Capsule G03XA01000C1001XX No A/KK i)Endometriosis and gynaecomastia ii)Menorrhagia i)200 - 800 mg daily for max of 9 months
iii)Prophylaxis of hereditary angioedema ii)200 mg daily for 12 weeks ii)400 mg
daily. Reduce to 200 mg daily after 2
months attack free period

Danazol 200 mg Capsule G03XA01000C1002XX No A/KK i)Endometriosis and gynaecomastia ii)Menorrhagia i)200 - 800 mg daily for max of 9 months
iii)Prophylaxis of hereditary angioedema ii)200 mg daily for 12 weeks ii)400 mg
daily. Reduce to 200 mg daily after 2
months attack free period

Dapsone 100 mg Tablet J04BA02000T1001XX Yes B i)Leprosy ii) Dermatitis herpetiformis i) ADULT: 6 - 10 mg/kg weekly/ 1.4mg/kg
daily (around 50 - 100 mg daily). CHILD:
1 - 2 mg/kg/day. Maximum: 100 mg/day
ii) ADULT: 50 - 300 mg daily

Darbepoetin alfa 120mcg/0.5ml injection B03XA02-000-P50-04- No A* Treatment of anaemia associated with chronic renal failure, Hemodialysis patients: Initial dose:
XXX including patients on dialysis and patients not on dialysis. 20mcg IV once weekly Initial dose for
Prescribing restriction: Patients who require 2 or more switched ESA-treated patient: 15 –
subcutaneous erythropoietin injections per week, where 60mcg IV once weekly Maintenance
logistics or compliance is an issue. dose: 15 – 60mcg IV once weekly, then
30 – 120mcg IV biweekly. Peritoneal
dialysis patients and patients with
chronic kidney disease not on dialysis:
Initial dose: 30mcg IV or SC biweekly
Initial dose for switched ESA-treated
patient: 30 – 120mcg IV or SC biweekly
Maintenance dose: 30 – 120mcg IV or SC
biweekly, then 60 – 180mcg IV or SC
once every four weeks.

Darbepoetin alfa 20mcg/0.5ml injection B03XA02-000-P50-01- No A* Treatment of anaemia associated with chronic renal failure, Hemodialysis patients: Initial dose:
XXX including patients on dialysis and patients not on dialysis. 20mcg IV once weekly Initial dose for
Prescribing restriction: Patients who require 2 or more switched ESA-treated patient: 15 –
subcutaneous erythropoietin injections per week, where 60mcg IV once weekly Maintenance
logistics or compliance is an issue. dose: 15 – 60mcg IV once weekly, then
30 – 120mcg IV biweekly. Peritoneal
dialysis patients and patients with
chronic kidney disease not on dialysis:
Initial dose: 30mcg IV or SC biweekly
Initial dose for switched ESA-treated
patient: 30 – 120mcg IV or SC biweekly
Maintenance dose: 30 – 120mcg IV or SC
biweekly, then 60 – 180mcg IV or SC
once every four weeks.

Darbepoetin alfa 40mcg/0.5ml injection B03XA02-000-P50-03- No A* Treatment of anaemia associated with chronic renal failure, Hemodialysis patients: Initial dose:
XXX including patients on dialysis and patients not on dialysis. 20mcg IV once weekly Initial dose for
Prescribing restriction: Patients who require 2 or more switched ESA-treated patient: 15 –
subcutaneous erythropoietin injections per week, where 60mcg IV once weekly Maintenance
logistics or compliance is an issue. dose: 15 – 60mcg IV once weekly, then
30 – 120mcg IV biweekly. Peritoneal
dialysis patients and patients with
chronic kidney disease not on dialysis:
Initial dose: 30mcg IV or SC biweekly
Initial dose for switched ESA-treated
patient: 30 – 120mcg IV or SC biweekly
Maintenance dose: 30 – 120mcg IV or SC
biweekly, then 60 – 180mcg IV or SC
once every four weeks.

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Daunorubicin HCl 20 mg Injection L01DB02110P4001XX Yes A* i) Acute myeloblastic leukaemia (AML) ii) Acute lymphoblastic i) 45 - 60 mg/m2 IV daily for 3 - 5 days ii)
leukemia (ALL) 25 - 45 mg/m2 once a week for first 4
weeks during induction phase. Caution:
Total cumulative dose of daunorubicin
and doxorubicin must not exceed 500
mg/m2 due to risk of cardiotoxicity.
CHILD: 30-45 mg/m2/dose infusion over
6 hours. Schedule depends on protocol.
Need to check cardiac function closely
by echocardiography every cumulative
dose of 100mg/m2 to max. 360 mg/m2

Decitabine 50 mg Injection L01BC08000P3001XX No A* Myelodysplastic syndromes (MDS) including: Previously 15 mg/m2 by continuous IV infusion
treated and untreated de novo and secondary MDS of all over 3 hours repeated every 8 hours for
French-American-British subtypes (refractory anemia, 3 days. Repeat this treatment cycle every
refractory anemia with ringed sideroblasts, refractory anemia 6 weeks for a minimum of 4 cycles.
with excess blasts, refractory anemia with excess blasts in However, complete or partial response
transformation, and chronic myelomonocytic leukemia) and may take longer than 4 cycles.
Intermediate-1, Intermediate-2, and High-Risk International Treatment may be continued as long as
Prognostic Scoring System (IPSS) groups there is continued

Deferasirox 125 mg Dispersible Tablet V03AC03000T4001XX No A* Treatment of chronic iron overload due to blood transfusions Initial 20 mg/kg/day. Starting dose can
(transfusional haemosiderosis) in adult and pediatric patients also be based on transfusion rate and
aged 2 years and above. existing iron burden. In patients not
adequately controlled with doses of
30mg/kg/day (e.g serum ferritin levels
persistently above 2,500 microgram/L
and not showing a decreasing trend over
time), doses up to 40mg/kg/day may be
considered.

Deferasirox 500 mg Dispersible Tablet V03AC03000T4002XX No A* Treatment of chronic iron overload due to blood transfusions Initial 20 mg/kg/day. Starting dose can
(transfusional haemosiderosis) in adult and pediatric patients also be based on transfusion rate and
aged 2 years and above. existing iron burden. In patients not
adequately controlled with doses of
30mg/kg/day (e.g serum ferritin levels
persistently above 2,500 microgram/L
and not showing a decreasing trend over
time), doses up to 40mg/kg/day may be
considered.

Deferiprone 500 mg Tablet V03AC02000T1001XX No A* Treatment of iron overload in patients with thalassemia major 25 mg/kg 3 times a day for total daily
for whom desferrioxamine therapy is contraindicated or dose of 75 mg/kg. Doses greater 100
inadequate. Add on therapy to desferrioxamine for mg/kg are not recommended
thalassemia patients with cardiac complication

Denosumab in 1.0 mL solution (60 M05BX04000P4001XX No A* Post-Menopausal Osteoporosis. (To be used by Orthopaedic A single subcutaneous injection of 60 mg
mg/mL) Pre-filled syringe (subcutaneous Specialist, Rheumatologist and Endocrinologist) administered once every 6 months.
injection) Patients should receive calcium and
vitamin D supplements whilst
undergoing treatment.
Desferrioxamine B Methanesulphonate V03AC01196P3001XX Yes A i) Acute iron poisoning in children ii) Investigation and i) 2 g by IM immediately and 5 g by
0.5 g Injection treatment of haemochromatosis iii) Diagnosis and treatment mouth after gastric lavage ii) 0.5 - 1.5 g
of aluminium toxicity in patients with renal failure and dialysis by IM injection daily iii) Diagnosis: 5 mg
iv) Chronic iron toxicity or overload per kg by slow intravenous infusion
during the last hour of haemodialysis.
Treatment: 5 mg per kg once a week by
slow intravenous infusion during the last
hour of dialysis iv) 30 - 50 mg/kg

Desflurane Liquid N01AB07000L5001XX No A i) Induction and maintenance of anaesthesia in adult ii) ADULT: Induction , initially 3% in oxygen
Maintenance of anaesthesia in infants & children or nitrous oxide/oxygen and increased
by 0.5%-1% every 2-3 breaths or as
tolerated (up to 11%), until loss of
consciousness. Maintenance: 2.5%-8.5%
with or without concomitant nitrous
oxide CHILD: maintenance, inhaled in
concentrations of 5.2%-10% with or
without concomitant nitrous oxide

Desloratadine 2.5mg/5ml syrup R06AX27000L9001XX No A* Allergic rhinitis and chronic idiopathic urticaria. Prescribing For children only: 1-5 yrs: 2.5ml once a
Restriction(s): For use in children 1-2 years old only. day (with or without meal) 6-11 yrs: 5ml
once a day (with or without meal)

Desloratadine 5 mg Tablet R06AX27000T1001XX No A* Allergic rhinitis and chronic idiopathic urticaria Adults and Adolescents (12 years of age
and older): 5mg once a day regardless of
mealtime.
Desmopressin 0.1 mg Tablet H01BA02122T1001XX No A i)Central diabetes insipidus ii)Primary nocturnal enuresis i)ADULT and CHILD : 0.1-0.2mg 3 times
iii)Treatment of nocturia associated with nocturnal polyuria in daily, up to 0.1-1.2mg daily ii) ADULT &
adult Child≥5 yr 0.2-0.4mg at night iii)Initially
0.1 mg at night. May be increased to 0.2
mg and then to 0.4 mg by means of
weekly increase

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Desmopressin 0.2 mg Tablet H01BA02122T1002XX No A i)Central diabetes insipidus ii)Primary nocturnal enuresis i)ADULT and CHILD : 0.1-0.2mg 3 times
iii)Treatment of nocturia associated with nocturnal polyuria in daily, up to 0.1-1.2mg daily ii) ADULT &
adult Child≥5 yr 0.2-0.4mg at night iii)Initially
0.1 mg at night. May be increased to 0.2
mg and then to 0.4 mg by means of
weekly increase
Desmopressin 100 mcg/ml Nasal Spray H01BA02122A4101XX No A i) Diabetes Insipidus ii) Primary nocturnal enuresis i) ADULT : 10 - 20 mcg 1-2 times daily.
CHILD: 5 - 10mcg 1-2 times daily ii) 10-40
mcg nocte
Desmopressin Acetate 4 mcg/ml H01BA02122P3001XX No A Diabetes insipidus ADULT : 1 - 4 mcg IV daily. CHILD :0.4
Injection mcg daily
Desogestrel 0.075 mg Tablet G03AC09000T1001XX No A* Contraception. Only for women who should not take Tablets must be taken in the order
combined oral contraceptives (COCs) eg Obese, smoker, directed on the package every day at
migraine, breast feeding about the same time with some liquid as
needed. One tablet is to be taken daily
for 28 consecutive days. Each
subsequent pack is started immediately
after finishing the previous pack.

Desogestrel 150 mcg & Ethinylestradiol G03AA09954T1002XX No A/KK Oral contraception One tablet daily for 21 days starting on
20 mcg Tablet 1st day of menses followed by 7 tablet-
free days.
Desogestrel 150 mcg & Ethinylestradiol G03AB05954T1001XX Yes C+ Contraception 1 tablet daily for 21 days, subsequent
30 mcg Tablet courses repeated after 7 day interval
(during which withdrawal bleeding
occurs)
Desvenlafaxine Succinate 50 mg N06AX23999T5002XX No A* Major depression Recommended dose is 50mg once daily,
Extended Release Tablet with or without food.
Dexamethasone 0.5 mg Tablet H02AB02000T1001XX No A i) Prophylaxis and management of nausea and vomiting in 0.5mg to 10mg daily is given for oral
cancer chemotherapy, post-operation and palliative care, ii) administration, depending upon the
Treatment of adrenocortical function abnormalities, iii) Any disease being treated. Up to 15 mg daily
other treatment requiring corticosteroid therapy. in severe disease.

Dexamethasone 4mg Tablet H02AB02000T1003XX No A i) Prophylaxis and management of nausea and vomiting in 0.5mg to 10mg daily is given for oral
cancer chemotherapy, post-operation and palliative care, ii) administration, depending upon the
Treatment of adrenocortical function abnormalities, iii) Any disease being treated.
other treatment requiring corticosteroid therapy.

Dexamethasone and Neomycin Sulphate S01CA01990G5101XX No A Treatment of ocular inflammation when concurrent use of an Apply 1 - 1.5 cm 3 - 4 times daily, may be
and Polymyxin B Eye Ointment antimicrobial is judged necessary used adjunctively with drops at bedtime

Dexamethasone and Neomycin Sulphate S01CA01990D2001XX No A Treatment of ocular inflammation when concurrent use of an 1 - 2 drops hourly for severe cases and 4 -
and Polymyxin B Sulphate Ophthalmic antimicrobial is judged necessary 6 hourly for mild infection
Suspension
Dexamethasone Sodium Phosphate 0.1% S01BA01162D2001XX No A Acute steroid responsive inflammatory and allergic conditions 1 - 2 drops 4 - 6 times a day
Eye Drops
Dexamethasone Sodium Phosphate 4 H02AB02162P3001XX Yes B i) Prophylaxis and management of nausea and vomiting in Initially 0.5 - 9 mg IM, IV or infusion
mg/ml Injection cancer chemotherapy, post-operation and palliative care, ii) daily, depending upon the disease being
Treatment of adrenocortical function abnormalities, iii) Any treated
other treatment requiring corticosteroid therapy.

Dexchlorpheniramine Maleate 2 mg R06AB02253T1001XX No B Symptomatic treatment of allergic rhinitis and allergic ADULT : 2 mg 3 times daily. CHILD : 2 -
Tablet dermatoses 12 years : 2 mg 3 times daily
Dexchlorpheniramine Maleate 2 mg/5 R06AB02253L9001XX No B Symptomatic treatment of allergic rhinitis CHILD 2 - 5 years : 0.5 mg every 4 - 6
ml Syrup hours; 6 - 11 years : 1 mg every 4 - 6
hours
Dexmedetomidine HCl 100 mcg/ml N05CM18110P4001XX No A* i) Sedation of intubated and mechanically ventilated ICU i) Not to be infused for more than 24
Injection patients. For use only by specialist anaesthetist ii) For sedation hours, 1 mcg/kg over 10 minutes as
of non-intubated patients prior to and/or during surgical and loading dose. Maintenance dose: 0.2 -
other procedures 0.7 mcg/kg/hr ii) Not to be infused for
more than 24 hours, 1 mcg/kg over 10
minutes as loading dose. Maintenance
dose: 0.2 - 0.7 mcg/kg/hr

Dextran 40 Injection B05AA05000P6001XX No A* Condition associated with peripheral local slowing of the Initially 500-1000 ml by infusion, further
blood flow, prophylaxis of post surgical thromboembolic doses are given according to the
disease patient's condition
Dextrose 10% Injection B05BA03000P6002XX Yes B For parenteral replenishment of fluid and minimal According to the needs of the patient
carbohydrate calories as required by the clinical condition of
the patient
Dextrose 20% Injection B05BA03000P6003XX Yes B For parenteral replenishment of fluid and minimal According to the needs of the patient
carbohydrate calories as required by the clinical condition of
the patient
Dextrose 30% Injection B05BA03000P3004XX Yes B For parenteral replenishment of fluid and minimal According to the needs of the patient
carbohydrate calories as required by the clinical condition of
the patient
Dextrose 5% Injection B05BA03000P6001XX Yes B For parenteral replenishment of fluid and minimal According to the needs of the patient
carbohydrate calories as required by the clinical condition of
the patient
Dextrose 50% Injection B05BA03000P3005XX Yes B For parenteral replenishment of fluid and minimal According to the needs of the patient
carbohydrate calories as required by the clinical condition of
the patient
Dextrose Powder V04CA02000F2101XX No B Use as a diagnostic agent for diabetes 75 g stat

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Generic Name MDC NEML Category Indications Dosage

Diatrizoate Meglumine and Sodium V08AA01254L9901XX No A i) Contrast medium for the radiological examination of the i) ADULT and CHILD more than 10 year,
Amidotrizoate Solution gastrointestinal tract (primarily in cases in which barium ORALLY: 60 -100 ml RECTALLY, contrast
sulphate is contraindicated) ii) Computerised tomography in medium should be diluted with 3-4
abdominal region iii) Treatment of Mecolinium ileus times its volume of water. ORALLY:
CHILD less than 10 years,: 15- 30 ml
NEWBORN, INFANT contrast medium
should be diluted with 3 times its
volume of water. RECTALLY: CHILD more
than 5 years, contrast medium should be
diluted with 4-5 times its volume of
water. Younger patients a dilution with 5
times its volume is recommended ii)
Adult, orally, 25-77 mL in 1000 mL tap
water 15-30 minutes prior to imaging

Diazepam 2 mg Tablet N05BA01000T1001XX Yes B i) Muscle spasm of varied aetiology, including tetanus ii) i) ADULT: 2-10 mg 3-4 times daily. CHILD
Anxiety disorders 6 months and older: 0.12 - 0.8 mg/kg
daily in divided doses, every 6-8 hours ii)
ADULT : 2 mg 3 times daily, increased in
severe anxiety to 15 - 30 mg daily in
divided doses. ELDERLY (or delibitated)
half adult dose. CHILD (night terrors), 1 -
5 mg at bedtime

Diazepam 5 mg Rectal Solution N05BA01000G2001XX Yes C Status epilepticus, skeletal muscle spasm Status epilepticus - ADULT: 0.5 mg/kg
repeated after 12 hours if necessary.
CHILD (febrile convulsions, prolonged or
recurrent): 0.5 mg/kg (maximum 10 mg),
repeated if necessary. Not
recommended for children below 2
years

Diazepam 5 mg Tablet N05BA01000T1002XX Yes B i) Muscle spasm of varied aetiology, including tetanus ii) i) ADULT: 2-10 mg 3-4 times daily. CHILD
Anxiety disorders 6 months and older: 0.12 - 0.8 mg/kg
daily in divided doses, every 6-8 hours ii)
ADULT : 2 mg 3 times daily, increased in
severe anxiety to 15 - 30 mg daily in
divided doses. ELDERLY (or delibitated)
half adult dose. CHILD (night terrors), 1 -
5 mg at bedtime

Diazepam 5 mg/ml Injection N05BA01000P3001XX Yes B i) Status epilepticus ii) Skeletal muscle spasm iii) Anxiety i) Status epilepticus, by slow IV: 5-10
disorders every 10-15 minute (rate not more than
5 mg/min), to a total dose of 30 mg, may
repeat in 2 hour if needed. Infants 30
days to 5 years, 0.05-0.3 mg/kg/dose
given over 2-3 minutes, every 15-30
minutes to a total dose of 5 mg, repeat
in 2-4 hours if necessary. CHILD more
than 5 years, 1 mg by slow IV, every 2-5
minutes, maximum 10 mg, repeat in 2-4
hours if necessary ii) Skeletal muscle
spasm, by slow IV or IM, 5-10 mg
repeated if necessary in 3-4 hours. CHILD
(tetanus): 30 days - 5 years, 1-2 mg IM or
IV slowly every 3-4 hours as needed. 5
years and above, 5-10 mg IM or IV slowly
every 3-4 hours if needed iii) Anxiety
disorders, 2-10 mg by slow IV (not more
than 5 mg/min). Repeat if necessary
every 3-4 hours

Diclofenac 1% Gel M02AA15520G3001XX No A Post-traumatic inflammation of the tendons,ligaments & Apply 3 - 4 times daily and gently rubbed
joints. Localised forms of soft tissue rheumatism and in
degenerative rheumatism
Diclofenac 100mg Suppository M01AB05520S2004XX No A Pain and inflammation in rheumatic disease and juvenile Diclofenac Suppositories are normally
arthritis inserted one, two or three times a day
up to a maximum total daily dose of 150
mg.
Diclofenac 12.5 mg Suppository M01AB05520S2001XX No A Pain and inflammation in rheumatic disease and juvenile ADULT: 75 - 150 mg daily in divided
arthritis doses. CHILD 1-12 years, 12.5- 25 mg
daily
Diclofenac 25 mg Suppository M01AB05520S2002XX No A Pain and inflammation in rheumatic disease and juvenile ADULT: 75 - 150 mg daily in divided
arthritis doses. CHILD 1-12 years, 12.5- 25 mg
daily
Diclofenac 50 mg Tablet M01AB05520T1001XX Yes B Pain and inflammation in rheumatic disease ADULTS: Initial dose of 150 mg daily.
Mild or long term: 75 - 150 mg daily in 2
to 3 divided doses after food. Maximum
200mg/day. PAEDS more than 6 months
: 1 - 3 mg/kg body weight daily in divided
doses. Maximum 3mg/kg/day (Max
150mg/day).

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Diclofenac Sodium 50 mg Suppository M01AB05520S2003XX No A Pain and inflammation in rheumatic disease and juvenile ADULTS: 75 - 150 mg daily in divided
arthritis doses. Maximum 150mg/day. PAEDS
more than 6 months : 1 - 3 mg/kg body
weight daily in divided doses. Maximum
3mg/kg/day (Max 150mg/day).

Diclofenac Sodium 75 mg/3 ml Injection M01AB05520P3001XX No A/KK Pain and inflammation in rheumatic disease IM 75 mg once daily (2 times daily in
severe cases) for not more than 2 days.
Max 150mg/day. Not suitable for
children.
Didanosine 100 mg Tablet (ddI) J05AF02000T1002XX Yes A* HIV infection, in combination with other antiretrovirals ADULT less than 60 kg: 125 mg twice
daily or 250 mg once daily; more than 60
kg: 400 mg once daily or 200 mg twice
daily. CHILD: 2 weeks to less than 3
months: 50mg/m2 twice daily; 3-8
months: 100mg/m2 twice daily

Didanosine 2 g Oral Solution (ddI) J05AF02000F2101XX Yes A* HIV infection, in combination with other antiretrovirals ADULT less than 60 kg: 125 mg twice
daily or 250 mg once daily; more than 60
kg: 400 mg once daily or 200 mg twice
daily. CHILD: 2 weeks to less than 3
months: 50mg/m2 twice daily; 3-8
months: 100mg/m2 twice daily

Didanosine 25 mg Tablet (ddI) J05AF02000T1001XX Yes A* HIV infection, in combination with other antiretrovirals ADULT less than 60 kg: 125 mg twice
daily or 250 mg once daily; more than 60
kg: 400 mg once daily or 200 mg twice
daily. CHILD: 2 weeks to less than 3
months: 50mg/m2 twice daily; 3-8
months: 100mg/m2 twice daily

Didanosine 250 mg Enteric Coated J05AF02000C1001XX Yes A* HIV infection, in combination with other antiretrovirals ADULT less than 60 kg: 250 mg once
Capsule daily; 60 kg or greater: 400 mg once
daily. Dose may varies if taken in
combination with tenofovir
Didanosine 400 mg Enteric Coated J05AF02000C1002XX Yes A* HIV infection, in combination with other antiretrovirals ADULT less than 60 kg: 250 mg once
Capsule daily; 60 kg or greater: 400 mg once
daily. Dose may varies if taken in
combination with tenofovir
Dienogest 2mg tablet G03DB08000T1001XX No A/KK Treatment of endometriosis One tablet daily. Treatment can be
started on any day of menstrual cycle.
Tablets must be taken continously
without regard to vaginal bleeding.

Diethylcarbamazine Citrate 50 mg Tablet P02CB02136T1001XX No B i) Bancrofti filariasis, onchocerciasis, loasis, creeping eruption i) 1 mg/kg on the first day and increased
ii) Ascariasis iii) Tropical eosinophilia gradually over 3 days to 6 mg/kg daily in
divided doses. This dosage is maintained
for 21 days. ii) 13 mg/kg once daily for 7
days. CHILD : 6 - 10 mg/kg 3 times daily
for 7 days iii) 6 mg/kg/day in 3 divided
doses for 21 days

Digoxin 0.25 mg Tablet C01AA05000T1001XX Yes B Heart failure , with atrial fibrillation, supraventricular Rapid digitalisation: 0.75 -1.5 mg in
arrhythmias (particularly, atrial fibrillation) divided doses over 24 hours; less urgent
digitalisation, 250 mcg-500 mcg daily
(higher dose may be divided).
Maintenance : 62.5mg -500 mcg daily
(higher dose may be divided) according
to renal function and , in atrial
fibrillation, on heart rate response; usual
range, 125-250 mcg daily (lower dose
may be appropriate in elderly)

Digoxin 250 mcg/ml Injection C01AA05000P3001XX No A Heart failure with atrial fibrillation, supraventricular Rapid digitilisation: ADULT & CHILD over
arrhythmias (particularly atrial fibrillation) 10 years, initially 0.75 - 1.5 mg, followed
by 250 mcg 6 hourly until digitilisation is
complete
Digoxin 50 mcg/ml Elixir C01AA05000L1001XX Yes B Heart failure, supraventricular arrhythmias (particularly atrial Rapid digitalization, give in divided
fibrillation) doses; PREMATURE: 20-30 mcg/kg;
FULLTERM: 25-35 mcg/kg; CHILD 1-2
years : 35 to 60 mcg/kg; CHILD 2-5 years:
30-40 mcg/kg; CHILD 5-10 years: 20- 35
mcg/kg; CHILD over 10 years: 10-15
mcg/kg. For daily maintenance doses or
for gradual digitalization, give 20% to
30% of oral digitalizing dose for
premature infants or 25% to 35% of oral
digitalizing dose for all other pediatric
patients

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Digoxin 62.5 mcg Tablet C01AA05000T1002XX Yes B Heart failure, with atrial fibrillation, supraventricular Rapid digitalisation: 1-1.5 mg in divided
arrhythmias (particularly, atrial fibrillation) doses over 24 hours; less urgent
digitalisation, 250 mcg-500 mcg daily
(higher dose may be divided).
Maintenance: 62.5 - 500 mcg dailly
(higher dose may be divided) according
to renal fuction, and in atrial fibrillation,
on heart-response; usual range :125 -
250 mcg daily (lower doses may be
appropriate in the elderly)

Dihydrocodeine Tartrate 30 mg Tablet N02AA08123T1001XX Yes B For the control of moderate to severe chronic pain ADULT: 30 - 60 mg every 4 - 6 hours.
PAED, over 4 yrs: 0.5 - 1 mg/kg body
weight every 4-6 hours
Dihydroergocristine or Co-dergocrine C04AE01196T1001XX No A/KK Adjunct in elderly with mild to moderate dementia, 3-6 mg daily in divided doses
Mesilate 1 mg Tablet prevention of migraine and vascular headache
Diltiazem HCl 30 mg Tablet C08DB01110T1001XX Yes B Treatment of angina pectoris in the following cases: i) Initially 30mg tds, may increase to 60mg
inadequate response or intolerance to beta-blockers and tds (elderly initially twice daily; increased
Isosorbide Dinitrate ii) contraindication to beta-blockers iii) if necessary to 360 mg daily.
coronary artery spasm
Dimenhydrinate Injection 10ml/vial N07CA00000P2001XX No B Prevention and relief of motion sickness, treatment of vertigo, Usual Adult & Adolescent Dose:
(50mg/ml) nausea or vomiting associated with electroshock therapy, Antiemetic; or Antivertigo agent ?
anaesthesia and surgery; labyrinthine disturbances and Intramuscular, 50 mg repeated every
radiation sickness. four hours as needed. Intravenous, 50
mg in 10 mL of 0.9% sodium chloride
injection, administered slowly over a
period of at least two minutes, repeated
every four hours as needed. Usual
Pediatric Dose: Antiemetic; or
Antivertigo agent ? Intramuscular, 1.25
mg per kg of body weight or 37.5 mg per
square meter of body surface, every six
hours as needed, not to exceed 300 mg
per day. Intravenous, 1.25 mg per kg of
body weight or 37.5 mg per square
meter of body surface, in 10 ml of 0.9%
sodium chloride injection, administered
slowly over a period of at least two
minutes, every six hours as needed, not
to exceed 300 mg per day.

Dimenhydrinate Syrup 15mg/5ml N07CA00000L9003XX No B For prevention and treatment of motion sickness. Also used as ADULT: 50-100 mg every 4 hours as
anti-emetic agent in irradiation sickness, postoperative needed. For motion sickness, take
vomiting, drug induced nausea and vomiting, and for medicine at least 30 minutes, and
symptomatic treatment of nausea and vertigo due to preferably 1-2 hours before travelling.
Meniere`s disease and other labyrinthine disturbances. Usual adult prescribing limit: Up to 400
mg daily. CHILD: Children 6-12 years: 25-
50 mg every 6-8 hours as needed
(maximum of 150 mg daily).

Dimenhydrinate Tablet 50mg N07CA00000T1001XX No B Prevention and treatment of the nausea, vomiting and ADULT: 50-100 mg every 4 hours as
dizziness associated with motion sickness. Symptomatic needed. For motion sickness, take
treatment of nausea and vertigo caused by Meniere's disease medicine at least 30 minutes, and
and other vestibular disturbances. preferably 1-2 hours before travelling.
Usual adult prescribing limit: Up to 400
mg daily. CHILD: 6-12 years: 25-50 mg
every 6-8 hours as needed (maximum of
150 mg daily).

Dimercaprol 50 mg/ml Injection V03AB09000P3001XX No B Poisoning by antimony, arsenic, bismuth, gold, mercury, By IM: 2.5 - 3 mg/kg every 4 hours for 2
possibly thallium; adjunct (with calcium disodium edetate) in days, 2 - 4 times on the third day, then 1 -
lead poisoning 2 times daily for 10 days or until
recovery. For ophthalmic use :
instillation of 50 mg/ml oily solution in
conjunctival sac, within 5 minutes of
contamination
Dinoprostone (Prostagladin E2) 3 mg G02AD02000S1001XX No A Induction of labour 3 mg vaginal tablet to be inserted high
Vaginal Tablet into the posterior formix. A second 3 mg
tablet may be inserted after 6-8 hours if
labour is not established. Max 6 mg

Diosmin 450 mg and Hesperidin 50 mg C05CA53931T1001XX No A/KK i) Haemorrhoids ii) Chronic venous insufficiency i) Acute attack: 6 tablets daily for the
Tablet first 4 days, then 4 tablets daily in 2
divided doses for 3 days and 2 tablets
thereafter. Chronic: 2 tablets daily ii) 2
tab daily with meals

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Diphenhydramine Hydrochloride 10 R06AA02110L1001XX Yes C Cough and allergic rhinitis Allergic rhinitis 1) Adults & Children over
mg/5 ml Oral solution 12 years of age : 25 to 50 mg 3 to 4
times a day 2) Children 6 to 12 years of
age: 10 mg 3 to 4 times a day 3) Children
1 to 6 years of age: 5 mg 3 to 4 times a
day. Maximum daily dosage <300 mg
(adults and children) Cough and cold
1)Adults: 25 mg every 4 hrs. Not to
exceed 150 mg in 24 hours 2) Children (6
to 12years): 12.5 mg every 4 hours. Not
to exceed 75 mg in 24 hours 3) Children
(2 to 6 years): 6.25 mg every 4 hours.
Not to exceed 25 mg in 24 hours

Diphenhydramine Hydrochloride 14 R06AA52110L2101XX Yes C Cough ADULT : 5 - 10 ml 2 - 3 times daily. CHILD

mg/5 ml Expectorant : 2.5 - 5 ml 2 - 3 times daily (not to be
used in children less than 2 years of age)

Diphenhydramine Hydrochloride 7 mg/5 R06AA52110L9003XX Yes C Cough ADULT : 5 - 10 ml 2 - 3 times daily. CHILD
ml Expectorant : 2.5 - 5 ml 2 - 3 times daily (not to be
used in children less than 2 years of age)

Diphenoxylate HCl 2.5mg with Atropine A07DA01922T1001XX Yes B Acute diarrhoea ADULT initially 4 tablet followed by 2
Sulphate 0.025mg Tablet tablet 4 times daily until diarrhoea is
controlled
Diphtheria and Tetanus Vaccine Injection J07AM51963P3001XX Yes C+ Immunisation against diphtheria and tetanus Prophylactic: 2 or 3 doses by deep SC or
IM injection, 0.5 or 1 ml. Each second
dose at 4 - 6 weeks then 4 - 6 months.
Booster at 4 - 6 years
Diphtheria Antitoxin Injection J07AF01000P3001XX Yes B Diphtheria Therapeutic: 10,000 - 30,000 units by IM
or IV. Increase to 40,000 - 100,000 units
in severe cases. Doses up to 30,000 units
may be given IM
Diphtheria, Pertussis, Tetanus and J07AG52000P3001XX No C Immunisation of children against Haemophilus Type B 0.5 ml given by IM
Conjugated Haemophilus Type B 10 mcg infections, diphtheria, tetanus and pertussis
Vaccine
Diphtheria, Pertussis, Tetanus and J07CA05963P3001XX No C+ Active immunisation against diphtheria, tetanus, pertussis and Primary vaccination: 3 doses of 0.5 ml
Hepatitis B Vaccine hepatitis B in infants from 6 weeks onwards each within the first 6 months of life.
Administer each dose at intervals of at
least 4 weeks. A booster dose can be
administered in the second year of life

Diphtheria, Pertussis, Tetanus Vaccine J07AJ52963P3001XX Yes C Prophylactic immunisation against diphtheria, pertussis and By deep SC or IM injection: 3 doses each
Injection tetanus of 0.5 or 1 ml with intervals of 6 - 8
weeks and 4 - 6 months respectively
between the doses. Booster 1 and 5
years after primary immunisation

Diphtheria, Tetanus, Acellular Pertussis, J07CA06963P3001XX Yes C+ Immunisation of children against Diphtheria, Tetanus, Primary : 0.5 ml by IM at 1 - 2 months
Inactivated Polio Virus, Haemophilus Acellular Pertussis, Polio and Haemophilus Influenza Type B intervals Booster : Second year of life
Influenza Type B (DTaP-IPV-HiB) Vaccine infection
Injection (Single Dose)

Dipyridamole 75 mg Tablet B01AC07000T1001XX No B As an adjunct to oral anticoagulation/ antiplatelet therapy in 75-150 mg 3 times daily to be taken 1
the prophylaxis of cerebrovascular events hour before meals
Distigmine Bromide 5 mg Tablet N07AA03320T1001XX No A i) Myasthenia gravis ii) Prevention and treatment of post- i) ADULT : 5 mg daily 30 minutes before
operative intestinal atony, urinary retention and neurogenic breakfast. Increase at intervals of 3 - 4
bladder days if necessary to maximum of 20 mg
daily. CHILD : Up to 10 mg daily
according to age ii) Urinary retention : 5
mg daily 30 minutes before breakfast.
Neurogenic bladder : 5 mg daily or on
alternate days 30 minutes before
breakfast

Dithranol 0.1 - 5% in Vaseline/ Ointment D05AC01000G5001XX No A Short contact treatment for plaque psoriasis and alopecia For application to skin or scalp. 0.1-0.5%
areata suitable for overnight treatment. 1-2%
for max 1 hour.
Dithranol 1 % in Lassars Paste D05AC01000G6001XX No A Treatment of quiescent or chronic psoriasis of the skin, scalp Apply liberally and carefully to the
and alopecia areata lesions with a suitable applicator. A
dressing may be applied
Dobutamine 12.5 mg/ml Injection C01CA07110P3001XX No A Hypotension and heart failure Initial 0.5-1 mcg/kg/min by IV,
maintenance 2.5-10mcg/kg/min.
Frequently,doses up to 20mcg/kg/min
are required for adequate hemodynamic
improvement. On rare
occasions,infusion rates up to
40mcg/kg/min

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Docetaxel 40mg/ml Injection L01CD02000P3002XX Yes A* i) Adjuvant treatment of patients with high risk node-positive i) 75 mg/m2 IV over 1 hour after
breast cancer in combination with doxorubicin and doxorubicin 50 mg/m2 and
cyclophosphamide ii) Breast cancer, locally advanced or cyclophosphamide 500 mg/m2 every 3
metastatic, not previously on cytotoxic therapy, in weeks for 6 cycles ii) 75 mg/m2 IV over 1
combination with doxorubicin iii) First line therapy in non hour every 3 week in combination with
small cell lung cancer in stage 3- 4 and performance status 0- doxorubicin 50 mg/m2 iii) Administer IV
1, in combination with cisplatin iv) Inoperable locally advanced over 1 hour every 3 weeks.
squamous cell carcinoma of head and neck, in combination Chemotherapy-naive patients 75 mg/m2
with cisplatin and 5-FU for induction treatment v) Prostate immediately followed by 75 mg/m2
cancer, in combination with prednisolone cisplatin over 30-60 mins or carboplatin
(AUC 6 mg/mL/min) over 30-60 minutes.
Monotherapy of non small cell lung
cancer (NSCLC) after failure of prior
platinum-based chemotherapy 75
mg/m2 iv) 75 mg/m2 as a 1 hour
infusion followed by cisplatin 75 mg/m2
over 1 hour, on day one, followed by 5-
fluorouracil as a continuous infusion at
750 mg/m2 per day for five days. This
regimen is administered every 3 weeks
for 4 cycles.

Dolutegravir 50mg Tablet J05AX12000T3201XX No A* Dolutegravir is indicated in combination with other anti- i) HIV-1 patients without documented or
retroviral medicinal products for the treatment of Human clinically suspected resistance to the
Immunodeficiency Virus (HIV) infected adults and adolescents integrase class: 50 mg (one tablet), once
above 12 years of age. Restriction: For patients who are not daily, orally. ii) HIV-1 patients with
able to tolerate or failing treatment or resistance to the first resistance to the integrase class: 50 mg
line therapy (efavirenz and nevirapine). (one tablet), twice daily, orally.

Domperidone 1 mg/ml Suspension A03FA03000L8001XX No B Nausea, vomiting, dyspepsia, gastro-esophageal reflux Chronic dyspepsia : CHILD 2.5 mL/10 kg
body weight 3 times daily and once
more in the evening if necessary. Dosage
may be doubled in adults & childs over 1
year. Acute and subacute conditions
(particularly nausea and vomiting).
CHILD: 5 mL/10 kg bodyweight. All to be
taken 3-4 times daily

Domperidone 10 mg Tablet A03FA03253T1001XX No B Nausea, vomiting, dyspepsia, gastro-esophageal reflux Chronic dyspepsia ADULT 10 mg 3 times
daily. Acute and subacute conditions
(particularly nausea and
vomiting):ADULT 20 mg 3-4 times daily

Donepezil HCl 10 mg Tablet N06DA02110T1002XX No A Treatment of mild to moderate dementia in Alzheimer's 5 - 10 mg once daily at bedtime.
disease, as well as in patients with severe Alzheimer's disease. Maximum 10 mg daily
[psychiatrists and neurologists only]
Donepezil HCl 5 mg Tablet N06DA02110T1001XX No A Treatment of mild to moderate dementia in Alzheimer's 5 - 10 mg once daily at bedtime.
disease, as well as in patients with severe Alzheimer's disease. Maximum 10 mg daily

Donepezil Hydrochloride 10mg N06DA02110T4002XX No A* Treatment of mild to moderate dementia in Alzheimer's Initiated at 5mg/day (one a day dosing),
Orodispersible Tablet disease, as well as in patients with severe Alzheimer's disease. should be maintained for at least 1
[psychiatrists and neurologists only] month in order to allow the earliest
clinical responses and to allow steady
state concentration to be achieved. The
maximum recommended daily dose is 10
mg.
Donepezil Hydrochloride 5mg N06DA02110T4001XX No A* Treatment of mild to moderate dementia in Alzheimer's Initiated at 5mg/day (one a day dosing),
Orodispersible Tablet disease, as well as in patients with severe Alzheimer's disease. should be maintained for at least 1
[psychiatrists and neurologists only] month in order to allow the earliest
clinical responses and to allow steady
state concentration to be achieved. The
maximum recommended daily dose is 10
mg.
Dopamine HCl 40 mg/ml Injection C01CA04110P3001XX Yes B Non-hypovolemic hypotension Initial dose 2-5 mcg/kg/min with
incremental changes of 5-10
mcg/kg/min at 10-15 minutes intervals
until adequate response is noted. Most
patients are maintained at less than 20
mcg/kg/min. If dosage exceeds
50 mcg/kg/min, assess renal function
frequently
Doripenem Monohydrate 500 mg J01DH04000P4001XX No A* Ventilator-associated pneumonia (VAP) patients at risk or 500mg every 8 hours as a one hour
Injection involving multidrug resistant pathogens especially infusion for 5 to 14 days according to
Pseudomonas aeruginosa infections severity, site of infection and the
patient's clinical response.
Dorzolamide HCl 2% Ophthalmic S01EC03110D2001XX No A* All glaucoma patients where beta-blockers are contraindicated Monotherapy : 1 drop 3 times daily.
Solution and when intraocular pressure is not well controlled by other Adjunctive therapy with an ophthalmic
drugs beta-blocker : 1 drop 2 times daily.
When substituting for another
ophthalmic antiglaucoma agent with this
product, discontinue the other agent
after proper dosing on one day and start
Trusopt on the next day. If more than 1
topical ophthalmic drug is used, the
drugs should be administered at least 10
mins apart

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Dothiepin HCl 25 mg Capsule N06AA16110C1001XX No A Depression of any aetiology Initially 75 mg (ELDERLY 50-75 mg) daily
in divided doses or single dose at
bedtime, increased gradually as
necessary to 150 mg daily (ELDERLY 75
mg may be sufficient), up to 225 mg
daily in some circumstances. CHILD is
not recommended
Dothiepin HCl 75 mg Tablet N06AA16110T1001XX No A Depression of any aetiology Initially 75 mg (ELDERLY 50-75 mg) daily
in divided doses or single dose at
bedtime, increased gradually as
necessary to 150 mg daily (ELDERLY 75
mg may be sufficient), up to 225 mg
daily in some circumstances. CHILD is
not recommended
Doxazosin Mesilate 4 mg CR Tablet C02CA04196T5001XX No A* Benign Prostatic Hyperplasia 4 mg once daily to maximum 8mg/day

Doxorubicin HCl 10 mg Injection L01DB01110P4001XX Yes A i) Solid tumours, leukaemia, non-Hodgkin's lymphoma ii) i) 30 - 75 mg/m2 IV as a single dose at 21
Leukaemia (ALL induction) iii) Multiple myeloma day intervals ii) 25 - 45 mg/m2 once a
week for the first 4 weeks during
induction or re-induction phase (refer to
specific protocol. Caution: Total
cumulative dose of doxorubicin must not
exceed 550 mg/m2 due to risk of
cardiotoxicity. CHILD: 30 mg/m2/dose
over 6 - 24 hours for 1 - 2 days. Need to
check cardiac function closely by
echocardiography every cumulative dose
of 100 mg/m2 to maximum 360 mg/m2
iii) 9 mg/m2 over 24 hours infusion for 4
days at monthly intervals

Doxorubicin HCl 50 mg Injection L01DB01110P4002XX Yes A i) Solid tumours, leukaemia, non-Hodgkin's lymphoma ii) i) 30 - 75 mg/m2 IV as a single dose at 21
Leukaemia (ALL induction) iii) Multiple myeloma day intervals ii) 25 - 45 mg/m2 once a
week for the first 4 weeks during
induction or re-induction phase (refer to
specific protocol. Caution: Total
cumulative dose of doxorubicin must not
exceed 550 mg/m2 due to risk of
cardiotoxicity. CHILD: 30 mg/m2/dose
over 6 - 24 hours for 1 - 2 days. Need to
check cardiac function closely by
echocardiography every cumulative dose
of 100 mg/m2 to maximum 360 mg/m2
iii) 9 mg/m2 over 24 hours infusion for 4
days at monthly intervals

Doxycycline 100 mg Capsule J01AA02000C1001XX Yes B Infections due to susceptible organisms ADULT: 200 mg on the first day followed
by 100 mg daily. Severe infections: 200
mg daily
Doxycycline 100 mg Tablet J01AA02000T1001XX Yes B Infections due to susceptible organisms ADULT: 200 mg on the first day followed
by 100 mg daily. Severe infections: 200
mg daily
D-Penicillamine 0.25 g Capsule M01CC01000C1001XX Yes A i) Treatment of severe lead poisoning, it is used as adjunctive i) Heavy metal poisoning: 900mg-
treatment following initial treatment with another chelating 1800mg daily. Duration of treatment is
agent. May also be used as sole therapy in the treatment of dictated by the urinary heavy metal
asymptomatic patients with moderately elevated blood excretion. Simultaneous oral vitamin B6
concentrations ii) Wilson's Disease: to aid in elimination of replacement with at least 40mg daily is
copper ions essential ii) Wilson's disease: 0.25g - 1.5g
daily on an incremental basis. Maximal
daily dose: 2g. Maintenance dose: 0.75g -
1g daily

Duloxetine 30 mg Capsule N06AX21110C1001XX No A* Major depressive disorder, diabetic peripheral neuropathic ADULT: 60 mg once daily up to a
pain maximum dose of 120mg/day (in divided
doses) CHILD and ADOLESCENT under 18
years not recommended

Duloxetine 60 mg Capsule N06AX21110C1002XX No A* Major depression, diabetic peripheral neuropathic pain ADULT: 60 mg once daily up to a
maximum dose of 120mg/day (in divided
doses) CHILD and ADOLESCENT under 18
years not recommended

Dutasteride 0.5 mg Capsule G04CB02000C1001XX No A* Benign prostatic hyperplasia in men with an enlarged prostate 0.5 mg daily
gland
Dutasteride 0.5mg and Tamsulosin G04CA52953C1001XX No A* Combination therapy for the treatment of moderate to severe One capsule daily
0.4mg Capsule symptoms of BPH with: i) Large prostate (>30g) ii) Poor risk or
not fit for surgery iii)Those who are awaiting their turn for
surgery

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Dydrogesterone 10 mg Tablet G03DB01110T1001XX No A/KK i) Dysmenorrhoea ii) Endometriosis iii) Dysfunctional uterine i) 10 mg bd from day 5 - 25 of cycle ii) 10
bleeding (to arrest and to prevent bleeding) iv) Threatened mg bd - tds from day 5 - 25 of the cycle
abortion v) Habitual abortion vi) Post menopausal complaints or continuously iii) To arrest bleeding :10
(hormone replacement therapy in combination with mg bd with an oestrogen once daily for 5
oestrogen) - 7 days, To prevent bleeding : 10 mg bd
with an oestrogen once daily from day
11 - 25 of the cycle iv) 40 mg at once,
then 10mg 8hrly until symptoms remit v)
10 mg bd until 20th week of pregnancy
vi) 10-20 mg daily during last 12-14 days
of each cycle

Ear Wax Softener S02DA30900D10XXXX No B Occlusion or partial occlusion of the external auditory meatus Instill 5 drops into the ears. Refer
by soft wax or wax plug product information leaflet
Edrophonium Chloride 10 mg/ml N07AA00100P3001XX No B i) For reversal of neuromuscular block ii) Diagnosis of i) Intravenous injection on over several
Injection myasthenia gravis minutes, 500 - 700 mcg/kg (after or with
atropine sulphate 600 mcg) ii)
Intravenous injection 2 mg followed by 8
mg if no response occurs within 30
seconds. CHILD: 20 mcg followed by 80
mcg/kg after 30 seconds

Efavirenz 100 mg Capsule J05AG03000C1002XX Yes A* Combination therapy for HIV infections with a protease ADULT: 600 mg once daily. ADOLESCENT
inhibitor and or Nucleoside Reverse Transcriptase Inhibitors & CHILD less than 17 years, more than
(NRTIs) 40 kg: 600 mg once daily, 32.5 - less than
40 kg: 400 mg once daily, 25 - less than
32.5 kg: 350 mg once daily, 20 - less than
25 kg: 300 mg once daily, 15 - less than
20 kg: 250 mg once daily, 13 - less than
15 kg: 200 mg once daily. No studies in
children less than 3 years or less than 13
kg. Formulation unsuitable for children
less than 40 kg

Efavirenz 200 mg Capsule J05AG03000C1003XX Yes A* Combination therapy for HIV infections with a protease ADULT: 600 mg once daily. ADOLESCENT
inhibitor and or Nucleoside Reverse Transcriptase Inhibitors & CHILD less than 17 years, more than
(NRTIs) 40 kg: 600 mg once daily, 32.5 - less than
40 kg: 400 mg once daily, 25 - less than
32.5 kg: 350 mg once daily, 20 - less than
25 kg: 300 mg once daily, 15 - less than
20 kg: 250 mg once daily, 13 - less than
15 kg: 200 mg once daily. No studies in
children less than 3 years or less than 13
kg. Formulation unsuitable for children
less than 40 kg

Efavirenz 50 mg Capsule J05AG03000C1001XX Yes A* Combination therapy for HIV infections with a protease ADULT: 600 mg once daily. ADOLESCENT
inhibitor and or Nucleoside Reverse Transcriptase Inhibitors & CHILD less than 17 years, more than
(NRTIs) 40 kg: 600 mg once daily, 32.5 - less than
40 kg: 400 mg once daily, 25 - less than
32.5 kg: 350 mg once daily, 20 - less than
25 kg: 300 mg once daily, 15 - less than
20 kg: 250 mg once daily, 13 - less than
15 kg: 200 mg once daily. No studies in
children less than 3 years or less than 13
kg. Formulation unsuitable for children
less than 40 kg

Efavirenz 600 mg Tablet J05AG03000T1001XX Yes A/KK Combination therapy for HIV infections with a protease ADULT: 600 mg once daily. ADOLESCENT
inhibitor and or Nucleoside Reverse Transcriptase Inhibitors & CHILD less than 17 years, more than
(NRTIs) 40 kg: 600 mg once daily, 32.5 - less than
40 kg: 400 mg once daily, 25 - less than
32.5 kg: 350 mg once daily, 20 - less than
25 kg: 300 mg once daily, 15 - less than
20 kg: 250 mg once daily, 13 - less than
15 kg: 200 mg once daily. No studies in
children less than 3 years or less than 13
kg. Formulation unsuitable for children
less than 40 kg

Eltrombopag Olamine 25 mg Film-coated B02BX05999T1001XX No A* Short term use in idiopathic thrombocytopenic purpura Individualised dosage based on the
Tablet patients as bridging therapy for splenectomy or surgery and in patient's platelet count. Adult Initially 50
cases of severe bleeding. mg once daily. East Asian patient 25 mg
once daily. Then, adjust dose to maintain
platelet count ≥50,000/microliter. Max:
75 mg daily.

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Empagliflozin 10mg tablet A10BK03-000-T32-01- No A* Indicated in the treatment of type 2 diabetes mellitus to Starting dose is 10 mg once daily. In
XXX improve glycaemic control in adults as: Add-on combination patient with eGFR ≥60 ml/min/1.73m2
therapy: In combination with other glucose–lowering who need tighter glycaemic control, the
medicinal products including insulin, when these, together dose can be increased up to 25 mg once
with diet and exercise, do not provide adequate glycaemic daily (maximum).
control. Prescribing Restriction: The use of empagliflozin is
restricted to: 1. Secondary prevention of cardiovascular
disease (patient that has previous cardiovascular event); 2.
HbA1c not more than 8.5% on dual combination anti-diabetic
therapy; 3. BMI: 30kg/m2 and above; 4. Creatinine clearance
60ml/min or EGFR 60ml/min/1.73m2 and above.

Empagliflozin 25mg tablet A10BK03-000-T32-02- No A* Indicated in the treatment of type 2 diabetes mellitus to Starting dose is 10 mg once daily. In
XXX improve glycaemic control in adults as: Add-on combination patient with eGFR ≥60 ml/min/1.73m2
therapy: In combination with other glucose–lowering who need tighter glycaemic control, the
medicinal products including insulin, when these, together dose can be increased up to 25 mg once
with diet and exercise, do not provide adequate glycaemic daily (maximum).
control. Prescribing Restriction: The use of empagliflozin is
restricted to: 1. Secondary prevention of cardiovascular
disease (patient that has previous cardiovascular event); 2.
HbA1c not more than 8.5% on dual combination anti-diabetic
therapy; 3. BMI: 30kg/m2 and above; 4. Creatinine clearance
60ml/min or EGFR 60ml/min/1.73m2 and above.

Emulsificants Ointment D02AC00952G5001XX No C Xerosis and ichthyosis Use as a soap and emollient
Enalapril 10 mg Tablet C09AA02253T1002XX Yes B i) Hypertension ii) Congestive heart failure i) Initially 5 mg daily, (ELDERLY 2.5 mg
once daily), usual maintenance dose 10 -
20 mg daily. Maximum: 40 mg/day in 1 -
2 divided doses ii) Initially 2.5 mg daily,
usual maintenance dose 20 mg daily in 1 -
2 divided doses; maximum: 40 mg/day

Enalapril 20 mg Tablet C09AA02253T1003XX Yes B i) Hypertension ii) Congestive heart failure i) Initially 5 mg daily, (ELDERLY 2.5 mg
once daily), usual maintenance dose 10 -
20 mg daily. Maximum: 40 mg/day in 1 -
2 divided doses ii) Initially 2.5 mg daily,
usual maintenance dose 20 mg daily in 1 -
2 divided doses; maximum: 40 mg/day

Enalapril 5 mg Tablet C09AA02253T1001XX Yes B i) Hypertension ii) Congestive heart failure i) Initially 5 mg daily, (ELDERLY 2.5 mg
once daily), usual maintenance dose 10 -
20 mg daily. Maximum: 40 mg/day in 1 -
2 divided doses ii) Initially 2.5 mg daily,
usual maintenance dose 20 mg daily in 1 -
2 divided doses; maximum: 40 mg/day

Enoxaparin Sodium 20 mg Injection B01AB05520P5001XX No A* i) Prevention of Deep Vein Thrombosis(DVT) especially in i) Prophylaxis fo DVT especially in
perioperative and high risk surgical cases ii) Treatment of DVT surgical patients: moderate risk, 20 mg
iii) Unstable angina and non Q wave Myocardial Infarction SC approximately 2 hours before surgery
then 20 mg every 24 hours for minimum
7 - 10 days, high risk (eg orthopaedic
surgery, medical patients, 40mg every 24
hours for at least 6 days until patient
ambulant, max 14 days. ii) Treatment of
DVT or pulmonary embolism, 1.5 mg/kg
every 24 hours, usually for 5 days and
until adequate oral anticoagulation
established. iii) Unstable angina and non-
ST-segment-elevation myocardial
infarction 1 mg/kg every 12 hours,
usually for 2 - 8 days

Enoxaparin Sodium 40 mg Injection B01AB05520P5002XX No A* i) Prevention of Deep Vein Thrombosis(DVT) especially in i) Prophylaxis for DVT especially in
perioperative and high risk surgical cases ii) Treatment of DVT surgical patients: moderate risk, 20 mg
iii) Unstable angina and non Q wave Myocardial Infarction SC approximately 2 hours before surgery
then 20 mg every 24 hours for minimum
7 - 10 days, high risk (eg orthopaedic
surgery, medical patients, 40mg every 24
hours for at least 6 days until patient
ambulant, max 14 days. ii) Treatment of
DVT or pulmonary embolism, 1.5 mg/kg
every 24 hours, usually for 5 days and
until adequate oral anticoagulation
established. iii) Unstable angina and non-
ST-segment-elevation myocardial
infarction 1 mg/kg every 12 hours,
usually for 2 - 8 days

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Enoxaparin Sodium 60 mg Injection B01AB05520P5003XX No A* i) Prevention of Deep Vein Thrombosis(DVT) especially in i) Prophylaxis fo DVT especially in
perioperative and high risk surgical cases ii) Treatment of DVT surgical patients: moderate risk, 20 mg
iii) Unstable angina and non Q wave Myocardial Infarction SC approximately 2 hours before surgery
then 20 mg every 24 hours for minimum
7 - 10 days, high risk (eg orthopaedic
surgery, medical patients, 40mg every 24
hours for at least 6 days until patient
ambulant, max 14 days. ii) Treatment of
DVT or pulmonary embolism, 1.5 mg/kg
every 24 hours, usually for 5 days and
until adequate oral anticoagulation
established. iii) Unstable angina and non-
ST-segment-elevation myocardial
infarction 1 mg/kg every 12 hours,
usually for 2 - 8 days

Entacapone 200 mg Tablet N04BX02000T1001XX Yes A Parkinson's Disease. An adjunct to standard 200 mg to be taken with each daily dose
levodopa/benserazide or levodopa/carbidopa for use in of levodopa/dopa-decarboxylase
patients with parkinson's disease and end of dose motor inhibitor. Max 2g daily. May be taken
fluctuations, who cannot be stabilised on those combinations with or without food

Entecavir 0.5 mg Tablet J05AF10000T1001XX No A* First line treatment of Chronic Hepatitis B in patients who 0.5-1mg once daily. Renal Dose
satisfy the criteria for treatment and require long-term Adjustment: 0.5-1mg every 48hours (30-
therapy or have a very high baseline viral load 49ml/min); 0.5-1mg every 72hours (10-
29ml/min); 0.5mg-1mg every 5-7 days
(<10ml/min; HD or CAPD).

Eperisone HCl 50 mg Tablet M03BX09110T1001XX No A Myotonic symptoms associated with cervical syndrome, 50 mg 3 times daily
periarthritis of shoulder and lumbago spastic paralysis
Ephedrine 0.5% w/v Nasal Drops R01AA03110D6001XX No A/KK Decongestion of the upper respiratory tract 2 drops 3 times daily. Maximum use for
1 week
Ephedrine HCl 30 mg/ml Injection R03CA02110P3001XX No B Treatment of bronchial spasm in asthma, adjunct to correct By IM, SC or IV. Severe, acute
haemodynamic imbalances and treat hypotension in epidural bronchospasm : 12.5-25 mg. Further
and spinal anaesthesia dosage should be determine by patient
response. When used as a pressor agent
: ADULT 25 - 50 mg SC/IM. If necessary, a
second IM dose of 50 mg or an IV dose
of 25 mg may be given. Direct IV
injection, 10 - 25 mg may be given
slowly. Maximum parenteral ADULT
dose : 150 mg in 24 hours. CHILD : 3
mg/kg or 100 mg/m2 SC or IV daily, in 4 -
6 divided doses

Epirubicin 10 mg Injection L01DB03110P4001XX No A* Breast cancer, Non-Hodgkin's lymphoma, Leukaemia (ALL i) 75 - 90mg/m2 body area injected IV in
induction), gastric cancer, ovarian cancer 3 - 5 min, repeated at 21 day
intervals.Higher doses up to 135mg/m2
as single agent and 120mg/m2 as
combination (effective in treatment of
breast cancer) CHILD: 50 mg/m2 over 6
hours. Schedule depends on protocol.

Epirubicin 50 mg Injection L01DB03110P4002XX No A* Breast cancer, Non-Hodgkin's lymphoma, Leukaemia (ALL i) 75 - 90mg/m2 body area injected IV in
induction), gastric cancer, ovarian cancer 3 - 5 min, repeated at 21 day
intervals.Higher doses up to 135mg/m2
as single agent and 120mg/m2 as
combination (effective in treatment of
breast cancer) CHILD: 50 mg/m2 over 6
hours. Schedule depends on protocol.

Erlotinib 100 mg Tablet L01XE03110T1003XX No A* Second line treatment of patients with locally advanced or 150 mg taken at least one hour before or
metastatic non-small cell lung cancer (NSCLC) who have two hours after the ingestion of food
previously failed one line of chemotherapy, and who have once daily. Reduce in steps of 50 mg
activating mutations of epidermal growth factor receptor when necessary. Continue treatment
(EGFR). Prescribing restrictions: - Adenocarcinoma histology - until disease progression or
ECOG Performance Status 0-1 - Must be prescribed by an unacceptable toxicity occurs. May
oncologist or oncology-trained respiratory physician. - Must require dose modifications when
not have received prior TKI for this condition. coadministered with strong CYP3A4
inhibitors or inducers; or in cigarette
smoking patients.

Erlotinib 150 mg Tablet L01XE03110T1002XX No A* Second line treatment of patients with locally advanced or 150 mg taken at least one hour before or
metastatic non-small cell lung cancer (NSCLC) who have two hours after the ingestion of food
previously failed one line of chemotherapy, and who have once daily. Reduce in steps of 50 mg
activating mutations of epidermal growth factor receptor when necessary. Continue treatment
(EGFR). Prescribing restrictions: - Adenocarcinoma histology - until disease progression or
ECOG Performance Status 0-1 - Must be prescribed by an unacceptable toxicity occurs. May
oncologist or oncology-trained respiratory physician. - Must require dose modifications when
not have received prior TKI for this condition. coadministered with strong CYP3A4
inhibitors or inducers; or in cigarette
smoking patients.

Ertapenem 1 g Injection J01DH03520P4001XX No A* i) Patient with confirm ESBL producing gram-negative ADULT: 1 g once daily. CHILD 3 month to
infection. ii) Empiric treatment for severe community acquired 12 years: 15 mg/kg twice daily. Not to
pneumonia or other infections when Pseudomonas aeruginosa exceed 1 g/ day
is not suspected.

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Erythromycin Ethylsuccinate 200 mg/5 J01FA01238F2101XX Yes B Treatment of susceptible bacterial infections Child: 30-50 mg/kg daily, increased to
ml Suspension twice the usual dose in severe cases. 2-8
yr: 1 g daily in divided doses; <2 yr: 500
mg daily in divided doses.

Erythromycin Ethylsuccinate 400 mg J01FA01238T1001XX Yes B Treatment of susceptible bacterial infections Adult 400 mg 6 hrly or 800 mg 12 hrly.
Tablet Max: 4 g/day. Childn 30-50 mg/kg in
divided doses. Childn 2-8 yr 1 g/day in
divided doses in severe cases. Infant &
childn ≤2 yr 500 mg/day in divided
doses.
Erythromycin Ethylsuccinate 400 mg/5 J01FA01238F2102XX Yes B Treatment of susceptible bacterial infections Child: 30-50 mg/kg daily, increased to
ml Suspension twice the usual dose in severe cases. 2-8
yr: 1 g daily in divided doses; <2 yr: 500
mg daily in divided doses.

Erythromycin Lactobionate 500 mg J01FA01129P3001XX No A* Only for treatment of i) certain forms of meningitis ii) Adult & Child: 25 - 50mg/kg /day
Injection septicaemia not responding to usual antibiotics iii) infusion every 6 hours. Maximum: 4
mycoplasma pneumonia iv) infection with gram-positive g/day.
organisms (e.g. tetanus, streptococcal infection) associated
with Penicillin allergy, only when oral erythromycin cannot be
given
Erythromycin Stearate 250 mg Tablet J01FA01258T1001XX Yes B Infections due to susceptible organism Child: 30-50 mg/kg daily, increased to
twice the usual dose in severe cases. 2-8
yr: 1 g daily in divided doses; <2 yr: 500
mg daily in divided doses.

Erythropoietin Human Recombinant B03XA01000P5005XX No A* i) Treatment of anaemia associated with chronic renal failure. i) ADULT by IV injection over 1-5
10,000 IU/ml Injection Dialysis patients who are haemoglobin less than 8 g or minutes, initially 50 units/kg 3 times
exhibiting symptoms of anaemia although haemoglobin more weekly adjusted according to response
than 8 g and pre-transplant cases ii) Anaemia in cancer (non- in step of 25 units/kg 3 times weekly at
myeloid malignancies) with concomitant chemotherapy interval of at least 4 weeks. CHILD
initially as for adult. Maintenance,
bodyweight under 10 kg usually 75-150
units/kg 3 times weekly, bodyweight 10-
30 kg usually 60-150 units/kg 3 times
weekly, bodyweight over 30 kg usually
30-100 units/kg 3 times weekly ii) ADULT
by SC injection (max. 1 ml per injection
site), initially 150 units/kg 3 times
weekly, increased if appropriate rise in
haemoglobin not achieved after 4 weeks
to 300 units/kg 3 times weekly.
Discontinue if inadequate response after
4 weeks at higher dose

Erythropoietin Human Recombinant B03XA01000P5001XX No A* i) Treatment of anaemia associated with chronic renal failure. i) ADULT by IV injection over 1-5
1000 IU/0.5ml Injection Dialysis patients who are haemoglobin less than 8 g or minutes, initially 50 units/kg 3 times
exhibiting symptoms of anaemia although haemoglobin more weekly adjusted according to response
than 8 g and pre-transplant cases ii) Anaemia in cancer (non- in step of 25 units/kg 3 times weekly at
myeloid malignancies) with concomitant chemotherapy interval of at least 4 weeks. CHILD
initially as for adult. Maintenance,
bodyweight under 10 kg usually 75-150
units/kg 3 times weekly, bodyweight 10-
30 kg usually 60-150 units/kg 3 times
weekly, bodyweight over 30 kg usually
30-100 units/kg 3 times weekly ii) ADULT
by SC injection (max. 1 ml per injection
site), initially 150 units/kg 3 times
weekly, increased if appropriate rise in
haemoglobin not achieved after 4 weeks
to 300 units/kg 3 times weekly.
Discontinue if inadequate response after
4 weeks at higher dose

Erythropoietin Human Recombinant B03XA01000P5002XX No A i) Treatment of anaemia associated with chronic renal failure. i) ADULT by IV injection over 1-5
2000 IU/0.5ml Injection Dialysis patients who are haemoglobin less than 8 g or minutes, initially 50 units/kg 3 times
exhibiting symptoms of anaemia although haemoglobin more weekly adjusted according to response
than 8 g and pre-transplant cases ii) Anaemia in cancer (non- in step of 25 units/kg 3 times weekly at
myeloid malignancies) with concomitant chemotherapy interval of at least 4 weeks. CHILD
initially as for adult. Maintenance,
bodyweight under 10 kg usually 75-150
units/kg 3 times weekly, bodyweight 10-
30 kg usually 60-150 units/kg 3 times
weekly, bodyweight over 30 kg usually
30-100 units/kg 3 times weekly ii) ADULT
by SC injection (max. 1 ml per injection
site), initially 150 units/kg 3 times
weekly, increased if appropriate rise in
haemoglobin not achieved after 4 weeks
to 300 units/kg 3 times weekly.
Discontinue if inadequate response after
4 weeks at higher dose

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Erythropoietin Human Recombinant B03XA01000P5003XX No A* i) Treatment of anaemia associated with chronic renal failure. i) ADULT by IV injection over 1-5
3000 IU/0.3ml Injection Dialysis patients who are haemoglobin less than 8 g or minutes, initially 50 units/kg 3 times
exhibiting symptoms of anaemia although haemoglobin more weekly adjusted according to response
than 8 g and pre-transplant cases ii) Anaemia in cancer (non- in step of 25 units/kg 3 times weekly at
myeloid malignancies) with concomitant chemotherapy interval of at least 4 weeks. CHILD
initially as for adult. Maintenance,
bodyweight under 10 kg usually 75-150
units/kg 3 times weekly, bodyweight 10-
30 kg usually 60-150 units/kg 3 times
weekly, bodyweight over 30 kg usually
30-100 units/kg 3 times weekly ii) ADULT
by SC injection (max. 1 ml per injection
site), initially 150 units/kg 3 times
weekly, increased if appropriate rise in
haemoglobin not achieved after 4 weeks
to 300 units/kg 3 times weekly.
Discontinue if inadequate response after
4 weeks at higher dose

Erythropoietin Human Recombinant B03XA01000P5004XX No A i) Treatment of anaemia associated with chronic renal failure. i) ADULT by IV injection over 1-5
4000 IU Injection Dialysis patients who are haemoglobin less than 8 g or minutes, initially 50 units/kg 3 times
exhibiting symptoms of anaemia although haemoglobin more weekly adjusted according to response
than 8 g and pre-transplant cases ii) Anaemia in cancer (non- in step of 25 units/kg 3 times weekly at
myeloid malignancies) with concomitant chemotherapy interval of at least 4 weeks. CHILD
initially as for adult. Maintenance,
bodyweight under 10 kg usually 75-150
units/kg 3 times weekly, bodyweight 10-
30 kg usually 60-150 units/kg 3 times
weekly, bodyweight over 30 kg usually
30-100 units/kg 3 times weekly ii) ADULT
by SC injection (max. 1 ml per injection
site), initially 150 units/kg 3 times
weekly, increased if appropriate rise in
haemoglobin not achieved after 4 weeks
to 300 units/kg 3 times weekly.
Discontinue if inadequate response after
4 weeks at higher dose

Escitalopram 10 mg Tablet N06AB10124T1001XX No A* i) Major depression ii) Treatment of panic disorder with or i) 10 mg once daily; may be increased to
without agoraphobia max 20 mg daily. ii) Panic disorder with
or without agoraphobia :Initially 5 mg
for the first week, thereafter increased
to 10 mg daily. Max 20 mg daily,
ELDERLY initially half the adult dose,
lower maintenance dose may be
sufficient. CHILD and ADOLESCENT under
18 years not recommended

Esmolol HCl 10 mg/ml Injection C07AB09110P3001XX No A* Tachycardia and hypertension in perioperative period By IV infusion usually within range of 50 -
200 mcg/kg/min
Esomeprazole 20 mg Tablet A02BC05000T1002XX No A* i)Gastro-oesophageal reflux disease ii)H. pylori eradication i)20mg daily for 4-8 weeks ii)40mg daily
for 10 days in combination with
amoxicillin 1g twice daily or
clarithromycin 500mg twice daily
Esomeprazole 40 mg Injection A02BC05000P3001XX No A* i) Acute erosive/ ulcerative oesophagitis ii) Non -variceal upper i) 20- 40 mg once daily for 2-5 days ii) 80
gastrointestinal bleed mg by IV bolus followed by 8mg/hour
infusion for 72 hours
Esomeprazole 40 mg Tablet A02BC05000T1001XX No A* i)Gastro-oesophageal reflux disease ii)H. pylori eradication i)20mg daily for 4-8 weeks ii)40mg daily
for 10 days in combination with
amoxicillin 1g twice daily or
clarithromycin 500mg twice daily
Essential Phospholipids, nicotinamide, A05BA00924C1001XX No A/KK Nutritional supplement in liver disorders Please refer to product leaflet
cyanocobalamine, tocopheryl,
pyridoxine, thiamine, riboflavine capsule

Estradiol 1 mg & Estradiol 1 mg with G03FB08954T1001XX No A* Hormone Replacement Therapy for women with disorders due One tablet daily without pill-free
Dydrogesterone 10 mg to natural or surgically induced menopause with intact uterus. interval, starting with 1 mg of Estradiol
for first 14 days, followed by 1mg
Estradiol with 10 mg Dydrogestrone
daily for the next 14 days

Estradiol 1 mg & Norethisterone Acetate G03FA01122T1001XX No A* Hormone replacement therapy for oestrogen deficiency 1 tablet per day without interruption
0.5 mg Tablet symptoms in women more than 1 year after menopause and
prevention of osteoporosis in post menopausal women

Estradiol 1 mg with Dydrogesterone 5 G03FB08954T1002XX No A* i) Hormone replacement therapy for the relief of symptoms One tablet daily, taken continuously
mg Tablet due to oestrogen deficiency ii) Prevention of postmenopausal without interruption. Should be used
osteoporosis in women with a uterus only in postmenopausal women more
than 12 month after menopause
Estradiol Valerate 1 mg Tablet G03CA03256T1002XX No A* Oestrogen replacement therapy - only those who cannot 1 mg daily continuously or 21 day
tolerate Premarin regimen with 1 week of tablet free
interval

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Generic Name MDC NEML Category Indications Dosage

Estradiol Valerate 2 mg and Norgestrel G03FB01953T1001XX No B Pre and post menopausal syndrome, primary and secondary Start on the 5th day of menstrual cycle -
500 mcg with Estradiol Valerate 2 mg amenorrhea, menstrual irregularities. Deficiency symptoms 1 tab daily for 21 days then stop for 7
Tablet after oophorectomy or radiological castration for days. If patient forgets dose at usual
noncarcinomatous disease time, it should be taken within following
12 hours
Etanercept 25 mg Injection L04AA11000P4001XX No A* i)Moderately to severe rheumatoid arthritis as monotherapy Adult & geriatric dose: Rheumatoid
or in combination with methotrexate in patients with arthritis, psoriatic arthritis, ankylosing
inadequate response to methotrexate alone. ii)Active spondylitis; 50 mg SC once-weekly for
polyarticular-course juvenile idiopathic arthritis in children 2- once-weekly dosing or 25 mg SC twice
17 years with inadequate response to, or who have proved weekly (individual doses should be
intolerant of methotrexate. iii)Psoriatic arthritis as separated by 72 to 96 hours) for twice-
monotherapy or in combination with methotrexate in patients weekly dosing. Plaque psoriasis; Initial:
inadequate response to methotrexate alone. iv)Active 50 mg SC twice weekly, 72 to 96 hours
ankylosing spondylitis in adults v)Moderate to severe plaque apart; maintain initial dose for 3 months
psoriasis who failed to respond to, or who have a (starting doses of 25 or 50 mg once
contraindication to, or are intolerant to other systemic weekly have also been used
therapy including cyclosporine, methotrexate or PUVA successfully). Maintenance dose: 50 mg
SC once weekly. Paediatric dose (2 to 17
years): Juvenile idiopathic arthritis; 0.8
mg/kg (max. 25 mg/dose) SC once
weekly for once-weekly dosing or 0.4
mg/kg (max. 25 mg/dose) SC twice
weekly (individual doses should be
separated by 72 to 96 hours) for twice-
weekly dosing.

Etanercept 50 mg Injection L04AB01000P4002XX No A* i) Moderately to severe rheumatoid arthritis as monotherapy Adult & geriatric dose: Rheumatoid
or in combination with methotrexate in patients with arthritis, psoriatic arthritis, ankylosing
inadequate response to methotrexate alone. ii) Active spondylitis; 50 mg SC once-weekly for
polyarticular-course juvenile idiopathic arthritis in children 2- once-weekly dosing or 25 mg SC twice
17 years with inadequate response to, or who have proved weekly (individual doses should be
intolerant of methotrexate. iii) Psoriatic arthritis as separated by 72 to 96 hours) for twice-
monotherapy or in combination with methotrexate in patients weekly dosing. Plaque psoriasis; Initial:
inadequate response to methotrexate alone. iv) Active 50 mg SC twice weekly, 72 to 96 hours
ankylosing spondylitis in adults v) Moderate to severe plaque apart; maintain initial dose for 3 months
psoriasis who failed to respond to, or who have a (starting doses of 25 or 50 mg once
contraindication to, or are intolerant to other systemic weekly have also been used
therapy including cyclosporine, methotrexate or PUVA successfully). Maintenance dose: 50 mg
SC once weekly. Paediatric dose (2 to 17
years): Juvenile idiopathic arthritis; 0.8
mg/kg (max. 25 mg/dose) SC once
weekly for once-weekly dosing or 0.4
mg/kg (max. 25 mg/dose) SC twice
weekly (individual doses should be
separated by 72 to 96 hours) for twice-
weekly dosing.

Ethambutol HCl 200 mg Tablet J04AK02110T1001XX Yes B Tuberculosis Adult: 15-25mg/kg daily (max 1200mg)
or 50mg/kg biweekly (max2000mg).
Children: 15-25mg/kg daily or 50 mg/kg
twice weekly.
Ethambutol HCl 400 mg Tablet J04AK02110T1002XX Yes B Tuberculosis Adult: 15-25mg/kg daily (max 1200mg)
or 50mg/kg biweekly (max2000mg).
Children: 15-25mg/kg daily or 50 mg/kg
twice weekly.
Ether Solvent N01AA01000L9901XX No C To remove adhesive plaster from the skin Dose depending on the route and
procedure
Ethinylestradiol 20 mcg & Drospirenone G03AA12954T1002XX No A* i)Oral contraception ii)Treatment of acne vulgaris in women 1 tab daily for 28 consecutive days
3 mg Tablet seeking oral contraception. iii) Treatment of symptoms of starting on 1st day of menstrual
premenstrual dysphoric disorder (PMDD) in women who bleeding.
choose to use an oral contraceptive as their method of
contraception.
Ethinylestradiol 20 mcg & Gestodene 75 G03AA10954T1001XX No A/KK Oral contraception 1 tablet to be taken daily for 21
mcg Tablet executive days starting on the first day
of menses. Each subsequent pack is
started after a 7 days tablet free interval.

Ethinylestradiol 20 mcg & Levonorgestrel G03AA07954T1002XX No A/KK i)Prevention of pregnancy ii)Treatment of moderate acne Beginning on day 1 of cycle, 1 tablet
100 mcg Tablet vulgaris not controlled by conventional therapy (e.g topical daily for 21 days followed by 7 tablet-
preparations and oral antibiotics) in post-menarchal, free days.
premenopausal women more than or 14 years who accept
contraception.
Ethionamide 250 mg Tablet J04AD03000T1001XX Yes A* As second-line therapy in the treatment of Multi Drug ADULT: 15-20mg/kg daily, in divided
Resistant Tuberculosis only in combination with other doses if necessary; maximum dose
efficacious agents and only when therapy with isoniazid, 1g/day. CHILD: 10-20mg/kg in 2-3
rifampicin, or other first-line agents has failed. divided doses or 15mg/kg/24hrs as a
single daily dose.

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Generic Name MDC NEML Category Indications Dosage

Ethosuximide 250 mg/5 ml Syrup N03AD01000L9001XX No B Absence seizures ADULT: Initially, 500 mg daily. Increased
by 250 mg at intervals of 4-7 days to
usual dose of 1-1.5 g daily. Maximum:
Up to 2 g, under strict supervision.
CHILD: Greater than or equal to 6 years:
Same as adult dose; less than 6 years:
Initially, 250 mg daily. Increased
gradually to usual dose of 20 mg/kg
daily. Maximum: Children greater than
or equal to 6 years: Same as adult dose;
less than 6 years: Up to 1 g

Ethyl Chloride 100ml Spray N01BX01000A4001XX Yes C For minor surgical procedures including lancing boils, incision Spray to affected area at a distance of
and drainage of small abscesses, pain due to athletic injuries about 30cm until a fine white film is
and pain due to injection administration produced
Etomidate 20 mg/10 ml Injection N01AX07000P3001XX No A* Induction of general anaesthesia for haemodynamically Adult: 300 mcg/kg given slowly over 30-
unstable patients 60 seconds into a large vein in the arm.
Child: Up to 30% more than the standard
adult dose. Elderly: 150-200 mcg/kg,
subsequently adjusted according to
effects.
Etonogestrel 68 mg Implant G03AC08000P1001XX No A/KK Contraception A single implant inserted subdermally
and can be left in place for three years.
The implant can be removed at any time
but not later than three years after the
date of insertion.

Etoposide 100 mg/5 ml Injection L01CB01000P3001XX Yes A* i) For treatment of children with solid tumours, juvenile i) CHILD: 60-120 mg/m2/day by IV for 3 -
myelomonocytic leukemia (JMML) and Langerhan cell 5 days every 3 - 6 weeks depending on
histiocytosis ii) Leukaemia, lymphoma iii) Testicular cancer, protocols ii) Maintenance or palliative
lung cancer, gestational trophoblastic disease, gastric cancer, chemotherapy for elderly acute myeloid
sarcoma leukemia, consolidation therapy for
acute lymphoblastic leukemia, stem cell
mobilization (Refer to protocol) iii) 100
mg/m2 by IV every other day for 3 doses
repeated every 3-4 weeks

Etoposide 50mg capsule L01CB01000C1003XX Yes A* Treatment of small cell lung cancer and malignant lymphomas Normal adult dose is 175mg-200mg daily
for 5 consecutive days orally, followed
by recession (withdrawal) interval of 3
weeks. Repeat administration as
necessary. Increase or reduce dose as
appropriate, according to the particular
disease or symptoms.

Etoricoxib 120 mg Tablet M01AH05000T1002XX No A* i)Acute and chronic treatment of signs and symptoms of i) OA: 60 mg once daily. RA: 90 mg once
osteoarthritis (OA) and rheumatoid arthritis (RA) ii)Acute daily ii & iii) Acute gouty arthritis and
gouty arthritis iii)Acute pain acute pain: 120 mg once daily (Given the
exposure to COX-2 inhibitors, doctors
are advised to use the lowest effective
dose for the shortest possible duration
of treatment)

Etoricoxib 60 mg Tablet M01AH05000T1003XX No A* i)Acute and chronic treatment of signs and symptoms of i) OA: 60 mg once daily. RA: 90 mg once
osteoarthritis (OA) and rheumatoid arthritis (RA) ii)Acute daily ii & iii) Acute gouty arthritis and
gouty arthritis iii)Acute pain acute pain: 120 mg once daily (Given the
exposure to COX-2 inhibitors, doctors
are advised to use the lowest effective
dose for the shortest possible duration
of treatment)

Etoricoxib 90 mg Tablet M01AH05000T1001XX No A* i)Acute and chronic treatment of signs and symptoms of i) OA: 60 mg once daily. RA: 90 mg once
osteoarthritis (OA) and rheumatoid arthritis (RA) ii)Acute daily ii & iii) Acute gouty arthritis and
gouty arthritis iii)Acute pain acute pain: 120 mg once daily (Given the
exposure to COX-2 inhibitors, doctors
are advised to use the lowest effective
dose for the shortest possible duration
of treatment)

Everolimus 0.25mg tablet L04AA18000T1001XX No A* Indicated for the prophylaxis of organ rejection in adult An initial dose regimen of 0.75 mg b.i.d.,
patients at low to moderate immunological risk receiving an which is recommended for the general
allogeneic renal or cardiac transplant in combination with kidney and heart transplant population.
ciclosporin for microemulsion and corticosteroids. The daily dose of everolimus should
always be given orally in two divided
doses (b.i.d.).
Everolimus 0.75mg tablet L04AA18000T1003XX No A* Indicated for the prophylaxis of organ rejection in adult An initial dose regimen of 0.75 mg b.i.d.,
patients at low to moderate immunological risk receiving an which is recommended for the general
allogeneic renal or cardiac transplant in combination with kidney and heart transplant population.
ciclosporin for microemulsion and corticosteroids. The daily dose of everolimus should
always be given orally in two divided
doses (b.i.d.).
Exemestane 25 mg Tablet L02BG06000T1001XX No A* Treatment of post-menopausal women with advanced breast 25 mg once daily
cancer whose disease has progressed following tamoxifen and
non-steroidal aromatase inhibitors
Ezetimibe 10 mg & Simvastatin 20 mg C10BA02000T1001XX No A* Primary hypercholesterolemia Usual starting dose: 10/20 mg/day
Tablet

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Generic Name MDC NEML Category Indications Dosage

Ezetimibe 10 mg Tablet C10AX09000T1001XX No A* i) Co-administration with statins for patients who have chronic 10 mg once daily. Not recommended for
heart disease or are chronic heart disease equivalent or children less than 10 years old
familial hypercholesterolaemia with target LDL-C not achieved
by maximum dose of statins ii) Monotherapy in patients with
documented biochemical intolerance to statins

Ezetimibe 10mg/ Simvastatin 40mg C10BA02000T1003XX No A* Primary hypercholesterolemia Usual starting dose: 10/20 mg/day
Tablet
Factor IX Injection B02BD04000P9901XX No A Prevention and control of bleeding in patients with factor IX Dose varies according to the patient and
deficiency due to haemophilia B the circumstances of the bleeding. i)
Mild haemorrhage: initial dose of 30
units/kg body weight. ii) Moderate
haemorrhage: initial dose of 50 units/kg
iii) Major haemorrhage/surgery: Initial
dose of 75 - 100 units/kg. Half of these
doses may be repeated after 18-24 hrs if
necessary.

Factor IX, Factor II & Factor X in B02BD01000P4002XXX No A* i) Treatment and perioperative prophylaxis of bleeding in 25 – 50 IU/kg, depending on the INR
combination 500IU/vial injection acquired deficiency of prothrombin complex factors, such as
deficiency caused by treatment with vitamin K antagonists, or
in case of overdose of vitamin K antagonists, when rapid
correction of the deficiency is required. ii) Treatment and
prophylaxis of bleeding in patients with single or multiple
congenital deficiencies of factor IX, II or X when purified
specific coagulation factor product is not available. Cautionary
Notes: i) in serious life threatening haemorrhage, or if urgent
immediate clinical requirement for reversal of anticoagulated
state is required (especially if baseline INR >4), a 3-factor PCC
lacking factor VII may not be as effective as 4-factor PCC in
providing timely haemostasis. ii) The use of pure factor IX
concentrates is recommended for the treatment of
Haemophilia B (factor IX deficiency) as opposed to PCC in view
of risks of thrombosis or disseminated intravascular
coagulation (DIC). PCC should not be used in patients with
inhibitors.

Factor IX, Factor II, Factor VII and Factor B02BD01000P4001XX No A* i) Treatment and perioperative prophylaxis of bleeding in Amount and frequency of administration
X In Combination Injection acquired deficiency of the prothrombin complex coagulation should be calculated on an individual
factors, such as deficiency caused by treatment with vitamin K patient basis. Individual dosage
antagonists, or in case of overdose of vitamin K antagonists, requirements can only be identified on
when rapid correction of the deficiency is required. ii) the basis of regular determinations of
Treatment and perioperative prophylaxis of bleeding in the individual plasma levels of the
congenital deficiency of any of the vitamin K dependent coagulation factors of interest or on the
coagulation factors only if purified specific coagulation factor global tests of the prothrombin complex
product is not available. levels (INR, Quick's test) and a
continuous monitoring of the clinical
condition of the patient. An approximate
calculation is as follows: Required dose
(IU) = body weight (kg) x desired factor
rise (IU/dl or % of normal) x reciprocal of
the estimated recovery, i.e. Factor II = 53
Factor VII = 59 Factor IX = 77 Factor X =
56 As product may differ from one to
another, it is strongly advised to refer to
the manufacturer (product insert) in
regards to dosing calculation.

Factor VIIa (Recombinant) eptacog alfa B02BD08000P4005XX No A* Treatment of bleeding episodes and prevention of excessive Initially 4.5 KIU (90 mcg)/kg body weight
(activated) 100 KIU (2 mg) Injection bleeding in connection with surgery in patients with inherited IV bolus over 2-5 minutes, followed by 3-
or acquired haemophilia with inhibitors to coagulation factors 6 KIU (60-120 mcg)/kg body weight
VIII or IX depending on type & severity of
haemorrhage or surgery performed.
Dosing interval: initially 2-3 hour to
obtain haemostasis and until clinically
improved. If continued therapy is
needed, dose interval can be increased
successively to every 4, 6, 8 or 12 hours

Factor VIIa (Recombinant) eptacog alfa B02BD08000P4004XX No A* Treatment of bleeding episodes and prevention of excessive Initially 4.5 KIU (90 mcg)/kg body weight
(activated) 50 KIU (1 mg) Injection bleeding in connection with surgery in patients with inherited IV bolus over 2-5 minutes, followed by 3-
or acquired haemophilia with inhibitors to coagulation factors 6 KIU (60-120 mcg)/kg body weight
VIII or IX depending on type & severity of
haemorrhage or surgery performed.
Dosing interval: initially 2-3 hour to
obtain haemostasis and until clinically
improved. If continued therapy is
needed, dose interval can be increased
successively to every 4, 6, 8 or 12 hours

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Factor VIII (Human blood coagulation B02BD06000P4002XX No A* i)The treatment and prophylaxis of haemorrhage or surgical i. Von Willebrand Disease: Spontaneous
factor) & Von Willebrand factor Injection bleeding in Von Willebrand Disease (VWD) when 1-deamino-8- Bleeding Episodes: Initially, factor VIII
D-arginine vasopressin (desmopressin, DDAVP) treatment 12.5-25 IU/kg and ristocetin cofactor 25-
alone is ineffective or contraindicated. ii)The treatment and 50 IU/kg followed by factor VIII 12.5
prophylaxis of bleeding associated with factor VIII deficiency IU/kg and ristocetin cofactor 25 IU/kg
due to haemophilia A. subsequently every 12-24 hrs. Minor
Surgery: Factor VIII 30 IU/kg and
ristocetin cofactor 60 IU/kg daily. Major
Surgery: Initially, factor VIII 30-40 IU/kg
and ristocetin cofactor 60-80 IU/kg
followed by factor VIII 15-30 IU/kg and
ristocetin cofactor 30-60 IU/kg
subsequently every 12-24 hrs.
Prophylaxis: Factor VIII 12.5-20 IU/kg
and ristocetin cofactor 25-40 IU/kg 3
times weekly. ii. Hemophilia A therapy:
Minor haemorrage: 10-15 IU/kg every 12-
24 hours. Moderate to severe
haemorrhage: 15-40 IU/kg every 8 to 24
hours. Minor surgery: Loading dose 20-
30 IU/kg, maintenance dose 15-30 IU/kg.
Major surgery: Loading dose 40-50
IU/kg, maintenance dose 10-40 IU/kg.
Prophylaxis: 25-40 IU/kg three times
weekly As product may differ from one
to another, it is strongly advised to refer
Factor VIII Inhibitor Bypassing Activity B02BD03000P4001XX No A i)Treatment and prophylaxis of hemorrhages in hemophilia A As a general guideline, a dose of 50 to
Injection and B patients with inhibitors. ii) Treatment and prophylaxis of 100IU/kg body weight is recommended,
hemorrhages in non-hemophilic patients who have developed not exceeding an individual dose of
inhibitors to Factors VIII, IX and XI. iii)Treatment of patients 100IU/kg bw and a maximum daily dose
with acquired inhibitors to Factors X and XIII. iv)In the of 200IU/kg bw.
combination with Factor VIII concentrate for a long-term
therapy to achieve a complete and permanent elimination of
the Factor VIII inhibitor so as to allow for regular treatment
with Factor VIII concentrate as in patients without inhibitor.

Factor VIII Injection B02BD02999P9901XX No A Prevention and control of bleeding in patients with factor VIII Dose varies according to the patient and
deficiency due to classical haemophilia A the circumstances of the bleeding. i)
Mild to moderate: Usually a single dose
of 10-15units/kg. ii) More serious
haemorrhage/minor surgery:Initially 15-
25 units/kg followed by 10-15 units/kg
every 8 - 12 hours if required iii) Severe
haemorrhage/major surgery: Initial : 40 -
50 units/kg followed by 20 - 25 units/kg
every 8-12 hrs.

Fat Emulsion 10% for IV Infusion B05BA02000P6001XX No A Source of lipid in patients needing IV nutrition Dose to be individualised. ADULT usual
Injection lipid requirement 2-3 g/kg/day. INFANT
0.5 - 1 g/kg/day
Fat Emulsion 20% for IV Infusion B05BA02000P6002XX No A Source of lipid in patients needing IV nutrition Dose to be individualised. ADULT usual
Injection lipid requirement 2-3 g/kg/day. INFANT
0.5-1 g/kg/day
Felodipine 10 mg Extended Release C08CA02000T1002XX No A/KK Hypertension Initiate at 5 mg once daily. Usual dose, 5 -
Tablet 10 mg once daily in the morning

Felodipine 5 mg Extended Release Tablet C08CA02000T1001XX No A/KK Hypertension Initiate at 5 mg once daily. Usual dose, 5 -
10 mg once daily in the morning

Fenofibrate 145 mg tablet C10AB05000T1002XX No A/KK As second line therapy after failed gemfibrozil in patients: i) 145mg once daily, with or without food
Hypercholesterolemia and hypertriglyceridemia alone or
combined [type IIa,IIb,III and V dysplipidemias] in patients
unresponsive to dietary and other non-pharmacological
measures especially when there is evidence of associated risk
factors ii) Treatment of secondary hyperlipoproteinemias if
hyperlipoprotenemia persists despite effective treatment of
underlying disease iii) Dyslipidemia in Type 2 Diabetes Mellitus

Fentanyl 12mcg/h Transdermal Patch N02AB03136M7005XX No A* As a second line drug in the management of chronic severe ADULT and CHILD over 2 years previously
cancer pain not responding to non-narcotic analgesic. Not to treated with a strong opioid analgesic,
be used in opiod naive patients.The use is to be restricted to initial dose based on previous 24-hour
pain specialists, palliative medicine specialists and oncologists opioid requirement (consult product
literature). If necessary dose should be
adjusted at 72-hour intervals in steps of
12-25 mcg/hr

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Generic Name MDC NEML Category Indications Dosage

Fentanyl 25 mcg/h Transdermal Patch N02AB03136M7001XX No A* As a second line drug in the management of chronic cancer Patients who have not previously
pain. The use is to be restricted to pain specialists, palliative received a strong opioid analgesic, initial
medicine specialists and oncologists. dose , one 25 mcg/hour patch to be
replaced after 72 hours. Patients who
have received a strong opioid analgesic,
initial dose based on previous 24 hours
opioid requirement (oral morphine
sulphate 90 mg over 24 hours = one 25
mcg/hour patch). Not recommended in
children.

Fentanyl 50 mcg/h Transdermal Patch N02AB03136M7002XX No A* As a second line drug in the management of chronic cancer Patients who have not previously
pain. The use is to be restricted to pain specialists, palliative received a strong opioid analgesic, initial
medicine specialists and oncologists dose , one 25 mcg/hour patch to be
replaced after 72 hours. Patients who
have received a strong opioid analgesic,
initial dose based on previous 24 hours
opioid requirement (oral morphine
sulphate 90 mg over 24 hours = one 25
mcg/hour patch). Not recommended in
children.

Fentanyl Citrate 50 mcg/ml Injection N01AH01136P3001XX No A Short duration analgesia during pre-medication induction and Dose should be individualized according
maintenance of anaesthesia, and in the immediate post- to age, body weight, physical status,
operative period. underlying pathological conditions and
type of surgery and anaesthesia. ADULT:
Premedication: IM 50 - 100 mcg, 30 - 60
mins prior to surgery. Adjunct to general
anaesthesia: Induction IV 50 - 100mcg,
repeat 2 - 3 mins intervals until desired
effect is achieved. IV/IM 25 - 50mcg in
elderly and poor risk patients.
Maintenance: IV/IM 25 - 50mcg. Adjunct
to regional anaesthesia: IM/slow IV 50 -
100mcg when additinal analgesia is
required. Post-operatively (recovery
room): IM 50 - 100mcg for pain control,
tachypnoea and emergency delirium.
May be repeated in 1- 2 hours as
needed. CHILD (2 - 12 years): Induction
& maintenance: 2 - 3 mcg/kg.

Ferric Ammonium Citrate 800 mg/10 ml B03AB06136L2101XX No C Prevention and treatment of iron-deficiency anaemias CHILD up to 1 year 5 ml, 1 - 5 years 10
Paediatric Mixture ml, taken well diluted with water
Ferrous controlled release 500 mg, B03AE10903T1001XX No A/KK Anemia due to iron deficiency, megaloblastic anemia where One tablet daily
Vitamin B1, Vitamin B2, Vitamin B6, there is an associated deficiency of Vitamin C and Vitamin B-
Vitamin B12, Vitamin C, Niacinamide, complex particularly in pregnancy. In primary health clinic, the
Calcium Pantothenate, Folic Acid 800 indication is restricted to anemia due to iron deficiency in
mcg Tablet pregnant women ONLY.
Ferrous Fumarate 200 mg Tablet B03AA02138T1001XX Yes C+ Prevention and treatment of iron-deficiency anaemias Adult: Usual dose range: Up to 600 mg
daily. May increase up to 1.2 g daily if
necessary. Child: As syrup containing
140 mg(45 mg iron)/5ml. Preterm
neonate: 0.6-2.4 ml/kg daily; up to 6
years old: 2.5-5ml twice daily
Filgrastim (G-CSF) 30 MU/ml Injection L03AA02000P3001XX No A* i) Reduction in the duration of neutropenia and incidence of i) Adult: SC or IV 5 mcg/kg/day.
febrile neutropenia in cytotoxic chemotherapy for malignancy Initiation: 24 - 72 hours after
except chronic myeloid leukemia and myelodysplastic chemotherapy. Duration: Until a
syndrome ii) Haemopoeitic stem cell transplantation clinically adequate neutrophil recovery is
(HSCT)/stem cell harvesting achieved (absolute neutrophil count of
at least 1 x 109/L on 2 consecutive days)
ii) Refer to protocol

Filgrastim 30 MU in 0.5 ml Injection L03AA02000P5001XX No A* i) Reduction in the duration of neutropenia and incidence of i) ADULT: 5 mcg/kg/day by SC or IV.
febrile neutropenia in cytotoxic chemotherapy for malignancy Initiation: 24 - 72 hours after
except chronic myeloid leukemia and myelodysplastic chemotherapy. Duration: Until a
syndrome ii) Haemopoeitic stem cell transplantation clinically adequate neutrophil recovery is
(HSCT)/stem cell harvesting achieved (absolute neutrophil count of
at least 1 x 109/L on 2 consecutive days)
ii) Refer to protocol

Finasteride 5 mg Tablet G04CB01000T1001XX Yes A* Treatment and control of benign prostatic hyperplasia 5 mg a day as a single dose. Clinical
responses occur within 12 weeks - 6
months of initiation of therapy. Long-
term administration is recommended for
maximal response
Fingolimod 0.5mg Capsule L04AA27110C1001XX No A* Treatment of patients with relapsing forms of multiple 0.5mg orally once daily
sclerosis to reduce the frequency of clinical exacerbations and
to delay the accumulation of physical disability

Flavoxate HCl 100 mg Tablet G04BD02110T1001XX No A Urinary frequency and incontinence, dysuria, urgency, bladder ADULT: 200 mg 3 times daily. CHILD
spasm due to catheterisation under 12 years not recommended

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Flecainide Acetate 100 mg Tablet C01BC04122T1001XX No A* i) Sustained monomorphic ventricular tachycardias ii) Ventricular arrhythmias: 100 mg twice
Preexcited atrial fibrillation associated with Wolff-Parkinson daily, maximum 400 mg/day (usually
White Syndrome iii) Reciprocating Atrio-Ventricular reserved for rapid control or in heavily
tachycardias (AVT) associated with Wolff-Parkinson White built patients), reduced after 3 - 5 days if
Syndrome iv) Supraventricular tachycardias due to Intra-Atrio possible. Supraventricular arrhythmias:
Ventricular Nodul Reentry 50 mg twice daily, increased if required
to maximum of 150 mg twice daily

Fluconazole 100 mg Capsule J02AC01000C1002XX Yes A i) Oropharyngeal candidiasis, atrophic oral candidiasis i) Oropharyngeal candidiasis: 50 - 100
associated with dentures, other candidal infections of mucosa mg daily for 7 - 14 days (Maximum 14
ii) Tinea pedis, corporis, cruris, versicolor and dermal days) except in severely
candidiasis iii) Invasive candidal & cryptococcal infections immunocompromised patients,
(including meningitis) iv) Prevention of relapse of cryptococcal treatment can be continued for longer
meningitis in AIDS patients after completion of primary periods. Atrophic oral candidiasis
therapy v) Prevention of fungal infections in associated with dentures: 50 mg daily
immunocompromised patients considered at risk as a for 14 days. Other candidal infections of
consequence of HIV infections or neutropenia following mucosa: 50 - 100 mg daily for 14 - 30
cytotoxic chemotherapy, radiotherapy or bone marrow days. CHILD: 3 - 6 mg/kg on first day
transplant then 3 mg/kg daily (every 72 hours in
NEONATE up to 2 weeks old, every 48
hours in NEONATE 2 - 4 weeks old) ii) 50
mg daily for 2 - 4 weeks, maximum 6
weeks iii) 400 mg initially then 200 - 400
mg daily for 6 - 8 weeks. CHILD: 6 - 12
mg/kg daily (every 72 hours in NEONATE
up to 2 weeks old, every 48 hours in
NEONATE 2 -4 weeks old) iv) 100 - 200
mg daily v) 50 - 400 mg daily. CHILD: 3 -
12 mg/kg daily (every 72 hours in
NEONATE up to 2 weeks old, every 48
hours in NEONATE 2 - 4 weeks old)

Fluconazole 2 mg/ml Injection J02AC01000P9901XX Yes A i) Oropharyngeal candidiasis, atrophic oral candidiasis i) 50 - 100 mg daily for 7 - 14 days
associated with dentures, other candidal infections of mucosa (Maximum 14 days) except in severely
ii) Tinea pedis, corporis, cruris, versicolor and dermal immunocompromised patients,
candidiasis iii) Invasive candidal& cryptococcal infections treatment can be continued for longer
(including meningitis) iv) Prevention of relapse of cryptococcal periods. Atrophic oral candidiasis
meningitis in AIDS patients after completion of primary associated with dentures: 50 mg daily
therapy v) Prevention of fungal infections in for 14 days. Other candidal infections of
immunocompromised patients considered at risk as a mucosa: 50 - 100 mg daily for 14 - 30
consequence of HIV infections or neutropenia following days. CHILD: 3 - 6 mg/kg on first day
cytotoxic chemotherapy, radiotherapy or bone marrow then 3 mg/kg daily (every 72 hours in
transplant NEONATE up to 2 weeks old, every 48
hours in NEONATE 2 - 4 weeks old) ii) 50
mg daily for 2 - 4 weeks, maximum 6
weeks iii) 400 mg initially then 200 - 400
mg daily for 6 - 8 weeks. CHILD: 6-12
mg/kg daily (every 72 hours in NEONATE
up to 2 weeks old, every 48 hours in
NEONATE 2 - 4 weeks old) iv) 100 - 200
mg daily v) 50 - 400 mg daily. CHILD: 3 -
12 mg/kg daily (every 72 hours in
NEONATE up to 2 weeks old, every 48
hours in NEONATE 2 - 4 weeks old)

Fluconazole 50 mg Capsule J02AC01000C1001XX Yes A i) Oropharyngeal candidiasis, atrophic oral candidiasis i) Oropharyngeal candidiasis: 50 - 100
associated with dentures, other candidal infections of mucosa mg daily for 7 - 14 days (Maximum 14
ii) Tinea pedis, corporis, cruris, versicolor and dermal days) except in severely
candidiasis iii) Invasive candidal & cryptococcal infections immunocompromised patients,
(including meningitis) iv) Prevention of relapse of cryptococcal treatment can be continued for longer
meningitis in AIDS patients after completion of primary periods. Atrophic oral candidiasis
therapy v) Prevention of fungal infections in associated with dentures: 50 mg daily
immunocompromised patients considered at risk as a for 14 days. Other candidal infections of
consequence of HIV infections or neutropenia following mucosa: 50 - 100 mg daily for 14 - 30
cytotoxic chemotherapy, radiotherapy or bone marrow days. CHILD: 3 - 6 mg/kg on first day
transplant then 3 mg/kg daily (every 72 hours in
NEONATE up to 2 weeks old, every 48
hours in NEONATE 2 - 4 weeks old) ii) 50
mg daily for 2 - 4 weeks, maximum 6
weeks iii) 400 mg initially then 200 - 400
mg daily for 6 - 8 weeks. CHILD: 6 - 12
mg/kg daily (every 72 hours in NEONATE
up to 2 weeks old, every 48 hours in
NEONATE 2 -4 weeks old) iv) 100 - 200
mg daily v) 50 - 400 mg daily. CHILD: 3 -
12 mg/kg daily (every 72 hours in
NEONATE up to 2 weeks old, every 48
hours in NEONATE 2 - 4 weeks old)

Flucytosine 2.5 g/250 ml Injection J02AX01000P9901XX No A* Treatment of systemic fungal infection ADULT: 100 - 200 mg/kg daily in 4
divided doses by IV infusion over 20 - 40
minutes not more than 7 days

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Generic Name MDC NEML Category Indications Dosage

Flucytosine 500 mg Tablet J02AX01000T1001XX No A* Only for the treatment of fungal meningitis ADULT: 50 - 150 mg/kg/day in 4 divided
doses
Fludarabine Phosphate 10 mg Tablet L01BB05162T1001XX No A* B-cell chronic lymphocytic leukemia who have not responded 40 mg /m2 given daily for 5 consecutive
to or whose disease had progressed during or after treatment days every 28 days. Courses may be
with at least one standard alkylating-agent containing regimen repeated every 28 days, usually for up to
6 cycles. Duration of treatment depends
on treatment success and tolerability of
the drug

Fludarabine Phosphate 50 mg Injection L01BB05162P4001XX No A* B-cell chronic lymphocytic leukaemia who have not responded 25 mg/m2 daily for 5 consecutive days
to or whose disease had progressed during or after treatment every 28 days. May be administered up
with at least one standard alkylating-agent containing regimen to the achievement of a maximal
response (usually 6 cycles) and then the
drug should be discontinued. Reduce
dose by up to 50% in patients with mild
to moderate renal impairment (30-
70ml/min)

Fludrocortisone Acetate 0.1 mg Tablet H02AA02122T1001XX No A As an adjunct to glucocorticoids in the management of Adrenocorticoid insufficiency (chronic):
primary adrenocortical insufficiency in Addison's disease and ADULT 1 tablet daily. Salt-losing
treatment of salt-losing adrenogenital syndrome adrenogenital syndrome: ADULT 1 - 2
tablets daily. CHILD and INFANT 0.5 - 1
tablet daily
Flumazenil 0.1 mg/ml Injection V03AB25000P3001XX Yes B i) Diagnosis and/or management of benzodiazepine overdose i) Initial, 0.2 mg IV over 30 seconds; if
due to self-poisoning or accidental overdose ii) Reversal of desired level of consciousness not
sedation following anaesthesia with benzodiazepine obtained after an additional 30 seconds,
give dose of 0.3 mg IV over 30 seconds;
further doses of 0.5 mg IV over 30
seconds may be given at 1-minutes
intervals if needed to maximum total
dose of 3 mg; patients with only partial
response to 3 mg may require additional
slow titration to a total dose of 5 mg; if
no response 5 minutes after receiving
total dose of 5 mg, overdose is unlikely
to be benzodiazepine and further
treatment with flumazenil will not help
ii) 0.2 mg IV over 15 seconds; if desired
level of consciousness is not obtained
after waiting 45 seconds, a second dose
of 0.2 mg IV may be given and repeated
at 60-seconds intervals as needed (up to
a maximum of 4 additional times) to a
maximum total dose of 1 mg; most
patients respond to doses of 0.6 to 1 mg;
in the event of resedation, repeated
doses may be given at 20-minutes
intervals if needed; for repeat treatment,
no more than 1 mg (given as 0.5
Flunarizine HCl 5 mg Capsule N07CA03110C1001XX Yes B i) Migraine prophylaxis ii) Maintenance treatment of vestibular i) ADULT: 5 - 10 mg daily preferably at
disturbances and of cerebral and peripheral disorders night. ELDERLY more than 65 years: 5 mg
at night. Maintenance 5-day treatment
at the same daily dose ii) 5 - 10 mg at
night. If no improvement after 1 month,
discontinue treatment

Fluorescein 1 mg Ophthalmic Strip S01JA01520M9901XX Yes B Diagnostic fluorescein angiography or angioscopy of the Moisten tip with tear fluid from lower
fundus and of the iris vasculature fornix, sterile water or ophthalmic
solution and gently stroke across the
conjunctiva
Fluorescein Sodium 10% in 5 ml Injection S01JA01520P3001XX No A Diagnostic fluorescein angiography or angioscopy of the 500 mg IV
fundus and of the iris vasculature
Fluorometholone 0.1% Ophthalmic S01BA07000D2001XX No A* Treatment of steroid responsive ocular inflammation 1-2 drops qds. During the initial 24-48
Suspension hr, dose may be increased to 2 drops 2
hrly.
Fluorouracil 1 g/20 ml Injection L01BC02000P4002XX Yes A* Cancers of gastro-intestinal tract, breast and pancreas, head 500 - 600 mg/m2 IV in combination with
and neck. Ophtalmological indication: trabeculectomy other cytotoxic agents, repeated every 3
weeks or 300 - 450 mg/m2 IV slow bolus
daily for 5 days in combination with
biological response modifiers, repeated
every 4 weeks or 3000 - 3750 mg/m2 as
a continuous infusion over 5 days in
combination with a platinum compound
every 3 to 4 weeks

Fluorouracil 100 mg Tablet L01BC02000T1001XX No A Colorectal cancer 15 mg/kg (max: 1 g/day), may be given
once weekly for maintenance. Max: 1
g/week.

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Generic Name MDC NEML Category Indications Dosage

Fluorouracil 50 mg / ml in 5 ml Injection L01BC02000P4001XX Yes A* Cancers of gastro-intestinal tract, breast and pancreas, head Intravenous Infusion: 15 mg/kg
and neck. Ophtalmological indication: trabeculectomy bodyweight (to a maximum of 1 g daily)
diluted in 300-500mL of 5% glucose
given over a period of 4 hours. 12 mg/kg
bodyweight daily for 3 consecutive days.
Providing there are no signs of toxic
effects, the patient may then be given
6mg/kg I.V. on the 5th, 7th and 9th days.
If after the 9th day there is still no sign
of toxicity, the patient may be placed on
maintenance therapy. Maintenance
Therapy: 5 - 10mg/kg bodyweight by I.V.
injection once a week.

Fluoxetine HCl 20 mg Capsule N06AB03110C1001XX No A i) Depression ii) Obsessive-compulsive disorder i) 20 mg once daily increased after 3
weeks if necessary, usual dose 20 - 60
mg (ELDERLY 20 - 40 mg) once daily max
80 mg once daily (ELDERLY max 60 mg
once daily). ii) Initially 20 mg once daily
increased after 2 weeks if necessary,
usual dose 20 - 60 mg (ELDERLY 20 - 40
mg) once daily, max 80 mg (ELDERLY
max 60 mg) once daily, discontinue if no
improvement within 10 weeks. CHILD
and ADOLESCENT under 18 years are not
recommended

Flupenthixol Decanoate 20mg/ml N05AF01135P2001XX Yes B Chronic psychoses By deep IM, initial test dose of 5-20 mg,
lnjection then after at least 7 days. 20 - 40 mg
repeated at intervals of 2 - 4 weeks.
Maximum 400 mg weekly. Usual
maintenance dose 50 mg every 4 weeks
to 300 mg every 2 weeks. ELDERLY,
initially quarter to half adult dose. CHILD
not recommended. Deep IM
recommended. Not for IV use

Fluphenazine Decanoate 25 mg/ml N05AB02135P3001XX Yes B Long term management of psychotic disorders By deep IM : Test dose 12.5 mg (6.25 mg
Injection in ELDERLY), then after 4-7 days 12.5 mg-
100 mg repeated at intervals of 14-35
days, adjusted according to response.
CHILD not recommended

Flutamide 250 mg Tablet L02BB01000T1001XX No A* Metastatic prostatic carcinoma 250 mg 3 times daily
Fluticasone Furoate 27.5 mcg/dose Nasal R01AD08139A4101XX No A* Treatment of nasal symptoms (rhinorrhea, nasal congestion, Adults/Adolescents (≥12 years) : 1-2
Spray nasal itching and sneezing) and ocular symptoms sprays (27.5 mcg/spray) in each nostril
(itching/burning, tearing/watering, and redness of the eye) of once daily. Children (2-11 years) : 1-2
seasonal and perennial allergic rhinitis. sprays (27.5 mcg/spray) in each nostril
once daily
Fluticasone propionate & formoterol R03AK11989A2101XX No A/KK Indicated in the regular treatment of asthma where the use of Two inhalations (puffs) twice daily
fumarate dihydrate (125/5mcg) per a combination product (an inhaled corticosteroid and a long- normally taken in the morning and in the
actuation pressurized inhalation, acting β2 agonist) is appropriate: - For patients not adequately evening.
suspension controlled with inhaled corticosteroids and "as required"
inhaled short-acting β2 agonist. - For patients already
adequately controlled on both an inhaled corticosteroid and a
long-acting β2 agonist.

Fluticasone propionate & formoterol R03AK11989A2102XX No A/KK Indicated in the regular treatment of asthma where the use of Two inhalations (puffs) twice daily
fumarate dihydrate (250/10mcg) per a combination product (an inhaled corticosteroid and a long- normally taken in the morning and in the
actuation pressurized inhalation, acting β2 agonist) is appropriate: I) For patients not evening.
suspension adequately controlled with inhaled corticosteroids and 'as
required' inhaled short-acting β2 agonist. II) For patients
already adequately controlled on both an inhaled
corticosteroid and a long-acting β2 agonist.

Fluticasone Propionate 125 mcg/dose R03BA05133A2101XX No B Prophylactic treatment for asthma ADULT and CHILD more than 16 years i)
Inhaler Mild asthma : 100 mcg - 250 mcg twice
daily ii) Moderate asthma : 250 - 500
mcg twice daily iii) Severe asthma : 500
mcg - 1000 mcg twice daily.
Alternatively, the starting dose of
fluticasone dipropionate may be gauged
at half the total daily dose of
beclomethasone dipropionate or
equivalent administered by inhalation.
CHILD 4 - 11 years, 50 mcg twice daily
(maximum 100 mcg twice daily), CHILD 1-
4 years, 50-100mcg microgram twice
daily
Fluvoxamine 100 mg Tablet N06AB08253T1002XX Yes B Depression For depression, initially 50 - 100 mg daily
in the evening, increased if necessary to
300 mg daily (over 150 mg in divided
doses); usual maintenance dose 100 mg
daily. CHILD and ADOLESCENT under 18
years not recommended

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Generic Name MDC NEML Category Indications Dosage

Fluvoxamine 50 mg Tablet N06AB08253T1001XX Yes B Depressive disorder For depression, initially 50 - 100 mg daily
in the evening, increased if necessary to
300 mg daily (over 150 mg in divided
doses); usual maintenance dose 100 mg
daily. CHILD and ADOLESCENT under 18
years not recommended

Folic Acid 5 mg Tablet B03BB01000T1001XX Yes C+ i) For the prevention and treatment of folate deficiency states i) ADULT initially 10-20mg mg daily for
ii) For the prevention of neural tube defect in the foetus 14 days or until haematopoietic
response obtained. Daily maintenance:
2.5 mg-10mg .CHILD up to 1 year:250
mcg/kg daily; 1 to 5 years:2.5mg/day;6-
12 years: 5mg/day ii) 5 mg daily starting
before pregnancy and continued
through the first trimester

Follitropin Alpha (Recombinant Human G03GA05000P3002XX No A* i) Infertility treatment in anovulatory women who have been i) 75 - 150 IU daily, should commence
FSH) 300 IU/0.5 ml Injection unresponsive to treatment with clomiphene citrate ii) within the first 7 days of the menstrual
Stimulation of follicular development for intra-uterine cycles cycle and increased by 37.5 IU or 75 IU
iii) Stimulation of follicular development in assisted at 7 or 14 days interval. Max daily dose
reproductive technology in the management of infertility 225 IU ii) 150 - 225 IU daily commencing
on days 2 or 3 of the cycle. Max daily
dose 450 IU

Follitropin Alpha (Recombinant Human G03GA05000P3001XX No A* i) Infertility treatment in anovulatory women who have been i) 75 - 150 IU daily, should commence
FSH) 75 IU Injection unresponsive to treatment with clomiphene citrate ii) within the first 7 days of the menstrual
Stimulation of follicular development for intra-uterine cycles cycle and increased by 37.5 IU or 75 IU
iii) Stimulation of follicular development in assisted at 7 or 14 days interval. Max daily dose
reproductive technology in the management of infertility 225 IU ii) 150 - 225 IU daily commencing
on days 2 or 3 of the cycle. Max daily
dose 450 IU

Follitropin Beta (Recombinant Human G03GA06000P3002XX No A* Infertility treatment in anovulatory women who have been To be individualized. Give in multiples of
FSH) 300 IU Injection unresponsive to treatment with clomiphene citrate. 50 IU. Starting dose can be 50 IU - 200 IU
Stimulation of follicular development for intra-uterine daily. It can be a step-up regime or a
insemination cycles and assisted reproductive technology in step-down, depending on the protocol
the management of infertility. and the ovarian response

Follitropin Beta (Recombinant Human G03GA06000P3001XX No A* Infertility treatment in anovulatory women who have been To be individualized. Give in multiples of
FSH) 50 IU Injection unresponsive to treatment with clomiphene citrate. 50 IU. Starting dose can be 50 IU - 200 IU
Stimulation of follicular development for intra-uterine daily. It can be a step-up regime or a
insemination cycles and assisted reproductive technology in step-down, depending on the protocol
the management of infertility. and the ovarian response

Fondaparinux Sodium 12.5 mg/ml B01AX05520P5002XX No A* i) Treatment of acute Deep Vein Thrombosis (DVT). ii) The recommended dose to be
Injection in Prefilled Syringe Treatment of Pulmonary Embolism (PE) administered by SC injection once daily
is: 5mg for body weight less than 50kg,
7.5mg for body weight 50 to 100kg,
10mg for body weight greater than
100kg. Treatment should be continued
for at least 5 days and until adequate
oral anticoagulation is established (INR 2
to 3). Concomitant treatment with
vitamin K antagonists should be initiated
as soon as possible, usually within 72
hours. The usual duration of treatment is
5 to 9 days

Fondaparinux Sodium 2.5 mg/0.5 ml B01AX05520P5001XX No A* i) Prevention of venous thromboembolic events (VTE) in i) 2.5 mg once daily given by SC,
Injection orthopedic surgery (e.g. hip fracture, major knee or hip administered 6 hr following surgical
replacement surgery), abdominal surgery in patients at risk of closure provided homeostasis has been
thromboembolic complication. ii) Treatment of unstable established. Usual duration of therapy is
angina or non-ST segment elevation myocardial infarction 5 to 9 days; for hip fracture patients, an
[UA/NSTEMI] in patients for whom urgent invasive extended course of up to 24 days is
management (PCI) is not indicated. iii) Treatment of ST recommended. ii) ADULT more than 18
segment elevation myocardial infarction (STEMI) in patients years: 2.5 mg once daily given by SC,
managed with thrombolytics or are not receiving other forms initiated as soon as possible after
of reperfusion therapy diagnosis and continued for up to 8 days
or until hospital discharge. If patient
needs to undergo PCI, unfractionated
heparin to be admin as per local practice
protocol, taking into account the
patient's bleeding risk and time of last
dose of fondaparinux. Fondaparinux may
be restarted no earlier than 2 hr after
sheath removal. iii) ADULT more than 18
years: 2.5 mg once daily; first dose to be
given IV (directly through an existing IV
line or as infusion in 25 or 50 ml of 0.9%
saline over 1-2 min), subsequent doses
to be given SC. Treatment to be initiated
as soon as diagnosis is made and
continued up to a max of 8 days or until
hospital discharge, whichever comes
Frusemide 10 mg/ml Injection C03CA01000P3001XX Yes B Pulmonary oedema Initially 20 -40 mg IM or slow IV (rate not
exceeding 4 mg/min). CHILD: 0.5 - 1.5
mg/kg. Max: 20 mg daily

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Generic Name MDC NEML Category Indications Dosage

Frusemide 10mg/ml oral solution C03CA01000L9001XX No B Pulmonary oedema ADULT: The usual initial oral dose is
40mg once daily, adjusted as necessary
according to response. Mild cases may
respond to 20mg daily or 40mg on
alternate days. Some patients may need
doses of 80mg or more daily given as
one or two doses daily; or intermittently.
Severe cases may require gradual
titration of the frusemide dosage up to
600mg daily. Children: The usual dose is
1 to 3mg/kg daily up to a maximum dose
of 40mg daily.

Frusemide 40 mg Tablet C03CA01000T1001XX Yes B Pulmonary oedema ADULT: Initial 40 - 80 mg on morning if

required, can be increased to a max of 1
g/day in certain cases especially in
chronic renal failure. CHILD : 1 - 3 mg/kg
daily
Fuller's Earth Powder V03AB00000F2101XX No C Adsorbent in pesticide poisoning Adult: 100-150g every 2-4 hours. Child: 1-
2g/kg. (100g of Fuller's Earth is mixed
with 200ml water. Repeat until Fuller's
Earth is seen in stool (normally between
4-6 hours)
Fusidate, Sodium 250 mg Tablet J01XC01520T1001XX No A* Treatment of infections caused by susceptible organisms ADULT: 500 mg 3 times daily, skin and
especially Staphylococcal infections including Methicillin soft tissue infection: 250 - 500 mg twice
Resistant Staphylococcus aureus (MRSA) daily
Fusidic Acid 1% Eye Drops S01AA13000D2001XX No A For staphylococcal infections 1 drop in conjunctival sac 12 hourly. To
be continued for 2 days after the eye
appears normal. On the first day of
treatment, may be applied more
frequently : 1 drop 4 hourly. Surgical
prophylaxis : 1 drop every 12 hours, 24 -
48 hours before operation
Fusidic Acid 2% Cream D06AX01000G1001XX Yes A Skin infections caused by staphylococci, streptococci, Apply to affected area 2 - 3 times daily
corynebacterium minutissumun and other sodium fusidate-
sensitive organisms
Fusidic Acid 2% in Betamethasone D07CC01948G1001XX Yes A/KK Inflammatory dermatosis where bacterial infection is likely to Uncovered lesion- Apply 2 to 3 times
Valerate 0.1% Cream occur eg atopic eczema, discoid eczema, stasis eczema, daily. Covered lesions- Less frequent
seborrhoic dermatitis, contact dermatitis, lichen simplex applications may be adequate
chronicus, psoriasis, discoid lupus erythematosus

Fusidic Acid 50 mg/ml Suspension J01XC01000L8001XX No A* Treatment of infections caused by staphylococcal especially ADULT : 15 ml 3 times daily. CHILD 1 - 5
Methicillin Resistant Staphylococcus aureus (MRSA) years: 5 ml 3 times daily; 5 - 12 years: 10
ml 3 times daily. INFANT : 1 ml/kg body
weight daily in 3 - 4 divided doses

Fusidic Acid 500 mg Injection J01XC01520P4001XX No A* Treatment of severe staphylococcal infections especially ADULT : 500 mg 3 times daily diluted to
Methicillin Resistant Staphylococcus aureus (MRSA). To be 250 - 500 ml infused slowly over 2 hours.
used in combination therapy only Maximum : 2 g daily. CHILD and INFANT :
20 mg/kg/day divided into 3 equal doses
infused slowly over 2 - 4 hours

Gabapentin 100 mg Tablet N03AX12000T1002XX No A* i) Add-on therapy for intractable partial epilepsy, refractory to ADULT & CHILD > 12 yrs: 900-
standard anti-epileptic drugs ii) Treatment of various types of 3600mg/day. Therapy may be initiated
neuropathic pain, both peripheral (which includes diabetic by administering 300mg TDS on day 1, or
neuropathy, post-herpetic neuralgia, trigeminal neuralgia) in by titrating the dose as: 300mg once on
adult more than 18 years day 1, 300mg BD on day 2, 300mg TDS
on day 3. Thereafter, then dose may be
increased in 3 equally divided doses up
to max 3600mg/day.CHILD 3-12 yr:
Initially 10-15 mg/kg/day in 3 divided
dose. Effective dose: CHILD 3 to less than
5 yrs: 40mg/kg/day in 3 divided doses,
CHILD 5-12 yrs: 25-35mg/kg/day in 3
divided doses ii) ADULT: 900mg/day in 3
equally divided doses. Max 3600mg/day

Gabapentin 300 mg Capsule N03AX12000C1001XX No A* i) Add-on therapy for intractable partial epilepsy, refractory to ADULT & CHILD > 12 yrs: 900-
standard anti-epileptic drugs ii) Treatment of various types of 3600mg/day. Therapy may be initiated
neuropathic pain, both peripheral (which includes diabetic by administered 300mg TDS on day 1, or
neuropathy, post-herpetic neuralgia, trigeminal neuralgia) in by titrating the dose as: 300mg once on
adult more than 18 years day 1, 300mg BD on day 2, 300mg TDS
on day 3. Thereafter, may be increased
in 3 equally divided doses up to max
3600mg/day.CHILD 3-12 yr: Initially 10-
15 mg/kg/day in 3 divided dose.
Effective dose: CHILD 3 to less than 5 yrs:
40mg/kg/day in 3 divided doses, CHILD 5-
12 yrs: 25-35mg/kg/day in 3 divided
doses ii) ADULT: 900mg/day in 3 equally
divided doses. Max 3600mg/day

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Generic Name MDC NEML Category Indications Dosage

Gabapentin 600 mg Tablet N03AX12000T1001XX No A* i) Add-on therapy for intractable partial epilepsy, refractory to ADULT & CHILD > 12 yrs: 900-
standard anti-epileptic drugs ii) Treatment of various types of 3600mg/day. Therapy may be initiated
neuropathic pain, both peripheral (which includes diabetic by administered 300mg TDS on day 1, or
neuropathy, post-herpetic neuralgia, trigeminal neuralgia) in by titrating the dose as: 300mg once on
adult over 18 years day 1, 300mg BD on day 2, 300mg TDS
on day 3. Thereafter, may be increased
in 3 equally divided doses up to max
3600mg/day.CHILD 3-12 yr: Initially 10-
15 mg/kg/day in 3 divided dose.
Effective dose: CHILD 3 to less than 5 yrs:
40mg/kg/day in 3 divided doses, CHILD 5-
12 yrs: 25-35mg/kg/day in 3 divided
doses ii) ADULT: 900mg/day in 3 equally
divided doses. Max 3600mg/day

Gadobenate Dimeglumine Injection V08CA08996P3001XX No A* i) MRI of the liver for the detection of focal liver lesions in i) MRI of liver: 0.05ml/kg body weight.
Solution patients with known or suspected primary liver cancer (e.g. This corresponds to 0.1ml/kg of the
Hepatocellular carcinoma) or metastatic disease; ii) MRI of the 0.5M solution ii) MRI of brain & spine:
brain and spine where it improves the detection of lesion and 0.1mmol/kg body weight. This
provides diagnostic information additional to that obtained corresponds to 0.2ml/kg of the 0.5M
with unenhanced MRI; iii) Contrast-enhanced MR-angiography solution iii) MRA: 0.1mmol/kg body
where it improves the diagnostic accuracy for detecting weight. This corresponds to 0.2ml/kg of
clinically significant steno-occlusive vascular disease in the 0.5M solution
patients with suspected or known vascular disease of the
abdominal or peripheral arteries.

Gadobutrol 1 mmol/ml injection V08CA09000P3001XX No A* In adults, adolescents and children aged 2 years and older with A single intravenous injection of 0.1
diagnostic difficulty especially in patients with renal mmol/kg (equivalent to 0.1 ml/kg body
impairment for: i) Contrast enhancement in cranial and spinal weight). Max: 0.3 mmol/kg (equivalent
magnetic resonance imaging (MRI). ii) Contrast enhanced MRI to 0.3 ml/kg body weight)
of liver or kidneys in patients with high suspicion or evidence
of having focal lesion to classify these lesions as benign or
malignant. iii)Contrast enhancement in Magnetic Resonance
Angiography (CE-MRA).

Gadopentetate Dimeglumine 469 mg/ml V08CA01000P3001XX No A i) Cranial and spinal magnetic resonance imaging ii) Whole The usual dose in adults, children, and
body magnetic resonance imaging neonates is 0.2 mL/kg (0.1 mmol/kg)
intravenously. For cranial and spinal
imaging, a further dose of 0.2 mL/kg (0.1
mmol/kg) may be given within 30
minutes if necessary; in adults this
second dose may be 0.4 mL/kg (0.2
mmol/kg). For whole body imaging in
adults and children over 2 years, a dose
of 0.4 mL/kg (0.2 mmol/kg) may be
needed in some cases to produce
adequate contrast and in special
circumstances a dose of 0.6 mL/kg (0.3
mmol/kg) may be used in adults

Gadoterate Meglumine (Gadoteric Acid) V08CA02254P3001XX No A High risk patients undergoing Magnetic Resonance Imaging for The recommended dose is 0.1 mmol/kg
0.5 mmol/ ml Injection cerebral and spinal disease, diseases of the vertebral column (equivalent to 0.2 mL/kg in adults,
and other whole body pathology children and infants. In angiography,
depending on the results of the
examination being performed, a second
injection may be administered during
the same session if necessary

Gadoxetic acid disodium 0.25 mmol/ml V08CA10520P3001XX No A* For use in adults for the enhancement of magnetic resonance 0.1ml/kg body weight (equivalent to 25
solution for injection (10ml pre-filled imaging (MRI) of focal liver lesions µmol per kg body weight). Not
syringe) recommended for patients younger than
18 years
Gamma Benzene Hexachloride 0.1 % P03AB02100L6001XX Yes B For treatment of head lice Leave lotion on hair for exactly 4
Lotion minutes. Then wash off of the hair and
skin with warm water.
Gamma Benzene Hexachloride 1% P03AB02100G1002XX Yes A/KK Only for scabies in adult weighing more than 50kg. Use should Only for single application. Adult: Apply
Cream/Lotion be restricted to patients who have failed treatment with or a thin layer of 1% topical preparation
cannot tolerate other medications that pose less risk onto all skin areas from the neck to toes.
Completely wash off from the body with
warm water after 8-12 hr.

Ganciclovir Sodium 50 mg/ ml Injection J05AB06520P3001XX No A* Treatment of cytomegalovirus (CMV) disease in Initial: 5 mg/kg infused over 1 hour 12
immunocompromised patients, prevention of CMV disease hourly for 14 - 21 days (CMV retinitis
during immunosuppressive therapy following organ treatment) or 7 - 14 days (CMV disease
transplantation prevention). Long term maintenance: 6
mg/kg daily for 5 days/week or 5 mg/kg
daily for 7 days/week

Ganirelix 0.25 mg/0.5 ml Injection H01CC01000P2001XX No A* Prevention of premature luteinizing hormone surges in Given by SC 0.25 mg once daily, starting
women undergoing controlled ovarian hyperstimulation for on day 6 of ovarian stimulation and
assisted reproduction technique continued until ovulation induction

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Gefitinib 250 mg tablet L01XE02000T1001XX No A* i) First line treatment of adult patients with locally advanced 250mg tablet once a day, taken with or
or metastatic Non Small Cell Lung Cancer (NSCLC) who have without food
activating mutations of the EGFR TK. Prescribing Restriction: -
Adenocarcinoma histology - Patient's ECOG Performance
Status 0-1 - Must be prescribed by an oncologist or oncology-
trained respiratory physician. ii) For second line treatment of
patients with locally advanced or metastatic non-small cell
lung cancer (NSCLC) who have previously failed chemotherapy,
and who have activating mutation of epidermal growth factor
receptor (EGFR). Prescribing Restriction: - Adenocarcinoma
histology - Patient's ECOG Performance Status 0-1 - Must be
prescribed by an oncologist or oncology-trained respiratory
physician. - Must not have received prior TKI for this
condition.

Gemcitabine HCl 1 g Injection L01BC05110P4002XX No A* i) Locally advanced or metastatic non-small cell lung cancer ii) i) Alone or with cisplatin: 1000 mg/m2
Locally advanced or metastatic pancreatic cancer iii) In day 1 & 8 every 3 weeks or 1000 mg/m2
combination with carboplatin in the treatment of patients day 1, day 8, day 15 every 4 weeks ii)
with recurrent epithelial ovarian carcinoma, who have Initially 1000 mg/m2 weekly for 7 weeks
relapsed more than six months, following platinum-based followed by 1 week rest. Subsequent
therapy iv) In combination with paclitaxel for treatment of cycles 1000 mg/ m2 weekly for 3 weeks
patients with metastatic breast cancer who have relapsed followed by 1 week rest iii) Gemcitabine
following adjuvant/ neoadjuvant chemotherapy. Prior 1000 mg/m2 as 30 minutes IV infusion
chemotherapy should have included an anthracycline unless day 1 & 8 of each 21-day cycle followed
clinically contraindicated by carboplatin on day 1 to attain a target
AUC of 4 mg/ml/minute iv) 1250 mg/m2
on days 1 and 8 of each 21-day cycle
with paclitaxel 175 mg/m2 given as a 3-
hour infusion before gemcitabine on day
1 of each 21-day cycle

Gemcitabine HCl 200 mg Injection L01BC05110P4001XX No A* i) Locally advanced or metastatic non-small cell lung cancer ii) i) Alone or with cisplatin: 1000 mg/m2
Locally advanced or metastatic pancreatic cancer iii) In day 1 & 8 every 3 weeks or 1000 mg/m2
combination with carboplatin in the treatment of patients day 1, day 8, day 15 every 4 weeks ii)
with recurrent epithelial ovarian carcinoma, who have Initially 1000 mg/m2 weekly for 7 weeks
relapsed more than six months, following platinum-based followed by 1 week rest. Subsequent
therapy iv) In combination with Paclitaxel, for treatment of cycles 1000 mg/ m2 weekly for 3 weeks
patients with metastatic breast cancer who have relapsed followed by 1 week rest iii) Gemcitabine
following adjuvant/ neoadjuvant chemotherapy. Prior 1000 mg/m2 as 30 minutes IV infusion
chemotherapy should have included an anthracycline unless day 1 & 8 of each 21-day cycle followed
clinically contraindicated by carboplatin on day 1 to attain a target
AUC of 4 mg/ml/minute iv) 1250 mg/m2
on days 1 and 8 of each 21-day cycle,
with paclitaxel 175 mg/m2 given as a 3-
hour infusion before gemcitabine on day
1 of each 21-day cycle

Gemeprost (Prostagladin E1 Synthetic G02AD03000S1001XX No A Inducing abortion in the first trimester Cervical dilatation: 1 pessary 3 hourly
Analogue) 1 mg Pessary before surgery to a max of 5 pessaries
over 24 hours
Gemfibrozil 300 mg Capsule C10AB04000C1001XX Yes A/KK Treatment of hyperlipoprotinaemias (TYPES IIA, IIB, III, IV, V) ADULT: 1200 mg/day in 2 divided doses,
30 minutes before breakfast and dinner.
Dose range from 0.9-1.5 g daily

Gentamicin 0.1% Cream D06AX07183G1001XX No A* For localised infections Apply 2 - 3 times daily
Gentamicin 0.3% Eye Drops S01AA11183D2001XX Yes A/KK Broad spectrum antibiotic in superficial eye infections and also 1 - 2 drops every 4 hours, in severe
for Pseudomonas aeruginosa infection dosage may be increased up to
2 drops every hour
Gentamicin 0.3% Eye Ointment S01AA11183G5101XX Yes A/KK Conjunctivitis, blepharitis, blepharo-conjunctivitis, keratitis, Apply into the conjunctival sac 3 - 4
keratoconjunctivitis, episcleritis, dacrocystitis, corneal ulcers, times daily
styes and infected eye socket
Gentamicin 3% Fortified Eye Drops S01AA11183D2002XX Yes A Broad spectrum antibiotic in superficial eye infections and also Dose according to the needs of the
for Pseudomonas aeruginosa patient
Gentamicin 7.5 mg Beads J01GB03183P1001XX No A Treatment of chronic osteomyelitis of post-traumatic, post- 7.5 - 22.5 mg chains to fill affected cavity
operative or hematogenous origin
Gentamicin Sulphate 10 mg/ml Injection J01GB03183P3002XX Yes B Infections due to susceptible organisms ADULT: 3 - 5 mg/kg/day 8 hourly IM or
IV. CHILD up to 2 weeks: 3mg/kg every
12 hours; 2 weeks - 12 years: 2 mg/kg 8
hourly
Gentamicin Sulphate 40 mg/ml Injection J01GB03183P3003XX Yes B Infections due to susceptible organisms ADULT: 3 - 5 mg/kg/day 8 hourly IM or
IV. CHILD up to 2 weeks: 3mg/kg every
12 hours; 2 weeks - 12 years: 2 mg/kg 8
hourly
Gentamicin Sulphate and S01CA05990D2001XX No A/KK Inflammatory and allergic conditions involving superficial eye 2 drops 3 - 4 times daily
Betamethasone Disodium Phosphate Eye structures and when bacterial infection is present :
Drops conjunctivitis, blepharitis, keratitis, episcleritis, dacryocystitis,
hordeolum, meibomianitis, injuries involving anterior segment
of the eye
Gentamicin Sulphate and S01CA05990G5101XX No A Inflammatory and allergic conditions involving superficial eye Thin coating of ointment 3 - 4 times daily
Betamethasone Disodium Phosphate Eye structures and when bacterial infection is present :
Ointment conjunctivitis, blepharitis, keratitis, episcleritis, dacryocystitis,
hordeolum, meibomianitis, injuries involving anterior segment
of the eye

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Glibenclamide 5 mg Tablet A10BB01000T1001XX Yes B Diabetes mellitus type 2. Restriction : Use only in patient Range: 2.5 - 15 mg daily (with or
under 65 years old immediately after breakfast). Initially 2.5
mg daily increasing by 2.5 mg required
for metabolic control. Max: 20mg daily.

Gliclazide 30 mg Modified Release Tablet A10BB09000T5002XX Yes B Diabetes mellitus type 2 Initially, 30mg daily at breakfast time,
may increase in successive steps to 60,
90 or 120mg daily at 1 month intervals.
Max daily dose: 120mg

Gliclazide 60 mg Modified Release Tablet A10BB09000T5001XX Yes B Diabetes mellitus type 2 Initially, 30mg daily at breakfast time,
may increase in successive steps to 60,
90 or 120mg daily at 1 month intervals
(except in patients whose blood glucose
level was not reduced after 2 weeks of
treatment). Max daily dose: 120mg

Gliclazide 80 mg Tablet A10BB09000T1001XX Yes B Diabetes mellitus type 2 Initially 40-80mg daily. A single dose
should not exceed 160mg and when
higher doses are required, a twice daily
split dosage is advised and should be
divided. Maximum daily dose: 320mg.
For elderly, starting dose should be
40mg twice daily.
Glucagon (Lyophilised) 1 mg/ml Injection H04AA01000P4001XX No B Management of hypoglycaemia Adult, children > 20kg: 1mg by SC, IM or
IV. Children < 20kg : 0.5mg. If patient
does not respond within 10 minutes,
administer IV glucose. Repeat in 20
minutes if necessary.
Glutaraldehyde Solution 2% V07AV00000L9905XX Yes A 2% formulation - High level disinfection for heat sensitive 20 minutes or more immersion is
equipments such as endoscopes recommended for endoscopes before
the session and between patients after
thorough cleaning based on
manufacturer recommendation
Glycerin A06AX01000L5001XX No C+ As a lubricant and osmotic dehydrating agent Apply to area when required
Glycerin 25% and Sodium Chloride 15% A06AG20921G2001XX No C+ Constipation 1 enema as required
Enema
Glycerine 25% w/w in aqueous cream D02AX 000G1001XX No C For topical application to the skin, as an emollient for the Adults, children and elderly: Apply
symptomatic relief of dry skin conditions and as soap- sparingly to the affected area as
substitute for skin-washing. required or as directed by your
pharmacist or doctor.
Glyceryl Trinitrate 0.5 mg Sublingual C01DA02221T1001XX Yes C Prophylaxis and treatment of angina and left ventricular 0.5-1 mg sublingually may be repeated
Tablet failure every 5 minutes until relief is obtained.
Seek physician if the pain persists after a
total of 3 tablets in a 15 minutes period.

Glyceryl Trinitrate 5 mg/ml Injection C01DA02221P3001XX Yes A Prophylaxis and treatment of angina, left ventricular failure. Initial 5 mcg/min delivered via infusion
Not for direct IV injection. pump. Subsequent titration must be
adjusted to clinical situation with dose
increment becoming more cautious as
partial response is seen.
Glyceryl Trinitrate Aerosol Spray 400mcg C01DA02221A1001XX No B Prophylaxis and treatment of angina and left ventricular At the onset of an attack, one or two
(metered dose) failure metered sprays should be administered
on or under the tongue. A spray maybe
repeated approximately every 5 minutes
as needed. No more than 3 metered
sprays are recommended within 15
minute period. If chest pain persists
after a total of 3 sprays, prompt medical
attention is recommended. Aerosol may
be used prophylactically 5 to 10 minutes
before engaging in activities that might
precipitate an acute attack

Glycine 1.5% Irrigating Solution B05CX03000H3001XX No A Bladder irrigation during genitourinary surgery The dosage depends on the extent of the
procedure and its duration
Glycopyrrolate 200 mcg/ml Injection A03AB02320P3001XX No A* i) To reduce secretions (respiratory tract) for certain types of i) Pre-op: 4 mcg/kg via IM administration
surgery ii) Reversal of neuromuscular block in patients where 30-60 mins before procedure.
atropine is contraindicated Intraoperative: 0.1 mg via IV
administration, repeat at 2-3 min
intervals when needed. Max: 400
mcg/dose. ii) 0.2 mg by IV for each 1 mg
of neostigmine or 5 mg pyridostigmine

Glycopyrronium 50mcg, Inhalation R03BB06320A2001XX No A/KK For maintenance bronchodilator treatment to relieve One capsule daily. The recommended
Powder Hard Capsules symptoms in adult patients with chronic obstructive dose is the inhalation of the content of
pulmonary disease (COPD). COPD diagnosis is confirmed by one capsule once daily using inhaler. It is
spirometry. recommended to be administered, at
the same time of the day each day. No
relevant use of glycopyrronium in
pediatric population (<18 years) for
COPD.

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Generic Name MDC NEML Category Indications Dosage

Golimumab 50mg (0.5ml) solution for L04AB06000P5001XX No A* i) Rheumatoid arthritis (RA): In combination with i) Rheumatoid arthritis 50mg given as a
injection in a pre-filled syringe methotrexate (MTX), is indicated for: - The treatment of subcutaneous injection once a month,
moderate to severe active rheumatoid arthritis in adult on the same date each month.
patients when the response to DMARD therapy including MTX ii)Psoriatic arthritis 50mg given as a
has been inadequate. - The treatment of active, severe and subcutaneous injection once a month,
progressive rheumatoid arthritis in adult patients not on the same date each month. iii)
previously treated with MTX. ii) Psoriatic arthritis (PsA): Ankylosing spondylitis 50mg given as a
Golimumab alone or in combination with MTX, is indicated subcutaneous injection once a month,
for: The treatment of active psoriatic arthritis in adult patients on the same date each month.
when the response to previous DMARD therapy has been
inadequate. iii) Ankylosing spondylitis (AS): Golimumab(used
alone) is indicated for: The treatment of active ankylosing
spondylitis in adult patients when the response to
conventional therapy has been inadequate.

Goserelin 10.8 mg Depot Injection L02AE03000P2002XX No A Prostate cancer,endometriosis,leiomyoma uteri and assissted One 10.8mg depot injected
reproduction,breast cancer in premenopausal and subcutaneously into the anterior
perimenopausal women suitable for hormonal manipulation abdominal wall, every 12 weeks.

Goserelin 3.6 mg Depot Injection L02AE03000P2001XX No A Prostate cancer,endometriosis,leiomyoma uteri and assissted 3.6 mg depot injection every 28 days
reproduction,breast cancer in premenopausal and
perimenopausal women suitable for hormonal manipulation

Granisetron HCl 1 mg Tablet A04AA02110T1001XX Yes A Prevention and treatment of nausea and vomiting associated ADULT 1 mg twice daily or 2 mg once
with chemotherapy and radiotherapy daily with the first dose to be
administered within 1 hour prior to
cytostatic therapy and can be given for
up to 1 week following radiotherapy.
Maximum 9 mg/day
Granisetron HCl 1 mg/ml Injection A04AA02110P3001XX Yes A i) Prevention and treatment of nausea and vomiting associated i) ADULT 1-3 mg as an IV bolus not not
with chemotherapy and radiotherapy ii) Post-operative nausea less than 30 seconds; maximum 9
and vomiting mg/day. CHILD over 2 years; single dose
of 10-40 mcg/kg as an IV infusion;
maximum 3 mg/day ii) ADULT 1 mg by
slow IV injection over 30 seconds prior
to induction of anaesthesia

Griseofulvin (Ultramicrosize 125 mg = D01BA01000T1001XX Yes B Dermatophyte infections of the skin, scalp, hair and nails, ADULT: 500 mg daily up to 1 g daily in
250 mg Microsize) Tablet where topical therapy has failed or inappropriate divided doses, 2-8 wk in hair and skin
infections, 6 mth in fingernail infections
and 12 mth or more for toenail
infections. CHILD: 10 mg/kg daily in
divided doses or as a single dose

Haemodialysis Concentrate with Acetate B05ZA00908H1001XX Yes A For acute renal failure, chronic renal failure, overhydration, Dose depending on clinical cases
intoxication, adjustment of acid-base and electrolyte balance

Haemodialysis Concentrate with B05ZA00908H1002XX Yes A For acute renal failure, chronic renal failure, overhydration, Dose depending on clinical cases
Bicarbonate intoxication, adjustment of acid-base and electrolyte balance

Haemophilus Influenza Type B Conjugate J07AG01000P4001XX Yes C Immunisation of infants against Haemophilus Influenzae Type 0.5 ml IM
Vaccine Injection (Single Dose) B

Haloperidol 1.5 mg Tablet N05AD01000T1001XX Yes B Schizophrenia and other psychoses Adult:†0.5-5 mg bid/ d, may increase up
to 100 mg daily in severe or resistant
cases. Usual maintenance: 3-10 mg
daily.†Child: >3 yr: Ini ally, 25-50 mcg/kg
daily in 2 divided doses, increased
gradually if necessary. Max: 10 mg/day.

Haloperidol 5 mg Tablet N05AD01000T1002XX Yes B Schizophrenia and other psychoses Adult:†0.5-5 mg bid/ d, may increase up
to 100 mg daily in severe or resistant
cases. Usual maintenance: 3-10 mg
daily.†Child: >3 yr: Ini ally, 25-50 mcg/kg
daily in 2 divided doses, increased
gradually if necessary. Max: 10 mg/day.

Haloperidol 5 mg/ml Injection N05AD01000P3001XX Yes B Acute psychoses and mania ADULT: IM or IV , 2 mg - 10 mg then
every 4 - 8 hours according to response
to total maximum 18 mg daily. Use in
child is not recommended

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Heparin 1000 units/ml Injection B01AB01520P3001XX Yes B i) Prophylaxis and treatment of venous thrombosis and i) By IV injection, loading dose of 5000
pulmonary embolism. ii) Treatment of myocardial infarction units (10,000 units in severe pulmonary
and arterial embolism. iii) Prevention of clotting in arterial and embolism) followed by continuous
heart surgery and for prevention of cerebral thrombosis infusion of 15-25 units/kg/hr. By SC
injection (for DVT) of 15,000 units every
12 hours (laboratory monitoring on daily
basis essential to adjust dose). Small
adult or child, lower loading dose then,
15-25 units/kg/hr by IV infusion, or 250
units/kg every 12 hours by SC injection.
ii) As i), for unstable angina and acute
peripheral arterial occlusion. iii)
Prophylaxis in general surgery, by SC
injection, 5000 units 2 hour before
surgery, then every 8-12 hours for 7 days
or until patient is ambulant, during
pregnancy (with monitoring), 5000-
10000 units every 12 hours. An adjusted
dose regimen may be used for major
orthopaedic surgery or low molecular
weight heparin may be selected

Heparin 5000 units/ml Injection B01AB01520P3002XX Yes B i) Prophylaxis and treatment of venous thrombosis and i) By IV injection, loading dose of 5000
pulmonary embolism. ii) Treatment of myocardial infarction units (10,000 units in severe pulmonary
and arterial embolism. iii) Prevention of clotting in arterial and embolism) followed by continuous
heart surgery and for prevention of cerebral thrombosis infusion of 15-25 units/kg/hr. By SC
injection (for DVT) of 15,000 units every
12 hours (laboratory monitoring on daily
basis essential to adjust dose). Small
adult or child, lower loading dose then,
15-25 units/kg/hr by IV infusion, or 250
units/kg every 12 hours by SC injection.
ii) As i), for unstable angina and acute
peripheral arterial occlusion. iii)
Prophylaxis in general surgery, by SC
injection, 5000 units 2 hour before
surgery, then every 8-12 hours for 7 days
or until patient is ambulant, during
pregnancy (with monitoring), 5000-
10000 units every 12 hours. An adjusted
dose regimen may be used for major
orthopaedic surgery or low molecular
weight heparin may be selected

Heparin Sodium 50 units in Sodium B01AB01930P3001XX Yes B To maintain patency of peripheral venous catheters Flush with 5 ml (50 units) every 4 hours
Chloride Injection or as required
Hepatitis A, Inactivated Vaccine 160 J07BC02000P5001XX No A Vaccination against hepatitis A especially in those at risk of 0.5 ml per injection. ADULT and CHILD
antigen units Injection exposure to hepatitis A virus such as: i) Visitors ii) Chronic more than 15 years: A single primary
hepatitis B and C patient iii) Those requiring vaccination dose followed by a booster dose 6 - 12
against hepatitis A months later. CHILD 2 - 15 years: A single
primary dose followed by a booster dose
6 - 12 months later

Hepatitis B Immunoglobulin (Human) J06BB04000P3001XX No A i) For post-exposure prophylaxis of hepatitis B ii) Prophylaxis i) Adults: Recommended Dose: 1000-
Injection against recurrence of hepatitis B infection in chronic hepatitis 2000 IU IM and if necessary, the dose
B post liver transplantation should be increased or repeated.
Children: Inject 32-48 IU/kg of body
weight, should be administered within 7
days after exposure to HBsAg (preferably
within 48 hrs). Neonates: Recommended
Initial Dose: 100-200 IU. The 1st dose
should be administered within 5 days
after birth (preferably within 48 hrs) and
booster dose should be 32-48 IU/kg
body weight. The booster dose should
be administered between 2 and 3
months after the 1st administration. ii)
Different regimens depending on
hepatitis B virus (HBV) DNA positivity

Hepatitis B Vaccine Injection J07BC01000P4001XX Yes C+ Immunisation against infections caused by Hepatitis B virus Dose depends on the products used.
Please refer to package insert. Example:
1. Euvax-B Adult (from 16 years old) -
20mcg/dose Neonates, infants &
children up to and including 15 years -
10mcg/dose 2. Engerix-B Adult (from 20
years old) - 20mcg/dose Neonates,
infants & children up to and including 19
years - 10mcg/dose Second dose to be
given after 1 month and booster dose
after 6 months

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Homatropine 2% Eye Drops S01FA05330D2003XX Yes B i) Mydriasis and cycloplegia for refraction ii) Treatment of i) Adult: Instill 1 or 2 drops of 2%
anterior segment inflammation solution immediately before the
procedure, repeat at 5-10-minute
intervals if necessary. Child: Instill 1 drop
of 2% soln immediately before the
procedure, repeat at 10-min intervals if
necessary. ii) Adult: Instill 1-2 drops of
2% bd-tds up to every 3-4 hr as needed.
Child: 3 mth- 2 yr: instill 1 drop of 0.5%
soln once daily or on alternate days. >2
yr: instill 1 drop of 1% or 2% soln bd.

Human Albumin Injection B05AA01000P3001XX Yes B i) Acute hypovolemic shock ii) Hypoproteinaemia iii) Neonatal i) ADULT 25 g. CHILD 0.6 g/kg body
hyperbilirubinaemia weight ii) Maximum daily dose is 2g iii) 1
g/kg before exchange transfusion. Dose
is given at rate of 1 ml of 25% solution
per minute
Human Normal Globulin Injection J06BA02000P3001XX No A i) Hypogammaglobulinaemia and other deficiency states ii) i) 50 mg/kg body weight daily for 5 days,
Severe refractory idiopathic thrombocytopenia purpura then 25 - 50 mg/kg weekly for
(platelet less than 20,000) with internal bleeding, particularly maintenance according to the severity of
central nervous system iii) Septicaemia in the condition ii) 400 mg/kg daily for 5
immunocompromised patients or patients not responding to days with a further dose of 400 mg/kg as
antibiotics iv) Chronic lymphocytic leukaemia not responding required iii) Septicaemia in
to conventional therapy immunocompromised patients or
patients not responding to antibiotics iv)
250 mg/kg per month Dose varies
depending on brand used

Human Papillomavirus (Types 16, 18) J07BM02000P3001XX Yes C+ For the prevention of cervical cancer due to papilloma virus. Given by IM into deltoid region. ADULT
Vaccine Injection To be used as part of the public health program only and CHILD 10 - 25 years, 3 doses of 0.5
mL, at 0, 1 and 6 months
Human Papillomavirus (Types 6, 11, 16, J07BM01000P3001XX Yes C+ For the prevention of cervical cancer due to papilloma virus. Given by IM into deltoid region or higher
18) Vaccine Injection To be used as part of the public health program only anterolateral thigh. ADULT and CHILD 9 -
26 years, 3 doses of 0.5 mL, at 0, 2 and 6
months
Hydralazine HCl 20 mg Injection C02DB02110P3001XX No B Hypertensive crisis in pregnancy i) Slow IV injection, ADULT: 5-10 mg
diluted with 10ml sodium chloride 0.9%.
May be repeated after 20-30 minutes if
necessary. ii) IV infusion 200-300
mcg/minutes. Maintenance dose 50-150
mcg/minutes
Hydrochlorothiazide 25 mg Tablet C03AA03000T1001XX Yes B Diuretic, hypertension ADULT: Diuretics; 25-200 mg daily.
Hypertension 12.5-25 mg daily CHILD:
Oedema and hypertension; Adjunct; 1 to
2 mg/kg ORALLY daily in single or two
divided doses; Children 2-12 years old
MAX dose, not to exceed 100 mg
ORALLY daily; Infants less than 6 months
old, may require doses up to 3 mg/kg
ORALLY daily in two divided doses,
Infants up to 2 yrs old: MAX dose, not to
exceed 37.5 mg ORALLY daily

Hydrochlorothiazide 50 mg Tablet C03AA03000T1002XX Yes B Diuretic, hypertension ADULT: Diuretics; 25-200 mg daily.
Hypertension 12.5-25 mg daily CHILD:
Oedema and hypertension; Adjunct; 1 to
2 mg/kg ORALLY daily in single or two
divided doses; Children 2-12 years old
MAX dose, not to exceed 100 mg
ORALLY daily; Infants less than 6 months
old, may require doses up to 3 mg/kg
ORALLY daily in two divided doses,
Infants up to 2 yrs old: MAX dose, not to
exceed 37.5 mg ORALLY daily

Hydrocortisone 1% & Neomycin 0.5% D07CA01952G1001XX No B Inflammatory and pruritic manifestations of corticosteroid Apply to affected part 2-3 times daily
Cream responsive dermatoses (occasionally may cause sensitisation to
Neomycin)
Hydrocortisone 1% Cream D07AA02000G1001XX Yes B Inflammatory and pruritic manifestations of corticosteroid Apply sparingly to affected area 2 - 3
responsive dermatoses times daily until condition improve, then
reduce frequency
Hydrocortisone 1% Ointment D07AA02000G5001XX Yes B Inflammatory and pruritic manifestations of corticosteroid Apply sparingly to affected area 2 - 3
responsive dermatoses times daily until condition improve, then
reduce frequency
Hydrocortisone 10 mg Tablet H02AB09000T1001XX Yes B Glucocorticoid replacement therapy in primary or secondary ADULT: 20 - 30 mg daily in divided doses.
adrenal insufficiencies and long term management of CHILD: 10 - 30 mg daily in divided doses
congenital adrenal hyperplasia in children

Hydrocortisone Enema 0.1% A07EA02000G2001XX No B Adjunctive treatment for ulcerative colitis and proctitis ADULT 100 mg 1-2 times/day for 2-3
weeks. If used for longer than 3 weeks,
taper treatment over 2-3 weeks

Hydrocortisone Sodium Succinate 100 H02AB09520P4001XX Yes C Conditions responsive to systemic or local glucocorticoid Initially 100 - 500 mg IV over 30 seconds
mg Injection injection therapy especially in emergencies to more than 10 minutes. Dose may be
repeated at intervals of 2, 4 or 6 hours

Hydrogen Peroxide 1.5% Ear Drops S02AA06241D1001XX No C To soften impacted ear wax Instill 1 - 2 drops into the ear as required
(leave for a few minutess)

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Generic Name MDC NEML Category Indications Dosage

Hydrogen Peroxide 20 volume Solution D08AX01241L9901XX Yes C Skin disinfection, particularly cleansing and deodorising Hydrogen Peroxide 6% (=approx. 20 vol)
wounds and ulcers shall be dispensed. For cleansing
wounds: 1.5% to 6% solution apply 2-3
times daily or when nescessary. As a
mouthwash: rinse the mouth for 2-3
minutes with 15ml of hydrogen peroxide
6% diluted in half a tumblerful of warm
water 2-3 times daily. Disinfecting
cleaned equipment: immersion for 30
minutes in 6% solution. As ear drop for
removal of wax: hydrogen peroxide 6%
diluted with 3 parts of water preferably
just before use

Hydroxychloroquine Sulphate 200 mg P01BA02183T1001XX Yes A i) SLE and mixed connective tissue disease for skin, joint and i) Initially 400 mg daily in divided dose.
Tablet serosa ii) Second line therapy for acute rheumatoid arthritis Maintenance : 200 - 400 mg daily ii)
ADULT : 400 - 600 mg daily.
Maintenance: 200 - 400 mg daily. CHILD
: up to 6.5 mg/kg daily (maximum 400mg
daily)
Hydroxyethyl Cellulose Jelly V07AY00250G4001XX No B For lubricating purpose Apply sufficiently for lubricating purpose

Hydroxyethyl Starch 6% Injection B05AA07000P9901XX No B Therapy and prophylaxis of hypovolaemia and shock in ADULT daily dose up to 20 ml/kg/day.
connection with surgery trauma, infections and burns Normally 500-1500 ml. The rate of
infusion may approach 20 ml/kg/hour in
acute haemorrhagic shock, slower rates
in burns and septic shock. CHILD under
10 years do not exceed 15 ml /kg/hour.

Hydroxyprogesterone Caproate 250 G03DA03128P2001XX No A Habitual and threatened abortion 250 - 500 mg once weekly by IM
mg/ml Injection injection
Hydroxyurea 500 mg Capsule L01XX05000C1001XX No A i)Solid tumours ii) Chronic myelocytic leukaemia and i)Intermittent therapy : 80 mg/kg orally
myeloproliferative disease iii)Severe psoriasis eg. Extensive as a single dose every 3rd day.
plaque psoriasis, erythrodermic psoriasis, pustular psoriasis - Continuous therapy : 20 - 30 mg/kg
as third line therapy. orally as a single dose dly. Concomitant
therapy with irradiation : 80 mg/kg orally
as a single dose every 3rd
day.(administration of hydroxyurea
should be started at least 7 days before
initiation of irradiation and continued
during radiotherapy as well).
ii)Continuous therapy (20 - 30 mg/kg
orally as a single dose daily, therapy
should be interrupted if the white blood
cell count drops below 2500/mm3, or
the platelet count below 100,000/mm3.
iii) 500 mg tds.

Hydroxyzine HCl 25 mg Tablet N05BB01110T1001XX No A Allergic pruritus Initially 25 mg at night, increased if

necessary up to 25 mg 3-4 times daily.
ADULT and CHILD more than 10 years :
50 - 75 mg; 6 - 10 years: 25 - 50 mg; 2 - 5
years: 12.5 - 25 mg; to be taken daily in
divided doses
Hyoscine Hydrobromide 400 mcg/ml A04AD01330P3001XX Yes B To reduce oral secretions before surgery 200-600 mcg given as SC or IM 60
Injection minutes before induction of anaesthesia.
CHILD: 15 mcg/kg
Hyoscine N-Butylbromide 1 mg/ml A03BB01320L5001XX Yes B Gastrointestinal tract and genito-urinary tract spasm, ADULT 10-20mg, 3-4 times a day. CHILD
Liquid dyskinesia of the biliary system 6-12 years old: 10mg 3 times a day.

Hyoscine N-Butylbromide 10 mg Tablet A03BB01320T1001XX Yes B Gastrointestinal tract and genito-urinary tract spasm, ADULT 10-20mg, 3-4 times a day. CHILD
dyskinesia of the biliary system 6-12 years old: 10mg 3 times a day.

Hyoscine N-Butylbromide 20 mg/ml A03BB01320P3001XX Yes B Gastrointestinal tract and genito-urinary tract spasm, 20 mg IM/IV repeated after 30 min if
Injection dyskinesia of the biliary system needed. Max: 100 mg daily.
Ibandronic Acid 150 mg Tablet M05BA06000T1003XX No A* Treatment of postmenopausal osteoporosis to reduce the risk 150 mg once monthly
of fracture. Review treatment after 2 years and if there is
positive response, treatment may be continued up to 5 years
and then re-evaluate. Treatment should be stopped if there is
no positive response after 5 years. Otherwise, patient needs to
be given drug holiday for 1 to 2 years and then continue
treatment shall the benefit outweigh the risk.

Ibuprofen 200 mg Tablet M01AE01000T1001XX Yes B Pain and inflammation in rheumatic disease Dosage: ADULT : 200 - 400 mg 3 times
daily after food, maximum 3.2 g daily.
CHILD : 30-50 mg/kg body weight daily in
divided doses, maximum 2.4g daily.
Lowest effective dose for the shortest
possible duration.

Ichthammol Glycerin 10% Ear Drops S02AA30000D1001XX No C Ear wick for otitis externa with oedema 2 - 3 drops 3 - 4 times daily and in ear
wick for otitis externa

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Generic Name MDC NEML Category Indications Dosage

Idarubicin 10 mg Injection L01DB06110P4002XX No A* i) Acute promyelocytic leukaemia ii) Relapse Acute myeloid i) Induction phase: 12 mg/m2 IV slow
leukemia (with sibling match) iii) Acute myeloid leukemia, bolus on Days 3, 5 and 7. Consolidation
acute lymphoblastic leukemia (salvage therapy) phase, month 1: 12 mg/m2 IV on Days 1
and 2. Repeat monthly for 3 courses ii)
12 mg/m2 D1-3 iii) 12 mg/m2 D1-3 as
part of FLAG-IDA regimen. Children:
10mg/m2 IV daily for 3 days

Idarubicin 5 mg Injection L01DB06110P4001XX No A* i) Acute promyelocytic leukaemia ii) Relapse Acute myeloid i) Induction phase: 12 mg/m2 IV slow
leukemia (with sibling match) iii) Acute myeloid leukemia, bolus on Days 3, 5 and 7. Consolidation
acute lymphoblastic leukemia (salvage therapy) phase, month 1: 12 mg/m2 IV on Days 1
and 2. Repeat monthly for 3 courses ii)
12 mg/m2 D1-3 iii) 12 mg/m2 D1-3 as
part of FLAG-IDA regimen. Children:
10mg/m2 IV daily for 3 days

Idursulfase 2 mg/ml Injection A16AB09000P3001XX No A* Hunter syndrome (Mucopolysaccharidosis II, MPS II). 0.5 mg/kg of body weight administered
every week as an intravenous infusion.

Ifosfamide 1 g Injection L01AA06000P4001XX Yes A* i) Solid tumours ii) Leukaemia iii) Lymphoma i) 1.2 - 2.4 g/m2/day for 3 - 7 days as a
30 - 120 minutes infusion. Alternatively,
can also be given as a single high dose,
eg. 5 g/m2 in a 24 hour infusion. Cycles
may be repeated every 3 - 4 weeks ii)
CHILD: 400 - 3000 mg/m2/day for 3 - 5
days according to protocol iii) Refer to
protocols

Imatinib Mesylate 100 mg Tablet L01XE01196T1001XX No A* i) ADULT and CHILD: Philadelphia positive (Ph+) chronic i) ADULT: Chronic phase chronic myeloid
myeloid leukaemia in chronic phase and in early acceleration leukemia: 400 mg once daily.
after failure of interferon therapy ii) Treatment of patients Accelerated phase or blast crisis chronic
with unresectable and/or metastatic malignant myeloid leukemia: 600 mg once daily.
gastrointestinal stromal tumours (GIST) who are positive for CHILD more than 2 years, chronic and
CD117/c-kit advanced phase chronic myeloid
leukemia: 340 mg/m2 daily. Max: 800
mg/day ii) ADULT : 400mg/day

Imatinib Mesylate 400 mg Tablet L01XE01196T1002XX No A* i) ADULT and CHILD: Philadelphia positive (Ph+) chronic i) ADULT: Chronic phase chronic myeloid
myeloid leukaemia in chronic phase and in early acceleration leukemia: 400 mg once daily.
after failure of interferon therapy ii) Treatment of patients Accelerated phase or blast crisis chronic
with unresectable and/or metastatic malignant myeloid leukemia: 600 mg once daily.
gastrointestinal stromal tumours (GIST) who are positive for CHILD more than 2 years, chronic and
CD117/c-kit advanced phase chronic myeloid
leukemia: 340 mg/m2 daily. Max: 800
mg/day ii) ADULT : 400mg/day

Imiglucerase 400 IU Injection A16AB02000P4002XX No A* Non-neuronopathic (Type 1) or chronic neuronopathic (Type Dosage should be individualized to each
3) Gaucher disease and who exhibit clinically significant non- patient. Initial dosages range from 2.5
neurological manifestations of the disease. The non- units/kg of body weight 3 times a week
neurological manifestations of Gaucher disease include one or to 60 units/kg once every 2 weeks.
more of the following conditions: - anemia, after exclusion of Administered by intravenous infusion
other causes, such as iron deficiency - thrombocytopenia - over 1-2 hours.
bone disease, after exclusion of other causes, such as Vitamin
D deficiency - hepatomegaly or splenomegaly

Imipenem 500 mg and Cilastatin 500 mg J01DH51961P4002XX No A* Severe infections caused by susceptible pathogens especially Based on type or severity of infection,
Injection useful in infections involving ESBL organisms. Not to be used susceptibility of pathogen(s) and patient
for prophylaxis condition including body weight and
renal function. ADULT: 1 - 2 g/day in 3 -
4 divided doses. Maximum: 4 g/day or
50 mg/kg/day. Infusion rate: less than
500 mg dose: over 20 - 30 minutes,
more than 500 mg: dose over 40 - 60
minutes. CHILDREN: ≥ 40kg body weight
should receive adult doses. CHILDREN
AND INFANTS: <40kg body weight should
receive 15mg/kg at six hour intervals.
The total daily dose should not exceed
2g.

Imipramine HCI 25 mg Tablet N06AA02110T1001XX No B Depression Initially up to 75 mg daily in divided

doses increased gradually to 150 - 200
mg (up to 300 mg in hospital patients);
up to 150 mg may be given as a single
dose at bedtime. ELDERLY initially 10 mg
daily; increased gradually to 30 - 50 mg
daily; CHILD is not recommended

Imiquimod 5 % w/w Cream D06BB10000G1001XX No A* Treatment of external genital and perianal warts or condyloma Apply to affected area at bedtime for 3
acuminata in adults times a week for up to 16 weeks; leave
on skin for 6-10 hours
Immunoglobulin Tetanus Human 250 J06BB02000P3001XX Yes B Passive immunization against tetanus Prophylaxis of tetanus: IM 250 units.
Units/Vial Injection Treatment of tetanus: IM 30 - 300
units/kg

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Generic Name MDC NEML Category Indications Dosage

Indacaterol Maleate 150 mcg Inhalation R03AC18253C9901XX No A* Maintenance bronchodilator treatment of airflow obstruction Once-daily inhalation of the content of
Capsule in adult patients with chronic obstructive pulmonary disease one 150/300 microgram capsule.
(COPD). Maximum dose is 300 microgram once-
daily.
Indacaterol Maleate 300 mcg Inhalation R03AC18253C9902XX No A* Maintenance bronchodilator treatment of airflow obstruction Once-daily inhalation of the content of
Capsule in adult patients with chronic obstructive pulmonary disease one 150/300 microgram capsule.
(COPD). Maximum dose is 300 microgram once-
daily.
Indacaterol maleate and glycopyrronium R03AL04989C1101XX No A* As a once-daily maintenance bronchodilator treatment to One capsule inhalation daily.
bromide (fixed dose combination) relieve symptoms in adult patients with chronic obstructive
110/50mcg, inhalation powder hard pulmonary disease (COPD).
capsules
Indomethacin 100 mg Suppository M02AA23000S2001XX No B Pain and inflammation in rheumatic arthritis Adult: As supp: 100 mg to be inserted at
night and repeated in the morning if
necessary.
Indomethacin 25 mg Capsule M01AB01000C1001XX Yes B Pain and inflammation in rheumatic disease 50 - 200 mg daily in divided doses, with
food. Child not recommended.
Infliximab 100 mg Injection L04AB02000P4001XX No A* i) Rheumatoid arthritis (moderate to severe), in combination i) Rheumatoid arthritis: ADULT over 18
with methotrexate ii) Ankylosing spondylitis in patients with years old: 3 mg/kg at 0, 2, 6 weeks, then
active disease despite treatment with methotrexate iii) Crohn's every 8 weeks; May increase to 10
Disease in patients who have an inadequate response to mg/kg or increase dosing frequency to 4
conventional therapies. iv) Fistulizing Crohn's Disease in weekly for patients with incomplete
patients who have an inadequate response to conventional response. Discontinue if no response by
therapies v) Ulcerative Colitis in patients who have an 12 weeks of initial infusion or after dose
inadequate response to conventional therapies adjustment ii) Ankylosing spondylitis:
ADULT over 18 years: 5 mg/kg IV over 2
hour given at week 0, 2, and 6 then
every 6-8 weeks. Discontinue if no
response by 6 weeks of initial infusion.
iii), iv) & v)5 mg/kg given as an
intravenous infusion over a 2-hour
period followed by additional 5 mg/kg
infusion doses at 2 and 6 weeks after the
first infusion, then every 8 weeks
thereafter

Influenza Vaccine (Inactivated) Injection J07BB02963P30XXXX Yes B i) Prophylaxis of influenza for frontliners (KKM staff and CHILD 6-35 months: Single dose of 0.5
essential services personnel). ii) Prophylaxis of influenza in ml IM or deep SC; 3-8 years: 1-2 doses of
high risk groups, particularly individuals who have chronic 0.5 ml IM ADULT & CHILD more than 9
cardiovascular, pulmonary, metabolic or renal disease, or who years: Single dose of 0.5 ml IM
are immunocompromised and elderly patients. Refer to
current recommendation by WHO for selection of product of
inactivated influenza vaccines.
Insulin Aspart 100 IU/ml Injection A10AB05000P3001XX No A* Diabetic Type 1 and 2 in patients that still experienced Dose to be individualised. The average
hypoglycaemia with use of human insulin daily insulin requirement is between 0.5
to 1.0 units/kg body weight

Insulin Aspart 30% and Protaminated A10AD05000P3001XX No A/KK Diabetic type 1 and 2 in patients that still experienced Dose to be individualised. The average
Insulin Aspart 70% 100 U/ml Injection hypoglycaemia with use of human insulin daily insulin requirement is between 0.5
to 1.0 units/kg body weight

Insulin Detemir 100 IU/ml Injection in A10AE05000P5001XX No A/KK i)Type 1 Diabetes patients on basal bolus regimen, whom Individualized dose given via SC once or
Prefilled syringe/cartridge experience hypoglycemia with conventional insulin, to be used twice daily. Initiate at a dose of 10IU or
in combination with rapid or short-acting insulin. ii)Type 2 0.1-0.2IU/kg. For twice daily dosing, the
Diabetes patients on oral anti-diabetics and basal insulin evening dose can be administered either
regimen or basal bolus insulin regimen whom experience with the evening meal, at bedtime, or 12
hypoglycemia with conventional basal insulin. hours after the morning dose.

Insulin Glargine 300IU/3ml Prefilled Pen A10AE04000P5001XX No A/KK i) Diabetes mellitus type I in adults and child over 6 years ii)
ADULT and CHILD over 6 years:
for Injection Diabetes mellitus type II in adult individualised dose given by SC, once
daily at the same time every day. Adult
patients who are insulin naÔve may be
initiated with 10IU daily.
Insulin Glulisine 100u/ml solution for A10AB06000P5001XX No A* Treatment of adults, adolescents and children 6 years or older Glulisine should be given shortly (0-15
injection in pre-filled pen 3ml with diabetes mellitus, where treatment with insulin is min) before or soon after meals. Apidra
required. should be used in regimens that include
an intermediate or long acting insulin or
basal insulin analogue and can be used
with oral hypoglycaemic agents. The
dosage of Apidra should be individually
adjusted.

Insulin Lispro 100 IU/ml Injection in A10AB04000P5001XX No A* i) As initial therapy in children with Type 1 diabetes ii)Type 1 Dose to be individualized. The average
Prefilled syringe/cartridge diabetes patients on basal bolus regimen, not controlled or daily insulin requirement is between 0.5
experience hypoglycaemia with conventional insulin, to be to 1.0 units/kg body weight, given within
used in combination with long-acting insulin iii)Type 2 15 minutes before meal.
diabetes patients on basal bolus or premixed regimen, not
controlled or experience hypoglycaemia with conventional
insulin, to be used in combination with intermediate-acting
insulin or long-acting insulin iv)Patients with diabetes in
pregnancy with poor postprandial control or experience
hypoglycaemia with conventional short-acting insulin

Insulin Lispro 25% & Insulin Lispro A10AD04000P5001XX No A* Patients with Type 2 diabetes whom experience hypoglycemia Dose to be individualized. The average
Protamine 75% 100 U/ml Suspension for with the use of human premixed insulin. daily insulin requirement is between 0.5
Injection in Prefilled Syringe/Cartridge to 1.0 units/kg body weight

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Generic Name MDC NEML Category Indications Dosage

Insulin Lispro 50% & Insulin Lispro A10AD04000P5002XX No A* Patients with Type 2 diabetes whom experience hypoglycemia Dose to be individualized. The average
Protamine 50% 100U/ml Suspension for with the use of human premixed insulin. daily insulin requirement is between 0.5
Injection in Prefilled Syringe/Cartridge to 1.0 units/kg body weight.

Insulin Recombinant Neutral Human A10AB01000P3001XX Yes B Diabetes mellitus Dose to be individualised. The average
Short Acting 100 IU/ml Injection in 10ml daily insulin requirement is between 0.3-
vial 1.0 units/kg body weight/day. Daily
insulin requirement may be higher in
patients with insulin resistance, and
lower in patients with residual,
endogenous insulin production.

Insulin Recombinant Neutral Human A10AB01000P5001XX Yes B Diabetes mellitus Dose to be individualised. The average
Short-acting 100IU/ml Penfill and Refill daily insulin requirement is between 0.3-
1.0 units/kg body weight/day. Daily
insulin requirement may be higher in
patients with insulin resistance, and
lower in patients with residual,
endogenous insulin production.

Insulin Recombinant Synthetic Human A10AC01000P3001XX Yes B Diabetes mellitus Dose to be individualised. The daily
Intermediate-Acting 100IU/ml in Vial for insulin requirement is usually between
Injection 0.3 and 1.0IU/kg /day
Insulin Recombinant Synthetic Human A10AD01000P3001XX Yes B Diabetes mellitus Dose to be individualised. The average
Premixed 100IU/ml in Vial for Injection daily insulin requirement is between 0.3-
1.0 units/kg body weight/day. Daily
insulin requirement may be higher in
patients with insulin resistance, and
lower in patients with residual,
endogenous insulin production.

Insulin Recombinant Synthetic Human, A10AC01000P5001XX Yes B Insulin dependent diabetes mellitus, non insulin dependent Dose to be individualised. The daily
Intermediate-Acting 100 IU/ml Penfill diabetes unresponsive to treatment to diet or oral insulin requirement is usually between
and Refill hypoglycaemics, hyperkalaemia to assure proper utilisation of 0.3 and 1.0IU/kg /day
glucose and reduce glucosuria in non diabetic patients
receiving parenteral nutrition
Insulin Recombinant Synthetic Human, A10AD01000P5001XX Yes B Insulin dependent diabetes mellitus, non insulin dependent Dose to be individualised. The average
Premixed 100 IU/ml Penfill and Refill diabetes unresponsive to treatment to diet or oral daily insulin requirement is between 0.5-
hypoglycaemics, hyperkalaemia to assure proper utilisation of 1.0 units/kg body weight
glucose and reduce glucosuria in non diabetic patients
receiving parenteral nutrition
Interferon Alfa - 2a 3 MIU Injection L03AB04000P3001XX No A* For the treatment of i) Hairy cell leukaemia ii) Chronic i) Initial : 3 MIU SC daily. If intolerant, 1.5
myelogenous leukaemia iii) AIDS related Kaposi's Sarcoma iv) MIU daily or 3 MIU 3 times a week or 1.5
Chronic hepatitis B v) Chronic hepatitis C vi) Advanced renal MIU 3 times a week. Maintenance : 1.5-3
cell carcinoma MIU SC 3 times a week ii) Patient > 18
years : 3 MIU daily (days 1-3), 6 MIU
daily (days 4-6), 9 MIU daily (days 7-84)
iii) Patient > 18 years : Initially escalating
dose to 18-36 MIU SC/IM for 10-12
weeks. Maintenance: up to 36 MIU 3
times a week iv)2.5-5 MIU/m2 SC 3 times
a week for 4-6 months. CHILD: up to 10
MIU/m2 BSA v) Monotherapy : Initial : 3 -
6 MIU SC 3 times a week for 6 months.
Maintenance : 3 MIU 3 times a week for
an additional 6 months. vi) As an adjunct
to cytotoxic chemotherapy: An
escalating dose of 3 MIU 3 times a week
for 1 week, then 9 MIU 3 times a week
for 1 week, then 18 MIU 3 times a week
thereafter for 3-12 months SC

Interferon Alfa-2b 18 MIU Injection L03AB05000P5001XX No A For the treatment of i) Hairy cell leukaemia ii) Chronic i) 2 MIU SC or IM 3 times a week ii)
myelogenous leukaemia iii) AIDS related Kaposi's sarcoma iv) Patient more than 18 years: 3 - 9 MIU 3 -
Chronic hepatitis B v) Chronic hepatitis C vi) Advanced renal 5 times a week or daily depending on
cell carcinoma response iii) Patient more than 18 years.
Initially escalating dose to 18-36 MIU
SC/IM for 10-12 weeks. Maintenance: up
to 36 MIU 3 times weekly iv) 2.5-5
MIU/m2 SC 3 times weekly for 4-6
month. CHILD: up to 10 MIU/m2 BSA v)
3 MIU for 12 months vi) As an adjunct to
cytotoxic chemotherapy: An escalating
dose of 3 million IU 3 times/week for 1
week, then 9 million IU 3 times/week for
1 week, then 18 million IU 3 times/week
thereafter for 3-12 month SC or IM

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Generic Name MDC NEML Category Indications Dosage

Interferon Alfa-2b 30 MIU Multidose L03AB05000P5002XX No A For the treatment of i) Hairy cell leukaemia ii) Chronic i) 2 MIU SC or IM 3 times a week ii)
Injection Pen myelogenous leukaemia iii) AIDS related Kaposi's sarcoma iv) Patient more than 18 years: 3 - 9 MIU 3 -
Chronic hepatitis B v) Chronic hepatitis C vi) Advanced renal 5 times a week or daily depending on
cell carcinoma response iii) Patient more than 18 years.
Initially escalating dose to 18-36 MIU
SC/IM for 10-12 weeks. Maintenance: up
to 36 MIU 3 times weekly iv) 2.5-5
MIU/m2 SC 3 times weekly for 4-6
month. CHILD: up to 10 MIU/m2 BSA v)
3 MIU for 12 months vi) As an adjunct to
cytotoxic chemotherapy: An escalating
dose of 3 million IU 3 times/week for 1
week, then 9 million IU 3 times/week for
1 week, then 18 million IU 3 times/week
thereafter for 3-12 month SC or IM

Interferon Alpha - 2a 4.5 MIU Injection L03AB04000P3002XX No A* For the treatment of i) Hairy cell leukaemia ii) Chronic i) 2 MIU SC or IM 3 times a week ii)
myelogenous leukaemia iii) AIDS related Kaposi's Sarcoma iv) Patient more than 18 years: 3 - 9 MIU 3 -
Chronic hepatitis B v) Chronic hepatitis C vi) Advanced renal 5 times a week or daily depending on
cell carcinoma response iii) Patient more than 18 years.
Initially escalating dose to 18-36 MIU
SC/IM for 10-12 weeks. Maintenance: up
to 36 MIU 3 times weekly iv) 2.5-5
MIU/m2 SC 3 times weekly for 4-6
month. CHILD: up to 10 MIU/m2 BSA v)
3 MIU for 12 months vi) As an adjunct to
cytotoxic chemotherapy: An escalating
dose of 3 million IU 3 times/week for 1
week, then 9 million IU 3 times/week for
1 week, then 18 million IU 3 times/week
thereafter for 3-12 month SC or IM

Interferon Alpha 2b 3 MIU Injection L03AB05000P3001XX No A* For the treatment of i) Hairy cell leukaemia ii) Chronic i) 2 MIU/m2 SC or IM 3 times a week ii) 4
myelogenous leukaemia iii) AIDS related Kaposi's sarcoma iv) - 5 MIU/m2 SC daily. Treatment must be
Chronic hepatitis B v) Chronic hepatitis C vi) Advanced renal discontinued after 8 to 12 weeks of
cell carcinoma treatment if at least a partial
haematological remission or a clinically
meaningful cytoreduction has not been
achieved iii) Patient > 18 years : 30
MIU/m2 SC or IM three times a week
until disease progression or maximal
response has been achieved after 16
weeks of treatment. iv) 5 MIU daily or 10
MIU three times a week for 16 weeks.
CHILD : 3 MIU/m2 three times a week
for the first week of therapy followed by
dose escalation to 6 MIU/m2 (maximum
of 10MIU) three times a week SC for a
total duration of 16 to 24 weeks v) 3
MIU SC or IM 3 times a week.

Interferon beta -1b 250mcg (8MIU) L03AB08000P4001XX No A* i)Relapsing-remitting multiple sclerosis (RRMS): Reduction of 0.25 mg (8 MIU) by SC injection every
Injection frequency and degree of severity of clinical relapses in other day
ambulatory patients characterized by at least two attacks of
neurological dysfunction over the preceding two year period,
followed by complete or incomplete recovery ii)Secondary
progressive multiple sclerosis (SPMS):Reduction of frequency
and severity of clinical relapses and for slowing the
progression of disease

Interferon Beta-1a 22 mcg L03AB07000P5001XX No A* Multiple sclerosis of the relapsing remitting type with 2 or 22 mcg 3 times weekly
more relapses within the last 2 years
Interferon Beta-1a 44 mcg L03AB07000P5002XX No A* Multiple sclerosis of the relapsing remitting type with 2 or 44 mcg 3 times weekly
more relapses within the last 2 years
Iodamide Injection V08AA03000P3001XX No A For hysterosalpingography According to the procedure and route of
administration
Iodine and Potassium Iodide Solution H03CA00200L9901XX No B i) Pre-operative treatment of thyrotoxicosis ii) Thyrotoxicosis i) 1 ml daily in divided doses ii) 2 - 3 ml
crisis daily
Iodixanol 320 mg I/ml Injection V08AB09000P3001XX No A X-ray contrast medium for cardioangiography, cerebral Depending on type of examination
angiography, peripheral arteriography, abdominal
angiography, uroloraphy, venography, CT enhancement,
lumbar, thoracic and cervical myelography
Iohexol Injection V08AB02000P3001XX No A X-ray contrast medium for use in adults and children for Dose depending on the route and
cardioangiography, arteriography, urography, phlebography procedure
and CT-enhancement. Lumbar, thoracic, cervical myelography
and computed tomography of the basal cisterns, following
subarachnoid injection. Arthrography, endoscopic retrograde
pancreatography (ERCP), herniography,
hysterosalpingography, sialography and studies of the
gastrointestinal tract

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Generic Name MDC NEML Category Indications Dosage

Iopamidol Injection V08AB04000P3001XX No A i) Neuroradiology : myeloradiculography, cisternography and For angiography and cardiac cases- dose
ventriculography ii) Angiograph : cerebral arteriography, depending on the route and procedure.
thoracic aortography, abdominal aortography, For selected vascular examination -
angiocardiography, selective visceral arteriography, peripheral bottles of 30 ml and 100 ml; dose
arteriography, venography, digital subtraction angiography depending on the route and procedure
(DSA), DSA of cerebral arteries, DSA of peripheral arteries, DSA
of abdominal arteries iii) Urography : intravenous urography
iv) Contrast enhancement in CT Scanning, arthrography,
fistulography

Iopromide 300mg injection (623 mg of V08AB05000P3001XX No A i) For angiography, urography, aortography and the Dose depending on the route and
iopromide with 300 mg of iodine per mL) visualization of body cavities ii) Contrast enhancement during procedure
computerized tomography iii) To check functioning of a
dialysis shunt
Iopromide 370mg injection (769 mg of V08AB05000P3002XX No A i) For angiography, urography, aortography and the Dose depending on the route and
iopromide with 370 mg of iodine per mL) visualization of body cavities ii) Contrast enhancement during procedure
computerized tomography iii) To check functioning of a
dialysis shunt
Ipratropium Bromide 0.0125% R03BB01320A3001XX Yes B Only for treatment of : i) Patients with ischaemic heart disease ADULT : 500 mcg up to 4 times daily.
Nebulising Solution (125 mcg/ml) who develop extrasystole with salbutamol or terbutaline ii) CHILD 5 - 12 years : 125 - 250 mcg up to
Patients with chronic bronchitis who have airway obstruction 4 times daily, 12 years : 250 - 500 mcg
and who do not respond to salbutamol or terbutaline. up to 4 times daily
Reversible airways obstruction, particularly in chronic
obstructive pulmonary disease

Ipratropium Bromide 0.025% Inhalation R03BB01320A3002XX Yes B Only for treatment of : i) Patients with ischaemic heart disease ADULT : 500 mcg up to 4 times daily.
Solution (250 mcg/ml) who may develop extrasystole with salbutamol or terbutaline CHILD 5 - 12 years : 125 - 250 mcg up to
ii) Patients with chronic bronchitis who have airway 4 times daily, 12 years : 250 - 500 mcg
obstruction and who do not respond to salbutamol or up to 4 times daily
terbutaline. Reversible airways obstruction, particularly in
chronic obstructive pulmonary disease

Ipratropium Bromide 0.5 mg and R03AK04320A3001XX No B Management of reversible bronchospasm associated with Acute attacks : 1 unit dose vial. In severe
Salbutamol 2.5 mg per UDV obstructive airway diseases cases not relieved by 1 unit dose vial, 2
unit dose vials may require, patient
should consult a doctor immediately.
Maintenance : 1 unit dose vial 3 - 4
times daily
Ipratropium Bromide 20 mcg and R03AK03986A2101XX No B Management of symptoms in chronic obstructive airway ADULT & CHILD more than 6 years;
Fenoterol 50 mcg/dose Inhaler disorders with reversible bronchospasm such as bronchial Acute asthma 2 puffs. Severe cases: if
asthma and chronic bronchitis with or without emphysema breathing has not noticeably improved
after 5 mins, 2 further puffs may be
taken. Intermittent and long-term
treatment 1-2 puffs for each
administration, up to max 8 puffs/day
(average: 1-2 puffs three times daily)

Ipratropium Bromide 20 mcg and R03AK04320A1001XX No B Management of reversible bronchospasm associated with ADULT and ELDERLY : 2 inhalations 4
Salbutamol base 100 mcg/dose obstructive airway diseases times daily. Maximum : 12 inhalations
Inhalation daily. CHILD under 12 years not
recommended
Ipratropium Bromide 20 mcg/dose R03BB01320A1001XX Yes B Only for treatment of : i) Patients with chronic bronchitis who 20 - 40 mcg 3 - 4 times daily. In the early
Inhalation have airway obstruction and who do not respond to treatment, up to 80 mcg 3 - 4 times
Salbutamol or Terbutaline ii) Patients with ischaemic heart daily. CHILD up to 6 years : 20 mcg 3
disease who develop extrasystole with Salbutamol or times daily, 6 - 12 years : 20 - 40 mcg 3
Terbutaline times daily
Irinotecan HCl Trihydrate 20 mg/ml L01XX19110P3002XX No A* Only for patients with colorectal cancer who: i) have relapsed In combination therapy (for previously
Injection within 6 months after the end of adjuvant chemotherapy with untreated patients): 180 mg/m2 once
5-fluorouracil-based regime ii) have progressive disease every 2 weeks as an IV infusion over 90
despite 5-fluorouracil chemotherapy for advanced disease iii) mins followed by infusion with folinic
good performance status (WHO of 2 or less) The treatment acid and 5-fluorouracil. In monotherapy
must be given in a tertiary oncology centre or have clearance (for previously treated patients): 350
in writing by an oncologist mg/m2 administered as an intravenous
infusion over 90 minutes period once
every 3 weeks

Irinotecan HCl Trihydrate 40 mg/2 ml L01XX19110P3001XX No A* Only for patients with colorectal cancer who: i) have relapsed In combination therapy (for previously
Injection within 6 months after the end of adjuvant chemotherapy with untreated patients): 180 mg/m2 once
5-fluorouracil-based regime ii) have progressive disease every 2 weeks as an IV infusion over 90
despite 5-fluorouracil chemotherapy for advanced disease iii) mins followed by infusion with folinic
good performance status (WHO of 2 or less) The treatment acid and 5-fluorouracil. In monotherapy
must be given in a tertiary oncology centre or have clearance (for previously treated patients): 350
in writing by an oncologist mg/m2 administered as an intravenous
infusion over 90 minutes period once
every 3 weeks

Iron (III) hydroxide sucrose complex B03AC02250P3001XX Yes B Treatment of iron deficiency anaemia: a) where there is a Individualised dosage. ADULT and
20mg/ml solution for injection clinical need for rapid iron supply b) in patients who cannot ELDERLY: Cumulative dose is to be
tolerate oral iron therapy or who are non-compliant c) in administered in single doses of 100 - 200
active inflammatory bowel disease where oral iron mg of iron 2 - 3 times weekly depending
preparations are ineffective on Hb level. By IV drip infusion, slow IV
injection or directly into the venous limb
of the dialyser. Total cumulative dose:
1000 mg

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Generic Name MDC NEML Category Indications Dosage

Iron (III) Polymaltose Complex 10mg B03AB05000L9001XX No A Treatment of latent iron deficiency and iron deficiency Infants (up to 1 year): 2.5-5ml daily (25-
iron/ml syrup anaemia (manifest iron deficiency). 50mg iron) Children (1-12 years old): 5-
10ml daily (50-100mg iron) Children (>12
years), adults: 10-30 ml daily (100-
300mg iron) Pregnant woman 20-30ml
daily (200-300mg iron)

Iron (III)-hydroxide polymaltose complex B03AD04250T2001XX No A/KK Treatment of latent and manifest iron deficiency and Dosage and duration of therapy are
(IPC) 100mg iron and 0.35mg folic acid prevention of iron and folic acid deficiency before, during dependent upon the extent of iron
chewable tablet after pregnancy (during lactation) deficiency. Manifest iron deficiency: 1
chewable tablet two to three times daily
until a normalization of the hemoglobin
value is achieved. Afterwards the
therapy should be continued with 1
chewable tablet daily at least until the
end of pregnancy to replenish the iron
stores. Latent iron deficiency and
prevention of iron and folic acid
deficiency: 1 chewable tablet daily

Iron Dextran 50 mg Fe/ml Injection B03AC06000P3001XX Yes B Severe iron deficiency anaemia An initial test dose of 0.5 ml should be
given over the desired route. For severe
iron deficiency anaemia, 1-2 ml daily
given by deep IM. Dosage is
individualized according to total iron
deficit
Isoflurane Liquid N01AB06000L5001XX Yes B i) Induction and ii) Maintenance of anaesthesia i) Induction- Initiate at a concentration
of 0.5 % ii) Maintenance- 1 - 2.5 % in
oxygen or nitrous oxide mixture. 0.5 -
0.75 % with oxygen and nitrous oxide for
Caesarian section

Isoniazid 100 mg Tablet J04AC01000T1001XX Yes B i) Tuberculosis ii)Tuberculous meningitis i) & ii) ADULT 5-8mg/kg daily (Max
300mg) or 15-20mg/kg biweekly (max
1200mg)
Isoniazid 400 mg Tablet J04AC01000T1002XX Yes B i) Tuberculosis ii)Tuberculous meningitis i) & ii) ADULT 5-8mg/kg daily (Max
300mg) or 15-20mg/kg biweekly (max
1200mg)
Isoprenaline HCl 0.2 mg/ml Injection C01CA02110P3001XX No B Complete heart block (third-degree artrioventricular block) not If given as IM: Initially 0.2 mg (1 ml of
responding to atropine, while waiting for cardiac pacing 1:5000 solution), followed by 0.02-1 mg
depending on clinical response. If given
as SC: 0.2 mg (1 ml of 1:5000 solution),
followed by 0.15-0.2 mg depending on
clinical response. If given as IV : 1-2 mg
in 500 ml of dextrose 5%, infused at a
rate of 0.5-2 ml/min while the patient's
EKG is being monitored. The dose should
be titrated to produce the desired
clinical response

Isoprenaline HCl 1 mg/5 ml Injection C01CA02110P3002XX No B Complete heart block (third-degree artrioventricular block) not If given as IM: Initially 0.2 mg (1 ml of
responding to atropine, while waiting for cardiac pacing 1:5000 solution), followed by 0.02-1 mg
depending on clinical response. If given
as SC: 0.2 mg (1 ml of 1:5000 solution),
followed by 0.15-0.2 mg depending on
clinical response. If given as IV : 1-2 mg
in 500 ml of dextrose 5%, infused at a
rate of 0.5-2 ml/min while the patient's
EKG is being monitored. The dose should
be titrated to produce the desired
clinical response

Isosorbide Dinitrate 1 mg/ml Injection C01DA08221P3001XX Yes A Treatment for angina pectoris and left ventricular failure 2-10 mg/hour IV infusion after dilution,
higher doses up to 20 mg/hour may be
required
Isosorbide Dinitrate 10 mg Tablet C01DA08221T1001XX Yes B Prophylaxis and treatment for: i) Angina ii) Left ventricular i) 30 - 120 mg daily in divided doses ii)
failure 40 - 160 mg, up to 240 mg if required

Isosorbide Mononitrate 50 mg SR C01DA14221C2001XX Yes A Prophylaxis and treatment of angina pectoris 50 mg daily
Capsule
Isosorbide-5-Mononitrate 30 mg SR C01DA14221T5001XX Yes A Prophylaxis and treatment of angina pectoris Initiate at 30 mg for 1st 2-4 days to avoid
Tablet headache. Usual dose: 60 mg once daily,
may be increased to 120 mg once daily

Isosorbide-5-Mononitrate 60 mg SR C01DA14221T5002XX Yes A Prophylaxis and treatment of angina pectoris 60mg once daily, increase to 120 mg
Tablet daily

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Generic Name MDC NEML Category Indications Dosage

Isotretinoin 10 mg Capsule D10BA01000C1001XX Yes A* Only for treatment of i) Severe nodulo-cystic acne ii) Acne 0.5-1 mg/kg of body weight per day (in
conglobata iii) Acne fulminans iv) Severe acne vulgaris failing two divided doses) for 15 to 20 weeks;
conventional treatment. the maximum recommended dose is
2mg/kg of body weight per day. After
about 4 weeks, therefore, dosage for the
maintenance treatment should be
adjusted within the range 0f 0.1-1mg/kg
daily to meet individual need. Treatment
usually lasts a total of 16 weeks. There
should be an interval of at least 8 weeks
before re-starting treatment.

Isotretinoin 20 mg Capsule D10BA01000C1002XX Yes A* Only for treatment of i) Severe nodulo-cystic acne ii) Acne 0.5-1 mg/kg of body weight per day (in
conglobata iii) Acne fulminans iv) Severe acne vulgaris failing two divided doses) for 15 to 20 weeks;
conventional treatment WARNING: THIS DRUG IS the maximum recommended dose is
TERATOGENIC 2mg/kg of body weight per day. After
about 4 weeks, therefore, dosage for the
maintenance treatment should be
adjusted within the range 0f 0.1-1mg/kg
daily to meet individual need. Treatment
usually lasts a total of 16 weeks. There
should be an interval of at least 8 weeks
before re-starting treatment.

Itopride HCl 50 mg Tablet A03FA00110T1001XX No A* Treatment of gastrointestinal symptoms of functional, non- 50 mg 3 times daily before meal
ulcer dyspepsia (chronic gastritis) i.e sensation of bloating,
early satiety, upper abdominal pain or discomfort, anorexia,
heartburn, nausea and vomiting
Itraconazole 10 mg/ml Oral Solution J02AC02000L9901XX No A* Treatment of: i) oral and/or oesophageal candidiasis ii) i) 200 mg daily for 1 week. If no response
fluconazole resistant and/or oesophageal candidiasis after 1 week, continue treatment for
another week ii) 100 - 200 mg twice daily
for 2 weeks. If no response after 2
weeks, continue treatment for another 2
weeks. The 400 mg daily dose should not
be used for more than 14 days if there
are no signs of improvement

Itraconazole 100 mg Capsule J02AC02000C1001XX No A/KK i) Dermatomycosis including pityriasis versicolor ii) Oral i) 200 mg once daily for 7 days ii) 100 mg
candidiasis iii) Palmar tinea manus and plantar tinea pedis iv) daily for 15 days iii) 200 mg twice daily
Fingernail onychomycosis v) Toenail onychomycosis vi) for 7 days iv) 200mg twice daily for 1
Vulvovaginal candidiasis week per month for 2 months v) 200 mg
twice daily for 1 week per month for 3
months vi)200 mg morning and evening
for 1 day or 200 mg once daily for 3 days

Ivabradine 5 mg Tablet C01EB17110T1001XX No A* i) Symptomatic treatment of chronic stable angina pectoris in Initial dose 5 mg twice daily. May
patients with normal sinus rhythm, who have a increase dose after 3-4 weeks to 7.5 mg
contraindication or intolerance to beta blockers ii) Treatment twice daily depending on response.
of coronary artery disease. Symptomatic treatment of chronic ELDERLY, initial dose 2.5 mg twice daily
stable angina pectoris in coronary artery disease patients with and titrate to a maximum of 7.5 mg
normal sinus rhythm. Ivabradine is indicated : - in patients twice daily
unable to tolerate or with a contraindication to the use of beta-
blockers - or in combination with beta-blockers in patients
inadequately controlled with an optimal beta-blocker dose
and whose heart rate is > 60 bpm. Treatment of chronic heart
failure. Ivabradine is indicated in chronic heart failure NYHA II
to IV class with sinus rhythm and whose heart rate is ≥75bpm,
in combination with standard beta-blocker therapy or when
beta- blocker therapy is contraindicated or not tolerated.

Ivabradine 7.5 mg Tablet C01EB17110T1002XX No A* i) Symptomatic treatment of chronic stable angina pectoris in Initial dose 5 mg twice daily. May
patients with normal sinus rhythm, who have a increase dose after 3-4 weeks to 7.5 mg
contraindication or intolerance to beta blockers ii) Treatment twice daily depending on response.
of coronary artery disease. Symptomatic treatment of chronic ELDERLY, initial dose 2.5 mg twice daily
stable angina pectoris in coronary artery disease patients with and titrate to a maximum of 7.5 mg
normal sinus rhythm. Ivabradine is indicated : - in patients twice daily
unable to tolerate or with a contraindication to the use of beta-
blockers - or in combination with beta-blockers in patients
inadequately controlled with an optimal beta-blocker dose
and whose heart rate is > 60 bpm. Treatment of chronic heart
failure. Ivabradine is indicated in chronic heart failure NYHA II
to IV class with sinus rhythm and whose heart rate is ≥75bpm,
in combination with standard beta-blocker therapy or when
beta- blocker therapy is contraindicated or not tolerated.

Kanamycin 1 g Injection J01GB04183P4001XX Yes A* i) Treatment of gonorrhoea and neonatal meningitis ii) i) ADULT: 1 - 2 g daily IM in 1 - 2 equally
Treatment of TB patients who require reserved second line divided doses. CHILD: 30 - 50 mg/kg/day
drugs but have no pre-existing renal complications in 1 - 2 divided doses ii) ADULT: 2 g daily
IM in 2 equally divided doses twice a
week or 1 g once daily 3 days a week

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Generic Name MDC NEML Category Indications Dosage

Ketamine 10 mg/ml Injection N01AX03110P3001XX Yes B Sole anaesthetic for short procedures or induction of IV Initially, 1-4.5 mg/kg IV, a dose of 2
anaesthesia in certain types of patients (e.g in shock states) mg/kg produces anesth for 5-10 mins.
IM Initially, 6.5-13 mg/kg IM, a dose of
10 mg/kg produces anesth for 12-25
mins.
Ketamine 50 mg/ml Injection N01AX03110P3002XX Yes B Sole anaesthetic for short procedures or induction of IV Initially, 1-4.5 mg/kg IV, a dose of 2
anaesthesia in certain types of patients (e.g in shock states) mg/kg produces anesthesia for 5-10
mins. IM Initially, 6.5-13 mg/kg IM, a
dose of 10 mg/kg produces anesthesia
for 12-25 mins.
Ketoconazole 2% Shampoo D01AC08000L5201XX No A/KK Resistant dandruff only Apply twice weekly for 2 - 4 weeks.
Prophylaxis: Once every 1 - 2 weeks
Ketoconazole 200 mg Tablet J02AB02000T1001XX No A/KK i) Pityriasis versicolor ii) Systemic mycosis (other skin mycoses) i) 200 mg with meal once daily for 10
iii) Nail infections days ii) 200 - 400 mg daily for 4 weeks -
6 months iii) 200 - 400 mg daily for 6 -
12 months.
Ketoprofen 2.5% Gel M02AA10000G3001XX No A As a short term treatment for traumatic lesions, sprains, Apply onto affected areas 2-4 times daily
tendinitis, oedema, bruises up to 10 days.
Ketoprofen 200 mg Slow Release M01AE03000C2002XX No A/KK Pain and inflammation in rheumatic disease 200mg in the morning or evening.
Capsule Should be taken with food: Take
immediately after meals.
Ketoprofen 30 mg Transdermal Plaster M02AA10000M7001XX No A Treatment of signs & symptoms of arthritis deformans, Apply 1 plaster to the affected area
periarthritis humero-scapularis, tendinitis, peritendinitis, sore twice daily
muscle, swelling, pain resulting from trauma (eg. contusion,
distorsion, sprain).
Ketoprofen 50 mg/ml Injection M01AE03000P3001XX No A* To be used only in treatment of acute inflammatory conditions By deep IM into gluteal muscle, 50-100
mg every 4 hours. Maximum 200 mg in
24 hours for up to 3 days. Child not
recommended
Ketorolac Tromethamine 30 mg/ml M01AB15239P3001XX No A* Short term management of moderate to severe postoperative ADULT : 60mg as a single dose via IM inj
Injection pain or 30mg as a single IV dose.
Alternatively, 30mg every 6 hr via IM or
IV admin up to a max of 120mg daily.

Labetalol HCl 100 mg Tablet C07AG01110T1001XX Yes B Hypertension (including in pregnancy) ADULT: 100 mg daily with food,
increased at intervals of 14 days to usual
dose of 200 mg twice daily, up to 800 mg
twice daily (3 - 4 divided doses if higher
dose). Max: 2.4 g daily

Labetalol HCl 200 mg Tablet C07AG01110T1002XX Yes B Hypertension (including in pregnancy) ADULT: 100 mg daily with food,
increased at intervals of 14 days to usual
dose of 200 mg twice daily, up to 800 mg
twice daily (3 - 4 divided doses if higher
dose). Max: 2.4 g daily

Labetalol HCl 5 mg/ml Injection C07AG01110P3001XX Yes B Hypertension crisis ADULT: 20mg injected slowly for at least
2 min, followed by 40-80mg dose every
10 min, if necessary upto 300 mg.
Patient should remain supine during and
3 hr after the procedure.

Lactobacillus acidophilus 100 million G03CC06953T1001XX No A/KK i)Atrophic vaginitis due to estrogen deficiency during Atrophic vaginitis : 1 vaginal tablet daily
viable cells and estriol 0.03mg vaginal menopause and post-menopause, or as co-medication to for 6-12 days followed by a maintenance
tablet systemic hormone replacement therapy ii)Restoration of the dose of 1 vaginal tablet for 1-2 days per
Lactobacillus flora after local and/or systemic treatment with week Restoration therapy: 1-2 vaginal
anti-infective agents or chemotherapeutic agents tablet daily for 6-12 days Administration
The vaginal tablets should be inserted
deeply into the vagina in the evenings
before bedtime. ?In cases of a very dry
vagina, vaginal tablet can be moistened
with 1 or 2 drops of water before
insertion into the vagina. ?During
menstruation, treatment should be
interrupted and resumed afterwards
Should not use vaginal douches or rinses
during treatment

Lactulose 3.35 g/5 ml Liquid A06AD11000L5001XX Yes C+ i) Constipation ii) Hepatic encephalopathy i) ADULT 15 ml twice daily adjusted to
patient's need. CHILD 0.5 ml/kg/dose
once or twice daily ii) 30-50 ml 3-4 times
daily, dose adjusted to produce 2-3 soft
stools daily. CHILD 1 ml/kg/dose 3-4
times daily
Lamivudine 10 mg/ml Oral Solution J05AF05000L9901XX Yes A* HIV infection in combination with other antiretroviral agents ADULT: 150 mg twice daily or 300 mg
once daily. INFANT under 1 month: 2
mg/kg twice daily. CHILD 3 month or
over: 4 mg/kg twice daily. Maximum 300
mg daily
Lamivudine 100 mg Tablet J05AF05000T1001XX Yes A* Management of chronic hepatitis B infection associated with Adult:†100 mg once daily. For pa ents
evidence of hepatitis B viral replication and active liver with concomitant†HIV†infec on: 300 mg
inflammation once daily or in 2 divided doses.†Child:
>2 yr: 3 mg/kg once daily. Max: 100
mg/day.

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Generic Name MDC NEML Category Indications Dosage

Lamivudine 150 mg Tablet J05AF05000T1002XX Yes A/KK HIV infection in combination with other antiretroviral agents ADULT: 150 mg twice daily or 300 mg
once daily. INFANT under 1 month: 2
mg/kg twice daily. CHILD 3 month or
over: 4 mg/kg twice daily. Maximum 300
mg daily
Lamotrigine 100 mg Tablet N03AX09000T1002XX Yes A i) Adjunctive or monotherapy for partial seizures and i) Up to 200 mg daily in single or divided
generalised tonic-clonic seizures not satisfactorily controlled dosage ii) 25- 200 mg daily
with other antiepileptic drugs ii) Prevention of mood episodes
in adult 18 years and above with bipolar disorder,
predominately by preventing depressive episodes

Lamotrigine 25 mg Dispersible/Chewable N03AX09000T2001XX Yes A Add-on therapy in intractable partial seizures 25 mg daily - 50 mg twice daily
Tablet
Lamotrigine 5 mg Dispersible/Chewable N03AX09000T2002XX Yes A Management of seizures in children aged 2 - 12 years a) Add-on therapy in patients not taking
Tablet Valproate: week 1 and 2: 2 mg/kg/day
twice daily, week 3 and 4: 5 mg/kg/day
twice daily. Maintenance: 5 - 15
mg/kg/day twice daily b) Add-on therapy
in patients taking Valproate or other anti-
epileptic drugs, week 1 and 2: 0.2
mg/kg/day as a single dose (children less
than 25 kg may take 5 mg on alternate
days), week 3 and 4: 0.5 mg/kg/day as a
single dose. Maintenance dose: 1 -5
mg/kg/day once daily or twice daily

Lamotrigine 50 mg Tablet N03AX09000T1001XX Yes A i) Adjunctive or monotherapy for partial seizures and i) Up to 200 mg daily in single or divided
generalised tonic-clonic seizures not satisfactorily controlled dosage ii) 25- 200 mg daily
with other antiepileptic drugs ii) Prevention of mood episodes
in adult 18 years and above with bipolar disorder,
predominately by preventing depressive episodes

Lansoprazole 30 mg Tablet A02BC03000T1001XX No A* i) Peptic ulcer disease ii) Reflux oesophagitis iii) Zollinger- i) 30mg daily in the morning for up to 4
Ellison Syndrome iv) For eradication of Helicobacter pylori in weeks (duodenal ulcer) or up to 8 weeks
combination with antibiotic (gastric ulcer). Maintenance:
15mg/day.ii) 30mg OD in the morning
for up to 8 weeks if not healed.
Maintenance: 15mg OD. iii) Initially
60mg OM & adjust as required. Daily
doses >120mg should be given in 2
divided doses. iv) 30 mg twice daily in
combination with any of the 2 antibiotics
(clarithromycin 500 mg twice daily ,
amoxicillin 1 g twice daily or
metronidazole 400 mg twice daily) for 1-
2 weeks

Lanthanum Carbonate 1000mg V03AE03130T2004XX No A* Phosphate binding agent for the treatment of Initial: 750 to 1500 mg/day in divided
Chewable Tablet hyperphosphataemia in dialysis patients with sustained doses with meals, then titrate in
hypercalcaemia of more than three months and secondary increments of 750 mg/day at intervals of
hyperparathyroidism 2 to 3 weeks. Maintenance: 1500-3000
mg/day in divided doses. Max: 3750
g/day
Laronidase 2.9 mg/5ml Injection A16AB05000P3001XX No A* Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I 0.58 mg/kg of body weight administered
(MPS I) and for patients with the Scheie form who have once-weekly as an intravenous infusion
moderate to severe symptoms
L-Asparaginase 10,000 IU Injection L01XX02000P3001XX Yes A* i) Acute lymphoblastic leukemia ii) Non-hodgkin's lymphoma i) 5,000 iu/m2 for 10 days during
induction, 10,000 iu/m2 also used with
high dose methotrexate rescue in
consolidation phase of acute
lymphoblastic leukemia ii) CHILD: 5,000 -
25,000 iu/m2 per dose depending on
protocol
Latanoprost 0.005% and timolol maleate S01ED51990D2004XX No A* For reduction of Intraocular Pressure (IOP) in patients with 1 drop in the affected eye(s) once daily
0.5% eye drops Open-angle Glaucoma (OAG) and Ocular Hypertension (OH)
who are insufficiently responsive to topical beta-blocker.

Latanoprost 0.005% Eye Drops S01EE01000D2001XX No A* Reduction of elevated intraocular pressure in patients with The recommended dosage is one drop
open-angle glaucoma (1.5 µg) in the affected eye(s) once daily
in the evening. If more than one topical
ophthalmic drug is being used, the drugs
should be administered at least five (5)
minutes apart

Leflunomide 10 mg Tablet L04AA13000T1001XX Yes A* i) Persistent active rheumatoid arthritis ii) Active psoriatic Loading dose: 100 mg once daily for 3
arthritis days. Maintenance: 10-20 mg once daily

Leflunomide 20 mg Tablet L04AA13000T1002XX Yes A* i) Persistent active rheumatoid arthritis ii) Active psoriatic Loading dose: 100 mg once daily for 3
arthritis days. Maintenance: 10-20 mg once daily.

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Generic Name MDC NEML Category Indications Dosage

Lenalidomide 10 mg Capsule L04AX04000C1002XX No A* In combination with dexamethesone is indicated for the Recommended starting dose: 25 mg
treatment of multiple myeloma patients who have received at once daily on days 1 to 21 of repeated
least one prior therapy 28 day cycle with dexamethasone 40 mg
once daily on days 1 to 4, 9 to 12 and 17
to 20 of each 28 day cycle for the first 4
cycles of therapy, thereafter
dexamethasone 40 mg once daily on day
1 to 4 every 28 day cycle

Lenalidomide 15 mg Capsule L04AX04000C1003XX No A* In combination with dexamethesone is indicated for the Recommended starting dose: 25 mg
treatment of multiple myeloma patients who have received at once daily on days 1 to 21 of repeated
least one prior therapy 28 day cycle with dexamethasone 40 mg
once daily on days 1 to 4, 9 to 12 and 17
to 20 of each 28 day cycle for the first 4
cycles of therapy, thereafter
dexamethasone 40 mg once daily on day
1 to 4 every 28 day cycle

Lenalidomide 25 mg Capsule L04AX04000C1004XX No A* In combination with dexamethesone is indicated for the Recommended starting dose: 25 mg
treatment of multiple myeloma patients who have received at once daily on days 1 to 21 of repeated
least one prior therapy 28 day cycle with dexamethasone 40 mg
once daily on days 1 to 4, 9 to 12 and 17
to 20 of each 28 day cycle for the first 4
cycles of therapy, thereafter
dexamethasone 40 mg once daily on day
1 to 4 every 28 day cycle

Lenalidomide 5 mg Capsule L04AX04000C1001XX No A* In combination with dexamethesone is indicated for the Recommended starting dose: 25 mg
treatment of multiple myeloma patients who have received at once daily on days 1 to 21 of repeated
least one prior therapy 28 day cycle with dexamethasone 40 mg
once daily on days 1 to 4, 9 to 12 and 17
to 20 of each 28 day cycle for the first 4
cycles of therapy, thereafter
dexamethasone 40 mg once daily on day
1 to 4 every 28 day cycle

Letrozole 2.5 mg Tablet L02BG04000T1001XX No A* i) Treatment of hormone responsive metastatic or locally 2.5 mg once daily
advance breast cancer after failure of tamoxifen ii) Adjunct for
node positive postmenopausal women with early breast
cancer (positive or unknown oestrogen or positive
progesterone receptor status / receptor status) who have
received 5 years of adjuvant tamoxifen therapy

Leucovorin Calcium (Calcium Folinate) 15 V03AF03390T1001XX Yes A Treatment of folic acid antagonist overdose 15 mg every 6 hours for the next 48 - 72
mg Tablet hours
Leucovorin Calcium (Calcium Folinate) 3 V03AF03237P3001XX Yes A i) Biochemical modulator for 5-Fluorouracil in the treatment of i) 200mg/m2 by slow IV injection over a
mg Injection colorectal cancer ii) As rescue for high dose methotrexate iii) minimum 3 minutes, followed by 5-
Megaloblastic anaemias due to deficiency of folic acid Fluorouracil or 20mg/m2 IV followed by
5-Fluorouracil. In both cases, treatment
is repeated daily for 5 days; may repeat
at 4-week intervals for 2 courses then 4-
to 5-week intervals ii) 15 mg
(approximately 10mg/m2) every 6 hours
for 10 doses, starting 24 hours after the
beginning of the methotrexate infusion
iii) Up to 1 mg daily

Leucovorin Calcium (Calcium Folinate) 50 V03AF03237P3002XX Yes A i) Biochemical modulator for 5-Fluorouracil in the treatment of i) 200mg/m2 by slow IV injection over a
mg Injection colorectal cancer ii) As rescue for high dose methotrexate iii) minimum 3 minutes, followed by 5-
Gestational trophoblastic disease Fluorouracil or 20mg/m2 IV followed by
5-Fluorouracil. In both cases, treatment
is repeated daily for 5 days; may repeat
at 4-week intervals for 2 courses then 4-
to 5-week intervals ii) 15 mg
(approximately 10mg/m2) every 6 hours
for 10 doses, starting 24 hours after the
beginning of the methotrexate infusion
iii) 6 - 12 mg exactly 30 hours after each
dose of methotrexate. In EMA-CO
regime for high risk gestational
trophoblastic disease, use 30 mg IM

Leuprolide 22.5mg injection L02AE02122P2001XXX No A* Hormonal therapy in advanced prostate cancer. 22.5mg SC every 3 months
Leuprolide Acetate 11.25 mg Injection L02AE02122P5002XX No A* i) Endometriosis ii) Hormonal therapy in advanced prostate 11.25 mg every 3 months
cancer
Leuprolide Acetate 3.75 mg Injection L02AE02122P5001XX No A* i) Endometriosis ii) Hormonal therapy in advanced prostate i) 3.75 mg monthly for 3 - 6 months ii)
cancer 3.75 mg IM or SC injection monthly

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Generic Name MDC NEML Category Indications Dosage

Levetiracetam 100 mg/ml Injection N03AX14000P3001XX No A* i) Monotherapy therapy in the treatment of partial onset i) ADULTS and ADOLESCENT (from 16
seizures with or without secondary generalization in patients years): Starting dose: 250 mg twice daily,
from age 16 years of age with newly diagnosed epilepsy ii) Increase dose to 500 mg twice daily after
Adjunctive treatment in partial onset seizures with or without 2 week. Dose can be further increased
secondary generalization in adults and children from 4 years by 250 mg twice daily every 2 weeks
of age with epilepsy; juvenile myoclonic epilepsy and depending upon the clinical response.
idiopathic generalized tonic clonic epilepsy from 12 years of Max: 1500 mg twice daily. ii) ADULT
age. To be initiated when conventional IV antiepileptic drugs more than 18 years and ADOLESCENT
failed to achieve control, or oral form is temporarily not (12 to 17 years) more than or equal to
feasible in seizure emergencies 50 kg: Initially 500 mg twice daily may be
increased up to 1500 mg twice daily.
Dose changes can be made in 500 mg
twice daily increments or decrements 2
to 4 weekly. CHILD (4 to 11 years) and
ADOLESCENT (12 to 17 years) less than
50 kg : Initially 10 mg/kg twice daily, may
be increased up to 30 mg/kg twice daily.
Dose changes should not exceed
increments or decrements of 10 mg/kg
twice daily every 2 weeks. CHILD more
than or equal to 50 kg: Adult dose

Levetiracetam 100 mg/ml Oral Solution N03AX14000L9901XX No A* As adjunctive therapy in the treatment of partial onset CHILD: 4-11 years and adolescent (12-17
seizures with or without secondary generalization in adults years) less than 50 kg: Initially 10 mg/kg
and children from 4 years of age with epilepsy twice daily, may be increased up to 30
mg/kg twice daily. Dose changes should
not exceed increments or decrements of
10 mg/kg two times daily twice weekly

Levetiracetam 250 mg Tablet N03AX14000T1001XX No A* i) Monotherapy therapy in the treatment of partial onset i) Monotherapy ADULTS and
seizures with or without secondary generalization in patients ADOLESCENT (from 16 years) : Starting
from age 16 years of age with newly diagnosed epilepsy ii) dose: 250 mg twice daily, Increase dose
Adjunctive treatment in partial onset seizures with or without to 500 mg twice daily after 2 week. Dose
secondary generalization in adults and children from 4 years can be further increased by 250 mg
of age with epilepsy; juvenile myoclonic epilepsy and twice daily every 2 week depending
idiopathic generalized tonic clonic epilepsy from 12 years of upon the clinical response. Max: 1500
age mg twice daily. ii) ADULT more than 18
years and ADOLESCENT (12-17 years)
more than or equal to 50 kg: Initially 500
mg twice daily may be increased up to
1500 mg twice daily. Dose changes can
be made in 500 mg twice daily
increments or decrements 2-4 weekly.
CHILD (4-11 years) and ADOLESCENT (12-
17 years) less than 50 kg : Initially 10
mg/kg twice daily, may be increased up
to 30 mg/kg twice daily. Dose changes
should not exceed increments or
decrements of 10 mg/kg twice daily
every 2 weeks. CHILD more than or equal
to 50 kg: Adult dose

Levetiracetam 500 mg Tablet N03AX14000T1002XX No A* i) Monotherapy therapy in the treatment of partial onset i) Monotherapy ADULTS and
seizures with or without secondary generalization in patients ADOLESCENT (from 16 years) : Starting
from age 16 years of age with newly diagnosed epilepsy ii) dose: 250 mg twice daily, Increase dose
Adjunctive treatment in partial onset seizures with or without to 500 mg twice daily after 2 week. Dose
secondary generalization in adults and children from 4 years can be further increased by 250 mg
of age with epilepsy; juvenile myoclonic epilepsy and twice daily every 2 week depending
idiopathic generalized tonic clonic epilepsy from 12 years of upon the clinical response. Max: 1500
age mg twice daily. ii) ADULT more than 18
years and ADOLESCENT (12-17 years)
more than or equal to 50 kg: Initially 500
mg twice daily may be increased up to
1500 mg twice daily. Dose changes can
be made in 500 mg twice daily
increments or decrements 2-4 weekly.
CHILD (4-11 years) and ADOLESCENT (12-
17 years) less than 50 kg : Initially 10
mg/kg twice daily, may be increased up
to 30 mg/kg twice daily. Dose changes
should not exceed increments or
decrements of 10 mg/kg twice daily
every 2 weeks. CHILD more than or equal
to 50 kg: Adult dose

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Generic Name MDC NEML Category Indications Dosage

Levobupivacaine 5mg/ml Injection N01BB10110P3001XX No A Production of local or regional anesthesia for surgery and Surgical anesthesia : Lumber epidural :
obstetrics, and for postoperative pain management 10 - 20 ml (50 - 150 mg) , caesarean
section : 15 - 30 ml (75 - 150 mg),
intrathecal: 3 ml (15 mg), peripheral
nerve block : 1 - 40 ml,
ilioinguinal/iliohypogastric block. CHILD :
0.25 - 0.5 ml/kg (1.25-2.5 mg/kg)

Levocetirizine Dihydrochloride 5 mg R06AE09110T1001XX Yes A* Symptomatic treatment of allergic rhinitis (including persistent Children above 12 years and adults: 5 mg
Tablet allergic rhinitis) and chronic idopathic urticaria orally once daily (Swallow whole, do not
chew/crush).
Levodopa 100 mg and Benserazide 25 N04BA02977T4001XX Yes A* Parkinson's Disease Initially 1 cap tds. Max initial dose: 6
mg Dispersible Tablet caps/day. Patients previously on
immediate-release
Levodopa/Benserazide preparations:
Initially dose should substitute every
100mg of Levodopa with 1 controlled-
released cap, given at same dosage
frequency as before. Increase every 2-3
days.
Levodopa 100 mg and Carbidopa 25 mg N04BA02000T1001XX Yes B Parkinson's disease Patients not receiving Levodopa before,
Tablet initially 100 - 125 mg 3 - 4 times daily
adjusted according to response.
Maintenance: 0.75 - 2 g in divided doses.
In patients previously treated with
Levodopa the dose should be about 20 -
25% of the dose previously being taken

Levodopa 100 mg, Benserazide 25 mg N04BA02977C1001XX Yes B Parkinson's Disease Initial: 100/25 mg 1-2 times/day,
HBS capsule increase every 3-4 days until therapeutic
effect, optimal dosage: 400/100 mg to
800/200 mg/day divided into 4-6 doses.
Dose: 200/50 mg used only when
maintenance therapy is reached and not
to exceed levodopa 1000-1200
mg/benserazide 250-300 mg per day

Levodopa 100 mg, Carbidopa 25 mg and N04BA03977T1002XX No A* Idiopathic Parkinson's disease The optimum daily dosage must be
Entacapone 200 mg Tablet determined by careful titration of
levodopa in each patient. The daily dose
should preferably be optimised using 1
of the 4 available tablet strengths
(50/12.5/200mg, 100/25/200mg,
150/37.5/200mg or 200/50/200mg
levodopa/carbidopa/entacapone).
Patients should be instructed to take
only 1 tablet/dose administration. While
the experience with total daily dosage
>200 mg carbidopa is limited, the
maximum recommended daily dose of
entacapone is 2000 mg and therefore
the maximum dose, for the strengths of
50/12.5/200 mg, 100/25/200 mg and
150/37.5/200 mg, is 10 tablets/day. Ten
(10) tablets of the strength
150/37.5/200 mg equals carbidopa 375
mg/day. Therefore, using a maximum
recommended daily dose of carbidopa
375 mg, the maximum daily dose of
200/50/200 mg is 7 tablets per day. The
maximum total daily levodopa dose
administered should not exceed 1500
mg.

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Levodopa 150 mg, Carbidopa 37.5 mg N04BA03977T1003XX No A* Idiopathic Parkinson's disease The optimum daily dosage must be
and Entacapone 200 mg Tablet determined by careful titration of
levodopa in each patient. The daily dose
should preferably be optimised using 1
of the 4 available tablet strengths
(50/12.5/200mg, 100/25/200mg,
150/37.5/200mg or 200/50/200mg
levodopa/carbidopa/entacapone).
Patients should be instructed to take
only 1 tablet/dose administration. While
the experience with total daily dosage
>200 mg carbidopa is limited, the
maximum recommended daily dose of
entacapone is 2000 mg and therefore
the maximum dose, for the strengths of
50/12.5/200 mg, 100/25/200 mg and
150/37.5/200 mg, is 10 tablets/day. Ten
(10) tablets of the strength
150/37.5/200 mg equals carbidopa 375
mg/day. Therefore, using a maximum
recommended daily dose of carbidopa
375 mg, the maximum daily dose of
200/50/200 mg is 7 tablets per day. The
maximum total daily levodopa dose
administered should not exceed 1500
mg.
Levodopa 200 mg, Benserazide 50 mg N04BA02977T1001XX Yes B Parkinson's Disease Initial: 100/25 mg 1-2 times/day,
Tablet increase every 3-4 days until therapeutic
effect, optimal dosage: 400/100 mg to
800/200 mg/day divided into 4-6 doses.
Dose: 200/50 mg used only when
maintenance therapy is reached and not
to exceed levodopa 1000-1200
mg/benserazide 250-300 mg per day

Levodopa 200 mg, Carbidopa 50 mg & N04BA03977T1004XX No A* Idiopathic Parkinson's disease The optimum daily dosage must be
Entacapone 200 mg Tablet determined by careful titration of
levodopa in each patient. The daily dose
should preferably be optimised using 1
of the 4 available tablet strengths
(50/12.5/200mg, 100/25/200mg,
150/37.5/200mg or 200/50/200mg
levodopa/carbidopa/entacapone).
Patients should be instructed to take
only 1 tablet/dose administration. While
the experience with total daily dosage
>200 mg carbidopa is limited, the
maximum recommended daily dose of
entacapone is 2000 mg and therefore
the maximum dose, for the strengths of
50/12.5/200 mg, 100/25/200 mg and
150/37.5/200 mg, is 10 tablets/day. Ten
(10) tablets of the strength
150/37.5/200 mg equals carbidopa 375
mg/day. Therefore, using a maximum
recommended daily dose of carbidopa
375 mg, the maximum daily dose of
200/50/200 mg is 7 tablets per day. The
maximum total daily levodopa dose
administered should not exceed 1500
mg.
Levodopa 250 mg and Carbidopa 25 mg N04BA02000T1002XX Yes B Parkinson's disease Patients not receiving Levodopa before,
Tablet initially 100 - 125 mg 3 - 4 times daily
adjusted according to response.
Maintenance: 0.75 - 2 g in divided doses.
In patients previously treated with
Levodopa the dose should be about 20 -
25% of the dose previous being taken

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Levodopa 50 mg, Carbidopa 12.5 mg & N04BA03977T1001XX No A* Idiopathic Parkinson's disease The optimum daily dosage must be
Entacapone 200 mg Tablet determined by careful titration of
levodopa in each patient. The daily dose
should preferably be optimised using 1
of the 4 available tablet strengths
(50/12.5/200mg, 100/25/200mg,
150/37.5/200mg or 200/50/200mg
levodopa/carbidopa/entacapone).
Patients should be instructed to take
only 1 tablet/dose administration. While
the experience with total daily dosage
>200 mg carbidopa is limited, the
maximum recommended daily dose of
entacapone is 2000 mg and therefore
the maximum dose, for the strengths of
50/12.5/200 mg, 100/25/200 mg and
150/37.5/200 mg, is 10 tablets/day. Ten
(10) tablets of the strength
150/37.5/200 mg equals carbidopa 375
mg/day. Therefore, using a maximum
recommended daily dose of carbidopa
375 mg, the maximum daily dose of
200/50/200 mg is 7 tablets per day. The
maximum total daily levodopa dose
administered should not exceed 1500
mg.
Levofloxacin 0.5% ophthalmic solution S01AX19000D2001XX No A* For the treatment of bacterial conjunctivitis caused by Adult dose: 1 drop a time 3 times daily.
susceptible strains of the designated microorganisms. The dosage may be adjusted according
to the patient?s symptoms. Route of
administration: ophthalmic use only.

Levofloxacin 250 mg Tablet J01MA12000T1001XX Yes A* Community acquired pneumonia 500 mg daily for 7 - 14 days
Levofloxacin 500 mg Injection J01MA12000P3001XX Yes A* Community Acquired Pneumonia 500 mg daily for 7 - 14 days
Levofloxacin 500 mg Tablet J01MA12000T1002XX Yes A* Community acquired pneumonia 500 mg daily for 7 - 14 days
Levonorgestrel 1.5 mg Tablet G03AC03000T1001XX Yes A* Emergency contraception within 72 hours of unprotected 1.5 mg as a single dose as soon as
sexual intercourse for the female victim of sexual violence to possible after coitus [preferably within
prevent unwanted pregnancy 12 hours but no later than after 72
hours]
Levonorgestrel 150 mcg and G03AA07954T1001XX Yes C+ Contraception 1 tablet daily for 21 days from first day
Ethinyloestradiol 30 mcg Tablet of the cycle, followed by 7 tab free days

Levonorgestrel 52 mg Intrauterine G02BA03000P1001XX No A* i) Contraception (Initial release rate of 20 mcg/24 hours). ii) i) & ii):One unit intrauterine device to be
System Idiopathic menorrhagia inserted into the uterine cavity within 7
days of the onset of menstruation or
immediately after first trimester
abortion. Postpartum insertion should
be postponed until 6 weeks after
delivery.Can be inserted at any time of
amenorrheic woman. One unit IUD is
effective for 5 years
Levothyroxine Sodium 100 mcg Tablet H03AA01520T1001XX Yes B Hypothyroidism Start at low dose and increase at 2-4
weeks interval. Adult: Initially, 50-100
mcg/day may increase by 25-50 mcg at
approximately 3 to 4 weeks intervals
until the thyroid deficiency is corrected.
Maintenance: 100-200 mcg/day. CHILD;
0 - 3 months: 10 - 15 mcg/kg/day; 3 - 6
months: 8 - 10 mcg/kg/day; 6 - 12
months: 6 - 8 mcg/kg/day; 1 - 5 years: 5 -
6 mcg/kg/day; 6 - 12 years: 4 - 5
mcg/kg/day; more than 12 years: 2 -3
mcg/kg/day

Levothyroxine Sodium 25 mcg Tablet H03AA01152T1003XX Yes B Hypothyroidism Start at low dose and increase at 2-4
weeks interval. Usual recommended
dose for i) Treatment of benign
euthyroid goitre: 75-200mcg. ii)
Prophylaxis of relapse after surgery for
euthyroid goitre: 75-200mcg iii)
Substitution therapy in hypothyroidism:
ADULT Initially, 25-50mcg/day.
Maintenance: 100-200mcg/day.
CHILDREN Initially 12.5-50mcg/day,
Maintenance: 100-150mcg/m2 body
surface area iv) Concomitant
supplementation during anti-thyroid
drug treatment of hyperthyroidism: 50-
100mcg v) Suppression therapy in
thyroid cancer: 150-300mcg

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Levothyroxine Sodium 50 mcg Tablet H03AA01520T1002XX Yes B Hypothyroidism Start at low dose and increase at 2-4
weeks interval. Usual recommended
dose for i) Treatment of benign
euthyroid goitre: 75-200mcg. ii)
Prophylaxis of relapse after surgery for
euthyroid goitre: 75-200mcg iii)
Substitution therapy in hypothyroidism:
ADULT Initially, 25-50mcg/day.
Maintenance: 100-200mcg/day.
CHILDREN Initially 12.5-50mcg/day,
Maintenance: 100-150mcg/m2 body
surface area iv) Concomitant
supplementation during anti-thyroid
drug treatment of hyperthyroidism: 50-
100mcg v) Suppression therapy in
thyroid cancer: 150-300mcg

Lidocaine 25mg and Prilocaine 25mg N01BB52974G1001XX No A Used for painless venepunctures, radial artery cannulations Apply a thick layer under occlusive
Cream before extradural/spinal and other regional blocks in children dressing at least 1 hour before the
above 1 year old and adults. Also used in chronic renal failure procedure
patients for insertion of A-V fistulas and shunts for
haemodialysis.
Lidocaine Medicated Plaster 5% w/w N01BB02110M6001XX No A* Indicated for the symptomatic relief of neuropathic pain 1 patch /day (Adults & elderly. Cover the
associated with previous herpes zoster infection (post- painful area once daily for up to 12 hr
herpetic neuralgia, PHN). Restrictions: i) For elderly patients w/in 24-hr period. Subsequent plaster-
with polymedication status whom certain treatment was free interval: At least 12 hr. Not more
contraindicated or not tolerated. ii)Prescribed by pain than 3 plasters should be used at the
specialist only. same time)
Lignocaine 10 % w/w Spray N01BB02110A4001XX Yes B For surface anaesthesia in dental practice, in Spray to affected part
otorhinolaryngology and paracentesis
Lignocaine 2 % with Adrenaline N01BB52974P3001XX No B For local anaesthesia including infiltration, nerve and plexus By infiltration: 0.5 - 1 ml; not to exceed 7
(1:80,000) Injection blocks mg/kg body weight
Lignocaine 2% Jelly N01BB02110G4001XX Yes B Use for endotracheal tubes and instruments, painful Apply to affected area 10 mins before
procedures in the ear, nose and throat, burns, wounds, catheterization, etc
abrasions, lacerations; catheterisation of the male and female
urethra and for symptomatic treatment of cystitis and
urethritis
Lignocaine 2% Viscous Solution N01BB02110L5001XX Yes A For post-tonsilectomy, sore throat, dumping syndrome, As 2% soln: For pain: 300 mg rinsed and
hiccough, reflux vomiting, painful lesions of the mouth, ejected for mouth and†throat pain; or
cardiospasm, instrumentation of the respiratory and digestivegargled and swallowed if necessary for
tract pharyngeal pain. Not to be used more
frequently than every 3 hr. Max (topical
oral soln): 2.4 g/day.
Lignocaine 2% with Chlorhexidine 0.05% N01BB52974G3001XX No B To provide local anaesthesia and lubrication during Adult Male†Ins l 20 mL slowly into the
Gel catheterization, exploration by sound and other endourethral urethra until it reaches external
operations and examinations, cytoscopy and symptomatic sphincter, proximal to the prostrate.
treatment of painful cystitis and urethritis Subsequently, apply compression at the
corona for several mins. Fill the length of
the urethra w/ the remaining
gel.†Sounding procedure or
cytoscopy†Ins ll 40 mL (in 3-4 por ons)
into the insertion area then allow 5-10
mins for anaesth to take effect.†Adult
Female†Prior to urological procedure,
instill 5-10 mL in small portions to fill the
whole urethra & allow anaesth to take
effect in 3-5 mins.Childn <12 yr†Up to 6
mg/kg.

Lignocaine 4 % Solution N01BB02110L5002XX Yes B For anaesthesia of mucous membranes of the oropharyngeal, Bronchoscopy, 2 - 3 ml with suitable
tracheal and bronchial areas eg. in laryngoscopy and spray; biopsy in mouth, 3 - 4 ml with
bronchoscopy suitable spray or swab (with adrenaline if
necessary); maximum 7.5 ml

Lignocaine HCl (Lidocaine) 100 mg/ml C01BB01110P3002XX Yes B Ventricular tachycardia and ventricullar fibrillation. To be 50-100 mg IV as a bolus, repeated after 5
Injection diluted before use minutes if necessary. Maintenance : 1-4
mg/min by IV infusion under ECG
monitoring
Lignocaine HCl (Lidocaine) 2% Injection N01BB02110P3001XX Yes B For local or regional anaesthesia and nerve block. Not for IV Local anesthesia: ADULT Maximum: 100
use. mg; CHILD Maximum: 3 mg/kg
Lignocaine HCl (Lidocaine) 20 mg/ml C01BB01110P3001XX Yes B Ventricular tachycardia and ventricular fibrillation. For IV use. 50-100 mg IV as a bolus, repeated after 5
Injection To be diluted before use minutes if necessary. Maintenance : 1-4
mg/min by IV infusion under ECG
monitoring
Lignocaine HCl 1% Injection N01BB02110P3002XX Yes C+ Local or regional anaesthesia for episiotomy repairs According to patients weight and nature
of procedures, maximum 200mg. For
most obstetric procedures, the
preparation is diluted to 0.5%, which
gives the maximum effect with the least
toxicity. [lignocaine 1%, 1 part and
normal saline or sterile distilled water, 1
part]

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Lignocaine HCl 5% and Phenylephrine N01BB02984A4101XX No A* Preparation of nasal mucosa for surgery (eg. Cautery to Adults and children over 12 years : 5
HCl 0.5% Nasal Spray Little?s area), aid the treatment of acute nose bleeds and squirts per nostril. Children: 8 to 12
removal of foreign bodies from the nose, topical anaesthesia years 3 squirts per nostril, 4 to 8 years 2
of the pharynx prior to direct or indirect laryngoscopy, topical squirts per nostril, 2 to 4 years 1 squirt
anaesthesia and local vasoconstriction prior to endoscopy of per nostril. Doses are to be administered
the upper airways once only.
Lignocaine, Aluminium Acetate, Zinc C05AX03931G5001XX No A/KK Anorectal pain, pruritis, inflammation and irritation Apply once or twice daily. Not for
Oxide and Hydrocortisone Ointment prolonged use
Lignocaine, Aluminium Acetate, Zinc C05AX03931S2001XX No B Anorectal pain, pruritis, inflammation and irritation 1 suppository to be used once or twice
Oxide and Hydrocortisone Suppository daily. Not for prolonged use

Linagliptin 5 mg tablet A10BH05000T1001XX No A* FUKKM restriction: As add-on therapy for patient who failed Adults: 5 mg once daily. When linagliptin
therapy and/or contraindicated/unable to tolerate metformin is added to metformin, the dose of
and/or sulphonylurea. - Management of diabetes in patients metformin should be maintained and
with renal failure where metformin/sulphonylurea is linagliptin administered concomitantly.
contraindicated/untolerated and elderly with multiple co
morbidities that always experience hypoglycemia with other
antidiabetic. Not to be used in diabetic patient whose HBA1c
is more than 9%.

Linezolid 2 mg/ml Injection J01XX08000P3001XX No A* MRSA patient with severe sepsis requiring intensive care and ADULT: 600 mg twice daily for 10 - 14
not clinically responding to vancomycin days. CHILD: 10 mg/kg 3 times daily.
PREMATURE NEONATES less than 7
days: 10 mg/kg twice daily
Linezolid 20 mg/ml Suspension J01XX08000L8001XX No A* MRSA patients with severe sepsis requiring intensive care and CHILD: 10 mg/kg 3 times daily.
not clinically responding to vancomycin PREMATURE NEONATES less than 7
days: 10 mg/kg twice daily
Linezolid 600 mg Tablet J01XX08000T1001XX No A* MRSA patient with severe sepsis requiring intensive care and ADULT: Above 12 years 600 mg every 12
not clinically responding to vancomycin. hours for 10-14 days. CHILD :10 mg/kg 3
times daily. PREMATURE NEONATES less
than 7 days: 10 mg/kg twice daily

Liquid Paraffin A06AA01000L5001XX No C Constipation ADULT 10-30 ml daily at night but should
not be taken immediately before going
to bed. CHILD not recommended

Lithium Carbonate 300 mg Tablet N05AN01121T1001XX Yes A i) Prophylaxis and treatment of acute mania and hypomania Dose depends on the preparation used.
episodes ii)Prophylaxis of manic depression in bipolar illness Doses should be adjusted to produce a
or bipolar depression and recurrent depression serum-lithium concentration of 0.4-1
mmol/l.
Loperamide 2 mg Capsule A07DA03110C1001XX Yes B Adjunct to rehydration in acute diarrhoea in adult also in Acute diarrhoea: ADULT: 4 mg stat,
chronic diarrhoea in adult followed by 2 mg after each unformed
stool (up to 5 days). Usual 6- 8 mg daily.
Max: 16 mg daily. Chronic diarrhoea:
Initially 4-8 mg daily in divided doses,
adjust according to response. Max: 16
mg daily

Lopinavir 100 mg and Ritonavir 25 mg J05AE06964T1002XX No A As second line protease inhibitor if intolerant to indinavir/ Adult: (Therapy-naive patients) 400/100
Tablet ritonavir as part of HAART regimen. mg bd or 800/200 mg once daily;
(Therapy-experienced patients): 400/100
mg bd. Concomitant therapy (efavirenz,
nevirapine, amprenavir, fosamprenavir
or nelfinavir) 400/100 mg bd. Children
>40 kg or w/ BSA >1.4 m2 as adult dose.

Lopinavir 200 mg and Ritonavir 50 mg J05AE06964T1001XX Yes A As second line protease inhibitor if intolerant to indinavir/ Adult: (Therapy-naive patients) 400/100
Tablet ritonavir as part of HAART regimen mg bd or 800/200 mg once daily;
(Therapy-experienced patients): 400/100
mg bd. Concomitant therapy (efavirenz,
nevirapine, amprenavir, fosamprenavir
or nelfinavir) 400/100 mg bd. Children
>40 kg or w/ BSA >1.4 m2 as adult dose.

Lopinavir 80mg/Ritonavir 20mg (per ml) J05AE06964L9901XX Yes A Management of patients with asymptomatic and symptomatic Tab Adult Therapy-naive patients
Oral Solution (early or advanced) HIV Infection with CD4 cell counts <50 400/100 mg bd or 800/200 mg once
cubic mm daily. Therapy-experienced patients
400/100 mg bd. Concomitant therapy
(efavirenz, nevirapine, amprenavir,
fosamprenavir or nelfinavir) 400/100 mg
bd. Can be used w/ no dose adjustment.
Childn >40 kg or w/ BSA >1.4 m2 Adult
dose. Oral Soln Childn 6 mth-12 yr, 15-
40 kg 10/2.5 mg/kg bd; 7 to <15 kg 12/3
mg/kg bd. Max: 5 mL bd in childn >40 kg.
W/ efavirenz or nevirapine 15-45 kg
11/2.75 mg/kg bd; 7 to <15 kg 13/3.25
mg/kg.

Loratadine 1 mg/ml Syrup R06AX13000L9001XX Yes A Allergic rhinitis, chronic urticaria and other allergic ADULT and CHILD over 6 years : 10 mg
dermatological disorders once daily. CHILD 2 - 6 years: 5 mg once
daily
Loratadine 10 mg Tablet R06AX13000T1001XX Yes B Allergic rhinitis and allergic dermatoses ADULT and CHILD over 6 years 10 mg
once daily. CHILD 2 - 6 years: 5 mg once
daily

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Loratadine 5 mg and Pseudoephedrine R01BA52988T1001XX No A/KK For treatment of allergic rhinitis and allergic dermatoses ADULT and CHILD over 12 years 1 tablet
Sulphate 120 mg Tablet twice daily

Lorazepam 1 mg Tablet N05BA06000T1001XX No A/KK i) Severe anxiety ii) Insomnia i) 1 - 4 mg increase to 10 mg daily in
divided doses. ELDERLY (or delibitated)
half adult dose ii) 1 - 2 mg at bedtime
Not recommended in children

Losartan 50 mg Tablet C09CA01500T1001XX No B Patients intolerant of ACE inhibitors, only in the treatment of i) Hypertension: Usual starting and
Hypertensive patient with left ventricular hypertrophy ii) maintenance dose: 50 mg once daily.
Hypertension in diabetics with proteinuria or nephropathy Maximum increasing the dose to 100 mg
once daily. Patients with intravascular
volume-depletion starting dose of 25 mg
once daily. Renal protection in Type 2
diabetic patients with proteinuria and
hypertension, starting dose: 50 mg once
daily, may be increased to 100 mg once
daily based on blood pressure response

Losartan Potassium 100 mg & C09DA01935T1004XX No A* Hypertension in patients who cannot tolerate ACE inhibitors Fixed dose combination is not indicated
Hydrochlorothiazide 25 mg Tablet because of cough, hypertensive patient with left ventricular for initial therapy. i. Usual starting &
hypertrophy maintenance dose: 1 tab of losartan &
HCTZ 50/12.5 mg once daily. May be
increased to 2 tab of losartan & HCTZ
50/12.5 mg or 1 tab of losartan & HCTZ
100/25mg once daily if blood pressure
remain uncontrolled after about 3 weeks
of combination therapy with losartan &
HCTZ 50/12.5mg. Max: 1 tab of losartan
& HCTZ 100/25mg once daily or 2 tab of
Losartan & HCTZ 50/12.5 mg once daily.
ii. Usual starting dose: 50 mg losartan
once daily, may be titrated with a
combination of losartan 50mg & HCTZ
12.5 mg, maybe substituted with
losartan 100mg & HCTZ 12.5mg,
followed by losartan 100 mg & HCTZ 25
mg once daily.

Losartan Potassium 100 mg and C09DA01935T1003XX No A* Hypertension in patients who cannot tolerate ACE inhibitors Fixed dose combination is not indicated
Hydrochlorothiazide 12.5 mg Tablet because of cough, hypertensive patient with left ventricular for initial therapy. i. Usual starting &
hypertrophy maintenance dose: 1 tab of losartan &
HCTZ 50/12.5 mg once daily. May be
increased to 2 tab of losartan & HCTZ
50/12.5 mg or 1 tab of losartan & HCTZ
100/25mg once daily if blood pressure
remain uncontrolled after about 3 weeks
of combination therapy with losartan &
HCTZ 50/12.5mg. Max: 1 tab of losartan
& HCTZ 100/25mg once daily or 2 tab of
Losartan & HCTZ 50/12.5 mg once daily.
ii. Usual starting dose: 50 mg losartan
once daily, may be titrated with a
combination of losartan 50mg & HCTZ
12.5 mg, maybe substituted with
losartan 100mg & HCTZ 12.5mg,
followed by losartan 100 mg & HCTZ 25
mg once daily.

Losartan Potassium 100 mg Tablet C09CA01500T1002XX No B Patients intolerant of ACE inhibitors, only in the treatment of: Usual starting dose: 50 mg once daily.
i) Hypertensive patient with left ventricular hypertrophy May be increased to 100 mg once daily.
ii)Hypertension in diabetics with proteinuria or nephropathy

Losartan Potassium 50 mg and C09DA01935T1001XX No A/KK Hypertension in patients who cannot tolerate ACE inhibitors 1 tablet once daily, may increase to
Hydrochlorothiazide 12.5 mg Tablet because of cough, hypertensive patient with left ventricular maximum dose losartan 100 mg/
hypertrophy hydrochlorothiazide 25 mg once daily
Magnesium Sulphate 45% Paste D11AX05183G6001XX Yes C Inflammatory skin conditions such as boils and carbuncles Apply under dressing

Magnesium Sulphate 50% Injection B05XA05183P3001XX Yes C i)Treatment and prophylaxis of acute hypomagnesaemia ii) i)Mild hypomagnesemia (ADULT): 1gm
Prevention and treatment of life-threatening seizures in the magnesium sulphate (8mEq) IM every 6
treatment of toxemias of pregnancy (pre-eclampsia and hours for 4 doses. Severe
eclampsia) hypomagnesemia (ADULT): 0.25 g/kg IM
over 4 hours. Alternative dose of 5g may
be given by slow intravenous infusion
over 3 hours ii) Toxemia of pregnancy:
An initial intravenous dose of 4gm of
magnesium sulphate is recommended.
Followed by an intramuscular dose of 4-
5gm into each buttock. This may be
followed by a dose of 4-5gm into
alternate buttocks every 4 hours as
needed. Alternatively, the initial dose IV
dose may be followed by an infusion of 1-
2gm/hr

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Magnesium Trisilicate Mixture A02AA10912L2101XX Yes C Heartburn, dyspepsia 10-20 ml 3-4 times daily before meals

Magnesium Trisilicate Tablet A02AA10912T1001XX Yes C Heartburn, dyspepsia ADULT 1-2 tablet to be chewed up to 6
times a day before meals. CHILD over 6
years one tablet to be taken 3-4 times a
day
Magnesium, Aluminium Hydroxide and V07AB00900L8001XX No C As a buffering agent for reconstituting didanosine powder for DDI should be mixed with water and
Simethicone Suspension oral administration so as to prevent acid degradation of diluted with the appropriate dose of
didanosine which is used for the treatment of paediatric antacids to a final concentration of 10
patients (more than 6 months old) with symptomatic HIV mg per ml
infection
Malathion 1 % Shampoo P03AX03000L5201XX No C+ Lice infestation Wet hair, apply shampoo and work up
lather. Leave for 15 minutes and rinse,
comb. Repeat if necessary after 7 - 9
days
Mannitol 10% Injection (10 g/100 ml) B05BC01000P3001XX No A Cerebral oedema 0.25- 2 g/kg IV of a 15% to 25% solution
over 30-60 minutes. Safety and efficacy
not established in children under 12
years of age
Mannitol 20% Injection (20 g/100 ml) B05BC01000P3002XX No A Cerebral oedema 0.25- 2 g/kg IV of a 15% to 25% solution
over 30-60 minutes. Safety and efficacy
not established in children under 12
years of age
Measles and Rubella Virus Vaccine Live, J07BD52963P4002XX No C For active immunization against measles and rubella in infants, The vaccine should be reconstituted only
Attenuated (Freeze-dried) 10 doses/vial children, adolescents and young adults at risk. Immunization with the diluent supplied (sterile water
of susceptible non-pregnant adolescent and adult females is for injection) using a sterile syringe and
indicated if certain precautions are observed. The vaccine can needle. With gentle shaking the dried
be safely and effectively given simultaneously with DTP, DT, cake is easily dissolved. After
TT, Td, BCG, Polio Vaccine (OPV and IPV), Haemophilus reconstitution the vaccines should be
influenza type B, Hepatitis B, Yellow fever vaccine and vitamin used immediately. A single dose of 0.5ml
A supplementation. should be administered by deep SC
injection into the anterolateral aspect of
upper thigh in infants and upper arm in
older children. If the vaccines is not used
immediately then it should be stored in
the dark at 20C and 80C for no longer
than 6 hours.

Measle's Vaccine Injection (10 doses) J07BD01000P4001XX Yes C+ Prophylaxis against measles and to prevent development of By SC or IM injection, 0.5 ml as a single
infection (if given within 72 hours of contact) dose at 12 - 15 months of age
Measles, Mumps and Rubella (MMR) J07BD52963P4001XX Yes C+ For immunisation of children against measles, mumps and Subcutaneous or by intramuscular
Vaccine Injection (Single Dose) rubella injection, 0.5 ml
Mebeverine HCl 135 mg Tablet A03AA04110T1002XX No B Irritable bowel syndrome 135 mg 3 times daily
Meclozine HCl 25 mg and Pyridoxine 50 R06AE55919T1001XX No B Nausea and vomiting of pregnancy 1 - 2 tablet 2 - 3 times daily in severe
mg Tablet cases
Mecobalamin 500 mcg Tablet M09AX00000T1001XX No B Peripheral neuropathies 1 tablet 3 times daily. The dosage should
be adjusted according to age of patient
and severity of symptoms
Medroxyprogesterone Acetate 10 mg G03DA02122T1002XX Yes B i) Secondary amenorrhoea ii) Abnormal uterine bleeding due i) 5-10 mg daily for 5-10 days started
Tablet to hormonal imbalance anytime during cycle ii) 5-10 mg daily for
5-10 days on day 16-21 of menstrual
cycle. Optimum secretory
transformation 10 mg daily for 10 days
from day 16 of the cycle
Medroxyprogesterone Acetate 100 mg L02AB02122T1002XX Yes A Breast carcinoma, endometrial carcinoma, renal carcinoma 200-500 mg orally daily
Tablet
Medroxyprogesterone Acetate 5 mg G03DA02122T1001XX Yes B i) Secondary amenorrhoea ii) Abnormal uterine bleeding due i) 5-10 mg daily for 5-10 days started
Tablet to hormonal imbalance anytime during cycle ii) 5-10 mg daily for
5-10 days on day 16-21 of menstrual
cycle. Optimum secretory
transformation 10 mg daily for 10 days
from day 16 of the cycle
Medroxyprogesterone Acetate 50 mg/ml G03AC06122P3001XX Yes B Prevention of pregnancy and to provide long term 150mg to be administered once every 3
Injection contraception month
Medroxyprogesterone Acetate 500 mg L02AB02122T1001XX Yes A Breast carcinoma, endometrial carcinoma, renal carcinoma 200-500 mg orally daily
Tablet
Mefenamic Acid 250 mg Capsule M01AG01000C1001XX Yes B Mild to moderate pain ADULT: 250 - 500 mg 3 times daily after
meals. CHILD over 6 months: 6.5 - 25
mg/kg daily 3 - 4 times daily for not
longer than 7 days except in juvenile
arthritis
Mefenamic Acid 250 mg Tablet M01AG01000T1001XX Yes B Mild to moderate pain ADULT: 250 - 500 mg 3 times daily after
meals. CHILD over 6 months: 6.5 - 25
mg/kg daily 3 - 4 times daily for not
longer than 7 days except in juvenile
arthritis
Mefloquine HCl 250 mg Tablet P01BC02110T1001XX No A* For multi-drug resistant cases of malaria only Treatment of malaria : ADULT and CHILD
25 mg/kg usually given over 2-3 days.
Prophylaxis of malaria : ADULT 250 mg
once a week. CHILD over 5 kg : 5 mg/kg
once a week; prophylaxis should start 1-
3 weeks before departure and continue
for 4 weeks after last exposure

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Meloxicam 7.5 mg Tablet M01AC06000T1001XX No A/KK Only for patients not responding to other NSAIDs in the i) initially 7.5 mg daily. May be increased
treatment of i) painful osteoarthritis ii) rheumatoid arthritis to 15 mg daily ii) initially 15 mg daily.
May be reduced to 7.5 mg daily.
Maximum 15 mg daily. Child under 12
years not recommended

Melphalan 2 mg Tablet L01AA03000T1001XX No A i) Multiple myeloma ii) Neuroblastoma, rhabdomyosarcoma i) 8 - 10 mg/m2 for 4 days every 4 weeks
iii) Recurrent neuroblastoma (palliative) ii) 10 - 35 mg/m2 once every month For
dose regimes, refer to protocols

Melphalan 50 mg Injection L01AA03000P4001XX No B High dose conditioning therapy for stem cell transplantation in 200 mg/ m2 IV infusions in divided doses
multiple myeloma for Day 1 to day 3 followed by IV
infusions of autologous stem cells
Memantine HCI 10 mg Tablet N06DX01110T1001XX No A* As monotherapy or as adjunctive therapy with cholinesterase Adult Initially 5 mg/day on the 1st week,
inhibitors for the symptomatic treatment of patients with 5mg twice a day on the 2nd week, then
moderate to severe Alzheimer?s disease. 15 mg/day (10mg in the morning and
5mg in the evening) on the 3rd week.
From the 4th week on, continue
treatment with maintenance dose of 20
mg/day (10mg twice a day). Max: 20
mg/day.
Memantine HCl 20 mg Tablet N06DX01110T1002XX No A* As monotherapy or as adjunctive therapy with cholinesterase Adult Initially 5 mg/day on the 1st week,
inhibitors for the symptomatic treatment of patients with 5mg twice a day on the 2nd week, then
moderate to severe Alzheimer?s disease. 15 mg/day (10mg in the morning and
5mg in the evening) on the 3rd week.
From the 4th week on, continue
treatment with maintenance dose of 20
mg/day (10mg twice a day). Max: 20
mg/day.
Meningococcal A, C, Y, W 135 Vaccine J07AH04000P4001XX Yes B Immunisation against meningococcal diseases caused by Prophylaxis: 0.5 ml intramuscular
Injection Neisseria meningitis Group A, Group C, Group Y or Group W- injection.
135
Menotrophin (highly purified, multidose) G03GA02-000-P40-01- No A* Anovulation in women who have been unresponsive to Anovulation in women who have been
600 IU injection XXX treatment with clomiphene citrate or stimulation of follicle unresponsive to treatment with
growth as part of an assisted reproductive technology (ART) clomiphene citrate: The recommended
initial dose is 75-150 IU daily, which
should be maintained for at least 7 days.
The subsequent dosing should be
adjusted according to individual patient
response. Adjustments in dose should
not be made more frequently than every
7 days. The recommended dose
increment is 37.5 IU per adjustment and
should not exceed 75 IU. The maximum
daily dose should not be higher than 225
IU. If a patient fails to respond
adequately after 4 weeks of treatment,
that cycle should be abandoned and the
patient should recommence treatment
at a higher starting dose than in the
abandoned cycle. When an optimal
response is obtained, a single injection
of 5,000 IU to 10,000 IU of Human
Chorionic Gonadotrophin (hCG) should
be given 1 day after the last
menotrophin injection, The patient is
recommended to have coitus on the day
of and the day following hCG
Menotrophin, Highly Purified 75 IU G03GA02954P4003XX No A* Anovulation in women who have been unresponsive to The recommended initial dose of
Injection (Follicle Stimulating Hormone treatment with clomiphene citrate or stimulation of follicle MENOPUR is 75-150 IU daily. The
75 IU and Luteinizing Hormone 75 IU) growth as part of an assisted reproductive technology (ART) subsequent dosing should be adjusted
according to individual patient response.
Adjustments in dose should not be made
more frequently than every 7 days. The
recommended dose increment is 37.5 IU
per adjustment and should not exceed
75 IU. The maximum daily dose should
not be higher than 225 IU.

Menthol 1.6% in Industrial Methylated R01AX30000A9901XX No C Decongestion of the upper respiratory tract As directed for local use
Spirit Inhalation
Mepivacaine HCl 2% with Adrenaline N01BB53974P3001XX No B For local anaesthesia including infiltration and nerve blocks Adult: Single site in the jaw: 36 mg
(1:100,000) Injection (1.8ml). Entire oral cavity: 180 mg (9 ml).
Max: 400 mg (20 ml) per single dental
procedure
Mepivacaine HCl 3% Injection N01BB03110P3001XX No B For dental local anaesthesia including infiltration and nerve Adult: Single site in the jaw: 54 mg (1.8
blocks on patients in whom adrenalin might be ml). Entire oral cavity: 270 mg (9 ml).
contraindicated Max: 400 mg (13.3 ml) per single dental
procedure

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Mercaptopurine 50 mg Tablet L01BB02000T1001XX Yes A i) Langerhan's cell histocytosis ii) Acute lymphoblastic "Leukaemia adults: 2.5mg/kg or 80-
leukaemia iii) Acute promyelocytic leukaemia APML 00mg/m2 p.o per day, given as a single
(maintenance) dose. To be increased at the end of 4
weeks, If necessary, up to 5mg/kg p.o
per day. Maintainance dosage are
1.5mg/kg -2.5mg/kg p.o per day Children
age 5 and older: Induction:
2.5mg/kg/day p.o once daily.
Maintanance dose: 1.5mg/kg -2.5mg.kg
p.o once daily or 70-100mg/m2 p.o once
daily."
Meropenem 1 g Injection J01DH02000P4002XX No A* i. Emperical treatment for presume infections in patients ADULT: 0.5g - 1g 8 hourly CHILD: (aged 3
(adult and children) with febrile neutropenia, used as months and over): 10-40mg/kg 8 hourly,
monotherapy or in combination with anti-virals or antifungal if body weight over 50kg, adult dosage
agent ii. Septicaemia iii. Serious infections in renal impaired should be used
patients
Meropenem 500 mg Injection J01DH02000P4001XX No A* i. Emperical treatment for presume infections in patients ADULT: 0.5g - 1g 8 hourly CHILD: (aged 3
(adult and children) with febrile neutropenia, used as months and over): 10-40mg/kg 8 hourly,
monotherapy or in combination with anti-virals or antifungal if body weight over 50kg, adult dosage
agent ii. Septicaemia iii. Serious infections in renal impaired should be used
patients
Mesalazine 1 g Suppository A07EC02259S2002XX No A Inflammatory bowel disease of ulcerative colitis and Crohn's Ulcerative colitis : 1 g suppository insert
disease. rectally once daily at bedtime. The dose
may be increased to 500 mg 3 times
daily if the response is inadequate after
2 weeks of therapy. To achieve
maximum benefit, it is recommended
that the suppository be retained in the
rectum for a minimum of 1 to 3 hours or
longer. The usual course of therapy,
depending upon response, may last from
3 to 6 weeks. CHILD not recommended

Mesalazine 1g/100ml enema A07EC02-259-G20-02- No A Inflammatory bowel disease of ulcerative colitis and Crohn's 1 tube of enema at bedtime
XXX disease.
Mesalazine 250 mg Suppository A07EC02259S2001XX No A Inflammatory bowel disease of ulcerative colitis and Crohn's Ulcerative colitis : 1 g suppository insert
disease. rectally once daily at bedtime. The dose
may be increased to 500 mg 3 times
daily if the response is inadequate after
2 weeks of therapy. To achieve
maximum benefit, it is recommended
that the suppository be retained in the
rectum for a minimum of 1 to 3 hours or
longer. The usual course of therapy,
depending upon response, may last from
3 to 6 weeks. CHILD not recommended

Mesalazine 250mg MR Tablet A07EC02259T1001XX No A Inflammatory bowel disease of ulcerative colitis and Crohn's ADULT: 250 - 500 mg 3 - 4 times daily for
disease. 3 - 6 weeks. CHILD up 2 years with
Crohn's disease: 20 - 30 mg/daily in
divided doses
Mesalazine 500mg MR Tablet A07EC02259T1002XX No A Inflammatory bowel disease of ulcerative colitis and Crohn's ADULT: 250 - 500 mg 3 - 4 times daily for
disease. 3 - 6 weeks. CHILD up 2 years with
Crohn's disease: 20 - 30 mg/daily in
divided doses
Mesalazine 6.67% w/w Enema A07EC02259G2001XX No A Inflammatory bowel disease of ulcerative colitis and Crohn's 60 ml (4g) at bedtime, retained
disease. overnight, approximately 8 hours
Mesna 100 mg/ml Injection V03AF01520P3001XX No A For prevention of urotoxic effects of oxazaphosphorines e.g. IV injection at a dosage of 20% of the
ifosfamide and cyclophosphamide corresponding oxazaphosphorine dose
at the times 0 hour (concurrently with
the oxazaphosphorine), 4 hours and 8
hours thereafter. CHILD: Dose given at
greater frequency (e.g. 6 times) and a
shorter intervals (e.g. 3 hours)

Metformin 500 mg and Glibenclamide A10BD02926T1001XX No B As second-line therapy when diet, exercise and initial Initial dose:1.25 mg/250 mg ORALLY
2.5 mg Tablet treatment with sulphonylurea or metformin do not result in once daily; titrate in increments of 1.25
adequate glycemic control in patients with type 2 diabetes mg/250 mg per day every 2 weeks,2.5
mellitus mg/500 mg to 5 mg/500 mg ORALLY
twice daily; titrate in increments of 5
mg/500 mg up to MAX 20 mg/2000 mg
once daily
Metformin HCl 500 mg Extended Release A10BA02110T5001XX Yes A/KK Diabetes mellitus who experienced gastrointestinal side 500 mg once daily. Maximum dose 2000
Tablet effects with normal metformin mg once daily with evening meal

Metformin HCl 500 mg Tablet A10BA02110T1001XX Yes B Diabetes mellitus Initial: 500mg orally twice daily with
food. Maintenance: Titrate in 500mg
increments weekly, doses up to 2000 mg
daily may be divided into 2 equal doses.

Metformin HCl 750 mg Extended Release A10BA02110T5003XX Yes A/KK Diabetes mellitus who experienced gastrointestinal side 500 mg once daily. Maximum dose 2000
Tablet effects with normal metformin mg once daily with evening meal

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Methadone 5mg/ml Syrup N07BC02110L9001XX Yes A/KK Detoxification treatment of narcotic addiction Initial 10-20mg per day, increasing by 10-
20mg per day until there are no signs of
withdrawal or intoxication. Usual dose
40-60mg/day

Methotrexate 1000mg Injection L01BA01520P3005XX No A i) Solid tumours ii) Gestational trophoblastic disease iii) Acute i) 50 mg/m2 once every 3 weeks in
leukaemias, lymphomas combination with other drugs (for this
dose, use the 50 mg preparation) ii) 50
mg IV Day 1, 3, 5, 9 every 3 weeks. For
high risk gestational trophoblastic
disease, use 100 mg/m2 as part of EMA-
CO regime iii) High dose regimes: 500 -
3000 mg/m2 per dose may be used,
employing the 500 mg preparations.
CHILD: Central nervous system
prophylaxis for acute leukaemia 2
gm/m2 over 24 hours with folinic acid
rescue, 3 doses for B-cell lineage. 4
doses for T-lineage all every 3 weeks.
Relapse acute lymphoblastic leukaemia
(ALL): 1 gm/m2 over 36 hours with
folinic acid rescue every 3 weeks for 9
doses, maintenance: 50 mg/m2 every 2
weeks. B-cell lymphoma: 3 gm/m2 over
3 hours with folinic acid rescue for three
doses. Methotrexate level monitoring
recommended when using high dose
regimens. THE 500 MG STRENGTH IS
NOT FOR INTRATHECAL USE

Methotrexate 2.5 mg Tablet L01BA01000T1001XX Yes A i) Acute lymphoblastic leukaemia and acute promyelocytic i) ADULT: 20 mg/m2 weekly. CHILD: 20 -
leukemia (maintenance) ii) Extensive plaque psoriasis, 30 mg/m2 weekly according to protocol
erythrodermic psoriasis, pustular psoriasis, Reiter's syndrome, ii) Relapsed acute lymphoblastic
connective tissue disease leukaemia (ALL): 100 mg/m2/day for 5
days 6 weekly according to protocol iii)
Dose used by dermatologist: 5 - 25 mg
weekly. Liver biopsy after cumulative
dose of 1.5 gram and repeat liver biopsy
with additional gram received. Maximum
cumulative dose is 4 gram. Monitor full
blood count (FBC), renal and liver
function iv) Rheumatoid arthritis,
psoriatic arthropathy: dose used by
rheumatologist: 2.5 mg/week orally
starting dose, increasing to 7.5 - 20
mg/weekly

Methotrexate 50 mg Injection L01BA01520P3001XX No A i) Solid tumours ii) Gestational trophoblastic disease iii) Acute i) 50 mg/m2 once every 2 - 3 weeks in
leukaemia/lymphomas iv) Rheumatoid arthritis, psoriatic combination with other drugs ii) 50 mg
arthropathy, severe/erythrodermic psoriasis IV Day 1, 3, 5, 9 every 3 weeks. For high
risk gestational trophoblastic disease,
use 100 mg/m2 as part of EMA-CO
regime iii) High dose regimes: 500 - 3000
mg/m2 per dose may be used,
employing the 500 mg preparations.
CHILD: Central nervous system
prophylaxis for acute leukaemia 2
gm/m2 over 24 hours with folinic acid
rescue, 3 doses for B-cell lineage. 4
doses for T-lineage all every 3 weeks.
Relapse acute lymphoblastic leukaemia
(ALL): 1 gm/m2 over 36 hours with
folinic acid rescue every 3 weeks for 9
doses, maintenance: 50 mg/m2 every 2
weeks. B-cell lymphoma: 3 gm/m2 over
3 hours with folinic acid rescue for three
doses. Methotrexate level monitoring
recommended when using high dose
regimens. The 500 mg strength is not for
intrathecal (IT) use. Dosage for
intrathecal treatment and prophylaxis in
leukaemia: less than 1 year: 5 mg, 1 - 2
years: 7.5 mg, 2 - 3 years: 10 mg, more

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Methotrexate 500 mg/20 ml Injection L01BA01520P3002XX No A i) Solid tumours ii) Gestational trophoblastic disease iii) Acute i) 50 mg/m2 once every 3 weeks in
leukaemias, lymphomas combination with other drugs (for this
dose, use the 50 mg preparation) ii) 50
mg IV Day 1, 3, 5, 9 every 3 weeks. For
high risk gestational trophoblastic
disease, use 100 mg/m2 as part of EMA-
CO regime iii) High dose regimes: 500 -
3000 mg/m2 per dose may be used,
employing the 500 mg preparations.
CHILD: Central nervous system
prophylaxis for acute leukaemia 2
gm/m2 over 24 hours with folinic acid
rescue, 3 doses for B-cell lineage. 4
doses for T-lineage all every 3 weeks.
Relapse acute lymphoblastic leukaemia
(ALL): 1 gm/m2 over 36 hours with
folinic acid rescue every 3 weeks for 9
doses, maintenance: 50 mg/m2 every 2
weeks. B-cell lymphoma: 3 gm/m2 over
3 hours with folinic acid rescue for three
doses. Methotrexate level monitoring
recommended when using high dose
regimens. THE 500 MG STRENGTH IS
NOT FOR INTRATHECAL USE

Methoxsalen 1% Lotion D05AD02000L6001XX No A Repigmenting agent in vitiligo in conjuction with controlled Apply 0.1% lotion to area to be exposed
doses of UVA or sunlight to the UVA light ( need to dilute the 1%
lotion to 0.1% lotion, otherwise the skin
will burn)
Methoxsalen 10 mg Capsule D05BA02000C1001XX No A Protection before exposure to sunlight, psoriasis and vitiligo 0.2 - 0.6 mg/kg/body weight. For
repigmentation of larger lesions (greater
than 6 cm sq): 20 mg/day 2 hours before
exposure. Take with food or milk

Methoxy Polyethylene Glycol-epoetin B03XA03000P5001XX No A* Treatment of anaemia associated with chronic renal failure. Non Erythropoiesis Stimulating Agent
Beta 100 mcg/0.3 ml Injection in Prescribing restriction: Patients who require 2 or more (ESA)-treated patients : 0.6 mcg/kg, once
Prefilled Syringe subcutaneous erythropoietin injections per week, where every two weeks (IV or SC). When the Hb
logistics or compliance is an issue. is >11g/dl, administration can be
reduced to once monthly using the dose
equal to twice the previous two weekly
dose. ESA-treated patients : 120-360
mcg once monthly or 60-180 mcg every
two weeks.

Methoxy Polyethylene Glycol-epoetin B03XA03000P5005XX No A* Treatment of anaemia associated with chronic renal failure. Non Erythropoiesis Stimulating Agent
Beta 120 mcg/0.3 ml Injection in Prescribing restriction: Patients who require 2 or more (ESA)-treated patients : 0.6 mcg/kg, once
Prefilled Syringe subcutaneous erythropoietin injections per week, where every two weeks (IV or SC). When the Hb
logistics or compliance is an issue. is >11g/dl, administration can be
reduced to once monthly using the dose
equal to twice the previous two weekly
dose. ESA-treated patients : 120-360
mcg once monthly or 60-180 mcg every
two weeks.

Methoxy Polyethylene Glycol-epoetin B03XA03000P5006XX No A* Treatment of anaemia associated with chronic renal failure. Non Erythropoiesis Stimulating Agent
Beta 150 mcg/0.3 ml Injection in Prescribing restriction: Patients who require 2 or more (ESA)-treated patients : 0.6 mcg/kg, once
Prefilled Syringe subcutaneous erythropoietin injections per week, where every two weeks (IV or SC). When the Hb
logistics or compliance is an issue. is >11g/dl, administration can be
reduced to once monthly using the dose
equal to twice the previous two weekly
dose. ESA-treated patients : 120-360
mcg once monthly or 60-180 mcg every
two weeks

Methoxy Polyethylene Glycol-epoetin B03XA03000P5007XX No A* Treatment of anaemia associated with chronic renal failure. Non Erythropoiesis Stimulating Agent
Beta 200 mcg/0.3 ml Injection in Prescribing restriction: Patients who require 2 or more (ESA)-treated patients : 0.6 mcg/kg, once
Prefilled Syringe subcutaneous erythropoietin injections per week, where every two weeks (IV or SC). When the Hb
logistics or compliance is an issue. is >11g/dl, administration can be
reduced to once monthly using the dose
equal to twice the previous two weekly
dose. ESA-treated patients : 120-360
mcg once monthly or 60-180 mcg every
two weeks.

Methoxy Polyethylene Glycol-epoetin B03XA03000P5002XX No A* Treatment of anaemia associated with chronic renal failure. Non Erythropoiesis Stimulating Agent
Beta 50 mcg/0.3 ml Injection in Prefilled Prescribing restriction: Patients who require 2 or more (ESA)-treated patients : 0.6 mcg/kg, once
Syringe subcutaneous erythropoietin injections per week, where every two weeks (IV or SC). When the Hb
logistics or compliance is an issue. is >11g/dl, administration can be
reduced to once monthly using the dose
equal to twice the previous two weekly
dose. ESA-treated patients : 120-360
mcg once monthly or 60-180 mcg every
two weeks

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Generic Name MDC NEML Category Indications Dosage

Methoxy Polyethylene Glycol-epoetin B03XA03000P5004XX No A* Treatment of anaemia associated with chronic renal failure. Non Erythropoiesis Stimulating Agent
Beta 75 mcg/0.3 ml Injection in Prefilled Prescribing restriction: Patients who require 2 or more (ESA)-treated patients : 0.6 mcg/kg, once
Syringe subcutaneous erythropoietin injections per week, where every two weeks (IV or SC). When the Hb
logistics or compliance is an issue. is >11g/dl, administration can be
reduced to once monthly using the dose
equal to twice the previous two weekly
dose. ESA-treated patients : 120-360
mcg once monthly or 60-180 mcg every
two weeks

Methyl Salicylate 25% Ointment M02AC00260G5001XX No C+ Relief of minor aches and pains of muscles and joints To be massage well to the affected area,
associated with simple backache, arthritis and rheumatic 3 - 4 times daily.
conditions.
Methyldopa 250 mg Tablet C02AB01110T1001XX Yes B Hypertension Adult: 250 mg 2 - 3 times daily, gradually
increased at intervals of 2 or more days,
maximum; 3 g/day. Elderly: initially 125
mg twice daily, increased gradually,
maximum; 2 g daily. Child: Initially, 10
mg/kg or 300 mg/m2 daily in 2-4 divided
doses; increase as necessary. Max: 65
mg/kg, 2 g/m2 or 3 g daily, whichever is
least.

Methylene Blue 1% Injection V03AB17100P3001XX No B For treatment of idiopathic and drug-induced Adult and children: 1 to 2 mg/kg (0.1 to
methaemoglobinemia 0.2 mL/kg of a 1% solution) IV very
slowly over 5 minutes. This dosage can
be repeated if necessary after one hour.

Methylphenidate HCl 10 mg Tablet N06BA04110T1001XX No A Attention deficit hyperactivity disorder (ADHD) CHILD over 6 years, initially 5 mg 1 - 2
times daily, increased if necessary at
weekly intervals by 5 - 10 mg daily to
maximum of 60 mg daily in divided
doses; discontinue if no response after 1
month, also suspend periodically to
assess child's condition (usually finally
discontinued during or after puberty)

Methylphenidate HCl 18 mg Extended- N06BA04110T5002XX No A* Attention deficit hyperactivity disorder (ADHD) CHILD over 6 years: Individualize dosage,
release Tablet to be taken once daily in the morning.
Dose may be adjusted in increments to a
maximum of 54 mg/day, at weekly
interval. Patient new to
methylphenidate: starting dose 18 mg
once daily; adults 18mg or 36mg once
daily. Patient currently using
methylphenidate: 18 - 36 mg. Maximum
54 mg/day. Discontinue if no response
after 1 month
Methylphenidate HCl 20 mg LA Capsule N06BA04110C2003XX No A* Attention deficit hyperactivity disorder (ADHD) 20 mg once daily to be taken in the
morning. Dosage be adjusted in
increments to a maximum of 60 mg/day

Methylphenidate HCl 36 mg Extended- N06BA04110T5003XX No A* Attention deficit hyperactivity disorder (ADHD) CHILD over 6 years: Individualize dosage,
release Tablet to be taken once daily in the morning.
Dose may be adjusted in increments to a
maximum of 54 mg/day, at weekly
interval. Patient new to
methylphenidate: starting dose 18 mg
once daily; adults 18mg or 36mg once
daily. Patient currently using
methylphenidate: 18 - 36 mg. Maximum
54 mg/day. Discontinue if no response
after 1 month
Methylphenidate HCl 40mg LA Capsule N06BA04110C2002XX No A* Attention deficit hyperactivity disorder (ADHD) 20 mg once daily to be taken in the
morning. Dosage be adjusted in
increments to a maximum of 60 mg/day

Methylprednisolone Acetate 40mg H02AB04134P3001XX Yes A* i) Intramuscular administration: anti-inflammatory treatment, i. Intramuscular route a) Asthma: may be
injection treatment of hematological and oncological disorders, used in place of a short burst of oral
endocrine disorders ii) Intrasynovial, periarticular, intrabursal steroids in vomiting or non-adherent
or soft tissue administration: Indicated as adjunctive therapy patients. The recommended dose is 80-
for short term administration in : Synovitis of osteoarthritis, 120mg intramuscularly as a one-dose b)
rheumatoid arthritis, acute and subacute bursitis, acute gouty Adrenogenital syndrome: 40mg every
arthritis, epicondylitis, acute nonspecific tenosynovitis, post- two weeks c) Rheumatoid arthritis
traumatic osteoarthritis iii) Intralesional use in alopecia areata, (maintenance): 40-120mg weekly d)
discoid lupus erythematosus; keloids, localized hypertrophic, Dermatologic lesions (acute severe
infiltrated inflammatory lesions of granuloma annulare, lichen dermatitis, chronic contact dermatitis,
planus, psoriatic plaques, lichen simplex chronicus seborrheic dermatitis): 40-120mg weekly
(neurodermatitis) *Restricted to patients experiencing side for 1-4 weeks ii. Intraarticular route
effects with triamcinolone acetonide Recommended dose is 4 to 80
milligrams, depending upon the size of
the joint. Injections may be repeated at
intervals of 1 to 5 or more weeks in
chronic cases iii.Intralesional route 20 to
60 milligrams methylprednisolone
acetate injected into the lesion

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Methylprednisolone Sodium Succinate H02AB04520P4001XX Yes A Suppression of inflammatory and allergic disorders, cerebral 15 - 30 mg/kg daily. Large doses may be
0.5 g Injection oedema, immunosuppression treatment of haematological repeated 4 - 6 hourly for up to 48 hours
and oncological disorders, treatment of shock states and
endocrine disorders
Methylprednisolone Sodium Succinate 1 H02AB04520P4002XX Yes A Suppression of inflammatory and allergic disorders, cerebral 15 - 30 mg/kg daily. Large doses may be
g Injection oedema, immunosuppression treatment of haematological repeated 4 - 6 hourly for up to 48 hours
and oncological disorders, treatment of shock states and
endocrine disorders
Metoclopramide HCl 1 mg/ml Syrup A03FA01110L9001XX Yes B i) Dyspepsia, flatulence, hiatus hernia, peptic ulceration, reflux i) CHILD over 5 years: 2.5 - 5 ml 3 times
oesophagitis, gastritis, duodenitis, cholelithiasis, nausea, daily. 3 - 5 years 2 ml 2 - 3 times daily. 1 -
vomiting ii) Promote bowel transit during diagnostic 3 years: 1 ml 2 - 3 times daily. Under 1
procedures year: 1 ml 2 times daily ii) Single dose
given 10 minutes before examination.
CHILD over 5 years: 2.5 - 5 ml. Between 3
- 5 years: 2 ml. Under 1 year: 1 ml

Metoclopramide HCl 10 mg Tablet A03FA01110T1001XX Yes B i) Dyspepsia, flatulence, hiatus hernia, peptic ulceration, reflux i) ADULT over 20 years: 10 mg 3 times
oesophagitis, gastritis, duodenitis, cholelithiasis, nausea, daily. ADULT between 12 - 20 years: 5
vomiting ii) Promote bowel transit during diagnostic mg 3 times daily. CHILD under 12 years:
procedures 0.12 mg/kg/dose 6 - 12 hourly ii) Single
dose 5 - 10 minutes before examination;
ADULT and CHILD over 15 years: 10 - 20
mg; CHILD less than 15 years: 0.12
mg/kg/dose 6 - 12 hourly

Metoclopramide HCl 5 mg/ml Injection A03FA01110P3001XX Yes B i) Dyspepsia, flatulence, hiatus hernia, peptic ulceration, reflux i) ADULT over 20 years: 10 mg 3 times
oesophagitis, gastritis, duodenitis, cholelithiasis, nausea, daily. ADULT between 12 - 20 years: 5
vomiting ii) Promote bowel transit during diagnostic mg 3 times daily. CHILD under 12 years:
procedures 0.12 mg/kg/dose 6 - 12 hourly ii) Single
dose 5 - 10 minutes before examination;
ADULT and CHILD over 15 years: 10 - 20
mg; CHILD less than 15 years: 0.12
mg/kg/dose 6 - 12 hourly

Metolazone 2.5 mg Tablet C03BA08000T1002XX No A* Oedema in congestive cardiac failure, nephrotic syndrome and Adult: 5-10 mg daily, increased if
impaired renal function necessary to 20 mg daily. Max: 80 mg in
24 hr. Elderly: Initially, 2.5 mg/day or
every other day. Should be taken with
food. Take after breakfast.

Metoprolol Tartrate 100 mg Tablet C07AB02123T1002XX Yes B Hypertension, angina, myocardial infarction, arrhythmias Hypertension: Initially 100 mg to
maximum 400 mg daily, Angina: 50 mg -
100 mg in 2 - 3 times daily. Myocardial
infarction: 200 mg daily in divided doses.
Arrythmias: 50 mg - 300 mg in 2 - 3
times daily
Metoprolol Tartrate 50 mg Tablet C07AB02123T1001XX Yes B Hypertension, angina, myocardial infarction, arrhythmias Hypertension: Initially 100 mg to
maximum 400 mg daily, Angina: 50 mg -
100 mg in 2 - 3 times daily. Myocardial
infarction: 200 mg daily in divided doses.
Arrythmias: 50 mg - 300 mg in 2 - 3
times daily
Metronidazole 0.5 g Suppository P01AB01000S2001XX No B Anaerobic infection Anaerobic infections Adult: As a 1-g
suppository 8 hrly for 3 days, then 12
hrly. Substitute oral therapy as soon as
possible. May be unsuitable for initiating
therapy in severe infections. Child: <1 yr:
125 mg; 1-5 yr: 250 mg; 5-10 yr: 500 mg.
All doses to be given 8 hrly for 3 days,
then 12 hrly thereafter. May be
unsuitable for initiating therapy in
severe infections. Prophylaxis of
postoperative anaerobic bacterial
infections Adult: 1 g 8 hrly starting 2 hr
before surgery.

Metronidazole 200 mg Tablet P01AB01000T1001XX Yes B Anaerobic infection Anaerobic bacterial infections Adult:
Initially, 800 mg followed by 400 mg 8
hly for about 7 days. Other
recommended doses: 500 mg 8 hrly or
7.5 mg/kg 6 hrly (max: 4 g in 24 hr).
Child: 7.5 mg/kg 8 hrly. Elderly: Use
lower end of adult dose
recommendations. Do not admin as a
single dose. Prophylaxis of postoperative
anaerobic bacterial infections Adult: 400
mg by mouth 8 hrly in the 24 hr prior to
surgery followed postoperatively by IV
or rectal admin until oral therapy is
possible. Other sources recommend that
oral doses be initiated only 2 hr prior to
surgery and that number of doses for all
admin routes be limited to a total of 4.
Elderly: Dose reduction may be
necessary. Tab: Should be taken with
food.

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Generic Name MDC NEML Category Indications Dosage

Metronidazole 200 mg/5 ml Suspension P01AB01000L8001XX Yes B Anaerobic infection CHILD: 7.5 mg/kg 3 times daily for 7 days

Metronidazole 500 mg/100 ml Injection J01XD01000P9901XX Yes A Anaerobic infections ADULT: 500 mg IV infusion 8 hourly.
CHILD: 7.5 mg/kg body weight every 8
hours. Neonates: 15mg/kg LD, followed
by 7.5mg/kg every 12 hourly. 1 month to
18 years: 7.5mg/kg (maximum 500mg)
every 8 hours.

Micafungin Sodium 50mg Powder for J02AX05520P4101XX No A* Treatment of invasive candidiasis, including candidemia in Dosage for adults, adolescents ≥ 16 years
Solution for Infusion adults when intolerance or resistance to Amphotericin B or of age and the elderly for the treatment
Fluconazole. of invasive candidiasis: - Body weight >
40kg: 100mg/day* - Body weight ≤ 40kg:
2mg/kg/day* *If the patient?s response
is inadequate, e.g. persistence of
cultures or if clinical condition does not
improve, the dose may be increased to
200 mg/day in patients weighing > 40kg
or 4mg/kg/day in patients weighing ≤
40kg. Treatment duration for invasive
candidiasis: The treatment duration of
candida infection should be a minimum
of 14 days. The antifungal treatment
should continue for at least one week
after two sequential negative blood
cultures have been obtained and after
resolution of clinical signs and symptoms
of infection.

Miconazole 2% Cream D01AC02221G1001XX Yes B i) Fungal infections: Tinea pedis, Tinea corporis, Tinea capitis Apply sparingly and rub gently onto
and other dermatophyte infections caused by Trichophyton affected area 1-2 times daily continuing
and Epidermophyton species ii) Antifungal agent that has been for 14 days after lesions have healed
in various candida infections including vaginal candidiasis

Miconazole Nitrate 2% Powder D01AC02221F2001XX Yes A Skin infections caused by dermatophytes or Candida Dust powder over infected area 1 - 2
times daily
Midazolam 5 mg/5 ml Injection N05CD08110P3001XX Yes A Pre-operative sedation, induction of general anaesthesia, Usual sedative range 2.5 - 7.5 mg (about
premedication and sedation in ICU and sedation for minor 70 mcg/kg by IV injection over 30
procedures seconds). Premedication by IM injection
70 - 100 mcg/kg 30 -60 minutes before
surgery; ELDERLY: 1 - 1.5 mg/kg.
Induction: Induction by slow IV infusion
200 - 300 mcg/kg (ELDERLY 100 - 200
mcg/kg. CHILD over 7 years 150 - 200
mcg/kg); Maximum: 0.35mg/kg.
Sedation in ICU 0.03 - 0.2 mg/kg/hour

Midazolam 5 mg/ml Injection N05CD08110P3002XX Yes A Pre-operative sedation, induction of general anaesthesia, Usual sedative range 2.5 - 7.5 mg (about
premedication and sedation in ICU and sedation for minor 70 mcg/kg by IV injection over 30
procedures seconds). Premedication by IM injection
70 - 100 mcg/kg 30 -60 minutes before
surgery; ELDERLY: 1 - 1.5 mg/kg.
Induction: Induction by slow IV infusion
200 - 300 mcg/kg (ELDERLY 100 - 200
mcg/kg. CHILD over 7 years 150 - 200
mcg/kg); Maximum: 0.35mg/kg.
Sedation in ICU 0.03 - 0.2 mg/kg/hour

Midazolam 7.5 mg Tablet N05CD08253T1001XX Yes A/KK Pre and post-operative sedation ADULT: Usually 7.5 - 15 mg at bedtime;
or for premedication, 30 - 60 minutes
before the procedure. For ELDERLY,
debilitated or impaired liver/kidney
function: 7.5 mg
Minocycline 100 mg Capsule J01AA08110C1002XX Yes A* As second-line treatment for leprosy only 100 mg daily 6 - 18 months
Minocycline 50 mg Capsule J01AA08110C1001XX Yes A* As second-line treatment for leprosy only 100 mg daily 6 - 18 months
Minoxidil 5 mg Tablet C02DC01000T1001XX No A* Severe hypertension ADULTS and CHILD above 12 years old:
Initially 5 mg daily in single or divided
doses (elderly 2.5 mg). May increase by
5 - 10 mg daily at intervals of 3 or more
days until optimum control is achieved.
Maximum 50 mg daily

Mirtazapine 15 mg Orodispersible Tablet N06AX11000T4001XX No A* Major depression Initially 15 mg daily at bedtime increased
according to response up to 45 mg daily
as a single dose at bedtime or in 2
divided doses. CHILD and ADOLESCENT
under 18 years not recommended

Mirtazapine 30 mg Orodispersible Tablet N06AX11000T4002XX No A* Major depression Initially 15 mg daily at bedtime increased
according to response up to 45 mg daily
as a single dose at bedtime or in 2
divided doses. CHILD and ADOLESCENT
under 18 years not recommended

Mitomycin C 0.002% Eye Drops S01AX00000D2003XX No A Pterygium, conjunctival tumour, glaucoma surgery 1 - 2 drops several times a day
Mitomycin C 0.02% Eye Drops S01AX00000D2001XX No A Pterygium, conjunctival tumour, glaucoma surgery 1 - 2 drops several times a day
Mitomycin C 0.04% Eye Drops S01AX00000D2002XX No A Pterygium, conjunctival tumour, glaucoma surgery 1 - 2 drops several times a day

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
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Generic Name MDC NEML Category Indications Dosage

Mitomycin-C 10 mg Injection L01DC03000P4001XX No A* i) Gastrointestinal, lung, breast, cervical cancers ii) Bladder i) 10 - 20 mg/m2 body surface area (BSA)
tumours iii) Opthalmological conditions: conjunctival given as a single dose through a running
squamous neoplasia, squamous cell carcinoma of conjunctiva, IV infusion repeated every 6 - 8 weeks.
trabeculectomy chronic lymphocytic leukaemia, chronic The whole schedule may be repeated
myelogenous leukaemia. Gastric, colorectal, lung cancer depending on the bone marrow ii) 10 -
40 mg daily or every other day
(intravesical) iii) 0.4 mg topically as a
single application for opthalmological
conditions, duration: 1 to 3 minutes

Mitoxantrone 20 mg/10ml Injection L01DB07110P3001XX No A* Acute leukaemia, elderly patients with acute myeloid 10 - 12 mg/m2 IV daily for 3 days, in
leukaemia (AML), relapsed/resistant acute leukaemia, non- combination with other cytotoxic agents.
Hodgkin's lymphoma (NHL) Refer to protocol. CHILD: 5 - 10 mg/m2
daily for 3 - 5 days according to protocol.
Treatment of acute leukaemia, ADULT: 8 -
12 mg/m2/day once daily for 4 - 5 days.
CHILD more than 2 years: same as adult
dose. CHILD 2 years: 0.4 mg/kg/day once
daily for 3 - 5 days

Mixed Gas-Gangrene Antitoxin 25,000 J06AA05000P3001XX Yes B Mixed gas-gangrene Prophylactic: 25,000 units IM or IV.
units/5 ml Injection Therapeutic: Not less than 75,000 units
IV
Moclobemide 150 mg Tablet N06AG02000T1001XX No A* Treatment of depressive syndrome Initially 300 mg daily in divided doses.
Gradually to increase up to 600 mg daily
in divided doses depending on response.
Usual range 150 - 600 mg daily. Not
recommended in children

Modified Fluid Gelatin 4% Injection B05AA06905P9901XX Yes B For primary volume replacement in hypovolaemia, peri- ADULT 500 - 1500 ml given as IV infusion
operative stabilization of the circulation, haemodilution,
extracorporeal circulation (haemodialysis and heart-lung
machine)
Modified Polypeptides (Polygeline) 3.5% B05AA10905P9901XX No B For primary volume replacement in hypovolaemia, peri- Administered by intravenous infusion
Injection operative stabilization of the circulation, haemodilution, only. Total dosage and rate of infusion
extracorporeal circulation (haemodialysis and heart-lung depend upon the amount of blood loss
machine) and hemodynamic parameters. The
usual dose is 500 to 1000 milliliters (mL),
with total dosage not to exceed 2500 mL
daily
Mometasone Furoate 0.1% Cream D07AC13139G1001XX Yes A* Steroid responsive dermatosis and vitiligo. Used where a Apply thin layer to the affected skin
potent steroid is required for short duration not more than 6 areas once daily until the lesion heals or
weeks for a duration of 3 weeks whichever is
sooner.Massage gently and thoroughly
until the medication disappears.

Mometasone Furoate 50 mcg Aqueous R01AD09139A4101XX No A* Allergic rhinitis ADULT and CHILD over 12 years: 100
Nasal Spray mcg/day (2 sprays) to each nostril once
daily. Maximum 200 mcg (4 sprays) once
daily. Reduce to 50 mcg (1 spray) once
daily when control achieved. CHILD 6 -
12 years old: 50 mcg (1 spray) to each
nostril once daily

Monobasic Sodium Phosphate 48%, A06AG01162L5001XX No A Bowel cleansing prior to colonoscopy, radiological 45 ml diluted with half a glass (120 ml)
Dibasic Sodium Phosphate 18% examination or bowel surgery of water, followed by one full glass (240
ml) of water to be taken depending on
the time of the procedure. For morning
procedure, 45 ml dilute with half glass of
water should be taken at 7 am and the
second 45 ml at 7 pm on the day before
the procedure. For afternoon procedure,
the first dose should be taken at 7 pm on
the day before and the second dose at 7
am on the day of the procedure. Solid
food must not be taken during the
preparation period; clear fluids or water
can be taken liberally. Not
recommended for use in children

Montelukast Sodium 10 mg Tablet R03DC03520T1001XX No A/KK Chronic treatment of asthma and relief of symptoms of CHILD more than 15 years and ADULT:
seasonal allergic rhinitis for children more than 15 years and 10 mg daily at bedtime
adults
Montelukast Sodium 4 mg Oral Granules R03DC03520F1001XX No A* Asthmatics, not controlled on high dose inhaled 12 months - 5 years: 1 packet of 4mg
corticosteroids more than 1600 mcg/day and with co-morbid oral granules daily at bedtime
allergic disorders. Chronic treatment of asthma
Montelukast Sodium 5 mg Tablet R03DC03520T2001XX No A* Asthmatics, not controlled on high dose inhaled CHILD 6 - 14 years: One 5 mg chewable
corticosteroids more than 1600 mcg/day and with co-morbid tablet daily at bedtime
allergic disorders. Chronic treatment of asthma
Morphine HCl 10 mg/5 ml Solution N02AA01110L9901XX Yes B For use in management of moderate to severe pain especially 5-20 mg or more regularly every 4 hours
that associated with neoplastic disease as needed in terminal pain
Morphine Sulphate 10 mg Controlled N02AA01183T5001XX Yes A Prolonged relief of severe pain associated with neoplastic 10 - 60 mg 12 hourly intervals, depend
Release Tablet disease; assists in procuring sleep where sleeplessness is due upon the severity of the pain. Children
to pain or shock (more than 1 year of age) with severe
cancer pain: 0.2 - 0.8mg/kg 12 hourly.

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Generic Name MDC NEML Category Indications Dosage

Morphine Sulphate 10 mg Immediate N02AA01183T6002XX Yes A* Relief of moderate to severe pain (cancer patient) 5-10 mg every four hours. The dose may
Release Tablet be increased according to needs
Morphine Sulphate 10 mg Suppository N02AA01183S2001XX No A* Relief of severe chronic pain (cancer patient) 15 - 30 mg regularly every 4 hours

Morphine Sulphate 10 mg/ml Injection N02AA01183P3001XX Yes B For moderate to severe pain especially that associated with ADULT: 5-20mg SC or IM every 4 hours
neoplastic disease in terminal pain CHILD: Up to 1 month:
0.15 mg/kg body weight; 1 - 12 months:
0.2 mg/kg body weight; 1 - 5 years: 2.5 -
5 mg ; 6 - 12 years: 5 - 10 mg

Morphine Sulphate 20 mg Suppository N02AA01183S2002XX No A* Relief of severe chronic pain (cancer patient) 15 - 30 mg regularly every 4 hours

Morphine Sulphate 30 mg Controlled N02AA01183T5002XX Yes A Prolonged relief of severe pain associated with neoplastic 10 - 60 mg 12 hourly intervals, depend
Release Tablet disease; assists in procuring sleep where sleeplessness is due upon the severity of the pain
to pain or shock
Morphine Sulphate 30 mg Suppository N02AA01183S2003XX No A* Relief of severe chronic pain (cancer patient) 15 - 30 mg regularly every 4 hours

Morphine Sulphate 5 mg Immediate N02AA01183T6001XX Yes A* Relief of moderate to severe pain (cancer patient) 5-10 mg every four hours. The dose may
Release Tablet be increased according to needs
Morphine Sulphate 60 mg Controlled N02AA01183T5003XX Yes A Prolonged relief of severe pain associated with neoplastic 10 - 60 mg 12 hourly intervals, depend
Release Tablet disease; assists in procuring sleep where sleeplessness is due upon the severity of the pain. Children
to pain or shock (more than 1 year of age) with severe
cancer pain: 0.2 - 0.8mg/kg 12 hourly.

Moxifloxacin 0.5% Ophthalmic Solution S01AX22110D2001XX No A* Treatment of conjunctivitis caused by susceptible organism CHILD more than 1 year and ADULT: 1
drop to affected eye(s) 3 times daily for
7 days
Moxifloxacin 400 mg Injection J01MA14110P3001XX No A* Second line therapy for Severe Community Acquired IV or Oral: 400 mg once daily. The
Pneumonia (CAP) patients with co-morbidity or with recent recommended total treatment duration
antibiotic therapy, suspected infections of resistant pathogens for sequential administration
including Streptococcus pneumoniae, Haemophilus influenzae (intravenous followed by oral therapy) is
& Mycoplasma pneumoniae. 7 to 14 days

Moxifloxacin 400mg Tablet J01MA14110T1001XX No A* Second line therapy for Severe Community Acquired IV or Oral: 400 mg once daily. The
Pneumonia (CAP) patients with co-morbidity or with recent recommended total treatment duration
antibiotic therapy, suspected infections of resistant pathogens for sequential administration
including Streptococcus pneumoniae, Haemophilus influenzae (intravenous followed by oral therapy) is
& Mycoplasma pneumoniae. 7 to 14 days

Multivitamin Drops A11BA00901D5001XX No B For prevention and treatment of vitamin deficiencies INFANT less than 1 year: 1 ml daily
Multivitamin Injection A11BA00901P3001XX No B For prevention and treatment of vitamin deficiencies Initially 2 - 4 pairs IV 4 - 8 hourly,
reducing to 1 pair IV daily. For less
serious cases, 1 pair IV 1 - 2 times daily
or based on individual requirements

Multivitamin Syrup A11BA00901L9001XX No C+ For prevention and treatment of vitamin deficiencies CHILD 5 ml daily or based on
manufacturer
Multivitamin Tablet A11BA00901T1001XX No B For prevention and treatment of vitamin deficiencies 1 - 2 tablets daily or based on individual
requirements
Mupirocin 2% Cream D06AX09000G1001XX Yes A Skin infection by Staphylococcus aureus (including MRSA), Adults and child over 1 year, apply up to
Staphylococcus epidermidis and beta-haemolytic 3 times daily for up to 10 days
streptococcus
Mupirocin 2% Ointment D06AX09000G5001XX Yes A For MRSA infections only ADULT and CHILD: Apply up to three
times daily for up to 10 days
Mycophenolate Mofetil 250 mg Capsule L04AA06236C1001XX No A* i) Prophylaxis of acute organ rejection in patients receiving i) Renal transplant rejection: ADULT: 1 g
allogenic renal, cardiac and hepatic transplant ii) Used with twice daily. CHILD (3 months and older):
steroids for induction and maintenance of severe lupus 600 mg/m(2)/dose, twice daily;
nephritis resistant or intolerant to cyclophosphamide therapy maximum daily dose, 2 g/10 mL. Cardiac
transplant rejection: 1.5 g twice daily.
Hepatic transplant rejection: 1.5 g twice
daily ii) Induction phase: 2 - 3 g/day for
up to 6 months. Maintenance phase:
dose gradually tapers to 1 g/day

Mycophenolate Mofetil 500 mg tablet L04AA06236T1002XX No A* i) Prophylaxis of acute organ rejection in patients receiving i) Renal transplant rejection: ADULT: 1 g
allogenic renal, cardiac and hepatic transplant ii) Used with twice daily. CHILD (3 months and older):
steroids for induction and maintenance of severe lupus 600 mg/m(2)/dose, twice daily;
nephritis resistant or intolerant to cyclophosphamide therapy maximum daily dose, 2 g/10 mL. Cardiac
transplant rejection: 1.5 g twice daily.
Hepatic transplant rejection: 1.5 g twice
daily ii) Induction phase: 2 - 3 g/day for
up to 6 months. Maintenance phase:
dose gradually tapers to 1 g/day

Mycophenolate Sodium 180mg Tablet L04AA06520T1001XX No A* Prophylaxis of acute transplant rejection in adult patients 720 mg twice daily
receiving allogenic renal transplant in combination with
ciclosporin and corticosteroids
Mycophenolate Sodium 360mg Tablet L04AA06520T1002XX No A* Prophylaxis of acute transplant rejection in adult patients 720 mg twice daily
receiving allogenic renal transplant in combination with
ciclosporin and corticosteroids
Nalbuphine HCl 10 mg/ml Injection N02AF02110P3001XX No B Perioperative analgesia, for relief of moderate to severe pain 10 - 20 mg SC, IM or IV every 3 - 6 hours

Naloxone HCl 0.02 mg/ml Injection V03AB15110P3001XX Yes B For the complete/partial reversal of narcotic depression 0.005 - 0.01 mg/kg body weight
including respiratory depression induced by opioids such as repeated at intervals of 2 - 3 minutes
natural and synthetic narcotics. Diagnosis of suspected acute according to the patient's needs by IM,
opioids overdosage IV or SC

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Naloxone HCl 0.4 mg/ml Injection V03AB15110P3002XX Yes B For the complete/partial reversal of narcotic depression Initially 0.4 - 2 mg IV repeated at
including respiratory depression induced by opioids such as intervals of 2 - 3 minutes according to
natural and synthetic narcotics. Diagnosis of suspected acute patient's needs
opioids overdosage
Naltrexone HCl 50 mg Tablet N07BB04110T1001XX No A Adjunct in relapse prevention treatment in detoxified formerly Initial 25 mg may be increased to 50 mg.
opioid-dependant patients Maintenance: 350 mg weekly;
administered as 50 mg daily. Dosing
interval may be lengthened to improve
compliance; 100 mg on alternate days or
150 mg every third day

Nandrolone Decanoate 25 mg/ml A14AB01135P3001XX No A Anabolic therapy ADULT: 25 - 50 mg every 3 weeks by IM.
Injection CHILD over 2 years: 25 - 50 mg every 3 to
4 weeks
Naproxen 250 mg Tablet M01AE02000T1001XX Yes A/KK i) Rheumatic arthritis, osteoarthritis and ankylosing spondylitis i) 0.5 - 1 g daily in 2 divided doses ii) 750
ii) Acute gout iii) Muscular skeletal disorder, dysmenorrhoea mg initially then 250 mg 8 hourly iii) 500
mg initially then 250 mg every 6 - 8 hour
as required
Naproxen Sodium 275 mg Tablet M01AE02520T1001XX Yes A i) Rheumatic arthritis, osteoarthritis and alkylosing spondylitis 550 mg- 1100 mg in two divided doses
ii) Acute gout iii) Muscular skeletal disorder and
dysmenorrhoea
Neomycin 0.5% Cream D06AX04256G1001XX Yes B Infections of the skin due to susceptible organisms Apply sparingly to affected area up to 3
times daily (For short term use, 1 - 2
weeks)
Neomycin 0.5% in Betamethasone 17- D07CC01947G1001XX No B Treatment of the following conditions where bacterial Apply sparingly to affected area 2 - 3
Valerate 0.01% Cream infection is present or likely to occur: eczemas, prurigo times daily. (May cause sensitisation to
nodularis, psoriasis (excluding widespread plaque psoriasis), neomycin. Use with caution)
neurodermatoses, anal and genital intertrigo
Neomycin 0.5% in Betamethasone 17- D07CC01947G5001XX No B Treatment of the following conditions where bacterial Apply sparingly to affected area 2 to 3
Valerate 0.01% Ointment infection is present or likely to occur: eczemas, prurigo times daily. (May cause sensitisation to
nodularis, psoriasis (excluding widespread plaque psoriasis), Neomycin. Use with caution)
neurodermatoses, anal and genital intertrigo
Neomycin 0.5% in Betamethasone 17- D07CC01947G1002XX No A Treatment of the following conditions where bacterial Apply sparingly to affected area 2 - 3
Valerate 0.1% Cream infection is present or likely to occur: eczemas, prurigo times daily (May cause sensitisation to
nodularis, psoriasis (excluding widespread plaque psoriasis), neomycin. Use with caution)
neurodermatoses, anal and genital intertrigo
Neomycin 0.5% in Betamethasone 17- D07CC01947G5002XX No A Treatment of the following conditions where bacterial Apply sparingly to affected area 2 to 3
Valerate 0.1% Ointment infection is present or likely to occur: eczemas, prurigo times daily. (May cause sensitisation to
nodularis, psoriasis (excluding widespread plaque psoriasis), neomycin. Use with caution)
neurodermatoses, anal and genital intertrigo
Neomycin 0.5% Ointment D06AX04256G5001XX Yes B Infections of the skin due to susceptible organisms Apply sparingly to affected area up to 3
times daily (For short term use, 1- 2
weeks)
Neomycin with Polymyxin B Sulphate S01AA30990D2001XX No A Eye infections that require a broad spectrum antibiotic 1 - 2 drops in the affected eye 2 - 4 times
and Gramicidin Eye Drops daily. In severe infections : 1 - 2 drops
every 15 - 30 minutes
Neostigmine Methylsulphate 2.5 mg/ml N07AA01183P3002XX Yes B i) Myasthenia gravis ii) Reversal of non-depolarising i) ADULT: 1 - 2.5 mg at suitable intervals
Injection neuromuscular blockade by SC, IM or IV. Usual total daily dose 5 -
20 mg. CHILD: 200 - 500 mcg at suitable
intervals throughout the day. NEONATE:
50 - 250 mcg every 4 hours ii) By IV
injection over 1 minute, 50 - 70 mcg/kg
(maximum 5 mg) after or with atropine
sulphate 0.6 - 1.2 mg

Nepafenac 0.1% ophthalmic solution S01BC10-000-D20-01- No A* Reduction in the risk of postoperative macular oedema One drop 3 times/day beginning 1 day
XXX associated with cataract surgery in diabetic patients. prior to cataract surgery, continued on
the day of surgery and up to 60 days of
the postoperative period as directed by
the clinician. An additional drop should
be administered 30 to 120 minutes prior
to surgery.

Netilmicin Sulphate 100 mg/2 ml J01GB07183P3002XX No A Systemic infections ADULT: 4 - 6.5 mg/kg/day IM or IV in 2 -
Injection 3 equally divided doses for 7 - 14 days.
Maximum: 7.5 mg/kg/day. CHILD: 5 - 7.5
mg/kg/day 8 - 12 hourly depending on
gestation and age. Maximum: 7.5
mg/kg/day
Netilmicin Sulphate 150 mg/2 ml J01GB07183P3003XX No A Systemic infections ADULT: 4 - 6.5 mg/kg/day IM or IV in 2 -
Injection 3 equally divided doses for 7 - 14 days.
Maximum: 7.5 mg/kg/day. CHILD: 5 - 7.5
mg/kg/day 8 - 12 hourly depending on
gestation and age. Maximum: 7.5
mg/kg/day
Netilmicin Sulphate 50 mg/2 ml Injection J01GB07183P3001XX No A Systemic infections ADULT: 4 - 6.5 mg/kg/day IM or IV in 2 -
3 equally divided doses for 7 - 14 days.
Maximum: 7.5 mg/kg/day. CHILD: 5 - 7.5
mg/kg/day 8 - 12 hourly depending on
gestation and age. Maximum: 7.5
mg/kg/day

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Nevirapine 200 mg Tablet J05AG01000T1001XX Yes A/KK Treatment of HIV-1 infection in combination with other Combined with other antiretrovirals: 200
antiretroviral agents mg once daily for the 1st 14 days; up to
200 mg twice daily if rash does not
develop. Re-introduce at a lower dose
for the 1st 14 days if treatment is
interrupted for >7 days,necessitate
reintroduction at a lower dose for the
first 14 days.
Nevirapine 50mg/5ml Oral Suspension J05AG01000L8001XX No A/KK Treatment of HIV-1 infection in combination with other The total daily dose should not exceed
antiretroviral agents 400mg. Nevirapine may be dosed in
paediatric patients either by body
surface area (BSA) or by body weight.
i)By BSA using the Mosteller formula:
the recommended oral dose for
paediatric patients of all ages is 150
mg/m2 once daily for 2 weeks followed
by 150 mg/m2 twice daily thereafter.
ii)By body weight: -<8 years of age: 4
mg/kg once daily for 2 weeks followed
by 7 mg/kg twice daily thereafter. -≥8
years: 4 mg/kg once daily for 2 weeks
followed by 4 mg/kg twice daily
thereafter.
Nicotine 10 mg/ 16 hour Transdermal N07BA01000M7005XX Yes A/KK For the treatment of tobacco dependence by relieving nicotine Adult over 18 years old: 15 mg patch on
Patch withdrawal symptoms, thereby facilitating smoking cessation waking (usually in the morning) and
in smokers motivated to quit. remove 16 hours later (usually at
bedtime) for 8 weeks, then 10 mg patch
daily for 2 weeks followed by one 5 mg
patch daily for another 2 weeks. Apply to
dry non-hairy skin site. Application
limited to 16 hours in a 24-hr period in
each case. Review at 3 months.

Nicotine 14mg/24 hour Transdermal N07BA01000M7002XX No A/KK For the treatment of tobacco dependence by relieving nicotine Apply 1 patch daily for 24 hours as in the
Patch withdrawal symptoms, thereby facilitating smoking cessation product leaflet
in smokers motivated to quit.
Nicotine 15 mg/ 16 hour Transdermal N07BA01000M7006XX Yes A/KK For the treatment of tobacco dependence by relieving nicotine Adult over 18 years old: 15 mg patch on
Patch withdrawal symptoms, thereby facilitating smoking cessation waking (usually in the morning) and
in smokers motivated to quit. remove 16 hours later (usually at
bedtime) for 8 weeks, then 10 mg patch
daily for 2 weeks followed by one 5 mg
patch daily for another 2 weeks. Apply to
dry non-hairy skin site. Application
limited to 16 hours in a 24-hr period in
each case. Review at 3 months.

Nicotine 2 mg Gum N07BA01000M9901XX Yes A/KK For the treatment of tobacco dependence by relieving nicotine Smokes ≤ 20 sticks/day, chew 2mg gum.
withdrawal symptoms, thereby facilitating smoking cessation Smokes ≥ 20 sticks/day,chew 4 mg gum.
in smokers motivated to quit. (MAX 24 pieces /day for up to 12 week.)

Nicotine 21mg/24 hour Transdermal N07BA01000M7003XX No A/KK For the treatment of tobacco dependence by relieving nicotine Apply 1 patch daily for 24 hours as in the
Patch withdrawal symptoms, thereby facilitating smoking cessation product leaflet.
in smokers motivated to quit.
Nicotine 4 mg Gum N07BA01000M9902XX Yes A/KK For the treatment of tobacco dependence by relieving nicotine Smokes ≤ 20 sticks/day, chew 2mg gum.
withdrawal symptoms, thereby facilitating smoking cessation Smokes ≥ 20 sticks/day,chew 4 mg gum.
in smokers motivated to quit. (MAX 24 pieces /day for up to 12 week.)

Nicotine 7mg/24 hour Transdermal N07BA01000M7001XX No A/KK For the treatment of tobacco dependence by relieving nicotine Apply 1 patch daily for 24 hours as in the
Patch withdrawal symptoms, thereby facilitating smoking cessation product leaflet.
in smokers motivated to quit.
Nicotine Transdermal Patch 25mg/16 N07BA01000M7007XX No A/KK For the treatment of tobacco dependence by relieving nicotine The patch should be apply to an intact
hours. craving and withdrawal symptoms thereby facilitating smoking area of the skin upon waking up in the
cessation in smokers motivated to quit. Advice and support morning and removed at bedtime. Heavy
normally improve the success rate. smoker(those smoking 15 or more
cigarettes in a 24-hour period) are
recommended to start at Step 1 with
25mg/16 hours patch and use one patch
daily for 8 weeks. Gradual weaning from
the patch should then be initiated. One
15mg/16hours patch should be daily for
2 weeks followed by one 10mg/16 hours
patch daily for 2 weeks. Light smokers
(those smoking less than 15 cigarettes in
a 24-hour period) are recommended to
start at Step 2 (15mg/16hours patch) for
8 weeks and decrease the dose to Step 3
(10mg/16hours) for the final 4 weeks.
Heavy smoker Light smoker Dose
Regimen Duration Dose Regimen
Duration Step 1 25mg/16hr patch First 8
weeks Step 2 15mg/16hr patch Next 2
weeks Step 2 15mg/16hr patch First 8
weeks Step 3 10mg/16hr patch Last 2
weeks Step 3 10mg/16hr patch Last 4
weeks Combination therapy Highly
dependent smokers, smokers who

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Nicotinic Acid 50 mg Tablet A11HA01000T1001XX No B For prophylaxis and treatment of Vitamin B3 deficiency Prophylactic: 15 - 30 mg daily.
Therapeutic: 50 - 250 mg daily.
Maximum single dose: 200 mg.
Maximum dose in 24 hours: 800 mg
Nicotinic Acid 500 mg Tablet C10AD02000T1001XX No B Hyperlipidaemia 100 - 200 mg 3 times daily, gradually
increased over 2 - 4 weeks to 1 - 2 g 3
times daily with or after meals. CHILD:
100 - 250 mg/day in 3 divided doses with
meals, increase 100 mg/day weekly or
250 mg/day every 2 - 3 weeks as
tolerated. Maximum: 10 mg/kg/day

Nifedipine 10 mg Capsule C08CA05000C1001XX Yes B Hypertension 10 - 30 mg 3 times daily. Maximum: 120 -

180 mg per day
Nifedipine 10 mg Tablet C08CA05000T1001XX Yes B Hypertension Initial dose of 10 mg twice daily. Usual
range 10 - 30 mg 3 times daily.
Maximum: 120 - 180 mg per day.
Elderly: Dose reduction may be
necessary.
Nilotinib 150mg capsule L01XE08110T1001XX No A* For the treatment of adult patients with newly diagnosed 300mg twice daily. Dose adjustments or
Philadelphia chromosome positive chronic myelogenous modifications:For neutropenia &
leukemia in the chronic phase (CP). thrombocytopenia
Nilotinib 200 mg Capsule L01XE08110C1001XX No A* Treatment of chronic phase and accelerated phase 400 mg twice daily, 12 hours apart. No
Philadelphia chromosome positive chronic myelogenous food should be taken two hours before
leukaemia (CML) in adults who: i) Failed imatinib ie no and 1 hour after taking the dose
cytogenic response and no haematological response by 12
months ii) Have molecular resistance to Imatinib as shown by
molecular mutation studies iii) Are intolerant to Imatinib

Nimodipine 10 mg/50 ml Infusion C08CA06000P9901XX No A* Prophylaxis & treatment of ischaemic neurological deficits IV infusion of 1 mg/hour for a period of
Solution caused by cerebral vasospasm following subarachnoid 2 hours (about 15 mcg/kg/hour). IV
haemorrhage of aneurysmal origin therapy should be started no later than 4
days after haemorrhage & continue for
up to 10 - 14 days
Nimodipine 30 mg Tablet C08CA06000T1001XX No A* Prophylaxis & treatment of ischaemic neurological deficits 360 mg daily in divided doses for 7 days
caused by cerebral vasospasm following subarachnoid
haemorrhage of aneurysmal origin
Nitrazepam 5 mg Tablet N05CD02000T1001XX No B Epilepsy (infantile spasms) 5 - 10 mg at bedtime. ELDERLY or
debilitated 2.5 - 5 mg. CHILD not
recommended. Increasing slowly
according to response
Nitrofurantoin 100 mg Tablet J01XE01000T1002XX No B Uncomplicated lower urinary tract infections Acute uncomplicated urinary tract
infections Adult: 50-100 mg 4 times daily
for 7 days. Dual-release preparation: 100
mg bid. Child: >3 mth and older children:
3 mg/kg daily in 4 divided doses.
Prophylaxis of uncomplicated urinary
tract infections Adult: 50-100 mg at
bedtime. Child: >3 mth and older
children: 1 mg/kg once daily.

Nonacog alfa 1000 IU injection B02BD09000P4003XX No A* Treatment and prophylaxis of bleeding in patients with Number of factor IX units required =
haemophilia B (congenital factor IX deficiency) body weight (kg) x desired factor IX
increase (% or units/dL) x reciprocal of
observed recovery (units/kg per
units/dL). Average dose for secondary
prophylaxis for previously treated adult
patients (PTP) was 40 units/kg (range 13
to 78 units/kg) at intervals of 3 to 4 days

Nonacog alfa 2000 IU injection B02BD09000P4004XX No A* Treatment and prophylaxis of bleeding in patients with Number of factor IX units required =
haemophilia B (congenital factor IX deficiency) body weight (kg) x desired factor IX
increase (% or units/dL) x reciprocal of
observed recovery (units/kg per
units/dL). Average dose for secondary
prophylaxis for previously treated adult
patients (PTP) was 40 units/kg (range 13
to 78 units/kg) at intervals of 3 to 4 days

Nonacog alfa 250 IU injection B02BD09000P4001XX No A* Treatment and prophylaxis of bleeding in patients with Number of factor IX units required =
haemophilia B (congenital factor IX deficiency) body weight (kg) x desired factor IX
increase (% or units/dL) x reciprocal of
observed recovery (units/kg per
units/dL). Average dose for secondary
prophylaxis for previously treated adult
patients (PTP) was 40 units/kg (range 13
to 78 units/kg) at intervals of 3 to 4 days

Nonacog alfa 500 IU injection B02BD09000P4002XX No A* Treatment and prophylaxis of bleeding in patients with Number of factor IX units required =
haemophilia B (congenital factor IX deficiency) body weight (kg) x desired factor IX
increase (% or units/dL) x reciprocal of
observed recovery (units/kg per
units/dL). Average dose for secondary
prophylaxis for previously treated adult
patients (PTP) was 40 units/kg (range 13
to 78 units/kg) at intervals of 3 to 4 days

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Noradrenaline Acid Tartrate C01CA03123P3001XX No A Septic shock and shock where peripheral vascular resistance is Infuse and titrate to desired pressure
(Norepinephrine Bitartrate) 1 mg/ml low response. Range: 0.05 - 0.5
Injection mcg/kg/minute
Norethisterone 0.35 mg Tablet G03AC01000T1001XX No C+ Contraception 1 tablet daily starting on the first day of
the menstrual bleeding
Norethisterone Enanthate 200 mg/ml G03AC01257P3001XX Yes B Contraception By deep IM injection only. First injection
Injection is within first 5 days of the cycle. The
next 3 injections are given at 8 weeks
interval after which the injection interval
should be extended to 12 weeks

Norfloxacin 0.3% Eye Drops S01AX12000D2001XX No A* Superficial infections of the eye (Pseudomonas aeruginosa and ADULT and CHILD more than 1 year : 1-2
MRSA) and its adnexae drops 4 times daily. First day : 1 - 2 drops
two hourly during waking hours
(depending on severity)
Nystatin 100,000 units/g Cream D01AA01000G1001XX Yes C Prevention and treatment of cutaneous infections caused by Apply liberally to affected area twice
Candida albicans daily or as required. After lesion has
disappeared continue treatment for 10
days to prevent relapses. Nail infection:
Cut nails as short as possible. Apply
cream once daily until growth of new
nail has set in
Nystatin 100,000 units/g Ointment D01AA01000G5001XX Yes C Prevention and treatment of cutaneous or mucocutaneous Apply liberally to affected area twice
infections caused by Candida albicans daily or as required. After lesion has
disappeared continue treatment for 10
days to prevent relapses. Nail infection:
Cut nails as short as possible. Apply
cream once daily until growth of new
nail has set in
Nystatin 100,000 units/ml Suspension A07AA02000L8001XX Yes B Prevention and treatment of candidiasis of the skin and NEWBORN: 50,000-100,000 units daily.
mucous membranes, protection against candidas overgrowth CHILD up to 5 years: 100,000 -500,000
during antimicrobial /corticosteroid therapy and as selective units 6 hourly. CHILD up to 6-12 years
decontamination regimens and ADULT: 500,000-1,000,000 units 3
to 4 times daily
Nystatin 500,000 units Tablet A07AA02000T1001XX Yes B Prevention and treatment of candidiasis of the skin and ADULT: 500,000 -1,000,000 units 6
mucous membranes, protection against candidas overgrowth hourly, according to severity of
during antimicrobial /corticosteroid therapy and as selective infections. CHILD: 100,000-500,000 units
decontamination regimens 6 hourly
Octreotide 0.05 mg/ml Injection H01CB02122P3002XX No A i) Acromegaly ii) Treatment of patients with symptoms i, ii and iii) Initially 0.005 - 0.1 mg SC 1 - 2
associated with gastro-entero-pancreatic endocrine tumours times daily, increase gradually up to 0.1 -
iii) Carcinoid tumours with features of the carcinoid syndrome, 0.2 mg 3 times daily iv) 0.1 mg 3 times
VIPomas, glucagonomas, gastrinomas/Zollinger-Ellison daily for 7 consecutive days, starting on
syndrome, GRFomas, insulinomas iv) Prevention of the day of operation, at least 1 hour
complications following pancreatic surgery v) Emergency before laparotomy v) 25 mcg/hour for 5
management of bleeding gastro-eosophageal varices in days by continous IV infusion
patients with cirrhosis

Octreotide 0.1 mg/ml Injection H01CB02122P3001XX No A i) Acromegaly ii) Treatment of patients with symptoms i, ii and iii) Initially 0.005 - 0.1 mg SC 1 - 2
associated with gastro-entero-pancreatic endocrine tumours times daily, increase gradually up to 0.1 -
iii) Carcinoid tumours with features of the carcinoid syndrome, 0.2 mg 3 times daily iv) 0.1 mg 3 times
VIPomas, glucagonomas, gastrinomas/Zollinger-Ellison daily for 7 consecutive days, starting on
syndrome, GRFomas, insulinomas iv) Prevention of the day of operation, at least 1 hour
complications following pancreatic surgery v) Emergency before laparotomy v) 25 mcg/hour for 5
management of bleeding gastro-eosophageal varices in days by continous IV infusion
patients with cirrhosis

Octreotide Acetate 20 mg Injection H01CB02122P2001XX No A* i) Adjunctive treatment for active acromegaly (second/third 10 - 30 mg every 4 weeks as deep
line therapy in whom surgery or radiotherapy is inappropriate intragluteal injection
or ineffective- based on level of growth hormone and high IGF-
1 and residual pituitary tumor). ii) Treatment of symptoms
associated with functional gastro-entero-pancreatic endocrine
tumours. iii) Carcinoid tumours with features of the carcinoid
syndrome, VIPomas, Glucagonomas, Gastrinomas/Zollinger-
Ellison syndrome, Insulinomas, for pre-operative control of
hypoglycemia and for maintenance therapy, GRFomas.

Octreotide Acetate 30 mg Injection H01CB02122P2002XX No A* i) Adjunctive treatment for active acromegaly (second/third 10 - 30 mg every 4 weeks as deep
line therapy in whom surgery or radiotherapy is inappropriate intragluteal injection
or ineffective- based on level of growth hormone and high IGF-
1 and residual pituitary tumor). ii) Treatment of symptoms
associated with functional gastro-entero-pancreatic endocrine
tumours. iii) Carcinoid tumours with features of the carcinoid
syndrome, VIPomas, Glucagonomas, Gastrinomas/Zollinger-
Ellison syndrome, Insulinomas, for pre-operative control of
hypoglycemia and for maintenance therapy, GRFomas.

Ofloxacin 0.3% Otic Solution S02AA00000D1001XX No A/KK i. Acute otitis media with tympanostomy tubes ii. Chronic CHILD: 1 - 12 years: 5 drops twice daily
suppurative otitis media with perforated tympanic for 10 days. ADULT and CHILD over 12
membranes and iii. Otitis externa years: 6 - 10 drops twice daily and
remain in the ear about 10 minutes

Ofloxacin 100 mg Tablet J01MA01000T1001XX Yes A i) As second-line treatment of leprosy ii) As second-line i) 400 mg/day ii) 400 mg twice daily iii)
treatment for tuberculosis and multidrug resistant 200 mg twice daily
tuberculosis (MDR-TB) iii) Sequential therapy for UTI and
pyelonephritis

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Ofloxacin 200 mg Injection J01MA01000P4001XX No A Sequential therapy for UTI and pyelonephritis 200 mg IV twice daily for 3 - 5 days
followed with 200 mg tablet twice daily
for 3 - 5 days as maintenance dose (if
necessary)
Olanzapine 10 mg Disintegrating Tablet N05AH03000T4002XX No A* i) Acute and maintenance treatment of schizophrenia and i) 5 - 10 mg once daily, increase to 10 mg
other psychoses where positive and or negative symptoms are once daily within 5 - 7 days, adjust by 5 -
prominent ii) Short-term use for acute mania episodes 10 mg/day at 1 week intervals,
associated with Bipolar 1 disorder maximum 20 mg/day ii) 10 - 15 mg once
daily, increase by 5 mg/day at intervals
of not less than 24 hours. Maintenance 5
- 20 mg/day; maximum 20 mg/day

Olanzapine 10 mg Tablet N05AH03000T1002XX No A* i) Acute and maintenance treatment of schizophrenia and i) 5 - 10 mg once daily, increase to 10 mg
other psychoses where positive and or negative symptoms are once daily within 5 - 7 days, adjust by 5 -
prominent ii) Short-term use for acute mania episodes 10 mg/day at 1 week intervals,
associated with Bipolar 1 disorder maximum 20 mg/day ii) 10 - 15 mg once
daily, increase by 5 mg/day at intervals
of not less than 24 hours. Maintenance 5
- 20 mg/day; maximum 20 mg/day

Olanzapine 5 mg Tablet N05AH03000T1001XX No A* i) Acute and maintenance treatment of schizophrenia and i) 5 - 10 mg once daily, increase to 10 mg
other psychoses where positive and or negative symptoms are once daily within 5 - 7 days, adjust by 5 -
prominent ii) Short-term use for acute mania episodes 10 mg/day at 1 week intervals,
associated with Bipolar 1 disorder maximum 20 mg/day ii) 10 - 15 mg once
daily, increase by 5 mg/day at intervals
of not less than 24 hours. Maintenance 5
- 20 mg/day; maximum 20 mg/day

Olanzapine 5mg Disintegrating Tablet N05AH03000T4001XX No A* i) Acute and maintenance treatment of schizophrenia and i) 5 - 10 mg once daily, increase to 10 mg
other psychoses where positive and or negative symptoms are once daily within 5 - 7 days, adjust by 5 -
prominent ii) Short-term use for acute mania episodes 10 mg/day at 1 week intervals,
associated with Bipolar 1 disorder maximum 20 mg/day ii) 10 - 15 mg once
daily, increase by 5 mg/day at intervals
of not less than 24 hours. Maintenance 5
- 20 mg/day; maximum 20 mg/day

Olive Oil Ear Drops S02DC00000D1001XX No C Impacted wax softener 3 - 4 drops 3 - 4 or as directed
Olodaterol HCL 2.5mcg/puff, solution for R03AC19110A3001XX No A* Indicated as a maintenance bronchodilator treatment in 5 mcg (2 puffs) once daily.
inhalation patients with chronic obstructive pulmonary disease (COPD).

Olopatadine hydrochloride ophthalmic S01GX09110D2002XX No A* Temporary prevention of ocular itching due to allergic One drop in each affected eye once a
solution 0.2% conjunctivitis day
Omalizumab 150 mg (powder and R03DX05000P3001XX No A* i) For adults and adolescents (≥12 years), for severe persistent i) Adult & adolescent ≥12 yr, 150-375 mg
solvent for solution) allergic asthma whose symptoms are inadequately controlled SC every 2-4 wk, according to body wt &
with inhaled corticosetroids ii) For Children (6 to <12 years of baseline serum total IgE level.. For
age): As add-on therapy to improve asthma control with subcutaneous administration only. Do
severe persistent allergic asthma who have positive skin test not administer by the intravenous or
or in vitro reactivity to a perennial aero allergen and frequent intramuscular route. ii) Appropriate dose
daytime symptoms or night-time awakenings and who have and dosing frequency of omalizumab is
had multiple documented severe asthma exacerbations determined by baseline IgE (IU/ml),
despite daily high-dose inhaled corticosteroids, plus a long- measured before the start of treatment,
acting inhaled beta 2 agonist and body weight (kg). Prior to initial
dosing, patients should have their IgE
level determined for their dose
assignment. Based on these
measurements 150-375mg in 1 -3
injections may be needed for each
administration. Patients whose baseline
IgE levels or body weight in kilograms
are outside the limits of the dosing table
should not be given omalizumab. For
subcutaneous administration only.

Omeprazole 10 mg Capsule A02BC01000C1001XX Yes A/KK Only for : i)Reflux oesophagitis ii)For eradication of i)20 - 80 mg 1 - 2 times daily up to 8 - 12
Helicobacter pylori infection iii)Benign peptic ulcer not weeks ii)20 mg twice daily in
responding to conventional therapy iv)Zollinger-Ellison combination with any of the 2 antibiotics
Syndrome (clarithromycin 500 mg twice daily,
amoxicillin 1 g twice daily or
metronidazole 400 mg twice daily)for 1 -
2 weeks iii) 20 mg once daily for 4 - 6
weeks iv) ADULT: 20 - 120 mg once daily
adjusted according to the patient's
response. CHILD 0.4 - 0.8 mg/kg/day

Omeprazole 20 mg Capsule A02BC01000C1002XX Yes A/KK Only for : i)Reflux oesophagitis ii)For eradication of i)20 - 80 mg 1 - 2 times daily up to 8 - 12
Helicobacter pylori infection iii)Benign peptic ulcer not weeks ii)20 mg twice daily in
responding to conventional therapy iv)Zollinger-Ellison combination with any of the 2 antibiotics
Syndrome (clarithromycin 500 mg twice daily,
amoxicillin 1 g twice daily or
metronidazole 400 mg twice daily)for 1 -
2 weeks iii) 20 mg once daily for 4 - 6
weeks iv) ADULT: 20 - 120 mg once daily
adjusted according to the patient's
response. CHILD 0.4 - 0.8 mg/kg/day

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Omeprazole 40 mg Injection A02BC01000P4001XX No A* i) Reflux oesophagitis, eradication of H. Pylori infection, benign i) 40 mg IV once daily when oral therapy
peptic ulcer not responding to conventional therapy, Zollinger- is inappropriate ii) 40- 160 mg by IV in
Ellison Syndrome ii) Endoscopically confirmed peptic ulcer single or divided doses

Ondansetron 2 mg/ml Injection A04AA01110P3001XX Yes A i)Prevention of nausea and vomiting induced by chemotherapy i)8 mg given by IV infusion over 15
and radiotherapy ii)Postoperative nausea and vomiting minutes or by IM immediately before
treatment followed by 8 mg orally every
12 hours for up to 5 days. CHILD 5
mg/m2 body surface IV over 15 minutes
immediately before chemotherapy
followed by 4 mg orally every 12 hours
for up to 5 days ii)Prevention : 4 mg
given by IV at induction of anaesthesia.
CHILD over 2 years, 100 mcg/kg (max
4mg) by slow IV before, during or after
induction of anaesthesia. Treatment of
postoperative: 4 mg by IM or slow.
CHILD over 2 years 100 mcg/kg
(maximum 4mg) by slow IV

Ondansetron 4 mg Tablet A04AA01110T1001XX No A i)Prevention of nausea and vomiting induced by chemotherapy i)8 mg 1 - 2 hours before treatment then
and radiotherapy ii) Postoperative nausea and vomiting 8 mg every 12 hours for up to 5 days.
CHILD, treatment by infusion followed
by 4 mg by mouth every 12 hours for up
to 5 days ii)Prevention of postoperative
nausea and vomiting, 16 mg 1 hour
before anaesthesia or 8 mg 1 hour
before anaesthesia followed by 8 mg at
intervals of 8 hours for a further 2 doses

Ondansetron 8 mg Tablet A04AA01110T1002XX No A i)Prevention of nausea and vomiting induced by chemotherapy i)8 mg 1 - 2 hours before treatment then
and radiotherapy ii) Postoperative nausea and vomiting 8 mg every 12 hours for up to 5 days.
CHILD, treatment by infusion followed
by 4 mg by mouth every 12 hours for up
to 5 days ii)Prevention of postoperative
nausea and vomiting, 16 mg 1 hour
before anaesthesia or 8 mg 1 hour
before anaesthesia followed by 8 mg at
intervals of 8 hours for a further 2 doses

Ondansetron 8 mg/4ml Injection A04AA01110P3002XX Yes A i)Prevention of nausea and vomiting induced by chemotherapy i)8 mg given by IV infusion over 15
and radiotherapy ii)Postoperative nausea and vomiting minutes or by IM immediately before
treatment followed by 8 mg orally every
12 hours for up to 5 days. CHILD 5
mg/m2 body surface IV over 15 minutes
immediately before chemotherapy
followed by 4 mg orally every 12 hours
for up to 5 days ii)Prevention : 4 mg
given by IV at induction of anaesthesia.
CHILD over 2 years, 100 mcg/kg (max
4mg) by slow IV before, during or after
induction of anaesthesia. Treatment of
postoperative: 4 mg by IM or slow.
CHILD over 2 years 100 mcg/kg
(maximum 4mg) by slow IV

Oral Rehydration Salt A07CA00905F2101XX Yes C Replacement of fluid and electrolytes loss in diarrhoea ADULT: 200 - 400 ml ( 1 - 2 sachets ) for
every loose motion. CHILD: 200 ml (1
sachet) for every loose motion. In severe
dehydration 100 ml/kg for 3 - 4 hours.
INFANT: 1 - 1.5 times their usual feed
volume (50 ml per stool for small infant)

Orphenadrine 100 mg Tablet M03BC01110T1001XX No A Painful muscle spasm Initially 150 mg daily in divided doses.
Maximum: 400 mg daily
Ortho-phthalaldehyde 0.55% Solution V07AV00000L9909XX No A High level disinfectant for sensitive endoscopes or semi-critical Manual reprocessing, at least 12 minute
reusable medical devices immersion time at room temperature
(20 degree celcius) is required.
Automatic endoscope reprocessor, at
least 5 minute immersion time at a
minimum of 25 degree celcius is
required
Oseltamivir 60mg/5ml oral suspension. J05AH02000L8001XX No A/KK i) For treatment of patients with suspected or confirmed Children with body weight more than
influenza and severe disease (requiring hospitalization or 40kg is recommended to be dosed as
evidence of lower respiratory tract infection). ii) For treatment adults. The following weight adjusted
of patients with suspected or confirmed influenza and with co- dosing regimens are recommended for
morbidity and associated with increased risk of influenza children aged one year and older for
complications. Not to be used as prophylaxis. duration of five days: a) ≤15 kg: 30mg
twice daily b) >15kg to 23kg:45mg twice
daily c) >23kg to 40kg: 60mg twice daily

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Oseltamivir 75mg capsule. J05AH02000C1001XX No A/KK i) For treatment of patients with suspected or confirmed Recommended dose in adults and
influenza and severe disease (requiring hospitalization or adolescents ≥ 13 years of age and body
evidence of lower respiratory tract infection). ii) For treatment weight >40kg is 75mg twice daily for 5
of patients with suspected or confirmed influenza and with co- days. No dose adjustment is necessary
morbidity and associated with increased risk of influenza for patients with creatinine clearance
complications. Not to be used as prophylaxis. above 60 ml/min. Dose
recommendations for renal impairment
patients as follows: a) Creatinine
clearance of >30-60 mL/min: 30 mg
twice daily for 5 days b) Creatinine
clearance of 10-30 ml/min: 30 mg of
once daily for 5 days c) In patients
undergoing routine hemodialysis an
initial dose of 30 mg can be
administered prior to the start of dialysis
if influenza symptoms develop during
the 48 hours between dialysis sessions.
To maintain plasma concentrations at a
therapeutic level, a dose of 30 mg
should be administered after every
hemodialysis session. d) For peritoneal
dialysis a dose of 30 mg administered
prior to the start of dialysis followed by
further 30 mg doses administered every
5 days is recommended for treatment.
Dosing recommendation cannot be
Oxaliplatin 50 mg Injection L01XA03000P4001XX No A* Only for patients with colorectal cancer who: i) have relapsed 85 mg/m2 IV repeated every 2 weeks
within 6 months after the end of adjuvant chemotherapy with
5-fluorouracil-based regime ii) have progressive disease
despite 5-fluorouracil chemotherapy for advanced disease iii)
good performance status (WHO of 2 or less). The treatment
must be given in a tertiary oncology centre or have clearance
in writing by an oncologist

Oxybutynin Chloride 5 mg Tablet G04BD04110T1001XX No A* For the relief of symptoms of bladder instability associated ADULT: Initially 5 mg 2 - 3 times daily
with voiding in patients with uninhibited neurogenic or reflex increased if necessary to maximum 5 mg
neurogenic bladder (ie urgency, frequency, urinary leakage, 4 times daily. ELDERLY: Initially 2.5 - 3
urge incontinence, dysuria) mg twice daily, increased to 5 mg twice
daily according to response and
tolerance. CHILD over 5 years,
neurogenic bladder instability: 2.5 - 3 mg
twice daily increased to 5 mg twice daily
to maximum 3 times daily

Oxycodone HCl 10 mg Immediate N02AA05110C1002XX No A* i)As a second line drug in the management of opioid Initially 5 mg every 4 to 6 hours,
Release Capsules responsive, moderate to severe chronic cancer pain ii)As a increased if necessary according to
step-down analgesic drug in post-operative procedures severity of pain, usual max. 400 mg daily,
(Initiated by palliative medicine physicians, oncologists, but some patients may require higher
anaesthesiologists, haematologists and pain specialists only) doses

Oxycodone HCl 10 mg Prolonged Release N02AA05110T5001XX No A* Management of moderate to severe chronic cancer pain non- ADULT, ELDERLY and CHILDREN more
Tablet responsive to morphine (in accordance with WHO step-wise than 18 years, opioid-naive patients: 10
ladder of chronic pain management) [Initiated by Chronic Pain mg 12 hourly. Renal or hepatic
Specialist only] impairment: 5 mg 12 hourly. Titrate dose
carefully, as frequently as once a day if
necessary, to achieve pain relief

Oxycodone HCl 20 mg Immediate N02AA05110C1003XX No A* i)As a second line drug in the management of opioid Initially 5 mg every 4 to 6 hours,
Release Capsules responsive, moderate to severe chronic cancer pain ii)As a increased if necessary according to
step-down analgesic drug in post-operative procedures severity of pain, usual max. 400 mg daily,
(Initiated by palliative medicine physicians, oncologists, but some patients may require higher
anaesthesiologists, haematologists and pain specialists only) doses

Oxycodone HCl 20 mg Prolonged Release N02AA05110T5002XX No A* Management of moderate to severe chronic cancer pain non- ADULT, ELDERLY and CHILDREN more
Tablet responsive to morphine (in accordance with WHO step-wise than 18 years, opioid-naÔve patients: 10
ladder of chronic pain management) [Initiated by Chronic Pain mg 12 hourly. Renal or hepatic
Specialist only] impairment: 5 mg 12 hourly. Titrate dose
carefully, as frequently as once a day if
necessary, to achieve pain relief

Oxycodone HCl 40 mg Prolonged Release N02AA05110T5003XX No A* Management of moderate to severe chronic cancer pain non- Initially, 10 mg every 12 hours, increased
Tablet responsive to morphine (Initiated by palliative medicine if necessary according to severity of
physicians, oncologists, anaesthesiologists, haematologists pain, usual max. 200 mg every 12 hours,
and pain specialists only) but some patients may require higher
doses
Oxycodone HCl 5 mg Immediate Release N02AA05110C1001XX No A* i)As a second line drug in the management of opioid Initially 5 mg every 4 to 6 hours,
Capsules responsive, moderate to severe chronic cancer pain ii)As a increased if necessary according to
step-down analgesic drug in post-operative procedures severity of pain, usual max. 400 mg daily,
(Initiated by palliative medicine physicians, oncologists, but some patients may require higher
anaesthesiologists, haematologists and pain specialists only) doses

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Oxycodone Hydrochloride 10 mg/ml N02AA05110P3001XX No A* For the treatment of moderate to severe pain in patients with Adults over 18 years: The following
Injection cancer and post-operative pain. For the treatment of severe starting doses are recommended. A
pain requiring the use of a strong opioid. gradual increase in dose may be
required if analgesia is inadequate or if
pain severity increases. IV Bolus: Dilute
to 1 mg/ml in 0.9% saline, 5% dextrose
or water for injections. Administer a
bolus dose of 1 to 10 mg slowly over 1-2
minutes. Doses should not be
administered more frequently than
every 4 hours. IV Infusion: Dilute to 1
mg/ml in 0.9% saline, 5% dextrose or
water for injections. A starting dose of 2
mg/hour is recommended. IV PCA: Dilute
to 1 mg/ml in 0.9% saline, 5% dextrose
or water for injections. Bolus doses of
0.03 mg/kg should be administered with
a minimum lock-out time of 5 minutes.
SC Bolus: Use as 10 mg/ml
concentration. A starting dose of 5 mg is
recommended, repeated at 4-hourly
intervals as required. SC Infusion: Dilute
in 0.9% saline, 5% dextrose or water for
injections if required. A starting dose of
7.5 mg/day is recommended in opioid
naÔve patients, titrating gradually
Oxycodone Hydrochloride 10mg and N02AA55900T1002XX No A* The management of moderate to severe chronic pain Adults and paediatric patients from 18
Naloxone Hydrochloride Dihydrate 5mg unresponsive to non-narcotic analgesics. The opioid years of age: The usual starting dose for
Tablet antagonist naloxone in the fixed combination is added to opioid-naÔve patients or patients
counteract and/or prevent opioid-induced constipatio. For presenting with moderate to severe
pain specialist only chronic pain uncontrolled by weaker
opioids is one tablet 10mg/5mg at 12
hourly intervals, or one tablet
5mg/2.5mg 12-hourly for patients with
mild hepatic impairment and patients
with renal impairment. The dose should
then be cautiously titrated, as frequently
as every 1-2 days if necessary, to achieve
pain relief.

Oxycodone Hydrochloride 10mg N02AA05110T5301XX No A* Management of moderate to severe chronic cancer pain non- Adults, elderly and children over 12
Controlled Release Tablet responsive to morphine in accordance with WHO step-wise years: Usual starting dose for opioid-
ladder of chronic pain management. (Initiated by palliative naive patients or patients presenting
medicine physicians, oncologists, anaesthesiologists, with moderate to severe pain
haematologists and pain specialists only) uncontrolled by weaker opioids
(especially if they are receiving
concurrent sedatives, muscle relaxants
or other CNS medicines) is 10mg 12
hourly. The dose should then be
carefully titrated with longitudinal
patient monitoring, assessing whether
the pain is opioid responsive and
providing the patient significant pain
relief. Patients with renal or hepatic
impairment: The recommended adult
starting dose should be reduced by 1/3
to 1/2, and each patient should be
titrated to adequate pain control
according to their clinical situation.

Oxycodone Hydrochloride 20mg and N02AA55900T1003XX No A* The management of moderate to severe chronic pain Adults and paediatric patients from 18
Naloxone Hydrochloride Dihydrate 10mg unresponsive to non-narcotic analgesics. The opioid years of age: The usual starting dose for
Tablet antagonist naloxone in the fixed combination is added to opioid-naÔve patients or patients
counteract and/or prevent opioid-induced constipatio. For presenting with moderate to severe
pain specialist only chronic pain uncontrolled by weaker
opioids is one tablet 10mg/5mg at 12
hourly intervals, or one tablet
5mg/2.5mg 12-hourly for patients with
mild hepatic impairment and patients
with renal impairment. The dose should
then be cautiously titrated, as frequently
as every 1-2 days if necessary, to achieve
pain relief.

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Oxycodone Hydrochloride 20mg N02AA05110T5302XX No A* Management of moderate to severe chronic cancer pain non- Adults, elderly and children over 12
Controlled Release Tablet responsive to morphine in accordance with WHO step-wise years: Usual starting dose for opioid-
ladder of chronic pain management. (Initiated by palliative naive patients or patients presenting
medicine physicians, oncologists, anaesthesiologists, with moderate to severe pain
haematologists and pain specialists only) uncontrolled by weaker opioids
(especially if they are receiving
concurrent sedatives, muscle relaxants
or other CNS medicines) is 10mg 12
hourly. The dose should then be
carefully titrated with longitudinal
patient monitoring, assessing whether
the pain is opioid responsive and
providing the patient significant pain
relief. Patients with renal or hepatic
impairment: The recommended adult
starting dose should be reduced by 1/3
to 1/2, and each patient should be
titrated to adequate pain control
according to their clinical situation.

Oxycodone Hydrochloride 40mg and N02AA55900T1004XX No A* The management of moderate to severe chronic pain Adults and paediatric patients from 18
Naloxone Hydrochloride Dihydrate 20mg unresponsive to non-narcotic analgesics. The opioid years of age: The usual starting dose for
Tablet antagonist naloxone in the fixed combination is added to opioid-naÔve patients or patients
counteract and/or prevent opioid-induced constipation. For presenting with moderate to severe
pain specialist only chronic pain uncontrolled by weaker
opioids is one tablet 10mg/5mg at 12
hourly intervals, or one tablet
5mg/2.5mg 12-hourly for patients with
mild hepatic impairment and patients
with renal impairment. The dose should
then be cautiously titrated, as frequently
as every 1-2 days if necessary, to achieve
pain relief.

Oxycodone Hydrochloride 40mg N02AA05110T5303XX No A* Management of moderate to severe chronic cancer pain non- Adults, elderly and children over 12
Controlled Release Tablet responsive to morphine in accordance with WHO step-wise years: Usual starting dose for opioid-
ladder of chronic pain management (Initiated by palliative naive patients or patients presenting
medicine physicians, oncologists, anaesthesiologists, with moderate to severe pain
haematologists and pain specialists only) uncontrolled by weaker opioids
(especially if they are receiving
concurrent sedatives, muscle relaxants
or other CNS medicines) is 10mg 12
hourly. The dose should then be
carefully titrated with longitudinal
patient monitoring, assessing whether
the pain is opioid responsive and
providing the patient significant pain
relief. Patients with renal or hepatic
impairment: The recommended adult
starting dose should be reduced by 1/3
to 1/2, and each patient should be
titrated to adequate pain control
according to their clinical situation.

Oxycodone Hydrochloride 5 mg and N02AA55900T1001XX No A* The management of moderate to severe chronic pain Adults and paediatric patients from 18
Naloxone Hydrochloride Dihydrate unresponsive to non-narcotic analgesics. The opioid years of age: The usual starting dose for
2.5mg Tablet antagonist naloxone in the fixed combination is added to opioid-naÔve patients or patients
counteract and/or prevent opioid-induced constipation. For presenting with moderate to severe
pain specialist only chronic pain uncontrolled by weaker
opioids is one tablet 10mg/5mg at 12
hourly intervals, or one tablet
5mg/2.5mg 12-hourly for patients with
mild hepatic impairment and patients
with renal impairment. The dose should
then be cautiously titrated, as frequently
as every 1-2 days if necessary, to achieve
pain relief.

Oxymetazoline HCI 0.01% Nasal Drops R01AA05110D6003XX No A* Acute cold, paranasal sinusitis, syringitis, otitis media. Newborn (up to 4 weeks): 1 drop. Infant
(1 - 12 month): 1 - 2 drop. Doses to be
given twice or three times daily

Oxymetazoline HCl 0.025% (Paediatric) R01AA05110D6001XX No A/KK Acute colds, paranasal sinusitis and otitis media 1 - 2 drops twice daily in each nostril for
Nasal Drops child more than 1 year
Oxymetazoline HCl 0.025% (Paediatric) R01AA05110A4101XX No A Acute colds, paranasal sinusitis and otitis media 2 - 3 sprays into each nostril twice daily
Nasal Spray for child more than 1 year
Oxymetazoline HCl 0.05% (Adult) Nasal R01AA05110D6002XX No A/KK Acute colds, paranasal sinusitis and otitis media 1 - 2 drops twice daily in each nostril
Drops
Oxymetazoline HCl 0.05% (Adult) Nasal R01AA05110A4102XX No A Acute colds, paranasal sinusitis and otitis media 2 - 3 sprays into each nostril twice daily,
Spray maximum 6 sprays per nostril/day

Oxymetholone 50 mg Tablet A14AA05000T1001XX No A Anaemias caused by the administration of myelotoxic drugs, ADULT and CHILD: 1 - 5 mg/kg daily in
treatment of AIDS-wasting syndrome one daily dose. Usual effective dose 1 - 2
mg/kg/day, given for a minimum trial of
3 - 6 months because response may be
delayed

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Oxytetracycline with Polymyxin B S01AA30947G5101XX No B Conjunctivitis, dacryocystitis, blepharoconjunctivitis, keratitis, Apply into the conjunctival sac 4 times
Sulphate Eye Ointment trachoma, blepharitis, pre-op prophylaxis against infection daily

Oxytocin 10 units/ml Injection H01BB02000P3001XX Yes B Induction of labour IV: 0.5 - 1 milliunits/minute; gradually
increase dose in increments of 1 - 2
milliunits/minute until desired
contraction pattern is established; dose
may be decreased after desired
frequency of contractions is reached and
labor has progressed to 5 - 6 cm dilation

Oxytocin 5 units & Ergometrine Maleate G02AC01900P3001XX Yes C+ i) Prevention and treatment of post partum haemorrhage ii) i) 1 ml IM, may be repeated after 2
0.5 mg/ml Injection Management of third stage of labour hours. Should not exceed 3 ml within 24
hours ii) For routine management of
third stage of labour, 1 ml IM following
delivery of the anterior shoulder or
immediately after delivery of the child

Paclitaxel 100 mg/16.6 ml Injection L01CD01000P3002XX Yes A* i) Treatment of recurrent breast cancer, after failure of i) 175 mg/m2 IV over 3 hours every 3
anthracycline-based chemotherapy ii) Primary adjuvant weeks ii) 175 mg/m2 IV over 3 hour
therapy in advanced ovarian cancer in combination with followed by cisplatin 75 mg/m2 in every
cisplatin iii) Treatment of locally advanced or metastatic non- 3 weeks or 135 mg/m2 IV over 24 hours
small cell lung cancer (NSCLC) in chemonaive patients in followed by cisplatin 75 mg/m2 every 3
combination with platinum compounds weeks iii) 135 mg/m2 IV over 24 hours
followed by cisplatin 75 mg/m2 every 3
weeks
Paclitaxel 30 mg/5 ml Injection L01CD01000P3001XX Yes A* i) Treatment of recurrent breast cancer, after failure of i) 175 mg/m2 IV over 3 hours every 3
anthracycline-based chemotherapy ii) Primary adjuvant weeks ii) 175 mg/m2 IV over 3 hour
therapy in advanced ovarian cancer in combination with followed by cisplatin 75 mg/m2 in every
cisplatin iii) Treatment of locally advanced or metastatic non- 3 weeks or 135 mg/m2 IV over 24 hours
small cell lung cancer (NSCLC) in chemonaive patients in followed by cisplatin 75 mg/m2 every 3
combination with platinum compounds weeks iii) 135 mg/m2 IV over 24 hours
followed by cisplatin 75 mg/m2 every 3
weeks
Paliperidone 100 mg Prolonged Release N05AX13000P2004XX No A* Second or third line treatment of acute and maintenance Initiation: Deltoid IM 150 mg eq on
Injection treatment of schizophrenia in adults Day1, followed by deltoid IM 100 mg eq
on one week later. Maintenance:
Monthly dose of 75 mg eq ( this can be
increased or decreased based on
individual patient?s tolerability and/or
efficacy). These monthly maintenace
dose can be administered in either the
deltoid or gluteal muscle

Paliperidone 150 mg Prolonged Release N05AX13000P2005XX No A* Second or third line treatment of acute and maintenance Initiation: Deltoid IM 150 mg eq on
Injection treatment of schizophrenia in adults Day1, followed by deltoid IM 100 mg eq
on one week later. Maintenance:
Monthly dose of 75 mg eq ( this can be
increased or decreased based on
individual patient?s tolerability and/or
efficacy). These monthly maintenace
dose can be administered in either the
deltoid or gluteal muscle

Paliperidone 3 mg Extended Released N05AX13000T5001XX No A* Second or third line treatment of schizophrenia ADULT 6 mg once daily in the morning,
Tablet adjusted if necessary; usual range 3 -12
mg daily. Renal impairment (creatinine
clearance between 10-50 mL/min) 3 mg
once daily. Avoid if creatinine clearance
less than 10mL/min

Paliperidone 50 mg Prolonged Release N05AX13000P2002XX No A* Second or third line treatment of acute and maintenance Initiation: Deltoid IM 150 mg eq on
Injection treatment of schizophrenia in adults Day1, followed by deltoid IM 100 mg eq
on one week later. Maintenance:
Monthly dose of 75 mg eq ( this can be
increased or decreased based on
individual patient?s tolerability and/or
efficacy). These monthly maintenace
dose can be administered in either the
deltoid or gluteal muscle

Paliperidone 6 mg Extended Released N05AX13000T5002XX No A* Second or third line treatment of schizophrenia ADULT 6 mg once daily in the morning,
Tablet adjusted if necessary; usual range 3 -12
mg daily. Renal impairment (creatinine
clearance between 10-50 mL/min) 3 mg
once daily. Avoid if creatinine clearance
less than 10mL/min

Paliperidone 75 mg Prolonged Release N05AX13000P2003XX No A* Second or third line treatment of acute and maintenance Initiation: Deltoid IM 150 mg eq on
Injection treatment of schizophrenia in adults Day1, followed by deltoid IM 100 mg eq
on one week later. Maintenance:
Monthly dose of 75 mg eq ( this can be
increased or decreased based on
individual patient?s tolerability and/or
efficacy). These monthly maintenace
dose can be administered in either the
deltoid or gluteal muscle

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Paliperidone 9 mg Extended Released N05AX13000T5004XX No A* Second or third line treatment of schizophrenia ADULT 6 mg once daily in the morning,
Tablet adjusted if necessary; usual range 3 -12
mg daily. Renal impairment (creatinine
clearance between 10-50 mL/min) 3 mg
once daily. Avoid if creatinine clearance
less than 10mL/min

Palivizumab 100mg Injection J06BB16000P3001XX No A* For the prevention of serious lower respiratory tract disease 15 mg/kg IM once a month during
caused by respiratory syncytial virus (RSV) in paediatric season of RSV risk
patients at high risk of RSV disease
Pamidronate Disodium 30 mg Injection M05BA03520P3001XX No A* Hypercalcaemia of malignancy (tumour -induced Dose depends on the initial serum
hypercalcaemia) calcium levels. Doses range from a single
infusion of 30 - 90 mg
Pamidronate Disodium 90 mg Injection M05BA03520P3002XX No A* Hypercalcaemia of malignancy (tumour -induced Dose depends on the initial serum
hypercalcaemia) calcium levels. Doses range from a single
infusion of 30 - 90 mg
Pancreatin 150 mg Capsule A09AA02000C1001XX No A/KK Treatment of pancreatic exocrine insufficiency due to Initially 1 - 2 capsules with each meal.
conditions such as cystic fibrosis, chronic pancreatitis and non- May increase to 5 - 15 capsules daily
pancreatic diseases
Pancuronium Bromide 2 mg / ml M03AC01320P3001XX Yes B Muscle relaxant as an adjunct to general anaesthesia ADULT: Initially 50 - 100 mcg/kg IV, then
lnjection 10 - 20 mcg/kg as required. CHILD > 2
YEARS: Initially 60 - 100 mcg/kg then 10 -
20 mcg/kg. Intensive care, by IV, 60
mcg/kg every 60 - 90 minutes

Pantoprazole 40 mg Injection A02BC02000P3001XX No A* Bleeding peptic ulcer and acute stress ulceration 40 mg twice daily until oral
administration can be resumed. CHILD
not recommended
Pantoprazole 40 mg Tablet A02BC02000T1001XX No A/KK i) Helicobacter pylori eradication ii) Peptic ulcer disease iii) i) 40 mg twice daily in combination with
Erosive and non-erosive reflux oesophagitis (GERD and NERD) any of the 2 antibiotics (Clarithromycin
iv) Zollinger-Ellison Syndrome v) Prevention of NSAID induced 500 mg twice daily, Amoxicillin 1 g twice
gastropathy daily or Metronidazole 400 mg twice
daily) for 1-2 weeks ii) 40 mg daily for 2 -
4 weeks iii) 20 - 40 mg daily on morning
for 4 weeks iv) Initially 80 mg daily, dose
can be titrated up or down as needed. v)
20 mg daily. CHILD not recommended

Papaverine HCl 120 mg/10ml Injection A03AD01110P3002XX No A Relief of cerebral and peripheral ischaemia associated with ADULT: 30 - 120 mg may be repeated
arterial spasm and myocardial ischaemia complicated by every 3 hours as necessary. CHILD: 6
arrhythmias mg/kg daily in 4 divided doses
Paracetamol 10mg/ml in 100ml Solution N02BE01000P3101XX No A Mild to moderate pain and pyrexia Body Weight (BW) ≤ 10kg: 7.5mg/kg,
for IV Infusion max: 30mg/kg BW >10kg to ≤ 33kg:
15mg/kg, max 60mg/kg not exceeding
2g BW >33kg to ≤ 50kg: 15mg/kg, max
60mg/kg not exceeding 3g BW >50kg
(with risk of hepatotoxicity): 1g, max 3g
BW >50kg (without risk of
hepatotoxicity): 1g, max 4g OR as in the
product leaflet

Paracetamol 120 mg/5 ml Syrup N02BE01000L9001XX Yes C+ Mild to moderate pain and pyrexia CHILD: up to 1 year: 60 - 120 mg. 1 - 5
years: 120 - 240 mg. 6 - 12 years: 240 -
480 mg per dose. Repeat every 4 - 6
hours when necessary. Maximum of 4
doses in 24 hours
Paracetamol 125 mg Suppository N02BE01000S2002XX Yes C+ Symptomatic relief of fever and post operative pain whom ADULT & CHILDREN more than 12 years
cannot tolerate oral preparations. old: 500mg - 1g every 4-6 hours CHILD 6 -
12 years : 250 - 500 mg; 1 - 5 years : 125 -
250 mg; 3 - 11 months : 80 mg inserted
every 4 - 6 hours if necessary, maximum
4 doses in 24 hours. INFANTS under 3
months should not be given Paracetamol
unless advised by doctor; a dose of 10
mg/kg (5 mg/kg if jaundiced) is suitable.

Paracetamol 250 mg Suppository N02BE01000S2001XX Yes B Symptomatic relief of fever and post operative pain whom ADULT & CHILDREN more than 12 years
cannot tolerate oral preparations. old: 500mg - 1g every 4-6 hours CHILD 6 -
12 years : 250 - 500 mg; 1 - 5 years : 125 -
250 mg; 3 - 11 months : 80 mg inserted
every 4 - 6 hours if necessary, maximum
4 doses in 24 hours. INFANTS under 3
months should not be given Paracetamol
unless advised by doctor; a dose of 10
mg/kg (5 mg/kg if jaundiced) is suitable.

Paracetamol 250 mg/5 ml Syrup N02BE01000L8002XX No C+ Mild to moderate pain and pyrexia CHILD: 6 - 12 years: 250 - 500 mg per
dose. Repeat every 4 - 6 hours when
necessary. Maximum of 4 doses in 24
hours
Paracetamol 500 mg Tablet N02BE01000T1001XX Yes C+ Mild to moderate pain and pyrexia ADULT: 500 - 1000 mg every 4 - 6 hours,
maximum of 4 g daily
Paraffin Mole Alba (White Soft Paraffin) D02AC00000G5001XX Yes C Xerosis and ichthyosis Apply to the affected area

Paraffin Mole Flava D02AC00000G5002XX No C Xerosis and ichthyosis Apply to the affected area

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Paraldehyde Injection N05CC05000P3001XX No C Status epilepticus The usual intramuscular dose of
paraldehyde for status epilepticus is 0.15
to 0.3 milliliter/kilogram, a moderate
additional dose (0.05 milliliter/kilogram)
may be necessary. The dose may be
repeated in 2 to 6 hours and no more
than 5 milliliters should be administered
in one site

Parecoxib Sodium 40mg Injection M01AH04520P3001XX No A* Management of post operative pain in the immediate post 40 mg followed by 20 or 40 mg every 6
operative setting only to 12 hours, as required. Use limited to
two days only with a maximum dose of
80 mg/day. Reduce the initial dose by
50% in elderly less than 50 kg

Pazopanib Hydrochloride 200 mg Tablet L01XE11110T1001XX No A* For treatment of advanced and/or metastatic renal cell Recommended dose is 800 mg ORALLY
carcinoma (RCC) Restriction: i) KPS ≥ 70% ii) Clear cell histology once daily. Should be taken without food
iii) No brain metastasis iv) Haemoglobin ≥ 9g/dl v) Creatinine (at least one hour before or two hours
≤2x the ULN vi) Corrected calcium < 12mg/dl vii) Platelet count after meal). The dose should not exceed
of >100x103/uL viii) Neutrophil count >1,500/mm3 800 mg.

Pazopanib Hydrochloride 400 mg Tablet L01XE11110T1002XX No A* For treatment of advanced and/or metastatic renal cell Recommended dose is 800 mg ORALLY
carcinoma (RCC) Restriction: i) KPS ≥ 70% ii) Clear cell histology once daily. Should be taken without food
iii) No brain metastasis iv) Haemoglobin ≥ 9g/dl v) Creatinine (at least one hour before or two hours
≤2x the ULN vi) Corrected calcium < 12mg/dl vii) Platelet count after meal). The dose should not exceed
of >100x103/uL viii) Neutrophil count >1,500/mm3 800 mg.

Pefloxacin 400 mg Injection J01MA03196P3001XX No A Infections due to gram-positive and gram-negative pathogens Administered as a slow (one hour)
intravenous perfusion, after diluting the
contents of the 400 mg in 250 ml 5%
glucose (two perfusions daily, morning
and evening)
Pefloxacin 400 mg Tablet J01MA03000T1001XX No A i) Infections due to gram-positive and gram-negative ADULT i) 800 mg/day in 2 divided doses
pathogens ii) Uncomplicated UTI, chancroid gonococcal ii) 800 mg stat
urethritis
Pegfilgrastim Pre-filled Syringe 6 mg/0.6 L03AA13000P5001XX No A* Reduction in the duration of neutropenia, the incidence of Adults (≥18 years): One 6 mg dose (a
ml (10 mg/ml) febrile neutropenia and the incidence of infection as single pre-filled syringe) of pegfilgrastim
manifested by febrile neutropenia in patients treated with for each chemotherapy cycle,
cytotoxic chemotherapy for malignancy (with the exception of administered as a subcutaneous
chronic myeloid leukaemia and myelodysplastic syndromes) injection approximately 24 hours
following cytotoxic chemotherapy. Renal
impairment: Pharmacokinetics of
pegfilgrastim is not expected to be
affected by renal impairment. Hepatic
impairment: Pharmacokinetics of
pegfilgrastim is not expected to be
affected by hepatic impairment.
Paediatric population: Insufficient data
to recommend the use of pegfilgrastim
in children and adolescents under 18
years of age.

Peginterferon Alfa-2b 80 mcg Injection L03AB10000P5002XX No A* Treatment of: i) Chronic Hepatitis C ii) Chronic Hepatitis B i) Combination therapy with Ribavirin:
ADULT: SC 1.5 mcg/kg/week CHILD and
ADOLESCENT (3-17 yr): SC 60
mcg/m2/week for 24-48 weeks
Monotherapy: ADULT: SC 1
mcg/kg/week for 24 weeks to 1 year ii)
SC 1.0 - 1.5 mcg/kg once weekly for 52
weeks

Peginterferon Alpha-2a 135 mcg L03AB11000P5002XX No A* i) Chronic hepatitis C usually in combination with ribavirin i) 180 mcg weekly SC with ribavirin 800
Prefilled Syringe (Important to establish hepatitis C virus (HCV) genotype and mg daily for 24 weeks in patients in
viral load where combination treatment is advocated) ii) For genotype 2 and 3 and 180 mcg weekly
the treatment of both HbeAg-positive and HbeAg-negative SC with ribavirin (1000 - 1200 mg) for 48
chronic hepatitis B with compensated liver disease and weeks for those with genotype 1 and 4.
evidence of viral replication who are not responding or 135 mg dose may be used for patients
tolerating oral antiviral therapy (Initiated by Hepatologist and who cannot tolerate the 180 mcg dose ii)
Gasteroenterologist only) 180 mcg weekly SC for 48 weeks

Peginterferon Alpha-2a 180 mcg L03AB11000P5001XX No A* i) Chronic hepatitis C usually in combination with ribavirin i) 180 mcg weekly with ribavirin 800 mg
Prefilled Syringe (Important to establish hepatitis C virus (HCV) genotype and daily for 24 weeks in patients in
viral load where combination treatment is advocated) ii) For genotype 2 and 3 and 180 mcg weekly
the treatment of both HbeAg-positive and HbeAg-negative with ribavirin (1000 - 1200 mg) for 48
chronic hepatitis B with compensated liver disease and weeks for those with genotype 1 and 4.
evidence of viral replication who are not responding or 135 mg dose may be used for patients
tolerating oral antiviral therapy (Initiated by Hepatologist and who cannot tolerate the 180 mcg dose ii)
Gasteroenterologist only) 180 mcg subcutaneously once a week for
48 weeks

Pegylated Interferon Alpha-2b 100 mcg L03AB10000P5003XX No A* Treatment of: i) Chronic Hepatitis C ii) Chronic Hepatitis B i) Monotherapy: SC at a dose of 0.5 or 1
Injection mcg/kg once weekly for at least 6
months. Combination therapy: 1.5
mcg/kg/week SC in combination with
ribavirin capsules. ii) 1-1.5 mcg/kg once
weekly for at least 24 weeks and up to
52 weeks.

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Pegylated Interferon Alpha-2b 120 mcg L03AB10000P5004XX No A* Treatment of: i) Chronic Hepatitis C ii) Chronic Hepatitis B i) Monotherapy: SC at a dose of 0.5 or 1
Injection mcg/kg once weekly for at least 6
months. Combination therapy: 1.5
mcg/kg/week SC in combination with
ribavirin capsules. ii) 1-1.5 mcg/kg once
weekly for at least 24 weeks and up to
52 weeks.
Pegylated Interferon Alpha-2b 150 mcg L03AB10000P5005XX No A* Treatment of: i) Chronic Hepatitis C ii) Chronic Hepatitis B i) Monotherapy: SC at a dose of 0.5 or 1
Injection mcg/kg once weekly for at least 6
months. Combination therapy: 1.5
mcg/kg/week SC in combination with
ribavirin capsules. ii) 1-1.5 mcg/kg once
weekly for at least 24 weeks and up to
52 weeks.
Pegylated Interferon Alpha-2b 50 mcg L03AB10000P5001XX No A* Treatment of: i) Chronic Hepatitis C ii) Chronic Hepatitis B i) Monotherapy: SC at a dose of 0.5 or 1
Injection mcg/kg once weekly for at least 6
months. Combination therapy: 1.5
mcg/kg/week SC in combination with
ribavirin capsules. ii) 1-1.5 mcg/kg once
weekly for at least 24 weeks and up to
52 weeks.
Pegylated Liposomal Doxorubicin HCl 20 L01DB01110P3003XX Yes A* i) For patients with platinum-resistant ovarian cancer where 50 mg/m2 IV every 4 weeks for as long
mg/vial the disease relapses within 6 months after completion of the as the disease does not progress &
initial platinum-based chemotherapy ii) For patients with patient continues to tolerate
platinum-sensitive ovarian cancer where the disease responds treatment.For doses <90 mg: dilute in
to first-line platinum-based therapy but relapses 12 months or 250 ml Dextrose 5 % in Water. For doses
more after completion of the initial platinum based >90 mg: dilute in 500 ml Dextrose 5 % in
chemotherapy. As third line therapy for very selected patients. Water. To minimize the risk of infusion
(Gyne Oncology Specialist only) reactions, the initial dose is administered
at a rate no greater than 1 mg/minute.
Renal impairment: No dose adjustment
required in patients with creatinine
clearance 30-156 ml/min, no
pharmacokinetic data are available in
patients with creatinine clearance of less
than 30 ml/min. Hepatic impairment: At
initiation of therapy: Bilirubin 1.2 - 3.0
mg/dl, the first dose is reduced by 25 %,
Bilirubin > 3.0 mg/dl, the first dose is
reduced by 50 %.

Pemetrexed Disodium 100 mg Injection L01BA04016P3002XX No A* In combination with Cisplatin for the 2nd line treatment of Initial therapy 500 mg/m(2) IV over 10
patients with locally advanced or metastatic non small cell minutes on day 1, followed 30 minutes
lung cancer (NSCLC) other than predominantly squamous cell later by cisplatin 75 mg/m(2) infused IV
histology over 2 hours; repeat cycle every 21-days.
Prior chemotherapy : 500 mg/m(2) IV, as
a single-agent, over 10 minutes on day 1
of each 21-day cycle

Pemetrexed Disodium 500 mg Injection L01BA04016P3001XX No A* In combination with Cisplatin for the 2nd line treatment of Initial therapy 500 mg/m(2) IV over 10
patients with locally advanced or metastatic non small cell minutes on day 1, followed 30 minutes
lung cancer (NSCLC) other than predominantly squamous cell later by cisplatin 75 mg/m(2) infused IV
histology over 2 hours; repeat cycle every 21-days.
Prior chemotherapy : 500 mg/m(2) IV, as
a single-agent, over 10 minutes on day 1
of each 21-day cycle

Pentamidine Isethionate 300 mg P01CX01198P3001XX No A* Only for the treatment of pneumonia due to Pneumocytosis 4 mg/kg once daily by slow IV infusion
Injection carinii for at least 14 days
Pentoxifylline 400 mg Tablet C04AD03000T1001XX No A/KK Peripheral vascular disease 400 mg 2 - 3 times daily
Peracetic Acid and Hydrogen Peroxide V07AV00000L9906XX No A High level disinfectant or sterilant for heat labile endoscopes Immersion time based on manufacturer
recommendation
Perindopril 4 mg and Indapamide 1.25 C09BA04900T1001XX No A/KK Essential hypertension, for patients whose blood pressure is One tablet daily, preferably taken in the
mg Tablet insufficiently controlled by perindopril alone. morning and before a meal.
Perindopril 4 mg Tablet C09AA04000T1001XX Yes B i) Hypertension ii) Congestive heart failure iii) Stable coronary i) 4 mg as single dose, may be increased
artery disease to a single 8 mg dose. ELDERLY: Start
treatment with 2 mg dose. In renal
insufficiency, dose should be adapted
according to creatinine clearance ii)
Single starting oral dose of 2 mg should
be increased to a single 4 mg once BP
acceptability has been demonstrated iii)
4 mg once daily for 2 weeks, may be
increased to 8 mg once daily. ELDERLY: 2
mg once daily for 1 week, then 4 mg
once daily for the following week, may
be increased up to 8 mg once daily

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Perindopril 8 mg Tablet C09AA04000T1002XX Yes B i) Hypertension ii) Congestive heart failure iii) Stable coronary i) 4 mg as single dose, may be increased
artery disease to a single 8 mg dose. ELDERLY: Start
treatment with 2 mg dose. In renal
insufficiency, dose should be adapted
according to creatinine clearance ii)
Single starting oral dose of 2 mg should
be increased to a single 4 mg once BP
acceptability has been demonstrated iii)
4 mg once daily for 2 weeks, may be
increased to 8 mg once daily. ELDERLY: 2
mg once daily for 1 week, then 4 mg
once daily for the following week, may
be increased up to 8 mg once daily

Peritoneal Dialysis Solution (1.5% B05DB00908H2001XX Yes B For chronic renal disease requiring dialysis and for acute renal Dose depending on clinical cases
Dextrose) failure
Peritoneal Dialysis Solution (4.25% B05DB00908H2002XX Yes B For chronic renal disease requiring dialysis and for acute renal Dose depending on clinical cases
Dextrose) failure
Peritoneal Dialysis with 7.5% Icodextrin B05DB00908H2003XX Yes A* As a once replacement for a single glucose exchange as part of Administered as a single daily exchange
Solution a continuous ambulatory peritoneal dialysis (CAPD) or for the long dwell in continuous
automated peritoneal dialysis (APD) regimen for the treatment ambulatory peritoneal dialysis or
of chronic renal failure, particularly for patients who have lost automated peritoneal dialysis. The
ultra filtration on glucose solutions recommended dwell time is 8 to 16
hours
Permethrin 1% w/v Lotion. P03AC04000L6002XX No B For topical treatment of head lice. Apply lotion onto clean towel dried hair
ensuring every strand comes in contact
with lotion for at least 10 minutes. Rinse
completely. Re-apply after 10 days to
ensure total recovery.

Permethrin 5% w/v Lotion P03AC04000L6001XX Yes A/KK Treatment of scabies Two applications needed one week
apart. Apply thoroughly to all body parts
from neck down. Leave overnight for 8 -
14 hours. Washed off. Reapply after one
week. Not recommended for children
less than 2 months of age.

Perphenazine 4 mg Tablet N05AB03000T1001XX No B Schizophrenia and other psychoses ADULT: Initially 4 mg 3 times daily
adjusted according to response,
maximum 24 mg daily. ELDERLY: 1/4 to
1/2 adult dose. CHILD not recommended

Pethidine HCl 100 mg/2 ml Injection N02AB02110P3002XX No B For relief of moderate to severe pain (medical and surgical), ADULT: 0.5 - 2 mg/kg SC or IM every 3 -
pre-anaesthetic medication and obstetrical analgesia 4 hours if necessary. CHILD: by IM 0.5 - 2
mg/kg. Up to 1 year : 1- 2 mg/kg weight
IM, 1 - 5 years : 12.5 - 25 mg IM, 6 - 12
years: 25 - 50 mg IM
Pethidine HCl 50 mg/ml Injection N02AB02110P3001XX No B For relief of moderate to severe pain (medical and surgical), ADULT: 0.5 - 2 mg/kg SC or IM every 3 -
pre-anaesthetic medication and obstetrical analgesia 4 hours if necessary. CHILD: by IM 0.5 - 2
mg/kg. Up to 1 year : 1- 2 mg/kg weight
IM, 1 - 5 years : 12.5 - 25 mg IM, 6 - 12
years: 25 - 50 mg IM
Phenobarbitone 30 mg Tablet N03AA02000T1002XX Yes B Epilepsy ADULT: 60 - 180 mg daily on. CHILD: Up
to 8 mg/kg daily
Phenobarbitone Sodium 200 mg/ml N03AA02520P3001XX Yes B Status Epilepticus ADULT: 10 mg/kg IV at a rate of not
Injection faster than 100 mg/minute. Initial
maximum dose does not exceeding 1
gm. Daily maintenance of 1 - 4
mg/kg/day. CHILD: 10 - 20 mg/kg/dose
loading dose, followed by repeated
doses at 10 mg/kg/dose (strictly in ICU
setting). Maintenance 5 - 8 mg/kg/day

Phenol 80% w/w Liquid D08AE03000L5001XX No C As disinfectant Use in various dilutions

Phenoxybenzamine HCl 100 mg/2 ml C04AX02110P3001XX No A* Hypertensive episodes associated with phaeochromocytoma 1 mg/kg daily over at least 2 hours into
Injection large vein. Do not repeat within 24
hours.
Phenoxymethyl Penicillin 125 mg Tablet J01CE02500T1001XX Yes C i) Treatment or prophylaxis of infections caused by susceptible i) ADULT: 500 - 750 mg 6 hourly.CHILD;
organisms ii) Prophylactic, rheumatic fever up to 1 year: 62.5 mg, 1 - 5 years: 125
mg, 6 - 12 years: 250 mg 6 hourly ii)
ADULT: 125 - 250 mg twice daily. CHILD:
25 - 50 mg/kg in divided doses every 6 -
8 hours. Maximum: 3 g/day

Phenoxymethyl Penicillin 125 mg/5 ml J01CE02500F2101XX No C Treatment or prophylaxis of infections caused by susceptible CHILD: Up to 1 year: 62.5 mg 6 hourly; 1 -
Syrup organisms 5 years: 125 mg 6 hourly; 6 - 12 years:
250 mg 6 hourly
Phenoxymethyl Penicillin 250 mg Tablet J01CE02500T1002XX No C i) Treatment or prophylaxis of infections caused by susceptible i) ADULT: 500 - 750 mg 6 hourly.CHILD;
organisms ii) Prophylactic, rheumatic fever up to 1 year: 62.5 mg, 1 - 5 years: 125
mg, 6 - 12 years: 250 mg 6 hourly ii)
ADULT: 125 - 250 mg twice daily. CHILD:
25 - 50 mg/kg in divided doses every 6 -
8 hours. Maximum: 3 g/day

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Generic Name MDC NEML Category Indications Dosage

Phenylephrine HCI 2.5% Eye Drops S01FB01110D2001XX Yes B For pupillary dilation in uveitis, for refraction without Mydriasis and vasoconstriction: 1 drop
cyclopegic. For fundoscopy and other diagnostic procedures of 2.5% or 10% solution, repeated in one
hour if necessary. Chronic mydriasis: 1
drop of a 2.5% or 10% solution 2 - 3
times a day. Uveitis with posterior
synechiae (treatment) or synechiae,
posterior (prophylaxis): 1 drop of a 2.5%
or 10% solution, repeated in one hour if
necessary, not to exceed three times a
day. Treatment may be continued the
following day, if necessary

Phenylephrine HCl 10% Eye Drops S01FB01110D2002XX Yes B For pupillary dilation in uveitis, for refraction without Mydriasis and vasoconstriction: 1 drop
cyclopegic. For fundoscopy and other diagnostic procedures of 2.5% or 10% solution, repeated in one
hour if necessary. Chronic mydriasis: 1
drop of a 2.5% or 10% solution 2 - 3
times a day. Uveitis with posterior
synechiae (treatment) or synechiae,
posterior (prophylaxis): 1 drop of a 2.5%
or 10% solution, repeated in one hour if
necessary, not to exceed three times a
day. Treatment may be continued the
following day, if necessary

Phenytoin Sodium 100 mg Capsule N03AB02520C1002XX Yes B Epilepsy ADULT and CHILD more than 6 years:
300-400 mg/day in 3 - 4 divided doses
before meals. Maximum: 600 mg/day.
CHILD: Initially 5 mg/kg/day in 2 - 3
divided doses. Maintenance: 4 - 8
mg/kg/day. Maximum: 300 mg/day

Phenytoin Sodium 125 mg/5ml N03AB02520L8001XX Yes B Epilepsy ADULT: Patients with no previous
Suspension treatment may be started on 1
teaspoonful or 5 mL (125 milligrams) 3
times daily. It is then individualized to
the patient. An increase to 5
teaspoonfuls (625 milligrams) may be
made if necessary. CHILD: Initially 5
mg/kg/day in 2 - 3 divided doses.
Maintenance: 4 - 8 mg/kg/day.
Maximum: 300 mg/day. Children over 6
years and adolescents may require the
minimum adult dose (300mg/day).

Phenytoin Sodium 30 mg Capsule N03AB02520C1001XX Yes B Epilepsy ADULT and CHILD more than 6 years:
300-400 mg/day in 3 - 4 divided doses
before meals. Maximum: 600 mg/day.
CHILD: Initially 5 mg/kg/day in 2 - 3
divided doses. Maintenance: 4 - 8
mg/kg/day. Maximum: 300 mg/day

Phenytoin Sodium 50mg/ml lnjection N03AB02520P3001XX Yes B Status epilepticus i) Status epilepticus: ADULT 10 - 15
mg/kg by slow IV. Maximum 50
mg/minute. Maintenance: 100 mg
orally/IV every 6 - 8 hours. CHILD 15 - 20
mg/kg by slow IV. Maximum: 1 - 3
mg/kg/minute ii) Neurosurgery 100 - 200
mg IM approximately at 4 hourly interval

Phosphate Solution containing Sodium B05XA09902L5001XX No A For supplemental ionic phosphorus for correction of According to the needs of the patient
Acid Phosphate 1.936 g /15 ml hypophosphataemia

Phyllanthus Niruri Extract 250 mg HA05BA5999C1001XX No A/KK Liver tonic 2 capsules to be taken orally, 3 times a
Capsule day, before or after meals
Pilocarpine 1% Eye Drops S01EB01110D2001XX Yes B Miotics in chronic open-angle glaucoma 1 drop 1 - 4 times a day
Pilocarpine 2% Eye Drops S01EB01110D2002XX Yes B Miotics in chronic open-angle glaucoma 1 drop 1 - 4 times a day
Piperacillin 4 g & Tazobactam 500 mg J01CR05961P3001XX No A* Febrile neutropenia, lower respiratory tract infection and Adult and children more than 12 years:
Injection severe sepsis 4.5g 6 hourly, for neutropenia adult and
children more than 50kg: 4.5g 6 hourly.
Children less than 50kg: 90mg/kg 6
hourly
Piperacillin Sodium 4 g Injection J01CA12520P4002XX No A Infections due to Pseudomonas aeruginosa ADULT: 100 - 150 mg/kg IM/IV in divided
doses. Increase to 200 - 300 mg/kg in
severe infections & at least 16 g in life-
threatening infections. Single dose over
2 g: IV route only. Maximum: 24 g/day.
CHILD: 50-75 mg/kg/dose every 6 - 8
hourly
Piracetam 1 g Injection N06BX03000P3001XX No A* Treatment of cerebral functional impairment 30 - 160 mg/kg/day orally or parenterally
2 times daily or 3 to 4 times daily.
Maximum: 24 g/day
Piracetam 1.2 g Tablet N06BX03000T1001XX No A* Mild cognitive impairment, post concussional head syndrome, Initially 7.2 g daily in 2 - 3 divided doses,
head injury disorder, chronic vertigo and myoclonus increased according to response by 4.8 g
daily every 3 - 4 days to maximum of 20
g daily. CHILD under 16 years not
recommended

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Piracetam 20% Solution N06BX03000L5001XX No A* Children with learning disability, progressive myoclonic 30 - 160 mg/kg/day orally. To be given 2
epilepsy and hypoxia times daily or 3 - 4 times daily.
Maximum 24 g/day
Piribedil 50 mg Tablet N04BC08000T5001XX Yes A* Parkinson disease As monotherapy: 150 - 250 mg as 3 - 5
divided doses daily. As combination with
L-dopa therapy: 50 - 150 mg daily (50 mg
per 250 mg of L-dopa)

Piroxicam 10 mg Capsule M01AC01000C1001XX No A/KK i) Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis ii) i) 20 mg daily, maintenance 10 - 30 mg
Acute musculoskeletal disorders iii) Acute gout daily, in single or divided doses ii) 40 mg
daily in single or divided doses for 2
days, then 20 mg daily for 7 - 14 days iii)
40 mg initially, then 40 mg daily in single
or divided doses for 4 - 6 days

Pizotifen 0.5 mg Tablet N02CX01253T1001XX Yes B Prophylactic treatment of vascular headache Starting with 0.5mg daily, the dosage
should be progressively increased. The
average maintenance dosage is 1.5mg
daily in divided doses or as a single dose
at night. Max dose: 4.5 mg/day and 3
mg/dose. Child: >2 yr: Up to 1.5 mg daily
in divided doses. Max dose: 1 mg/dose.

Pneumococcal polysaccharide conjugate J07AL01-000-P30-01- No A* Active immunization for the prevention of pneumococcal Pneumococcal polysaccharide conjugate
vaccine (adsorbed) 13-valent injection XXX disease caused by Streptococcus pneumoniae serotypes vaccine (adsorbed), 13-valent [PCV13] is
1,3,4,5,6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in the to be administered as a single dose to
population with associated risk in IPD with the following adults 18 years and older including those
conditions: • Functional or anatomical asplenia; • Cochlear previously vaccinated with a
implant; • Congenital immune-deficiency; • Haematopoietic pneumococcal polysaccharide vaccine.
and solid organ transplant; • Adults aged 60 years and above The need for re-vaccination with a
with one of the following conditions: i) Chronic lung diseases, subsequent dose of PCV13 has not been
including chronic obstructive pulmonary disease (COPD), established
emphysema & asthma (requiring frequent hospital visit & use
of multiple medications). ii) Chronic liver disease including
cirrhosis, biliary atresia, chronic hepatitis iii) Chronic cardiac
disease, including congestive heart failure, congenital heart
disease, and cardiomyopathies

Pneumococcal Vaccine (Polyvalent) J07AL01000P3001XX Yes A Prevention of pneumococcal infections in high risk subjects Primary injection: 1 single injection (0.5
from the age of 2 years including patient with a history of ml) only. Booster: Must not be given
splenectomy or scheduled splenectomy within 5 years except in very high risk
patient who received the vaccine while
under immunosuppressive treatment

Podophyllum 10 - 20% Paint D06BB04000L7001XX No B External anogenital warts Apply 2 - 3 drops carefully to lesion after
protecting surrounding area with
vaseline. Wash off after 6 hours or if feel
burning sensation and repeat 2 - 3 times
weekly or once weekly

Policresulen 360 mg/g Concentrate G01AX03900L9901XX No A Local treatment of cervical and vaginal inflammation and For cauterization, undiluted once or
tissue damage eg. discharge due to bacterial, trichomonal and twice weekly whilst for vaginal douches,
fungal infections, protrusions of endocervical mucosa to be diluted 1 part concentrate to 5
(erosion), haemostasis following biopsy or excision of uterine parts of water
polyps
Poliomyelitis Oral Live Vaccine (10 J07BF02000D5001XX Yes C+ Immunisation against poliomyelitis Two drops (0.1 ml). Primary
Doses) immunization: 1 oral dose at 3,4 & 5
month of age. Booster doses at 1-4 years
& 7 years.
Polycitra Syrup A12BA02955L9001XX No C For treatment of calcium and uric acid stones The usual dose of potassium citrate is 30
- 60 mEq/day orally in 3 or 4 doses with
meals or within 30 minutes after meals.
ADULT: 15 ml 3 times daily well diluted
with water. CHILD 5-15 ml 3 times daily,
after meals and at bedtime.

Polyethylene Glycol /Macrogol 4000 A06AD15000F2101XX No A Bowel cleansing prior to colonoscopy, radiological 1 sachet dissolved in 1 L of water. 2-3 L
Powder examination or colonic surgery. Suitable for patients with of oral solution are required. When
heart failure or renal failure morning surgery is planned, the oral
solution is given in the late afternoon
the day prior. If surgery is scheduled in
afternoon, the oral solution should be
given on the same day for ingestion to
be completed three hours before
surgery
Polymyxin B Sulphate 10,000 U, S02CA03991D1001XX No B Treatment of bacterial infection and inflammation of the 3 drops 3 - 4 times daily. External
Neomycin Sulphate 5 mg and external auditory meatus auditory meatus and canal to be
Hydrocortisone 10 mg Ear Drops thoroughly cleansed and dried before
each application but soap should not be
used as the antibiotics may be
inactivated by it

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Posaconazole 40mg/ml Oral Suspension J02AC04000L8001XX No A* Prophylaxis of invasive fungal infections in the following adult Prophylaxis of invasive fungal infections:
patients: i. Patient receiving remission-induction 200mg (5ml) three times a day. The
chemotherapy for acute myelogenous leukemia (AML) or duration of therapy is based on recovery
myelodysplastic syndrome (MDS) expected to result in from neutropenia or
prolonged neutropenia and who are at high risk of developing immunosuppression. For patients with
invasive fungal infections. ii. Haematopoietic stem cell acute myelogenous leukemia or
transplant (HSCT) recipients who are undergoing high-dose myelodysplastic syndromes, prophylaxis
immunosuppressive therapy for graft versus host disease and with posaconazole should start several
who are at high risk of developing invasive fungal infections. days before the anticipated onset of
neutropenia and continue 7 days after
the neutrophil count rises above
500cell/mm3. Increasing the total daily
dose above 800mg does not further
enhance the exposure to posaconazole.

Potassium Chloride 0.15% w/v & Sodium A06AD10921L9902XX No B Prevention and treatment of potassium, sodium and chloride Dosage depends on the age, weight,
Chloride 0.9% w/v Injection depletion clinical and biological (acid-base balance)
conditions of the patient and
concomitant therapy. Maximum
recommended dose of potassium is 2 to
3 mmol/kg/24hr
Potassium Chloride 1 g/10 ml Injection B05XA01100P3001XX No B For the correction of severe hypokalaemia and when sufficient By slow IV infusion depending on the
potassium cannot be taken by mouth deficit or the daily maintenance
requirements. 1 g diluted in 500 ml
normal saline or glucose and given
slowly over 2 - 3 hours
Potassium Chloride 1 g/15 ml Mixture A12BA01100L2101XX Yes C Potassium depletion 1 g once or twice daily until serum
potassium is restored
Potassium Chloride 600 mg SR Tablet A12BA01100T5001XX Yes B For the treatment and specific prevention of hypokalaemia ADULT: 2 - 3 tablets daily. Severe
deficiency: 9 - 12 tablets daily or
according to the needs of the patient
Potassium Citrate 3 g/10 ml and Citric A12BA02955L2101XX No C For systemic or urine alkalinization ADULT: 15-30 ml well diluted with water.
Acid Mixture CHILD up to 1 year: 2.5 ml 3 times daily;
1 - 5 years: 5 ml 3 times daily; 6 - 12
years: 10 ml 3 times daily. To be taken
well diluted with water, after meals and
at bedtime.
Potassium Dihydrogen Phosphate B05XA06170P3001XX No A For treatment of hypophosphataemia Up to 10mmol phosphate administered
Injection over 12 hours
Potassium Iodide Mixture H03CA00200L2101XX No B Pre-operative management of hyperthyroidism and ADULT and CHILD: 50 - 250 mg 3 times
thyrotoxicosis daily
Potassium Permanganate 1:10,000 D08AX06362L9901XX Yes C+ Cleansing and deodorising suppurative eczematous reactions As soaks or wet dressing 1 - 3 times daily
Solution and wounds or as required
Potassium Permanganate 1:20,000 D08AX06362L9902XX Yes C Cleansing and deodorising suppurative eczematous reactions As a bath once to twice daily or as
Solution and wounds required
Povidone Iodine 10% (equivalent to 1% D08AG02000L9902XX Yes B Skin operation prior to surgery, in cleansing open wounds, as To be applied undiluted in pre-operative
iodine) Solution an antiseptic for operative wounds infections skin disinfection and general antisepsis.

Povidone Iodine 7.5% (equivalent to D08AG02000L9901XX Yes B As preoperative scrub for hands and skin Spread 5 ml over both hands and rub
0.75% iodine) Scrub thoroughly for about 5 minutes. Rinse
thoroughly. Repeat if desired. Pre-
operative use on patient: Apply scrub
and rub thoroughly for about 5 minutes.
Rinse off using a sterile gauze saturated
with water
Pralidoxime 25 mg/ml Injection V03AB04000P3002XX Yes B Antidote in the treatment of organophosphorus insecticide Adult: Used in combination with
poisoning and in the control of overdosage by anticholinergic atropine. Admin atropine via IM/IV inj
drugs used in the treatment of myasthenia gravis and repeat as needed until patient
shows signs of atropine toxicity.
Maintain atropinisation for at least 48
hr. As soon as the effects of atropine are
observed, 1-2 g of pralidoxime (chloride,
iodide or mesilate) may be given via
IM/IV inj. Repeat dose after 1 hr, then
every 8-12 hr, if necessary. In severe
poisoning, continuous infusion of 200-
500 mg/hr may be given, titrated
according to response. Alternatively,
pralidoxime chloride may be given at an
initial dose of 30 mg/kg via IV infusion
over 20 minutes or IV inj over 5 minutes,
followed by IV infusion at 8 mg/kg/hr.
Max: 12 g/24 hr. Child: As mesilate: 20-
60 mg/kg. Renal impairment: Dose
adjustment may be required.

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Pramipexole Dihydrochloride 0.125 mg N04BC05110T1001XX Yes A* Treatment for signs and symptoms of advanced idiopathic Dose escalation: 0.125 mg 3 times daily
Tablet Parkinson's disease. It may be used as monotherapy or in on week 1 then 0.25 mg 3 times daily
combination with levodopa week 2 then 0.5 mg 3 times daily on
week 3. Increase by 0.75 mg at weekly
intervals if needed up to maximum of
4.5 mg/day. Patient on levodopa:
Reduce dose. Renal impairment: In
patient with creatinine clearance <
20ml/min, the daily dose of pramipexole
should be started at 0.125 mg daily
instead of 0.25mg and the maximum
dose should not > 1.5 mg daily

Pramipexole Dihydrochloride 1 mg N04BC05110T1002XX Yes A* Treatment for signs and symptoms of advanced idiopathic Dose escalation: 0.125 mg 3 times daily
Tablet Parkinson's disease. It may be used as monotherapy or in on week 1 then 0.25 mg 3 times daily
combination with levodopa week 2 then 0.5 mg 3 times daily on
week 3. Increase by 0.75 mg at weekly
intervals if needed up to maximum of
4.5 mg/day. Patient on levodopa:
Reduced dose. Renal impairment: In
patient with creatinine clearance <
20ml/min, the daily dose of pramipexole
should be started at 0.125 mg daily
instead of 0.25mg and the maximum
dose should not > 1.5 mg daily

Pramipexole Dihydrochloride Extended N04BC05110T5001XX Yes A Treatment for signs and symptoms of advanced idiopathic Dose escalation: 0.375 mg/day on week
Release 0.375mg Tablet Parkinson's disease. It may be used as monotherapy or in 1, 0.75 mg/day on week 2, 1.5 mg/day
combination with levodopa on week 3. Increase by 0.75 mg at
weekly intervals if needed up to a max of
4.5 mg/day. Patient on l-dopa: reduce
dose. Renal Impairment: CrCl 30-50
mL/min Initially 0.375 mg every other
day. May be increased by 0.375 mg at
weekly intervals to max 2.25 mg/day

Pramipexole Dihydrochloride Extended N04BC05110T5003XX Yes A Treatment for signs and symptoms of advanced idiopathic Dose escalation: 0.375 mg/day on week
Release 1.5mg Tablet Parkinson's disease. It may be used as monotherapy or in 1, 0.75 mg/day on week 2, 1.5 mg/day
combination with levodopa on week 3. Increase by 0.75 mg at
weekly intervals if needed up to a max of
4.5 mg/day. Patient on l-dopa: reduce
dose. Renal Impairment: CrCl 30-50
mL/min Initially 0.375 mg every other
day. May be increased by 0.375 mg at
weekly intervals to max 2.25 mg/day

Prasugrel HCl 10 mg Tablet B01AC22110T1002XX No A* Co-administered with aspirin, is indicated to reduce the rate of Initiate treatment with a single 60mg
thrombotic cardiovascular (CV) events (including stent oral loading dose. Continue at
thrombosis) in patients with acute coronary syndromes who 10mg/5mg once daily with or without
are to be managed with percutaneous coronary intervention food. Patients should also take aspirin
(PCI) as follows: STEMI with or without diabetes, UA and (75 mg - 325 mg) daily.
NSTEMI with diabetes, age <75yrs old, weight >60kg, without
history of TIA stroke and clinically suspected clopidogrel
resistance subset. (Only to be used in Cardiology Centre as
third line treatment/ adjunctive therapy).

Pravastatin Sodium 20 mg Tablet C10AA03520T1001XX No A/KK Hypercholesterolaemia and coronary heart disease intolerant 10 - 20 mg once daily. Maximum: 40 mg
or not responsive to other forms of therapy. In health clinics, daily. In patients concomitantly taking
Pravastatin is restricted to HIV patients on HAART. cyclosporine, with or without other
immunosuppressive drugs: Initial dose is
10mg/day and titration to higher doses
should be performed with caution.
Maximum dose 20mg/day.

Prazosin HCl 1 mg Tablet C02CA01110T1001XX Yes B Hypertension Initially 0.5 mg 2 - 3 times daily, the
initial dose on retiring to bed at night;
increased to 1 mg 2 - 3 times daily after
3 - 7 days: further increased if necessary
to maximum 20 mg daily

Prazosin HCl 2 mg Tablet C02CA01110T1002XX Yes B Hypertension Initially 0.5 mg 2 - 3 times daily, the
initial dose on retiring to bed at night;
increased to 1 mg 2 - 3 times daily after
3 - 7 days: further increased if necessary
to maximum 20 mg daily

Prazosin HCl 5 mg Tablet C02CA01110T1003XX Yes B Hypertension Initially 0.5 mg 2 - 3 times daily, the
initial dose on retiring to bed at night;
increased to 1 mg 2 - 3 times daily after
3 - 7 days: further increased if necessary
to maximum 20 mg daily

Pre/Post Natal Vitamin & Mineral A11AA03903C1001XX No C+ Vitamin and mineral supplement for use during pregnancy and 1 capsule daily or based on individual
Capsule lactation requirements
Pre/Post Natal Vitamin & Mineral Tablet A11AA03903T1001XX No C+ Vitamin and mineral supplement for use during pregnancy and 1 tablet daily or based on individual
lactation requirements

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Prednisolone 2.5 mg/5 ml Syrup H02AB06000L9002XX Yes B i) Replacement therapy for primary and secondary i) 5 - 25 mg daily in divided doses ii) 10 -
adrenocortical insufficiency ii) Adrenogenital syndrome iii) 20 mg/m2 body surface daily in divided
Other therapy doses iii) ADULT: 5 - 60 mg daily. CHILD:
0.5 - 2 mg/kg/day in divided doses every
6 - 8 hours or as a single daily

Prednisolone 5 mg Tablet H02AB06000T1001XX Yes B i) Replacement therapy for primary and secondary i) 5 - 25 mg daily in divided doses ii) 10 -
adrenocortical insufficiency ii) Adrenogenital syndrome iii) 20 mg/m2 body surface daily in divided
Other therapy doses iii) ADULT: 5 - 60 mg daily. CHILD:
0.5 - 2 mg/kg/day in divided doses every
6 - 8 hours or as a single daily

Prednisolone acetate 1% ophthalmic S01BA04122D2001XX No A For steroid responsive inflammation of the palpebral and 1 to 2 drops to be instilled into the
suspension bulbar conjunctiva, cornea and anterior segment of the globe. conjunctival sac 2 to 4 times daily.
During the initial 24 to 48 hours the
dosage may be safely increased to 2
drops every hour. Care should be taken
not to discontinue therapy prematurely.

Pregabalin 150 mg Capsules N03AX16000C1002XX No A* i) Second line treatment of neuropathic pain in patients who i) Initially, 75 mg twice daily. May be
do not response to first line drugs ii) Fibromyalgia increased to 150 mg twice daily after 3-7
days. Max: 600 mg/day after an
additional 7-day interval ii) Initially, 75
mg twice daily. May be increased to 150
mg twice daily within 1 week or 225 mg
twice daily. Max: 450 mg/day

Pregabalin 75 mg Capsule N03AX16000C1001XX No A* i) Second line treatment of neuropathic pain in patients who i) Initially, 75 mg twice daily. May be
do not response to first line drugs ii) Fibromyalgia increased to 150 mg twice daily after 3-7
days. Max: 600 mg/day after an
additional 7-day interval ii) Initially, 75
mg twice daily. May be increased to 150
mg twice daily within 1 week or 225 mg
twice daily. Max: 450 mg/day

Primaquine 7.5 mg base Tablet P01BA03162T1001XX Yes B i) Treatment of malaria ii) Prophylaxis together with a i) 15 mg daily for 14 days, increased to
schizonticide such as chloroquine higher doses or longer course if
resistance in P.vivax occurs. ii) ADULT:
30 mg once weekly. CHILD: 0.5 mg once
weekly Child: 250 mcg/kg daily for 14
days. Should be taken with food. Take
with meals to avoid GI discomfort.

Primidone 250 mg Tablet N03AA03000T1001XX No B Epilepsy ADULT: Initially 1 tablet daily in the
evening, increasing by 1 tablet every 4 -
7 days to 3 - 4 tablets daily. Maximum
dosage: 1.5 g daily in divided doses.
CHILD: 6 - 8 years: Up to 1/2 adult dose

Probenecid 500 mg Tablet M04AB01000T1001XX No A Hyperuricemia associated with gout and gouty arthritis (for 500 mg to 1000 mg twice daily
cases allergic to allopurinol or serum uric acid not controlled
by allopurinol alone)
Procaine Benzylpenicillin Aqueous 3 J01CE09702P4001XX No B Treatment of infections due to Penicillin G-sensitive organisms ADULT: 300,000 - 900,000 units (300 -
mega units (3 g) Injection 900 mg) IM daily. CHILD: Up to 1 year:
150 mg IM daily. 1 - 5 years: 300 mg IM
daily. 6 - 12 years: 600 mg IM daily

Procaine Penicillin Fortified 4 MU J01CE09702P4002XX No B Treatment of infections due to Penicillin G-sensitive organisms ADULT: 300,000 - 900,000 units (300 -
Injection 900 mg) IM daily. CHILD: Up to 1 year:
150 mg IM daily. 1 - 5 years: 300 mg IM
daily. 6 - 12 years: 600 mg IM daily

Procarbazine HCl 50 mg Capsule L01XB01110C1001XX Yes A Lymphomas Adult: Monotherapy: Initially, 50

mg/day, increased by 50 mg daily to 250-
300 mg daily in divided doses. Continue
doses until max response is achieved or
appearance of signs of toxicity.
Maintenance: 50-150 mg/day or 1-2
mg/kg daily until a cumulative dose of at
least 6 g. Combination Therapy: 100
mg/m2 on days 1-14 of each 4- or 6-wk
cycle. Child: Initially, 50 mg/m2 daily, up
to 100 mg/m2 adjust according to
response.

Prochlorperazine Maleate 5mg Tablet N05AB04253T1002XX Yes B i) Severe nausea and vomiting ii) Vertigo/labyrinthine Nausea and vomiting Adult: As maleate
disorders or mesilate: 20 mg, further doses are
given if needed. Recommended buccal
dose: As maleate: 3-6 mg bid. Vertigo
Adult: As maleate or mesilate: 15-30 mg
daily, given in divided doses. May reduce
gradually to 5-10 mg daily.
Recommended buccal dose: 3-6 mg bid.
May be taken with or without food.

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Prochlorperazine Mesylate 12.5 mg/ml N05AB04253P3001XX Yes B i) Severe nausea and vomiting ii) Vertigo/labyrinthine Deep IM injection, 12.5 mg repeated if
Injection disorders necessary after 6 hours and then
followed by an oral dose. Not
recommended in children
Procyclidine HCl 5 mg/ ml Injection N04AA04110P3001XX No B i) All forms of Parkinson's disease (idiopathic paralysis i) Initial dose 2.5mg TDS, increasing by
agitants), post-encephalitis and arteriosclerosis ii) To control 2.5-5mg/day at intervals of 2 or 3 days
troublesome extrapyramidal symptoms induced by until the optimum clinical response is
neuroleptic drugs including pseudo-parkinsonism, acute achieved. Usual maintenance dose: 15-
dystonic reactions and akathisia 30mg/day. Max: 60mg/day ii) Initial dose
2.5mg TDS, increasing by 2.5mg daily
until symptoms are relieved. Usual
maintenance dose: 10-30mg/day. IV
Emergency: 5-10 mg. IM Emergency: 5-
10 mg as a single dose, may repeat after
20 mins if needed. Max: 20 mg/day.

Progesterone 100 mg capsule G03DA04000C1001XX No A* Supplementation of the luteal phase. Oral route: On average for progesterone
insufficiency, the daily dose of
progesterone is 200-300mg per day; one
capsule after breakfast and one to two
capsules at bedtime. Vaginal route: 4 to
6 capsules (in 2 to 3 divided doses) per
day starting from the day of the HCG
injection until the 12th week of
pregnancy.
Progesterone 8% Vaginal Gel G03DA04000G3001XX No A* Treatment of infertility due to inadequate luteal phase 90 mg intravaginally daily from day of
egg retrieval till pregnancy established

Prolase Tablet M09AB00000T1001XX No B Oedema and inflammation in conjunction with other physical 2 tablet 4 times daily
or chemotherapeutic measures
Promethazine HCl 25 mg/ml Injection R06AD02110P3001XX Yes B Allergic conditions By deep IM: ADULT: 25 - 50 mg,
maximum 100 mg. CHILD 5 - 10 years :
6.25 - 12.5 mg. By slow IV: 25 - 50 mg in
a solution of 2.5 mg/ml in water for
injection. Maximum 100 mg
Promethazine HCl 5 mg/5 ml Syrup R06AD02110L9001XX Yes B Allergic conditions CHILD 2 - 5 years: 5 - 15 mg daily 5 - 10
years : 10 - 25 mg daily
Proparacaine HCI 0.5% Ophthalmic S01HA04110D2001XX Yes B Topical anaesthesia in ophthalmic procedures Deep anaesthesia:1 or 2 drops in the
Drops (eyes) every 5 to 10 minutes for 3 to 5
doses. For minor surgical procedures:
instill 1 to 2 drops every 5 to 10 minutes
for 1 to 3 doses. Tonometry and/or
tonography procedure: 1 to 2 drops in
each eye before procedure.

Propiverine HCl 15 mg Tablet G04BD06110T1001XX No A* Treatment of urinary incontinence, urgency and frequency in ADULT: 15 mg twice daily to 3 times
neurogenic detrusor overactivity (detrusor hyperreflexia) and daily, increase to 4 times daily if
in idiopathic detrusor overactivity (overactive bladder) required. Max dose: 60 mg daily. CHILD
more than 5 years: 0.2 to 0.4 mg/kg per
day in 2 divided doses
Propofol 10mg/ml (1%) Injection N01AX10000P9901XX Yes A* Induction & maintenance of general anaesthesia. Sedation of Adult: Induction: 20- 40 mg by injection
ventilated ICU patients or infusion every 10 sec. Usual dose: 1.5-
2.5 mg/kg. Maintenance: 4-12 mg/kg/hr
or intermittent bolus inj of 20-50 mg.
Child: >8 yr: Induction dose of 2.5
mg/kg. Maintenance dose: 9-15
mg/kg/hr by IV infusion or intermittent
bolus inj. Elderly: Including neurosurgical
and debilitated patients: Infuse at a rate
of 20 mg every 10 sec. Maintenance: 3-6
mg/kg/hr. Usual dose needed: 1-1.5
mg/kg. Duration of use : Can be
administered for a maximum period of 7
days. Sedation: 0.3 - 4 mg/kg/hour up to
3 days

Propofol 20mg/ml (2%) emulsion for N01AX10000P9902XX Yes A* Induction & maintenance of general anaesthesia. Sedation of Adult: IV Induction and maintenance of
injection of infusion ventilated ICU patients general anesth Induction: 40 mg every
10 sec. Maintenance: 4-12 mg/kg/hr or
intermittent boluses of 20-50 mg.
Sedation In diagnostic and surgical
procedures: Initial: 6-9 mg/kg/hr by
infusion. Maintenance: 1.5-4.5
mg/kg/hr. For ventilated patients: 0.3-4
mg/kg/hr. Monitor lipid concentrations
if duration of sedation >3 days.

Propranolol HCl 1 mg/ml Injection C07AA05110P3001XX Yes A Arrhythmias and thyrotoxicosis crisis Slow IV injection in a dose of 1 mg over 1
minute, repeated if necessary every 2
minutes until a maximum of 10 mg has
been given in conscious patients and 5
mg in patients under anaesthesia. CHILD:
25 - 50 mcg/kg slow IV with appropriate
monitoring
Propranolol HCl 10 mg Tablet C07AA05110T1001XX Yes B Dysrythmias, tachycardia, hypertrophic obstructive 10 - 40 mg 3 - 4 times daily
cardiomyopathy (For cardiologist only)

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Propranolol HCl 40 mg Tablet C07AA05110T1002XX Yes B i) Hypertension ii) Angina iii) Myocardial infarct iv) Cardiac i) Initially 80 mg twice daily increased as
arrhythmia v) Portal hypertension vi) Migraine vii) required to a usual range of 160 - 320
Thyrotoxicosis mg daily. CHILD: Initial doses of 1 mg/kg
in divided doses, can be increased to 2 -
4 mg/kg/day in divided doses ii) Initial
dose of 40 mg 2 - 3 times daily.
Maintenance 120 - 240 mg daily iii)
40mg 4 times daily for 2 - 3 days then 80
mg twice daily, beginning 5 - 21 days
after infarction iv) 10 - 40 mg 3 - 4 times
daily v) Initially 40 mg twice daily. The
dose may be increased as required up to
160 mg twice daily vi) Initial prophylaxis
dose: 40 mg 2 - 3 times daily. The dose
may be increased at weekly intervals up
to 160 mg daily vii) Adjunct: 10 - 40 mg 3
- 4 times daily. CHILD: Arrythmias,
thyrotoxicosis: 0.25 - 0.5 mg/kg 3 - 4
times daily as required

Propylthiouracil 50 mg Tablet H03BA02000T1001XX Yes B Hyperthyroidism ADULT Initially 300-450mg in 8 hourly

intervals (can be given up to 600-
900mg/daily) until symptoms are
controlled in 1-2 months. Maintenance
50-150mg daily for at least 12-18
months. CHILDREN 6-10 years: 50-
150mg. CHILDREN > 10 years: 150-
300mg daily. All doses are to be given in
3 divided doses daily. Taken with food.

Protamine Sulphate 10 mg/ml Injection V03AB14183P3001XX Yes B Heparin overdose and following cardiac or arterial surgery or 5 ml slow IV injected over 10 minutes. If
dialysis procedures when required to neutralize the effects of administered within 15 minutes of
heparin administered during extracorporeal circulation heparin dose, 1 mg will neutralise
approximately 100 units of heparin. If
longer time has elapsed, less protamine
is required. Not more than 50 mg should
be injected at any one time. The dose is
dependent on the amount and type of
heparin to be neutralised, its route of
administration and the time elapsed
since it was last given and blood
coagulation studies.

Protein Free Haemodialysate 10% Jelly D03AX00000G4001XX No A Trophic lesions in patients with arterial occlusive disease and Apply 3 - 5 times daily
with chronic venous insufficiency, burn injuries, impaired
wound healing, decubitus ulcers and skin ulcer caused by
irradiation
Protein Free Haemodialysate 20% Eye S01XA20000G3001XX No A Eyes disorders e.g. burns, scalds, ulcers, prevention and Instill 1 drop 3 - 4 times daily
Gel treatment of radiation dermatitis, traumatic and ischaemic
wound
Protein Free Haemodialysate 5% D03AX00000G5001XX No A Trophic lesions in patients with arterial occlusive disease and Apply 3 - 5 times daily
Ointment with chronic venous insufficiency, burn injuries, impaired
wound healing, decubitus ulcers and skin ulcer caused by
irradiation
Protein Free Haemodialysate Dental D03AX00000G6001XX No A Painful and inflammatory affliction on the oral mucosa, gums Apply to lesions 3 - 5 times daily
Adhesive Paste and lips, teething pain, denture pressure sores, oral and
maxillofacial surgery and dressing after scaling
Pyrantel Pamoate 125 mg Tablet P02CC01127T1001XX No C Intestinal nematodes ADULT and CHILD : 2 years and older -
single dose 10mg/kg body weight once.
Maximum 1 g
Pyrantel Pamoate 250 mg Tablet P02CC01127T1002XX No C Intestinal nematodes ADULT and CHILD : 2 years and older -
single dose 10mg/kg body weight once.
Maximum 1 g
Pyrazinamide 500 mg Tablet J04AK01000T1001XX Yes B Tuberculosis Adult: 20-40mg/kg daily (max 1500mg)
or 50mg/kg biweekly (max 2000mg).
Children: 20-30mg/kg daily or 30-
40mg/kg thrice weekly.
Pyridostigmine Bromide 60 mg Tablet N07AA02320T1001XX Yes B Myasthenia gravis ADULT: 30 - 120 mg at suitable intervals
throughout the day, total daily dose 0.3 -
1.2 g. CHILD up to 6 years initially 30 mg,
6 - 12 years initially 60 mg, usual total
daily dose 30 - 360 mg

Pyridoxine HCl 10 mg Tablet A11HA02110T1001XX Yes C+ i)Pyridoxine-dependent convulsions in infant ii)Sideroblastic i) INFANT 4 mg/kg daily for short periods
anaemia iii)B6-deficient anaemia in adult iv) Prophylaxis to ii) 100 - 400 mg daily in divided doses iii)
peripheral neuritis in isoniazid therapy v) Nausea and vomiting ADULT 20 - 50 mg up to 3 times daily iv)
of pregnancy and irradiation sickness Prophylaxis 10 mg daily, therapeutic 50
mg 3 times daily v) 20 - 100 mg daily

Pyridoxine HCl 50 mg/2 ml Injection A11HA02110P3001XX No B i) Pyridoxine-dependent convulsions in infancy ii) Sideroblastic i) INFANT 4 mg/kg daily for short periods
anaemia iii) B6-deficient anaemia in adult iv) Prophylaxis to ii) 100 - 400 mg daily in divided doses iii)
peripheral neuritis in isoniazid therapy v) Nausea and vomiting ADULT 20 - 50 mg up to 3 times daily iv)
of pregnancy and irradiation sickness Prophylaxis 10 mg daily, therapeutic 50
mg 3 times daily v) 20 - 100 mg daily

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Quetiapine Fumarate 100 mg Immediate N05AH04138T1002XX No A* i) Schizophrenia ii) Short term treatment of acute manic i) Initial titration schedule over 4 days:
Release Tablet episodes associated with bipolar I disorder, either 25 mg twice daily on Day 1, increase in
monotherapy or adjunct to lithium or divalproex iii) Treatment steps of 25 - 50 mg 2 to 3 times daily on
of depressive episodes associated with bipolar disorder Days 2 and 3 to reach target dose of 300 -
400 mg daily by Day 4, given in 2 - 3
divided doses. Institute further dose
adjustments, if indicated, at intervals of
2 days or more, in steps of 25 - 50 mg
twice daily ii) 100 mg (Day 1), 200 mg
(Day 2), 300 mg (Day 3) & 400 mg (Day
4). Further dosage adjustments up to
800 mg/day by Day 6 should be in
increments of not more than 200
mg/day. Adjust dose within the range of
200 - 800 mg/day depending on clinical
response and tolerability of the patient.
Usual effective dose range: 400 - 800
mg/day iii) 50 mg ORALLY once a day on
Day 1, then 100 mg once daily on Day 2,
then 200 mg once daily on Day 3, then
300 mg once daily on Day 4 (all doses
given at bedtime); patients requiring
higher doses should receive 400 mg on
Day 5, increased to 600 mg on Day 8
(week 1)
Quetiapine Fumarate 200 mg Extended N05AH04138T5002XX No A* i)Schizophrenia ii) Moderate to severe manic episodes in i) & ii) 300 mg once daily on Day 1 then
Release Tablet bipolar disorder iii) Major depressive episodes in bipolar 600 mg on Day 2. Maintenance dose:
disorder 400 to 800 mg once daily. Maximum
dose: 800 mg daily iii) 50 mg on Day 1,
100 mg on Day 2, 200 mg on Day 3 and
300 mg on Day 4. Recommended daily
dose is 300 mg. May be titrated up to
600 mg daily. In elderly or hepatic
impairment:Start with 50mg/ day, may
be increased in increments of 50mg /day
to an effective dose.

Quetiapine Fumarate 200 mg Immediate N05AH04138T1004XX No A* i) Schizophrenia ii) Short term treatment of acute manic i) Initial titration schedule over 4 days:
Release Tablet episodes associated with bipolar I disorder, either 25 mg twice daily on Day 1, increase in
monotherapy or adjunct to lithium or divalproex iii) Treatment steps of 25 - 50 mg 2 to 3 times daily on
of depressive episodes associated with bipolar disorder Days 2 and 3 to reach target dose of 300 -
400 mg daily by Day 4, given in 2 - 3
divided doses. Institute further dose
adjustments, if indicated, at intervals of
2 days or more, in steps of 25 - 50 mg
twice daily ii) 100 mg (Day 1), 200 mg
(Day 2), 300 mg (Day 3) & 400 mg (Day
4). Further dosage adjustments up to
800 mg/day by Day 6 should be in
increments of not more than 200
mg/day. Adjust dose within the range of
200 - 800 mg/day depending on clinical
response and tolerability of the patient.
Usual effective dose range: 400 - 800
mg/day iii) 50 mg ORALLY once a day on
Day 1, then 100 mg once daily on Day 2,
then 200 mg once daily on Day 3, then
300 mg once daily on Day 4 (all doses
given at bedtime); patients requiring
higher doses should receive 400 mg on
Day 5, increased to 600 mg on Day 8
(week 1)
Quetiapine Fumarate 300 mg Extended N05AH04138T5003XX No A* i) Schizophrenia ii) Moderate to severe manic episodes in i) & ii) 300 mg once daily on Day 1 and
Release Tablet bipolar disorder iii) Major depressive episodes in bipolar 600 mg on Day 2. Maintenance dose:
disorder 400 ? 800 mg once daily. Maximum
dose: 800 mg daily iii) 50 mg on Day 1,
100 mg on Day 2, 200 mg on Day 3 and
300 mg on Day 4. Recommended daily
dose is 300 mg. May be titrated up to
600 mg daily
Quetiapine Fumarate 400 mg Extended N05AH04138T5004XX No A* i) Schizophrenia ii) Moderate to severe manic episodes in i) & ii) 300 mg once daily on Day 1 and
Release Tablet bipolar disorder iii) Major depressive episodes in bipolar 600 mg on Day 2. Maintenance dose:
disorder 400 ? 800 mg once daily. Maximum
dose: 800 mg daily iii) 50 mg on Day 1,
100 mg on Day 2, 200 mg on Day 3 and
300 mg on Day 4. Recommended daily
dose is 300 mg. May be titrated up to
600 mg daily

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Generic Name MDC NEML Category Indications Dosage

Quetiapine Fumarate 50 mg Extended N05AH04138T5001XX No A* i)Schizophrenia ii)Moderate to severe manic episodes in i) & ii) 300 mg once daily on Day 1 then
Release Tablet bipolar disorder iii)Major depressive episodes in bipolar 600 mg on Day 2. Maintenance dose:
disorder 400 to 800 mg once daily. Maximum
dose: 800 mg daily. iii)50 mg on Day 1,
100 mg on Day 2, 200 mg on Day 3 and
300 mg on Day 4. Recommended daily
dose is 300 mg. May be titrated up to
600 mg daily. In elderly or hepatic
impairment: Start with 50mg/ day, may
be increased in increments of 50mg /day
to an effective dose.

Quinine Dihydrochloride 600 mg/2 ml P01BC01110P3001XX Yes B Severe and complicated malaria By slow intravenous infusion (over 4
Injection hours). ADULT : 20 mg/kg followed by 10
mg/kg every 8 hours. CHILD : 20 mg/kg
followed by 10 mg/kg every 12 hours,
initial dose should be half in patients
who have received quinine, quinidine or
mefloquine during the previous 12 or 24
hours
Quinine Sulphate 300 mg Tablet P01BC01183T1001XX Yes B Severe and complicated malaria 300 - 600 mg daily. Treatment : 1.2 - 2 g
daily in divided doses. CHILDS less than 1
year : 100 - 200 mg daily, 1 - 3 years :
200 - 300 mg daily, 4 - 6 years: up to 500
mg daily, more than 7 years : up to 1 g
daily. All above doses are given for 7
days in 2 - 3 divided doses

Rabeprazole Sodium 20 mg Tablet A02BC04520T1001XX No A* i) Treatment and maintenance of erosive or ulcerative i) 10-20 mg daily for 4-8 weeks,
gastroesophageal reflux disease (GERD) ii) Duodenal ulcers maintenance 10-20 mg daily ii) 20 mg
daily at morning for up to 4-8 weeks

Rabies Vaccine Injection J07BG01000P4001XX No B Pre-exposure and post-exposure vaccination against rabies Pre-exposure (prophylaxis): 3 doses
scheduled on D0, D7 and D28. Booster
dose after every 6 months to 5 years
(refer to manufacturer's
recommendations). Post-exposure
prophylaxis: use after attack of a
potential rabid animal: 1 dose on D0, D3,
D7, D14 and D28. In previously
vaccinated individuals 2 doses on D0 and
D3.
Raloxifene HCl 60 mg Tablet G03XC01110T1001XX No A* Prevention and treatment of postmenopausal osteoporosis 1 tablet daily

Raltegravir 400 mg tablet J05AX08500T1001XX No A* Raltgeravir combination with other antiretroviral agents is 400mg administered orally, twice daily
indicated for the treatment of HIV-1 infection in patients who with or without food, to be given
are contraindicated to boosted Protease Inhibitor or who are combination with other antiretroviral
intolerant to boosted Protease Inhibitor. agent.

Ramipril 2.5 mg Tablet C09AA05000T1001XX No A i) Hypertension and congestive heart failure ii) Post- i) Hypertension: Initially 2.5 mg once
myocardial infarction iii) Reducing risk of myocardial daily, increased at intervals of 1 - 2
infarction, stroke or cardiovascular death in diabetics or weeks to maximum 10 mg once daily;
patients with increased cardiovascular risks Congestive heart failure:Initially 1.25 mg
once daily. Max: 10 mg/day ii) Initially
2.5 mg twice daily for 2 days then
increased to maximum 5 mg twice daily
iii) Initially 1.25 - 2.5 mg once daily,
increased to 5 mg once daily after 1
week, maximum dose: 10 mg once daily
after 3 weeks
Ramipril 5 mg Tablet C09AA05000T1002XX No A i) Hypertension and congestive heart failure ii) Post- i) Hypertension: Initially 2.5 mg once
myocardial infarction iii) Reducing risk of myocardial daily, increased at intervals of 1 - 2
infarction, stroke or cardiovascular death in diabetics or weeks to maximum 10 mg once daily;
patients with increased cardiovascular risks Congestive heart failure:Initially 1.25 mg
once daily. Max: 10 mg/day ii) Initially
2.5 mg twice daily for 2 days then
increased to maximum 5 mg twice daily
iii) Initially 1.25 - 2.5 mg once daily,
increased to 5 mg once daily after 1
week, maximum dose: 10 mg once daily
after 3 weeks
Ranibizumab 10 mg/ml Intravitreal S01LA04000P3001XX No A* i) Treatment of Neovascular (wet) Age-Related Macular 0.5 mg (0.05ml) as a single intravitreal
Injection Degeneration (ARMD). ii) Treatment of visual impairment due Injection.Interval between 2 doses
to diabetic macular edema (DME). iii) Treatment of visual should not be shorter than 1 month,
impairment due to macular edema secondary to retinal vein then monitor for visual acuity monthly.
occlusion (RVO). iv) Treatment of visual impairment due to Treatment is given monthly & continued
choroidal neovascularization (CNV) secondary to pathologic until max visual acuity is achieved,
myopia (PM). Note: Indication ii) and iii) approved to be used confirmed by stable visual acuity for 3
by retinal specialist only (PFUKKM 1/2015) consecutive monthly assessments.

Ranitidine 150 mg Tablet A02BA02110T1001XX Yes B i) Benign gastric and duodenal ulcer ii) Reflux oesophagitis iii) i) 150 mg twice daily (at morning and
Non-ulcer dyspepsia iv) Zollinger-Ellison Syndrome night) or 300 mg on night for 4-8 weeks.
Maintenance: 150-300 mg on night ii)
150 mg twice daily or 300 mg on night
for 8-12 weeks iii) 150 mg daily or twice
daily iv) 150 mg and may be increased as
necessary to 6 g/day

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Generic Name MDC NEML Category Indications Dosage

Ranitidine 150 mg/10 ml Syrup A02BA02110L9001XX No B Peptic ulcer disease CHILD 2-4 mg/kg 2 times daily.
Maximum 300 mg daily
Ranitidine 25 mg/ml Injection A02BA02110P3001XX No B i) Benign gastric/ duodenal ulceration, reflux oesophagitis, i) ADULT: Slow IV injection of 50 mg
Zollinger Ellison Syndrome ii) Stress ulcer prophylaxis in post- diluted to 20 ml and given over at least 2
operative and high risk patients minutes. May be repeated every 6-8
hours or IV infusion at rate of 25
mg/hour for 2 hours, may be repeated at
6-8 hours intervals or IM. CHILD: 1
mg/kg/dose 6-8 hourly. ii) Initial slow IV
injection of 50 mg, then continuous
infusion of 125-250 mcg/kg/hour

Ranitidine 300 mg Tablet A02BA02110T1002XX Yes B i) Benign gastric and duodenal ulcer ii) Reflux oesophagitis iii) i) 150 mg twice daily (at morning and
Non-ulcer dyspepsia iv) Zollinger-Ellison Syndrome night) or 300 mg on night for 4-8 weeks.
Maintenance: 150-300 mg on night ii)
150 mg twice daily or 300 mg on night
for 8-12 weeks iii) 150 mg daily or twice
daily iv) 150 mg and may be increased as
necessary to 6 g/day

Recombinant factor VIII 250 IU Injection B02BD02000P4001XX No A* i)Control and prevention of bleeding episodes in adults and The dosage and duration of treatment
children (0-16 years) with hemophilia A. ii)Surgical prophylaxis should be individualised and taking into
in adults and children with hemophilia A. iii)Routine account the severity of factor VIII
prophylactic treatment to reduce the frequency of bleeding deficiency, location and extent of
episodes and the risk of joint damage in children with no pre- bleeding and patient's clinical condition.
existing joint damage. Not indicated fot the treatment of von Dose can be calculated by using: i.
willebrand's disease. Required dose (IU) = body weight (kg) x
desired factor VIII rise (IU/dl or % of
normal) x 0.5 (IU/kg) or ii. Expected
factor VIII rise (% of normal) = 2 x (dose
administered)/ bodyweight (kg) Dose
administered should be titrated to
patient's clinical response

Recombinant Factor VIII 500 IU Injection B02BD02000P4002XX No A* i)Control and prevention of bleeding episodes in adults and The dosage and duration of treatment
children (0-16 years) with hemophilia A. ii)Surgical prophylaxis should be individualised and taking into
in adults and children with hemophilia A. iii)Routine account the severity of factor VIII
prophylactic treatment to reduce the frequency of bleeding deficiency, location and extent of
episodes and the risk of joint damage in children with no pre- bleeding and patient's clinical condition.
existing joint damage. Not indicated for the treatment of von Dose can be calculated by using: i.
willebrand's disease. Required dose (IU) = body weight (kg) x
desired factor VIII rise (IU/dl or % of
normal) x 0.5 (IU/kg) or ii. Expected
factor VIII rise (% of normal) = 2 x (dose
administered)/ bodyweight (kg) Dose
administered should be titrated to
patient's clinical response.

Remifentanil 5 mg Injection N01AH06110P4001XX No A* i) As an analgesic agent for use during induction and/or For IV use only. ADULT: Induction:Bolus
maintenance of general anaesthesia during surgical infusion: 1µg/kg over 30-60 seconds;
procedures including cardiac surgery. ii)Continuation of Continuous infusion: 0.5-1µg/kg/min;
analgesia into the immediate post-operative period under Maintenance: Continuous infusion:
close supervision, during transition to longer acting analgesia. 0.025 to 2 µg/kg/min. CHILD (1-12 years
iii)Provision of analgesia and sedation in mechanically of age): Induction: Insufficient data;
ventilated intensive care patients. Neonates: IV infusion 0.4-1.0
mcg/kg/minute depending on the
anaesthetic method and adjust
according to patient response,
supplemental IV inj of 1 mcg/kg dose
may be given. 1-12 yr: initially 0.1-1
mcg/kg by IV inj over at least 30 seconds
(excluded if not needed), followed by IV
infusion 0.05-1.3 mcg/kg/minute
depending on the anaesthetic method
and adjust according to patient
response, supplemental IV bolus inj may
be admin during infusion. 12-18 yr: 0.1-1
mcg/kg IV inj over at least 30 seconds
(excluded if not needed), followed by IV
infusion of 0.05-2 mcg/kg/minute
depending on anaesthetic method and
adjust according to patient response,
supplemental IV bolus inj may be admin
during infusion.
Ribavirin 200 mg Capsule J05AB04000C1001XX Yes A* For the treatment of chronic hepatitis C (in combination with ADULT (more than 18 years old):
interferon alfa-2a/2b) 50mg/kg/day Recommended: Body
weight: ≤ 75kg should receive 1000mg
daily as two 200mg capsules in the
morning and three 200mg capsules in
the evening Body weight: >75kg should
receive 1200mg as three 200mg capsules
in the morning and three 200mg
capsules in the evening Genotype 1,4: 48
weeks Genotype: 24 weeks duration
should be individualized in accordance
with the baseline characteristics of the
disease.

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Generic Name MDC NEML Category Indications Dosage

Riboflavine 3 mg Tablet A11HA04000T1001XX No C For prevention and treatment of riboflavine deficiency CHILD: 2.5-10 mg/day in divided doses.
ADULT: 5-30 mg/day in divided doses

Rifampicin 100 mg/5 ml Syrup J04AB02000L9001XX Yes A Tuberculosis and leprosy CHILD: 20 mg/kg body weight daily in 1 -
2 doses. Up to 1 year: 10 mg/kg body
weight in a single daily dose
Rifampicin 150 mg Capsule J04AB02000C1001XX Yes B i) Tuberculosis ii) Leprosy iii) Prophylaxis for meningococcal i) ADULT: 450 - 600 mg as a single
meningitis morning dose. CHILD: 10 - 20 mg/kg
body weight daily in 1 - 2 doses. Directly
observed therapy (DOT): 10 mg/kg twice
weekly or 3 times/week. Maximum: 600
mg ii) 600 mg/day iii) 600 mg twice daily
for 2 days
Rifampicin 150 mg, Isoniazid 75 mg, J04AM06000T1001XX Yes B Treatment of both pulmonary and extrapulmonary ADULT: 30 - 37 kg: 2 tablets daily, 38 - 54
Pyrazinamide 400 mg & Ethambutol HCl tuberculosis, in the intensive treatment phase kg: 3 tablets daily, 55 - 70 kg: 4 tablets
275 mg Tablet daily, more than 70 kg: 5 tablets daily

Rifampicin 150mg + Isoniazid 75mg J04AM02000T1001XX Yes B For pulmonary tuberculosis in which organisms are susceptible 30-37kg: 2 tablets once daily, 38-54kg: 3
tablet in continuation phase treatment for 4 months tablets once daily, 55-70kg: 4 tablets
once daily, Above 70kg: 5 tabs once daily

Rifampicin 300 mg Capsule J04AB02000C1002XX Yes B i) Tuberculosis ii) Leprosy iii) Prophylaxis for meningococcal i) Tuberculosis ADULT: Daily doses:
meningitis 10mg/kg/day Body weight doses: 10-
15/kg/day CHILD: 10 - 20 mg/kg body
weight daily in 1 - 2 doses. Maximum
daily dose : 600mg Directly observed
therapy (DOT): 10 mg/kg twice weekly or
3 times/week. Maximum: 600 mg ii)
Leprosy: ADULT: 600 mg/day CHILDREN:
10mg/kg iii) Prophylaxis for
meningococcal meningitis: ADULT: 600
mg twice daily for 2 days CHILDREN:
10mg/kg twice daily for 2 days INFANT:
5mg/kg twice daily for 2 days"

Rifampicin, Dapsone & Clofazimine J04AM02961T9901XX No B For the treatment of leprosy and tuberculosis Rifampicin: 600 mg once monthly,
Dapsone: 100 mg daily, Clofazimine: 300
mg once monthly and 50 mg daily (or
100 mg on alternate days)
Ringers Solution (contained sodium B05XA30905P6001XX No B As a source of electrolytes and water for According to the needs of the patient
chloride, potassium chloride and calcium hydration/replenishing of chloride
chloride)
Risperidone 1 mg Tablet N05AX08000T1001XX Yes B Psychoses and schizophrenia ADULT : 2 mg in 1 - 2 divided doses on
first day then 4 mg in 1 - 2 divided doses
on 2nd day then 6 mg in 1 - 2 divided
doses on 3rd day (slower titration
appropriate in some patients); usual
range 4 - 8 mg daily; dose above 10 mg
daily only if benefit outweigh risk
(maximum 16 mg daily). Elderly (or in
hepatic or renal impairment): initially 0.5
mg twice daily increased in steps of 0.5
mg twice daily to 1 - 2 mg twice daily.
Not recommended in children under 15
years

Risperidone 1 mg/ml Oral Solution N05AX08000L5001XX Yes A Psychoses and schizophrenia ADULT: 2 mg in 1 - 2 divided doses on
1st day then 4 mg in 1 - 2 divided doses
on 2nd day then 6 mg in 1 - 2 divided
doses on 3rd day (slower titration
appropriate in some patients); usual
range 4 - 8 mg daily; dose above 10 mg
daily only if benefit outweighs risk
(maximum 16 mg daily). Elderly (or in
hepatic or renal impairment): initially 0.5
mg twice daily increased in steps of 0.5
mg twice daily to 1-2 mg twice daily. Not
recommended in children under 15
years

Risperidone 2 mg Tablet N05AX08000T1002XX Yes B Psychoses and schizophrenia ADULT : 2 mg in 1 - 2 divided doses on
first day then 4 mg in 1 - 2 divided doses
on 2nd day then 6 mg in 1 - 2 divided
doses on 3rd day (slower titration
appropriate in some patients); usual
range 4 - 8 mg daily; dose above 10 mg
daily only if benefit outweigh risk
(maximum 16 mg daily). Elderly (or in
hepatic or renal impairment): initially 0.5
mg twice daily increased in steps of 0.5
mg twice daily to 1 - 2 mg twice daily.
Not recommended in children under 15
years

Risperidone 25 mg Injection (Long N05AX08000P3001XX No A* Treatment of acute and chronic schizophrenic psychosis and 25 mg IM every 2 weeks. Dose
Acting) other psychotic conditions, in which positive and negative increments (if required) to 37.5 mg or 50
symptoms are prominent. It also alleviates affective symptoms mg can be considered after a minimum
associated with schizophrenia of 4 weeks on each dosage

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Generic Name MDC NEML Category Indications Dosage

Risperidone 37.5 mg Injection (Long N05AX08000P3002XX No A* Treatment of acute and chronic schizophrenic psychosis and 25 mg IM every 2 weeks. Dose
Acting) other psychotic conditions, in which positive and negative increments (if required) to 37.5 mg or 50
symptoms are prominent. It also alleviates affective symptoms mg can be considered after a minimum
associated with schizophrenia of 4 weeks on each dosage
Risperidone 50 mg Injection (Long N05AX08000P3003XX No A* Treatment of acute and chronic schizophrenic psychosis and 25 mg IM every 2 weeks. Dose
Acting) other psychotic conditions, in which positive and negative increments (if required) to 37.5 mg or 50
symptoms are prominent. It also alleviates affective symptoms mg can be considered after a minimum
associated with schizophrenia of 4 weeks on each dosage
Ritonavir 100 mg Capsule J05AE03000C1001XX Yes A* Progressive or advanced HIV infection in combination with ADULT: (Single PI) initially 300 mg twice
other antiretroviral agents. Criteria for use: a) Clinical AIDS b) daily, increase by 100 mg twice daily
CD4 less than 350 cells or c) Viral load more than 10,000 increments to 600 mg twice daily. (Dual
copies/ml PI) Initially 200mg BD, then increase by
100mg BD & reaching 400mg BD within
2 wk.
Ritonavir 80 mg/ml Solution J05AE03000L9901XX Yes A* Progressive or advanced HIV infection in combination with ADULT: 400 - 600 mg twice daily. CHILD:
other antiretroviral agents. Criteria for use: a) Clinical AIDS b) >1 month, initiate at dise of 25mg/m2
CD4 less than 350 cells or c) Viral load more than 10,000 twice daily, titrate dose upward every 2-
copies/ml 3 days by 50mg/m2 twice daily
(maximum dose 600mg twice daily)

Rituximab 10 mg/ml Injection L01XC02000P3001XX No A* i) Treatment of patients with relapsed or chemo-resistant low i) 375 mg/m2 BSA administered as an IV
grade or follicular B-cell Non-Hodgkin's lymphoma ii) infusion through a dedicated line once
Adjunctive therapy with combination chemoagents for weekly for 4 weeks ii) Combination with
aggressive Non-Hodgkin Lymphoma iii) Severe active CHOP (cyclophosphamide, doxorubicin,
rheumatoid arthritis with inadequate response or intolerance prednisone and vincristine) as 375
to other disease-modifying anti-rheumatic drugs (DMARDs) mg/m2 BSA on day 1 of each
including one or more tumour necrosis factor (TNF) inhibitor chemotherapy cycle for 8 cycles after IV
therapies iv) Maintenance in relapsed/ refractory follicular administration of the glucocorticoid
lymphoma after response to induction therapy component of CHOP. iii) 1000 mg IV
infusion followed by a second 1000 mg
IV infusion two weeks later iv)
375mg/m2 BSA once every 3 months
until disease progression or for a
maximum period of two years.

Rivaroxaban 10 mg Tablet B01AX06000T1001XX No A* Prevention of venous thromboembolism in patients 10 mg once daily. Initial dose should be
undergoing elective hip or knee replacement surgery taken 6 to 10 hour post-surgery provided
that haemostasis has been established.
Duration of treatment: Major hip surgery
5 weeks. Major knee surgery 2 weeks

Rivaroxaban 15 mg Tablet B01AX06000T1002XX No A* i)Prevention of stroke and systemic embolism in adult patients i)20mg once daily or 15mg once daily
with non-valvular atrial fibrillation with one or more risk (for patients with moderate renal
factors, such as Congestive heart failure (CHF), hypertension, impairment (creatinine clearance 30-49
age ≥ 75 yrs, diabetes mellitus, prior stroke or transient ml/min) Dosage: ii) & (iii) 15mg BD for
ischaemic attack. ii)Treatment of deep vein thrombosis (DVT), 21 days, followed by 20mg OD.
and prevention of recurrent DVT and pulmonary embolism
(PE) following an acute DVT in adults. iii) Treatment of
Pulmonary Embolism (PE), and prevention of recurrent DVT
and pulmonary embolism (PE) following an acute PE in adults.

Rivaroxaban 20 mg Tablet B01AX06000T1003XX No A* i)Prevention of stroke and systemic embolism in adult patients i)20mg once daily or 15mg once daily
with non-valvular atrial fibrillation with one or more risk (for patients with moderate renal
factors, such as Congestive heart failure (CHF), hypertension, impairment (creatinine clearance 30-49
age ≥ 75 yrs, diabetes mellitus, prior stroke or transient ml/min) Dosage (ii) & (iii)15mg BD for 21
ischaemic attack. ii)Treatment of deep vein thrombosis (DVT), days, followed by 20mg OD.
and prevention of recurrent DVT and pulmonary embolism
(PE) following an acute DVT in adults. iii) Treatment of
Pulmonary Embolism (PE), and prevention of recurrent DVT
and pulmonary embolism (PE) following an acute PE in adults.

Rivastigmine 1.5 mg Capsule N06DA03123C1001XX No A* For psychiatrists and neurologists only. Mild to moderately Initial dose 1.5 mg 2 times daily, may
severe dementia associated with Alzheimer's or Parkinson's increase by 1.5 mg 2 times daily every 2
disease weeks to maximum of 6 mg 2 times
daily. If treatment is interrupted for
several days, should be reinitiated at the
lowest daily dose

Rivastigmine 2 mg/ml Oral Solution N06DA03123L9901XX No A* For psychiatrists and neurologists only. Mild to moderately Initial dose 1.5 mg 2 times daily. May be
severe dementia associated with Alzheimer's or Parkinson's increased after a minimum of 2 weeks of
disease treatment to 3 mg 2 times daily.
Subsequently to 4.5 mg 2 times daily, up
to maximum of 6 mg 2 times daily. If
treatment is interrupted for several
days, should be reinitiated at the lowest
daily dose

Rivastigmine 3 mg Capsule N06DA03123C1002XX No A* For psychiatrists and neurologists only. Mild to moderately Initial dose 1.5 mg 2 times daily, may
severe dementia associated with Alzheimer's or Parkinson's increase by 1.5 mg 2 times daily every 2
disease weeks to maximum of 6 mg 2 times
daily. If treatment is interrupted for
several days, should be reinitiated at the
lowest daily dose

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Generic Name MDC NEML Category Indications Dosage

Rivastigmine 4.5 mg Capsule N06DA03123C1003XX No A* For psychiatrists and neurologists only. Mild to moderately Initial dose 1.5 mg 2 times daily, may
severe dementia associated with Alzheimer's or Parkinson's increase by 1.5 mg 2 times daily every 2
disease weeks to maximum of 6 mg 2 times
daily. If treatment is interrupted for
several days, should be reinitiated at the
lowest daily dose

Rivastigmine 4.6mg/24hr Transdermal N06DA03123M7001XX No A* Mild to moderately severe dementia associated with Initial, 4.6 mg/24 hr patch TOPICALLY
Patch Alzheimer's or Parkinson's disease once daily; after a minimum of 4 weeks
and good tolerability, increase the dose
to 9.5 mg/24 hr patch once daily

Rivastigmine 6 mg Capsule N06DA03123C1004XX No A* For psychiatrists and neurologists only. Mild to moderately Initial dose 1.5 mg 2 times daily, may
severe dementia associated with Alzheimer's or Parkinson's increase by 1.5 mg 2 times daily every 2
disease weeks to maximum of 6 mg 2 times
daily. If treatment is interrupted for
several days, should be reinitiated at the
lowest daily dose

Rivastigmine 9.5 mg/24hr Transdermal N06DA03123M7002XX No A* Mild to moderately severe dementia associated with Initial, 4.6 mg/24 hr patch TOPICALLY
Patch Alzheimer's or Parkinson's disease once daily; after a minimum of 4 weeks
and good tolerability, increase the dose
to 9.5 mg/24 hour patch once daily

Rivastigmine Transdermal Patch N03DA03123M7003XX No A* i) Mild to moderately severe dementia associated with Initial, 4.6mg/24 hours patch TOPICALLY
13.3mg/24 hours Alzheimer's or Parkinson's disease. ii) Severe dementia of the once daily, after a minimum of 4 weeks
Alzheimer's type: - Patient with mild to moderately severe of treatment and if well tolerated, this
dementia (currently on lower strength of rivastigmine patch) increased to 9.5mg/24 hours or
and developed to severe dementia. - Use as second 13.3mg/24 hours (individual responses
line/alternative option if the first line medication with oral to rivastigmine may vary and some
tablet failed or patients are not able to tolerate the oral patients may derive additional benefit
medication. from higher doses)

Rocuronium Bromide 10 mg/ml Injection M03AC09320P3001XX No A* As an adjunct to general anaesthesia to facilitate endotracheal Adult: Initially, 600 mcg/kg by inj. Higher
intubation, to provide skeletal muscle relaxation during doses of 1 mg/kg may be used for
surgery and to facilitate mechanical ventilation in adults, intubation during rapid sequence
children and infants from 3 months of age induction of anaesthesia. Maintenance:
150 mcg/kg by inj (may reduce to 75-100
mcg/kg if inhalational anaesthesia is
used) or by infusion at a rate of 300-600
mcg/kg/hr. Doses should be based on
lean body weight for obese patients
weighing >30% above the ideal body
weight. Child: Infants and children >1
mth: Initially, 600 mcg/kg by inj.
Maintenance: 150 mcg/kg by inj or by
infusion at a rate of 300-600 mcg/kg/hr,
maintenance doses may be required
more frequently than in adult patients.
Elderly: Reduced maintenance doses: 75-
100 mcg/kg. Renal impairment: Initially,
600 mcg/kg by inj. Maintenance: 75-100
mcg/kg. Hepatic impairment: or biliary
tract disease: Initially, 600 mcg/kg by inj.
Maintenance: 75-100 mcg/kg.

Ropinirole HCI 2 mg Extended Release N04BC04110T5003XX Yes A* Treatment of idiopathic Parkinson?s disease. It may be used as ADULT: Initially 2 mg once daily for the
Tablet monotherapy or in combination with levodopa 1st week. May be increased by 2 mg at
≥1 week intervals. Max: 24 mg/day.
Switching from ropinirole immediate-
realease to prolonged-release tablet;
dose of ropinirole prolonged release
tablet should be based on the total daily
dose of ropinirole immediate-release tab
the patient was taking. Tablets should be
taken at a similar time each day with or
without food, must be swallowed whole
and must not be chewed, crushed or
divided.

Ropinirole HCI 4 mg Extended Release N04BC04110T5004XX Yes A* Treatment of idiopathic Parkinson?s disease. It may be used as ADULT: Initially 2 mg once daily for the
Tablet monotherapy or in combination with levodopa 1st week. May be increased by 2 mg at
≥1 week intervals. Max: 24 mg/day.
Switching from ropinirole immediate-
realease to prolonged-release tablet;
dose of ropinirole prolonged release
tablet should be based on the total daily
dose of ropinirole immediate-release tab
the patient was taking. Tablets should be
taken at a similar time each day with or
without food, must be swallowed whole
and must not be chewed, crushed or
divided.

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Generic Name MDC NEML Category Indications Dosage

Ropinirole HCl 0.25 mg Tablet N04BCO4110T1001XX Yes A* Parkinson disease in younger patients and patients with 0.25 mg 3 times daily gradually
dyskinesias, especially peak dose dyskinesias increasing till adequate response
obtained up to a maximum of 24
mg/day. Most patients need 3-9 mg/day

Ropinirole HCl 1 mg Tablet N04BCO4110T1002XX Yes A* Parkinson disease in younger patients and patients with 0.25 mg 3 times daily gradually
dyskinesias, especially peak dose dyskinesias increasing till adequate response
obtained up to a maximum of 24
mg/day. Most patients need 3-9 mg/day

Ropivacaine HCl 2 mg/ml Injection N01BB09110P3001XX No A* i) Surgical anaesthaesia including obstetrics ii) Acute pain Dose adjusted according to patient
management physical status and nature of procedure.
i) Lumbar epidural: 15-25 ml of 7.5
mg/ml solution; Caesarean section, 15-
20 ml of 7.5 mg/ml solution in
incremental doses ( max . total dose 150
mg). ii) lumbar epidural: 10-20 ml of
2mg/ml solution followed by 10-15 ml of
2 mg/ml solution at interval at of least
30 minutes. Labour pain 6-10 ml/hour of
2mg/ml solution

Ropivacaine HCl 7.5 mg/ml Injection N01BB09110P3002XX No A* i) Surgical anaesthaesia including obstetrics ii) Acute pain Dose adjusted according to patient
management physical status and nature of procedure.
i) Lumbar epidural: 15-25 ml of 7.5
mg/ml solution; Caesarean section, 15-
20 ml of 7.5 mg/ml solution in
incremental doses ( max . total dose 150
mg). ii) lumbar epidural: 10-20 ml of
2mg/ml solution followed by 10-15 ml of
2 mg/ml solution at interval at of least
30 minutes. Labour pain 6-10 ml/hour of
2mg/ml solution

Rosuvastatin 10 mg Tablet C10AA07390T1002XX No A* Dyslipidaemia not responsive to atorvastatin 40 mg or Initially 5-10 mg once daily (5mg in
equivalent doses of other statins patients with pre-disposing factors to
myopathy), increased if necessary at
intervals of at least 4 weeks to 20 mg
once daily, increased after further 4
weeks to 40 mg daily ONLY in severe
hypercholesterolemia with high
cardiovascular risk. Patient of Asian
origin, patients on concomitant
ciclosporin/fibrate and patients with risk
factors for myopathy/rhabdomyolysis
(including personal/family history of
muscular disorders/toxicity), the
maximum dose should be 20 mg daily

Rosuvastatin 20 mg Tablet C10AA07390T1003XX No A* Dyslipidaemia not responsive to atorvastatin 40 mg or Initially 5-10 mg once daily (5mg in
equivalent doses of other statins patients with pre-disposing factors to
myopathy), increased if necessary at
intervals of at least 4 weeks to 20 mg
once daily, increased after further 4
weeks to 40 mg daily ONLY in severe
hypercholesterolemia with high
cardiovascular risk. Patient of Asian
origin, patients on concomitant
ciclosporin/fibrate and patients with risk
factors for myopathy/rhabdomyolysis
(including personal/family history of
muscular disorders/toxicity), the
maximum dose should be 20 mg daily

Rotigotine 2 mg per 24 hour N04BC09000M7001XX No A* For stage IV Parkinson Disease with peak dyskinesia A single daily dose should be initiated at
Transdermal Patch 4mg/24 h and then increased in weekly
increments of 2mg/24 h to an effective
dose up to a maximal dose of 16mg/24
hr.
Rotigotine 4 mg per 24 hour N04BC09000M7002XX No A* For stage IV Parkinson Disease with peak dyskinesia A single daily dose should be initiated at
Transdermal Patch 4mg/24 h and then increased in weekly
increments of 2mg/24 h to an effective
dose up to a maximal dose of 16mg/24
hr.
Rotigotine 6 mg per 24 hour N04BC09000M7003XX No A* For stage IV Parkinson Disease with peak dyskinesia A single daily dose should be initiated at
Transdermal Patch 4mg/24 h and then increased in weekly
increments of 2mg/24 h to an effective
dose up to a maximal dose of 16mg/24
hr.
Rotigotine 8 mg per 24 hour N04BC09000M7004XX No A* For stage IV Parkinson Disease with peak dyskinesia A single daily dose should be initiated at
Transdermal Patch 4mg/24 h and then increased in weekly
increments of 2mg/24 h to an effective
dose up to a maximal dose of 16mg/24
hr.
Rubella Virus Vaccine Injection (Single J07BJ01000P3001XX No C Immunization against rubella (German measles) 0.5 ml SC as a a single dose
injection)

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Generic Name MDC NEML Category Indications Dosage

Ruxolitinib 15mg tablet L01XE18162T1002XX No A* For the treatment of disease-related splenomegaly or The recommended starting dose is 15
symptoms in adult patients with primary myelofibrosis (also mg twice daily for patients with a
known as chronic idiopathic myelofibrosis), post-polycythemia platelet count between 100,000/mm3
vera myelofibrosis or post-essential thrombocythemia and 200,000/mm3 and 20 mg twice daily
myelofibrosis. Place in therapy: To be used as 3rd line after for patients with a platelet count of
hydroxyurea and other best available treatment such as >200,000/mm3. There is limited
danazol and S.C. Interferon information to recommend a starting
dose for patients with platelet counts
between 50,000/mm3 and
<100,000/mm3. The maximum
recommended starting dose in these
patients is 5 mg twice daily and the
patients should be titrated cautiously.

Ruxolitinib 20mg tablet L01XE18162T1003XX No A* For the treatment of disease-related splenomegaly or The recommended starting dose is 15
symptoms in adult patients with primary myelofibrosis (also mg twice daily for patients with a
known as chronic idiopathic myelofibrosis), post-polycythemia platelet count between 100,000/mm3
vera myelofibrosis or post-essential thrombocythemia and 200,000/mm3 and 20 mg twice daily
myelofibrosis. Place in therapy: To be used as 3rd line after for patients with a platelet count of
hydroxyurea and other best available treatment such as >200,000/mm3. There is limited
danazol and S.C. Interferon information to recommend a starting
dose for patients with platelet counts
between 50,000/mm3 and
<100,000/mm3. The maximum
recommended starting dose in these
patients is 5 mg twice daily and the
patients should be titrated cautiously.

Ruxolitinib 5mg tablet L01XE18162T1001XX No A* For the treatment of disease-related splenomegaly or The recommended starting dose is 15
symptoms in adult patients with primary myelofibrosis (also mg twice daily for patients with a
known as chronic idiopathic myelofibrosis), post-polycythemia platelet count between 100,000/mm3
vera myelofibrosis or post-essential thrombocythemia and 200,000/mm3 and 20 mg twice daily
myelofibrosis. Place in therapy: To be used as 3rd line after for patients with a platelet count of
hydroxyurea and other best available treatment such as >200,000/mm3. There is limited
danazol and S.C. Interferon information to recommend a starting
dose for patients with platelet counts
between 50,000/mm3 and
<100,000/mm3. The maximum
recommended starting dose in these
patients is 5 mg twice daily and the
patients should be titrated cautiously.

Salbutamol 0.5 % Inhalation Solution R03AC02183A3001XX Yes B Asthma and other conditions associated with reversible 2 ml may be inhaled up to 4 times daily
airways obstruction over a period of 3 minutes per inhalation
(0.5 ml diluted in 2.5 ml of normal saline
by inhalation over 5 to 15 minutes)

Salbutamol 0.5 mg/ml Injection R03CC02183P3001XX No A Asthma and other conditions associated with reversible 500 mcg by SC/IM injection 4 hourly or
airways obstruction 250 mcg by slow IV. If required, by IV
infusion, initially 5 mcg/min adjusted
according to response and heart rate,
usually in the range 3 - 20 mcg/min

Salbutamol 100 mcg/dose Inhalation R03AC02183A1001XX Yes B Asthma and other conditions associated with reversible ADULT : 100 - 200 mcg up to 3 - 4 times
airways obstruction daily. CHILD : 100 mcg increased to 200
mcg if necessary
Salbutamol 2 mg Tablet R03CC02183T1001XX Yes B Asthma and other conditions associated with reversible CHILD 2 - 6 years : 1 - 2 mg 3 - 4 times
airways obstruction daily, 6 - 12 years : 2 mg 3 - 4 times
daily. CHILD over 12 years and ADULT : 2 -
4 mg 3 - 4 times daily
Salbutamol 2 mg/5 ml Syrup R03CC02183L9001XX Yes B Asthma and other conditions associated with reversible CHILD 2 - 6 years : 1 - 2 mg 3 - 4 times
airways obstruction daily, 6 - 12 years : 2 mg 3 -4 times daily

Salbutamol 200mcg/dose Inhaler R03AC02183A2001XX Yes B Asthma and other conditions associated with reversible CHILD : 100 - 200 mcg. Maintenance :
airways obstruction 100 - 200 mcg 2 - 4 times daily. ADULT :
100 - 400 mcg. Maitenance : 100 - 400
mcg 2 - 4 times daily
Salbutamol 5 mg/5 ml Injection R03CC02183P3002XX No A* Prevention of uncomplicated premature labour only Infusions containing 5 mg in 500ml (10
mcg/ml) at the rate of 10 - 45 mcg/min
increased at intervals of 10 minutes until
evidence of patient response as shown
by reduction of strength, frequency or
duration of contractions; maintain rate
for 1 hour after contractions have
stopped, then gradually reduce by 50%
every 6 hours

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Salicylazosulphapyridine (Sulfasalazine) A07EC01000T1001XX Yes A/KK i) Treatment of inflammatory bowel disease of ulcerative i) ADULT, acute attack 1-2 g 4 times daily
500 mg Tablet colitis and Crohn's disease ii) Rheumatoid arthritis until remission occurs (if necessary
corticosteroids may also be given),
reducing to a maintenance dose of 500
mg 4 times daily, CHILD over 2 years,
acute attack 40-60 mg/kg daily,
maintenance dose 20-30 mg/kg daily ii)
ADULT, initially; 0.5-1 g/day, increase
weekly to maintenance dose of 2 g/day
in 2 divided doses, maximun 3 g/day.
CHILD over 6 years, juvenile rheumatoid
arthritis: 30-50 mg/kg/day in 2 divided
doses up to a maximum of 2 g/day

Salicylic Acid 1 - 2% in Hydrocortisone D07XA01952G5001XX No B Seborrhoeic capitis Apply sparingly to affected areas 1-2
1% Ointment times daily
Salicylic Acid 2 - 10% Cream D01AE12000G1001XX Yes C Seborrhoeic dermatitis, scalp psoriasis and hyperkeratotic skin Apply sparingly to the affected area 2-3
conditions times daily
Salicylic Acid 2 - 10% Ointment D01AE12000G5001XX Yes C Seborrhoeic dermatitis, scalp, psoriasis and hyperkeratotic Apply sparingly to the affected area 2-3
skin disorders times daily
Salicylic Acid 2 % Lotion D01AE12000L6001XX Yes B Seborrhoeic dermatitis, scalp, psoriasis and hyperkeratotic Apply sparingly to the affected area 2-3
skin conditions times daily. Wash with cleanser 2 - 3
times per day
Salicylic Acid 20% Ointment D01AE12000G5002XX Yes C Plantar warts Apply daily and protect surrounding skin
(eg with soft paraffin or specially
designed plaster) ,may need to continue
up to 3 months
Salicylic Acid, Starch, Zinc Oxide Paste D01AE12952G6001XX No C Use as a protective or base Apply the paste liberally and carefully to
the lesions twice daily
Salmeterol 25 mcg and Fluticasone R03AK06989A2102XX No A* Regular treatment of reversible obstructive airway diseases ADULT and CHILD more than 12 years : 1
Propionate 125 mcg Inhalation including asthma. - 2 puff twice daily. CHILD over 4 years :
1 puff twice daily
Salmeterol 25mcg and Fluticasone R03AK06989A2104XX No A* Regular treatment of reversible obstructive airway diseases ADULT and CHILD more than 12 years : 2
Propionate 50mcg Inhalation including asthma in children, where use of lower dose of a puff twice daily. CHILD over 4 years : 2
combination (bronchodilator and inhaled corticosteroids) is puff twice daily No data on use for
appropriate. children aged under 4 years.

Salmeterol 50 mcg and Fluticasone R03AK06989A2101XX No A/KK i) Regular treatment of reversible obstructive airways diseases i) ADULT and CHILD more than 12 years :
Propionate 250 mcg Inhalation including asthma ii) For the regular treatment of chronic 1 puff twice daily. ii) For COPD: Dose is
obstructive pulmonary disease (COPD) including chronic one inhalation 50/250mcg to 50/500mcg
bronchitis and emphysema twice daily.

Salmeterol 50 mcg and Fluticasone R03AK06989A2106XX No A/KK Category of prescriber A/KK is only approved for indication (i): i) ADULT and CHILD more than 12 years :
Propionate 500 mcg Inhalation i) Regular treatment of reversible obstructive airways diseases 1 puff twice daily ii) ADULT 1 puff twice
including asthma. The following indication is still under daily
category of prescriber A*: ii) Chronic obstructive pulmonary
disease including chronic bronchitis and emphysema

Saxagliptin 2.5 mg Tablet A10BH03000T1001XX No A/KK FUKKM restriction: As add-on therapy for patient who failed Recommended starting dose and
therapy and/or contraindicated/unable to tolerate metformin maintenance dose in patients with
and/or sulphonylurea. i) As add on therapy in type 2 diabetes normal renal function and mild renal
patients inadequately controlled on metformin monotherapy insufficiency (CrCl more than 50 ml/min)
and high risk of hypoglycaemia, especially elderly patients with is 5 mg once daily. For patients with
co-morbidities. ii) As add on therapy in type 2 diabetes moderate to severe renal insufficiency
patients inadequately controlled with a sulphonylure and (CrCl less than or equal to 50 ml/min)
intolerant/contraindicated for metformin therapy iii) As add dose is 2.5 mg once daily
on therapy in type 2 diabetes patients inadequately controlled
on metformin and sulphonylurea combination therapy iv) In
patients with renal failure where metformin contraindicated
Not to be used in patients with HbA1c > 8% on
single/combination OAD, as insulin initiation is preferred.

Saxagliptin 2.5mg and Metformin HCl A10BD10926T1001XX No A FUKKM restriction: As add-on therapy for patient who failed The recommended starting dose of in
1000mg Extended-Release Tablet therapy and/or contraindicated/unable to tolerate metformin patients who need 5mg of saxagliptin
and/or sulphonylurea. Indicated as an adjunct to diet and and who are not currently treated with
exercise to improve glycemic control in adults with type 2 metformin is 5mg saxagliptin/500 mg
diabetes mellitus when treatment with both saxagliptin and metformin extended-release once daily
metformin is appropriate. with gradual dose escalation to reduce
the gastrointestinal side effects due to
metformin. In patients treated with
metformin, the dose of should provide
metformin at the dose already being
taken, or the nearest therapeutically
appropriate dose. Patients who need
2.5mg saxagliptin in combination with
metformin extended-release may be
treated with 2.5mg/1000mg. Patients
who need 2.5mg saxagliptin who are
either metformin naive or who require a
dose of metformin higher than 1000mg
should use the individual components.
Max daily recommended dose is
5mg/2000mg.

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Saxagliptin 5 mg Tablet A10BH03000T1002XX No A/KK FUKKM restriction: As add-on therapy for patient who failed 2.5-5mg once daily. Patients with CrCl <
therapy and/or contraindicated/unable to tolerate metformin 50ml/min, and when coadministered
and/or sulphonylurea. i) As add on therapy in type 2 diabetes with strong CYP450 3A4/5 inhibitors:
patients inadequately controlled on metformin monotherapy 2.5mg OD
and high risk of hypoglycaemia, especially elderly patients with
co-morbidities. ii) As add on therapy in type 2 diabetes
patients inadequately controlled with a sulphonylure and
intolerant/contraindicated for metformin therapy iii) As add
on therapy in type 2 diabetes patients inadequately controlled
on metformin and sulphonylurea combination therapy iv) In
patients with renal failure where metformin contraindicated
Not to be used in patients with HbA1c > 8% on
single/combination OAD, as insulin initiation is preferred.

Saxagliptin 5mg and Metformin HCl A10BD10926T1002XX No A FUKKM restriction: As add-on therapy for patient who failed The recommended starting dose of in
1000mg Extended-Release Tablet therapy and/or contraindicated/unable to tolerate metformin patients who need 5mg of saxagliptin
and/or sulphonylurea. - Indicated as an adjunct to diet and and who are not currently treated with
exercise to improve glycemic control in adults with type 2 metformin is 5mg saxagliptin/500 mg
diabetes mellitus when treatment with both saxagliptin and metformin extended-release once daily
metformin is appropriate. with gradual dose escalation to reduce
the gastrointestinal side effects due to
metformin. In patients treated with
metformin, the dose of should provide
metformin at the dose already being
taken, or the nearest therapeutically
appropriate dose. Patients who need
2.5mg saxagliptin in combination with
metformin extended-release may be
treated with 2.5mg/1000mg. Patients
who need 2.5mg saxagliptin who are
either metformin naive or who require a
dose of metformin higher than 1000mg
should use the individual components.
Max daily recommended dose is
5mg/2000mg.

Saxagliptin 5mg and Metformin HCl 500 A10BD10926T1003XX No A FUKKM restriction: As add-on therapy for patient who failed The recommended starting dose of in
mg Extended-Release Tablet therapy and/or contraindicated/unable to tolerate metformin patients who need 5mg of saxagliptin
and/or sulphonylurea. - Indicated as an adjunct to diet and and who are not currently treated with
exercise to improve glycemic control in adults with type 2 metformin is 5mg saxagliptin/500 mg
diabetes mellitus when treatment with both saxagliptin and metformin extended-release once daily
metformin is appropriate. with gradual dose escalation to reduce
the gastrointestinal side effects due to
metformin. In patients treated with
metformin, the dose of should provide
metformin at the dose already being
taken, or the nearest therapeutically
appropriate dose. Patients who need
2.5mg saxagliptin in combination with
metformin extended-release may be
treated with 2.5mg/1000mg. Patients
who need 2.5mg saxagliptin who are
either metformin naive or who require a
dose of metformin higher than 1000mg
should use the individual components.
Max daily recommended dose is
5mg/2000mg.

Secukinumab 150mg/ml injection L04AC10000P5001XXX No A* Psoriatic Arthritis: Secukinumab, alone or in combination with Psoriatic arthritis (PsA): Recommended
methotrexate (MTX), is indicated for the treatment of active dose: 150 mg by subcutaneous injection
psoriatic arthritis (PsA) in adult patients when the response to with initial dosing at Weeks 0, 1, 2 and 3,
previous disease-modifying anti-rheumatic drug (DMARD) followed by monthly maintenance
therapy has been inadequate. Ankylosing spondylitis: dosing starting at Week 4. For patients
Secukinumab is indicated for the treatment of active who are anti-TNFα inadequate
ankylosing spondylitis (AS) in adults who have responded responders (IR) or patients with
inadequately to conventional therapy. Prescribing Restriction: concomitant moderate to severe plaque
2nd or 3rd line, after failure of conventional DMARDs or TNF- psoriasis; Recommended dose: 300 mg
inhibitors by subcutaneous injection with initial
dosing at Weeks 0, 1, 2 and 3, followed
by monthly maintenance dosing starting
at Week 4. Each 300 mg dose is given as
two subcutaneous injections of 150 mg.
Ankylosing Spondylitis (AS):
Recommended dose: 150 mg by
subcutaneous injection with initial
dosing at Weeks 0, 1, 2 and 3, followed
by monthly maintenance dosing starting
at Week 4.

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Selected Plasma Protein 5 g/100 ml B05AA02000P3001XX No B For treatment of shock due to burns, crushing injuries, ADULT 12.5-25 g (250-500 ml) by IV.
Injection abdominal emergencies and where there is a predominant loss CHILD usual dose 33 ml/kg body weight
of plasma fluids and red blood cells, emergency treatment of at rate of 5-10 ml/min
shock due to haemorrhage and in infants and small children in
the initial therapy of shock due to dehydration and infection

Selegiline HCl 5 mg Tablet N04BD01110T1001XX Yes A* Only for treatment of late stage Parkinsonism with on and off 5 mg twice daily at breakfast and lunch.
phenomenon Maximum 10 mg/day
Selenium Sulphide 2.5% Shampoo D11AC03180L5201XX Yes A/KK Dandruff, seborrheic dermatitis of scalp Dandruff: apply 5-10 mL topically twice
weekly for 2 weeks, then 1-4 times per
month, as needed, leave on for 2-3 min,
then rinse thoroughly. Seborrheic
dermatitis of scalp: apply 5-10 mL
topically twice weekly for 2 weeks, then
1-4 times per month, as needed, leave
on for 2-3 min, then rinse thoroughly

Sertraline HCI 50 mg Tablet N06AB06110T1001XX Yes B Major depression, obsessive-compulsive disorder (OCD), panic Depression, obsessive-compulsive
disorder disorder: 50 mg/day, may increase in
steps of 50mg at weekly interval,
max:200mg/day. Panic disorder: Initially
25 mg/day. After 1 week, increase dose
to 50 mg/day. All dose changes should
be made at intervals of more than 1
week, max: 200 mg/day

Sevelamer 800mg Tablet V03AE02121T1001XX No A* Control of hyperphosphatemia in adult patients receiving Starting dose is one or two 800mg
haemodialysis and peritoneal dialysis. Restriction: Sevelamer tablets three times per day with meals.
carbonate 800mg tablet should be used in context of multiple Adjust by one tablet per meal in two
therapeutic approach which include calcium supplement, 1, 25- weeks interval as needed to obtain
hydroxy Vitamin D3 or one of its analogues to control the serum phosphorus target (1.13 to
development of renal bone disease. 1.78mmol/L).

Sevoflurane Liquid N01AB08000L5001XX No A* To be used only for i) induction and ii) maintenance of i) Adult: Given via a calibrated vaporiser:
anaesthesia Up to 5% v/v with oxygen or a mixture of
oxygen and nitrous oxide. Child: Given
via a calibrated vaporiser: Up to 7% v/v.
ii) Adult: 0.5-3% v/v with or without
nitrous oxide. Child: 0.5-3% v/v with or
without nitrous oxide.

Sildenafil Citrate 20 mg Film-coated G04BE03136T1004XX No A* Treatment of adult patients with pulmonary arterial ADULTS ≥ 18 years: The recommended
Tablet hypertension classified as WHO functional class II and III, to dose is 20mg three times a day. Tablets
improve exercise capacity. Efficacy has been shown in primary should be taken approximately 6 to 8
pulmonary hypertension and pulmonary hypertension hours apart with or without food.
associated with connective tissue disease. ELDERLY (≥65 years): Dosage
adjustments are not required in elderly
patients. Clinical efficacy as measured by
6-minute walk distance could be less in
elderly patients. IMPAIRED RENAL
FUNCTION: Initial dose adjustments are
not required in patients with renal
impairment, including severe renal
impairment (creatinine clearance
<30ml/min). A downward dose
adjustment to 20 mg twice daily should
be considered after a careful benefit-risk
assessment only if therapy is not well-
tolerated. IMPAIRED HEPATIC
FUNCTION: Initial dose adjustments are
not required in patients with hepatic
impairment (Child-Pugh class A and B). A
downward dose adjustment to 20mg
twice daily should be considered after a
careful benefit-risk assessment only if
therapy is not well-tolerated.
Silver Nitrate 0.5% Lotion D08AL01221L6001XX No B Use as antiseptic Apply undiluted to affected area for a
limited period
Silver Sulfadiazine 1% Cream D06BA01199G1001XX Yes B Prevention and treatment of infections in severe burns, leg Burns: Apply 3 mm thick layer twice
ulcers where infections may prevent healing and for the daily with sterile applicator. Leg ulcer:
prophylaxis of infections in skin grafting apply at least 3 times a week
Simvastatin 10 mg Tablet C10AA01000T1001XX Yes B Hypercholesterolaemia and coronary heart disease intolerant 10 - 20 mg once daily. Maximum: 80 mg
or not responsive to other forms of therapy daily
Simvastatin 20 mg Tablet C10AA01000T1002XX Yes B Hypercholesterolaemia and coronary heart disease intolerant 10 - 20 mg once daily. Maximum: 80 mg
or not responsive to other forms of therapy daily
Simvastatin 40 mg Tablet C10AA01000T1003XX Yes B Hypercholesterolaemia and coronary heart disease intolerant 10 - 20 mg once daily. Maximum: 80 mg
or not responsive to other forms of therapy daily
Sitagliptin 100 mg Tablet A10BH01000T1003XX No A* FUKKM Restriction: As add-on therapy for patient who failed ADULT over 18 years, 100 mg once daily:
therapy and/or contraindicated/unable to tolerate metformin 100mg once daily CrCl ≥ 30 to <
and/or sulphonylurea. - Management of diabetes in patients 50ml/min: 50mg once daily CrCl < 30
with renal failure where metformin/sulphonylurea is ml/min: 25mg once daily
contraindicated/untolerated and elderly with multiple co-
morbidities that always experience hypoglycemia with other
antidiabetic. Not to be used in diabetic patient whose HbA1c is
more than 9%.

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Sitagliptin 25 mg Tablet A10BH01000T1001XX No A* FUKKM restriction: As add-on therapy for patient who failed ADULT over 18 years, 100 mg once daily:
therapy and/or contraindicated/unable to tolerate metformin 100mg once daily CrCl ≥ 30 to <
and/or sulphonylurea. - Management of diabetes in patients 50ml/min: 50mg once daily CrCl < 30
with renal failure where metformin/sulphonylurea is ml/min: 25mg once daily
contraindicated/untolerated and elderly with multiple co
morbidities that always experience hypoglycemia with other
antidiabetic. Not to be used in diabetic patient whose HbA1c is
more than 9%.

Sitagliptin 50 mg and Metformin HCl A10BD07926T1003XX No A* FUKKM restriction: As add-on therapy for patient who failed 50 mg/500 mg twice daily. The
1000 mg Tablet therapy and/or contraindicated/unable to tolerate metformin recommended maximum daily dose is
and/or sulphonylurea. i) Type 2 diabetes patients, especially 100 mg sitagliptin plus 2000 mg
the elderly, with multiple co-morbidities that always metformin
experience hypoglycaemia with other antidiabetics who are
inadequately controlled on metformin or sitagliptin alone or
already being treated with the combination of sitagliptin and
metformin. ii) Newly diagnosed type 2 diabetes patients with
high baseline HbA1c and multiple co-morbidities who may
experience hypoglycaemia with other antidiabetics.

Sitagliptin 50 mg and Metformin HCl 500 A10BD07926T1001XX No A* FUKKM restriction: As add-on therapy for patient who failed 50 mg/500 mg twice daily. The
mg Tablet therapy and/or contraindicated/unable to tolerate metformin recommended maximum daily dose is
and/or sulphonylurea. i)Type 2 diabetes patients, especially 100 mg sitagliptin plus 2000 mg
the elderly, with multiple co-morbidities that always metformin
experience hypoglycaemia with other antidiabetics who are
inadequately controlled on metformin or sitagliptin alone or
already being treated with the combination of sitagliptin and
metformin. ii)Newly diagnosed type 2 diabetes patients with
high baseline HbA1c and multiple co-morbidities who may
experience hypoglycaemia with other antidiabetics.

Sitagliptin 50 mg and Metformin HCl 850 A10BD07926T1002XX No A* FUKKM restriction: As add-on therapy for patient who failed 50 mg/500 mg twice daily. The
mg Tablet therapy and/or contraindicated/unable to tolerate metformin recommended maximum daily dose is
and/or sulphonylurea. i) Type 2 diabetes patients, especially 100 mg sitagliptin plus 2000 mg
the elderly, with multiple co-morbidities that always metformin
experience hypoglycaemia with other antidiabetics who are
inadequately controlled on metformin or sitagliptin alone or
already being treated with the combination of sitagliptin and
metformin. ii) Newly diagnosed type 2 diabetes patients with
high baseline HbA1c and multiple co-morbidities who may
experience hypoglycaemia with other antidiabetics.

Sitagliptin 50 mg Tablet A10BH01000T1002XX No A* FUKKM restriction: As add-on therapy for patient who failed ADULT over 18 years, 100 mg once daily:
therapy and/or contraindicated/unable to tolerate metformin 100mg once daily CrCl ≥ 30 to <
and/or sulphonylurea. - Management of diabetes in patients 50ml/min: 50mg once daily CrCl < 30
with renal failure where metformin/sulphonylurea is ml/min: 25mg once daily
contraindicated/untolerated and elderly with multiple co
morbidities that always experience hypoglycemia with other
antidiabetic. Not to be used in diabetic patient whose HbA1c is
more than 9%.

Sodium Alginate 1000 mg/10 ml & A02BX13915L8001XX No A* Treatment of symptoms of gastro-oesophageal reflux eg. acid Adult, elderly & children ≥12 year: 5-10
Potassium Bicarbonate 200 mg/10 ml regurgitation, heartburn, indigestion due to the reflux of mL.
Suspension stomach contents not responding to conventional antacids or
as an addition to PPI when PPI alone fails to control the
symptoms
Sodium and Meglumine Diatrizoate 58- V08AA01993P3002XX No B For IV pyelography Depend on the type of procedure and
60% Injection the degree and extent of contrast
required
Sodium Bicarbonate 1 g/15 ml Mixture A02AH00131L2102XX No B i) Relief of discomfort in mild urinary tract ii) Alkalinisation of i) 3 g in every 2 hours until urinary pH
urine exceeds 7 ii) Maintenance of alkaline
urine 5-10 g daily
Sodium Bicarbonate 4.2% (0.5 mmol/ml) B05XA02131P3001XX Yes B For acceleration of excretion in drug intoxication (where IV infusion of 2 - 5 mmol/kg body weight
Injection excretion of the drug into the urine is accelerated by elevated over a period of 4 - 8 hours or according
urine pH) and for acidosis to the needs of the patients

Sodium Bicarbonate 5% w/v Ear Drops S02DC00131D1001XX No C To soften the impacted ear wax 2-3 drops 3-4 times daily

Sodium Bicarbonate 8.4% (1 mmol/ml) B05XA02131P3002XX Yes B For acceleration of excretion in drug intoxication (where According to the needs of the patient. In
Injection excretion of the drug into the urine is accelerated by elevated severe shock due to cardiac arrest: 50 ml
urine pH) and for acidosis by IV
Sodium Bicarbonate and Magnesium A02AH00912L2101XX No C Heartburn, for rapid relief of dyspepsia ADULT 10-20 ml 3 times daily
Carbonate Compound Mixture
Sodium Bicarbonate Mixture (Paediatric) A02AH00131L2101XX No C Heartburn for rapid relief of dyspepsia CHILD up to 1 year 5 ml; up to 1-5 years
10 ml in 4 to 6 divided doses
Sodium Bicarbonate, Citric Acid, Sodium B05CB10955M4001XX No B For relieving of discomfort in mild urinary tract infection, 4 - 8 g (1- 2 sachets) dissolved in a glass
Citrate and Tartaric Acid - 4 g per sachet symptomatic relief of dysuria to enchance the action to of cold water 4 times daily as prescribed
certain antibiotics especially some sulphonamides. In gout as
urinary alkalinizers to prevent cystallisation of urates

Sodium Biphosphate 16%, Sodium A06AG01162G2001XX No A Bowel cleansing before colonic surgery, colonoscopy or ADULT 133 ml (1 bottle) administered
Phosphate 6% Rectal Solution radiological examination to ensure the bowel is free of solid rectally. CHILD more than 2 years half
contents. It is not to be used for treatment of constipation the adult dose (66.6ml)

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Generic Name MDC NEML Category Indications Dosage

Sodium Biphosphate 16%, Sodium A06AG01162L9901XX No A Bowel cleansing before colonic surgery, colonoscopy or 45 ml diluted with half a glass (120 mL)
Phosphate 6% Solution radiological examination to ensure the bowel is free of solid of water, followed by one full glass (240
contents. It is not to be used for treatment of constipation mL) of water. Timing of doses is
dependent on the time of the
procedure. For morning procedure, first
dose should be taken at 7 a.m. and
second at 7 p.m. on day before the
procedure. For afternoon procedure,
first dose should be taken at 7 p.m. on
day before and second dose at 7 a.m. on
day of the procedure. Solid food should
not be taken during the bowel
preparation period. However clear fluids
or water can be taken liberally. CHILD
under 12 years not recommended

Sodium Chloride 0.18% with Dextrose B05XA03904P6001XX Yes B For replenishing fluid and energy and for restoring or According to the needs of the patient
10% Injection maintaining the concentration of sodium and chloride ions

Sodium Chloride 0.18% with Dextrose B05XA03904P6004XX Yes B For replenishing fluid and energy and for restoring or According to the needs of the patient
4.23% Injection maintaining the concentration of sodium and chloride ions

Sodium Chloride 0.45% Injection B05XA03100P6001XX Yes B For replenishing fluid and for restoring / maintaining the 100 - 1000 ml by IV or according to the
concentration of sodium and chloride ions needs of the patient
Sodium Chloride 0.45% with Dextrose B05XA03904P6002XX Yes B For replenishing fluid and energy and for restoring or According to the needs of the patient
10% Injection maintaining the concentration of sodium and chloride ions

Sodium Chloride 0.45% with Dextrose B05XA03904P6005XX Yes B For replenishing fluid and energy and for restoring or According to the needs of the patient
5% Injection maintaining the concentration of sodium and chloride ions

Sodium Chloride 0.9% Eye Drops S01XA03000D2001XX No C Irrigation of conjunctival sac 1 - 2 drops every 3 - 4 hours
Sodium Chloride 0.9% Injection B05XA03100P6002XX Yes C+ For replenishing fluid and for restoring/maintaining the 100 - 1000 ml by IV or according to the
concentration of sodium and chloride ions needs of the patient
Sodium Chloride 0.9% with Dextrose 5% B05XA03904P6003XX Yes C+ For replenishing fluid and energy and for restoring or According to the needs of the patient
Injection maintaining the concentration of sodium and chloride ions

Sodium Chloride 20% Injection B05XA03100P9902XX Yes B Addition of sodium electrolyte in parenteral nutrition bags According to the needs of the patient
especially in paediatrics or neonates with restricted fluid
allowance
Sodium Chloride 3% Injection B05XA03100P9901XX Yes B Acute dilutional hyponatraemia According to the needs of the patient
Sodium Chromate (Chromium-51) V09GX00143L9901XX No A* Labelling of erythrocytes for the investigation of Usual dose range : 10 - 200 microcuries
Solution haemotological disorders IV by IV injection
Sodium Citrate 0.3 M Solution B05CB02136L9901XX No B Prophylaxis for aspiration pneumonitis (use as an oral Dose depending on clinical cases.
solution) Usually, 30 ml given 10- 60 minutes
before anaesthesia prior to elective
cesarean surgery is an effective antacid

Sodium Citrate 3.8% Solution B05CB02136H3001XX No B Sterile solution for irrigation or washout of infected bladder Dose depending on clinical cases

Sodium Citrate, Citric Acid Mixture 3 B05CB02136L2101XX No B Citrates and citric acid solutions are used to correct the ADULT 10 - 20 ml. CHILD up to 1 year 2.5
g/10 ml acidosis of certain renal tubular disorders to treat metabolic ml tds; 1-5 year 5 ml tds; 6-12 years 10
acidosis for long-term urine alkalinization for prevention and ml tds. To be taken well diluted with
treatment of uric acid and calcium kidney stones and as water
nonparticulate neutralizing buffers
Sodium Cromoglycate 2% Eye Drops S01GX01520D2001XX No A/KK Prevention and treatment of allergic conjunctivitis including 1 or 2 drops 4 times daily
seasonal and perennial allergic conjunctivitis and vernal
keratoconjunctivitis
Sodium Dichloroisocyanurate 2.5 g V07AV00000T1001XX No C Low and medium level disinfectant 50 - 10,000 ppm av chlorine
Tablet
Sodium Dichloroisocyanurate 5 g Tablet V07AV00000T1002XX No C Low and medium level disinfectant 50 - 10,000 ppm av chlorine

Sodium Fusidate 2% Ointment D06AX01520G5001XX No A Skin infections caused by staphylococci, streptococci, Apply to affected area 2 - 3 times daily
corynebacterium minutissumun and other sodium fusidate-
sensitive organisms
Sodium glycerophosphate for addition B05XA14171P3001XX No A Indicated in adult patients and infants as a supplement in Adults: The recommended dosage is
into infusion solution, 20ml vial intravenous nutrition to meet the requirement of phosphate. individual. The recommended daily
dosage of phosphate during intravenous
nutrition would normally be 10-20mmol.
This can be met by using 10-20ml of
sodium glycerophosphate to the infusion
solution or to the admixture for which
compatibility has been proved. Infants:
The recommended dosage is individual.
The recommended dose for infants and
neonates is 1.0-1.5 mmol/kg
bodyweight/day.

Sodium Hypochlorite Solution V07AV00000L9903XX Yes C Low-level disinfectant and antiseptic Antiseptic: less than 0.5%. Disinfectant:
5%
Sodium Iodide (Iodide-131) Injection V09FX03200P3001XX No A* Used in the determination of various thyroid functions 5 - 50 millicuries
Sodium Iodide (Iodine-131) Capsule V09FX03200C1001XX No A* Determination of various thyroid functions 5 - 10 milicuries (5 mCi for whole body
scan)
Sodium Iodide (Iodine-131) Capsule V10XA01200C1001XX No A* i) Thyrotoxicosis ii) Thyroid carcinoma i) 2 - 30 millicuries ii) 80 - 300 millicuries
(Therapeutic)
Sodium Iodide (Iodine-131) Solution V10XA01200L9901XX No A* i) Thyrotoxicosis ii) Thyroid carcinoma i) 5-25 millicuries ii) 30-150 millicuries

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Generic Name MDC NEML Category Indications Dosage

Sodium Nitrite 30 mg/ml Injection V03AB08220P3001XX Yes B For cyanide poisoning Adult: 300 mg sodium nitrite IV over 3
minutes followed after 5 minutes with
12.5g sodium thiosulphate IV
administered over 10 minutes. CHILD: 4 -
10 mg/kg of sodium nitrite (max: 300
mg) followed by 400 mg/kg of sodium
thiosulfate, as a 25 or 50% solution
(max: 12.5 g). Methaemoglobin
concentration should not exceed 30-
40%. If symptoms of cyanide toxicity
recur, the doses of nitrite and thiosulfate
may be repeated after 30 min at half the
initial doses.

Sodium Nitroprusside 10 mg/ml C02DD01520P3001XX No A i) Hypertensive crisis ii) Controlled hypotension during i) By IV infusion, initially 0.5-1.5
Injection anaesthesia in order to reduce bleeding in surgical procedures mcg/kg/min, then adjusted before
increasement of 0.5 mcg/kg/min every 5
mins within range 0.5-8 mcg/kg/min
(lower doses in patients already
receiving other antihypertensives); stop
if marked response not obtained with
max dose in 10 minutes. Use only in
infusion with 5 % Dextrose IV. ii) By IV
infusion, max: 1.5 mcg/kg/min

Sodium Phosphate (Phosphorus-32) V10XX01162P3001XX No A* Polycythemia vera, chronic myeloid and chronic lymphocytic Initially 5 millicuries, follow if necessary
Injection leukaemia and palliative treatment of bone metastases by a dose of not more than 3 or 4
millicurie at intervals of not less than 2
months
Sodium Polystyrene Sulphonate Powder V03AE01520F2101XX No A Treatment and prevention of hyperkalaemia associated with ADULT : Oral : 15 g 1 - 4 times/day.
anuria or severe oliguria, in dialysis patients or those on Rectal : 30 g in 100 ml 2%
prolonged peritoneal dialysis methylcellulose and 100 ml water as a
daily retention enema. Retain for 9
hours followed by non-sodium cleansing
enema. CHILD : 1 g/kg in 1 - 4 doses in
acute hyperkalemia. Maintenance : 0.5
g/kg/daily
Sodium Tetradecyl Sulphate 1 % C05BB04183P3001XX No A* Sclerotherapy of oesophageal varices, haemorrhoids and 0.5-2 mL into the submucosal layer at
Injection varicose veins the base of the oesophageal varix or the
haemorrhoid; several injections may be
given at different sites, max. total
injected 10-15 mL of 1% per treatment

Sodium Tetradecyl Sulphate 3 % C05BB04183P3002XX No A* Sclerotherapy of oesophageal varices, haemorrhoids and 0.5-2 mL into the submucosal layer at
Injection varicose veins the base of the oesophageal varix or the
haemorrhoid, several injections may be
given at different sites, max. total
injected 10-15 mL of 1% per treatment

Sodium Thiosulphate 10-20% Solution D01AE00181L9901XX Yes C Fungicides. For the treatment of pityriasis versicolor Apply to all affected parts of the body
and face with a brush after a bath once
daily or twice daily or 3 times daily

Sodium Thiosulphate 500 mg/ml V03AB06181P3001XX Yes B For cyanide poisoning Adult: To be given after 300 mg of
Injection sodium nitrite has been admin over 5-20
min: 12.5 g of sodium thiosulfate (50 ml
of a 25% solution or 25 ml of a 50%
solution) given over 10 min.
Methaemoglobin concentration should
not exceed 30-40%. If symptoms of
cyanide toxicity recur, the doses of
nitrite and thiosulfate may be repeated
after 30 min at half the initial doses.
Child: To be given after 4-10 mg/kg of
sodium nitrite (max: 300 mg) has been
admin: 400 mg/kg of sodium thiosulfate,
as a 25 or 50% solution (max: 12.5 g).
Methaemoglobin concentration should
not exceed 30-40%. If symptoms of
cyanide toxicity recur, the doses of
nitrite and thiosulfate may be repeated
after 30 min at half the initial doses.

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Generic Name MDC NEML Category Indications Dosage

Sodium Valproate 200 mg Tablet N03AG01520T1001XX Yes B i. Epilepsy ii. Treatment and prevention of mania associated i. Epilepsy: ADULT: Initially 600 mg/day
with bipolar disorders in 2 - 3 divided doses, dose may be
increased by 200 mg at 3-day intervals to
max 2.5 g/day. Usual maintenance dose:
1-2 g/day (20-30 mg/kg/day). CHILD:
More than 20 kg. Initially 400 mg/day
with spaced increases until control is
achieved (usually 20-30 mg/kg/day),
dose may be increased to 35 mg/kg/day.
Less than 20 kg 20 mg/kg/day, in severe
cases the dose may be increased
provided plasma concentration can be
monitored. ii. Treatment and prevention
of mania associated with bipolar
disorders: Adults: The recommended
initial dose is 1000mg/day. The dose
should be increased as rapidly as
possible to achieve the lowest
therapeutic dose, which produces the
desired clinical effects. The
recommended maintenance dosage for
the treatment of bipolar disorder is
between 1000mg and 2000mg daily. In
exceptional cases, the dose may be
increased to not more than 3000mg
daily.
Sodium Valproate 200 mg/5 ml Syrup N03AG01520L9001XX Yes B Epilepsy ADULT: Initially 600 mg/day; dose may
be increased by 200 mg at 3-day
intervals to max 2500 mg/day. Usual
maintenance dose: 1000-2000 mg/day
(20-30 mg/kg/day). CHILD: More than 20
kg. Initially 400 mg/day with spaced
increases until control is achieved
(usually 20-30 mg/kg/day), dose may be
increased to 35 mg/kg/day. Less than 20
kg, 20 mg/kg/day. Severe cases: 50
mg/kg daily

Sodium Valproate 400 mg Injection N03AG01520P4001XX Yes B Status epilepticus ADULT and CHILD above 10 years: 10 to
15 mg/kg/day IV, may increase 5 to 10
mg/kg/week to achieve optimal clinical
response (Maximum 60 mg/kg/day or
less with a therapeutic range of 50 to
100 mcg/mL)
Solifenacin Succinate 5 mg Tablet G04BD08000T1001XX No A* Symptomatic treatment of urge incontinence and/or increased 5mg od. Dose can be increased to 10mg
urinary frequency and urgency as may occur in patients with if necessary.
overactive bladder syndrome.
Somatropin 10 mg (30IU) Injection H01AC01000P5002XX No A* To be used in children for: i) Growth failure due to inadequate i) 0.7-1 mg/m2/day or 0.025-0.035
endogenous growth hormone. ii) Growth failure in girls due to mg/kg/day SC/IM. ii) 1.4 mg/m2/day or
gonadal dysgenesis (Turner syndrome). iii) Growth failure in 0.045-0.05 mg/kg/day SC. iii) 0.035
short children born small gestational age (SGA) To be used in mg/kg/day or 1 mg/m2/day SC For adult:
adult for: i) Pronounced growth hormone deficiency (GHD) in a) Replacement therapy: The dosage
known hypothalamic-pituitary disease. ii) Childhood onset must be adjusted to the need of the
growth hormone insufficiency. individual patient. b) Childhood-onset
GHD: The recommended dose to restart
is 0.2?0.5 mg/day with subsequent dose
adjustment on the basis of IGF-I
concentration determination. c) Adult-
onset GHD: It is recommended to start
treatment with a low dose 0.1?0.3
mg/day and to increase the dosage
gradually at monthly intervals in order to
meet the need of the individual patient.
Serum IGF-I can be used as guidance for
the dose titration. Women may require
higher doses than men, with men
showing an increasing IGF-I sensitivity
over time. This means that there is a risk
that women, especially those on oral
oestrogen replacement, are under-
treated while men are over-treated.
Dose requirements decline with age.
Maintenance dosages vary from person
Somatropin 12 mg (36IU) Injection H01AC01000P3002XX No A* i) Growth failure due to inadequate endogenous growth i) 0.7-1 mg/m2/day or 0.025-0.035
hormone ii) Growth failure in girls due to gonadal dysgenesis mg/kg/day SC/IM ii) 1.4 mg/m2/day or
(Turner syndrome) iii) Growth failure in short children born 0.045-0.05 mg/kg/day SC iii) 0.035
small gestational age (SGA) mg/kg/day or 1 mg/m2/day SC

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Somatropin 5mg (15IU) Injection H01AC01000P3004XX No A* To be used in children for: i) Growth failure due to inadequate i) 0.7-1 mg/m2/day or 0.025-0.035
endogenous growth hormone. ii) Growth failure in girls due to mg/kg/day SC/IM ii) 1.4 mg/m2/day or
gonadal dysgenesis (Turner syndrome). iii) Growth failure in 0.045-0.05 mg/kg/day SC iii) 0.035
short children born small gestational age (SGA) To be used in mg/kg/day or 1 mg/m2/day SC For adult:
adult for: i) Pronounced growth hormone deficiency (GHD) in Indication ii): a) Replacement therapy:
known hypothalamic-pituitary disease. ii) Childhood onset The dosage must be adjusted to the
growth hormone insufficiency. need of the individual patient. b)
Childhood-onset GHD: The
recommended dose to restart is 0.2?0.5
mg/day with subsequent dose
adjustment on the basis of IGF-I
concentration determination. c) Adult-
onset GHD: It is recommended to start
treatment with a low dose 0.1?0.3
mg/day and to increase the dosage
gradually at monthly intervals in order to
meet the need of the individual patient.
Serum IGF-I can be used as guidance for
the dose titration. Women may require
higher doses than men, with men
showing an increasing IGF-I sensitivity
over time. This means that there is a risk
that women, especially those on oral
oestrogen replacement, are under-
treated while men are over-treated.
Dose requirements decline with age.
Somatropin 8 mg (24IU) Injection H01AC01000P3003XX No A* i) Growth failure due to growth hormone insufficiency i) 0.7-1 mg/m2/day or 0.025-0.035
ii)Growth failure in girls due to gonadal dysgenesis (Turner mg/kg/day SC/IM ii) 1.4 mg/m2/day or
syndrome) iii)Growth failure in short children born small 0.045-0.05 mg/kg/day SC iii) 0.035
gestational age(SGA) mg/kg/day or 1 mg/m2/day SC
Sotalol HCl 160 mg Tablet C07AA07110T1002XX No A* Ventricular tachyarrythmias Supraventricular and ventricular
arrhythmias Adult: Initially, 80 mg/day
as single or in 2 divided doses, increased
gradually every 2-3 days. Usual dose:
160-320 mg/day in 2 divided doses. Life-
threatening ventricular arrhythmias
Adult: Initially, 80 mg bid, increased
gradually every 3 days to 240-320
mg/day in divided doses if needed.
Maintenance: 160-320 mg/day in
divided doses. Max: 480-640 mg in
divided doses.

Sotalol HCl 80 mg Tablet C07AA07110T1001XX No A* Ventricular tachyarrythmias Supraventricular and ventricular

arrhythmias Adult: Initially, 80 mg/day
as single or in 2 divided doses, increased
gradually every 2-3 days. Usual dose:
160-320 mg/day in 2 divided doses. Life-
threatening ventricular arrhythmias
Adult: Initially, 80 mg bid, increased
gradually every 3 days to 240-320
mg/day in divided doses if needed.
Maintenance: 160-320 mg/day in
divided doses. Max: 480-640 mg in
divided doses.

Spironolactone 25 mg Tablet C03DA01000T1001XX Yes B Oedema and ascites in cirrhosis of the liver, congestive heart
ADULT: 100 - 200 mg daily in divided
failure doses. Increase to 400 mg if required.
CHILD: initially 3 mg/kg daily in divided
doses
Stavudine 30 mg, Lamivudine 150 mg & J05AR07964T1001XX Yes A/KK Fixed dose triple therapy for treatment of HIV infection in SLN 30: 30-60 kg 1 tablet twice daily. SLN
Nevirapine 200 mg Tablet adults once patients have been stabilized on the maintenance 40 ≥60 kg 1 tablet twice daily
regimen of nevirapine 200 mg twice daily and have
demonstrated adequate tolerability to nevirapine

Stavudine 40 mg, Lamivudine 150 mg & J05AR07964T1002XX Yes A* Fixed dose triple therapy for treatment of HIV infection in SLN 30: 30-60 kg 1 tablet twice daily. SLN
Nevirapine 200 mg Tablet adults once patients have been stabilized on the maintenance 40 ≥60 kg 1 tablet twice daily
regimen of nevirapine 200 mg twice daily and have
demonstrated adequate tolerability to nevirapine

Streptokinase 1,500,000 IU Injection B01AD01000P4001XX No A* Acute myocardial infarction, acute pulmonary embolism Myocardial infarction: 1,500,000 units
over 30 - 60 minutes. Pulmonary
embolism: 250,000 units by IV infusion
over 30 minutes, then 100,000 units
every hour for up to 12-72 hours with
monitoring of clotting factors

Streptomycin Sulphate 1 g Injection J01GA01183P4001XX Yes B Tuberculosis ADULT: 15 mg/kg daily; max: 1 g daily.
Reduce max daily dose to 500-750 mg in
patients >40 yr. As part of an
intermittent therapy: 25-30 mg/kg/day 2-
3 times/wk; max: 1.5 g/dose. Not >120 g
over the course of treatment should be
given unless there are no other
treatment options. Child: 20-40 mg/kg
(max: 1 g) daily or 25-30 mg/kg (max: 1.5
g) 2-3 times wkly.

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Generic Name MDC NEML Category Indications Dosage

Strontium Ranelate 2 g Granules M05BX03000F1001XX No A* Treatment of postmenopausal osteoporosis to reduce risk of 2 g sachet once daily
vertebral and hip fractures when biphosphonates are
contraindicated or not tolerated
Succindialdehyde 11% & V07AV00000L9907XX No A High level disinfection for endoscopes, ultrasonicprobes, Immersion time is based on
Dimethoxytetrahydrofuran 3% anaesthesia equipment etc manufacturers recommendation
Sucralfate 1 g Tablet A02BX02000T1001XX No A i) Benign gastric and duodenal ulceration ii) Stress ulcer i) 2 g twice daily or 1 g 4 times daily for 4-
prophylaxis 6 weeks or in resistant cases up to 12
weeks (maximum 8 g daily) ii) 1 g 6 times
daily (maximum 8 g daily). CHILD not
recommended
Sugammadex 100 mg/ml Injection V03AB35000P3001XX No A* Indicated for reversal of neuromuscular blockade induced by 2 mg/kg sugammadex is recommended,
rocuronium and vecuronium in selective patient group: obese, if spontaneous recovery has occurred up
elderly, underlying cardiovascular disease. For pediatric to at least the reappearance of second
population, sugammadex is recommended for routine reversal twitch tension of the train-of-four (T2). 4
mg/kg sugammadex is recommended if
recovery has reached at least 1- 2 post-
tetanic counts (PTC). For immediate
reversal following administration of
rocuronium a dose of 16 mg/kg
sugammadex is recommended

Sulfadoxine 500 mg and Pyrimethamine P01BD51981T1001XX Yes B Treatment of Plasmodium falciparum malaria in patients in Chloroquine resistant falciparum malaria
25 mg Tablet whom chloroquine resistance is suspected and malaria acute attack Adult: Per tab contains
prophylaxis for travellers to areas where chloroquine-resistant pyrimethamine 25 mg and sulfadoxine
malaria is endemic 500 mg: 2-3 tabs as a single dose. Do not
repeat for at least 7 days. Child:
Pyrimethamine 25mg + Sulfadoxine
500mg (Tablet): <2 yr (5-10 kg): 1/2
(half) tab as a single dose; 2-5 yr (>10-20
kg): 1 tab as a single dose; 5-10 yr (< 20-
30 kg): 1 1/2 (one and half) tab as a
single dose; 10-14 yr (> 30-45 kg): 2 tab
as a single dose. Do not repeat for at
least 7 days. Renal impairment: Dose
reduction may be needed. Severe:
contra-indicated. Hepatic impairment:
Dose reduction may be needed. Severe:
contra-indicated.

Sulphamethoxazole 200 mg & J01EE01961L8001XX Yes B Infections caused by susceptible pathogens Mild to moderate infections: more than
Trimethoprim 40 mg/5ml Suspension 2months: 8 - 12mg Trimethoprim/kg/day
divided every 12hours. Serious
Infections: 15-20mg
Trimethoprim/kg/day divided every
6hours.
Sulphamethoxazole 400 mg & J01EE01961P3001XX No A i) Severe or complicated infections when oral therapy is not i) ADULT: 960 mg twice daily increased
Trimethoprim 80 mg Injection feasible ii) Treatment and prophylaxis of pneumocystis carinii to 1.44 g twice daily in severe infections.
pneumonia (PCP) in immunocompromised patients CHILD: 36 mg/kg daily in 2 divided doses
increased to 54 mg/kg/day in severe
infections ii) Treatment: ADULT & CHILD
over 4 weeks: 120 mg/kg/day PO/IV
infusion in 2 - 4 divided doses for 14
days. Prophylaxis: ADULT: 960 mg once
daily or 960 mg on alternate days (3
times a week) or 960 mg twice daily on
alternate days (3 times a week). CHILD 6
weeks - 5 months: 120 mg twice daily on
3 consecutive days or 7 days per week; 6
months - 5 years: 240 mg; 6 - 12 years:
480 mg

Sulphamethoxazole 400 mg & J01EE01961T1001XX Yes B i) Severe or complicated infections due to susceptible i) ADULT: 1 - 3 tablets twice daily ii)
Trimethoprim 80 mg Tablet infection ii) Treatment and prophylaxis of pneumocystis carinii Treatment: ADULT & CHILD over 4
pneumonia (PCP) in immunocompromised patients weeks: 120 mg/kg/day in 2 - 4 divided
doses for 14 days. Prophylaxis: ADULT:
960 mg once daily or 960 mg on
alternate days (3 times a week) or 960
mg twice daily on alternate days (3 times
a week). CHILD; 6 weeks - 5 months: 120
mg twice daily on 3 consecutive days or
7 days per week; 6 months - 5 years: 240
mg; 6 - 12 years: 480 mg

Sulphur 2% & Salicylic Acid 2% Cream D10AB02951G1001XX No C Acne vulgaris and seborrhoeic dermatitis When used in scalp disorders, a small
amount of cream should be rubbed
gently into the roots of the hair. When
used in skin disorders, the cream should
be applied sparingly to the affected area.
Apply once daily or until noticeable
improvement, then once or twice a week

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Sulpiride 200 mg Tablet N05AL01000T1001XX Yes B Acute and chronic schizophrenia, chronic delusional psychoses 200-400 mg twice daily; 800 mg daily in
predominantly negative symptoms and
2.4 g daily in mainly positive symptoms.
Elderly, lower initial dose; increased
gradually according to response. Child
under 14 years not recommended

Sumatriptan 100 mg Tablet N02CC01000T1002XX Yes A/KK Treatment of acute migraine attacks 50 mg per attack and not more than 300
mg daily
Sumatriptan 50 mg Fast Disintegrating N02CC01000T5001XX Yes A Treatment of acute migraine attacks 50 mg per attack and not more than 300
Tablet mg daily
Sumatriptan 50 mg Tablet N02CC01000T1001XX Yes A/KK Treatment of acute migraine attacks 50 mg per attack and not more than 300
mg daily
Sumatriptan 6 mg/0.5 ml Injection N02CC01000P5001XX No A Treament of acute migraine attacks and cluster headache 6 mg given by SC as soon as possible
after onset. Dose may be repeated once
after not less than 1 hour if needed.
Max. 12 mg in 24 hours. Child not
recommended
Sunitinib malate 12.5mg capsule L01XE04253C1003XX No A* Treatment of advanced renal cell carcinoma (RCC) Restriction 50 mg orally once daily for 4 consecutive
criteria: i) KPS ≥70% ii) Clear cell histology iii) No brain weeks, followed by a 2-week off period
metastases iv) Haemoglobin ≥9g/dl v) Creatinine ≤2x the ULN to comprise a complete cycle of 6 weeks.
vi) Corrected calcium <12mg/dl vii) Platelet count of >100 x
103/uL viii) Neutrophil count>1500/mm3

Sunscreen 5 - 20% w/w Cream D02BA02000G1001XX No B Photodermatitis Apply to exposed areas at least 30
minutes prior to solar exposure; reapply
after swimming, prolonged perspiration
and after 2 hours of continuos sun
exposure
Suxamethonium Chloride 50 mg/ml lnj M03AB01100P3001XX Yes B Muscle relaxant as an adjunct to anaesthesia Intravenous: Muscle relaxant in general
anaesthesia Adult: As chloride: single
dose of 0.3-1.1 mg/kg injected;
supplementary doses of 50-100% of the
initial dose may be given at 5-10 min
intervals. Max dose (repeated IV
injection or continuous infusion): 500
mg/hr Child: As chloride: <1 yr: 2 mg/kg;
1-12 yr: 1 mg/kg. Intramuscular: Muscle
relaxant in general anaesthesia Adult: As
chloride: 3-4 mg/kg. Max total dose: 150
mg Child: As chloride: <1 yr: Up to 4-5
mg/kg; ≥1 yr: Up to 4 mg/kg. Max dose:
150 mg.

Synthetic ACTH (Tetracosactrin Acetate) H01AA02000P3001XX No A Diagnostic test to differentiate primary adrenal from Diagnostic test for investigation of
250 mcg/ml Injection secondary (pituitary) adrenocortical insufficiency adrenocortical insufficiency Adult: As
plain preparation: Measure plasma
cortisol concentration immediately
before and exactly 30 min after IM/IV inj
of 250 mcg. Post-inj rise in plasma
cortisol concentration ≥200 nmol/l (70
mcg/l) if normal adrenocortical function.
As depot preparation (if inconclusive
results with plain preparation): Measure
plasma cortisol concentration before
and exactly 30 min, 1, 2, 3, 4 and 5 hr
after an IM inj of 1 mg tetracosactide
acetate depot. Adrenocortical function
normal if the post-inj rise in plasma
cortisol concentration increases 2-fold in
1st hr, and continues to rise steadily.
Expected levels in 1st hr: 600-1,250
nmol/l, increasing slowly up to 1000-
1800 nmol/l by 5th hr. Child: IV 250
mcg/1.73 m2 BSA. Intramuscular

Tacrolimus 0.03% Ointment D11AH01000G5002XX No A* For short-term and intermittent long-term therapy in the Adult ≥16 years: Apply 0.03% or 0.1% to
treatment of patients with moderate to severe atopic the affected skin twice daily and rub in
dermatitis in whom the use of alternative, conventional gently and completely. Children ≥ 2
therapies are deemed inadvisable because of potential risks, years: Apply 0.03% ointment thinly to
or in the treatment of patients who are not adequately the affected skin bd and rub in gently
responsive to or are intolerant of alternative, conventional and completely. Treatment should be
therapies continued for 1 week after clearing of
signs & symptoms of atopic dermatitis.

Tacrolimus 0.1% Ointment D11AH01000G5001XX No A* For short-term and intermittent long-term therapy in the Adult ≥16 years: Apply 0.03% or 0.1% to
treatment of patients with moderate to severe atopic the affected skin twice daily and rub in
dermatitis in whom the use of alternative, conventional gently and completely. Children ≥ 2
therapies are deemed inadvisable because of potential risks, years: Apply 0.03% ointment thinly to
or in the treatment of patients who are not adequately the affected skin bd and rub in gently
responsive to or are intolerant of alternative, conventional and completely. Treatment should be
therapies continued for 1 week after clearing of
signs & symptoms of atopic dermatitis.

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Tacrolimus 0.5 mg Capsule L04AD02000C1003XX No A* i) Primary immunosuppression in liver and kidney allograft 0.1-0.2 mg/kg/day for liver
recipients. ii) Liver and kidney allograft rejection resistant to transplantation and at 0.15-0.3
conventional immunosuppressive agents. It is recommended mg/kg/day for kidney transplantation
to be used concomitantly with adrenal corticosteroids. administered as 2 divided doses.
Because of the risk of anaphylaxis. Injection should be
reserved for patients unable to take capsules only.

Tacrolimus 0.5mg Prolonged-Release L04AD02000C2203XX No A* i) Prophylaxis of transplant rejection in adult kidney or liver i) Prophylaxis of kidney transplant
Hard Capsule allograft recipients. ii) Treatment of kidney or liver allograft rejection: Tacrolimus PR therapy should
rejection resistant to treatment with other commence at dose of 0.20-0.30
immunosuppressive medicinal products in adult. mg/kg/day administered once daily in
the morning. Administration should
commence within 24 hours after
completion of surgery. ii) Prophylaxis of
liver transplant rejection: Tacrolimus PR
therapy should commence at a dose of
0.10-0.20 mg/kg/day administered once
daily in the morning. Administration
should commence within 12-18 hours
after completion of surgery. iii)
Treatment of allograft rejection:
Increased doses of tacrolimus,
supplemental corticosteroid therapy,
and introduction of short courses of
mono-/polyclonal antibodies have all
been used to manage rejection episodes.
If signs of toxicity such as severe adverse
reactions are noted, the dose of
Tacrolimus PR might need to be
reduced. iv) Treatment of allograft
rejection after kidney or liver
transplantation: For conversion from
other immunosuppressants to once daily
Tacrolimus 1 mg Capsule L04AD02000C1001XX No A* i) Primary immunosuppression in liver and kidney allograft 0.1-0.2 mg/kg/day for liver
recipients. ii) Liver and kidney allograft rejection resistant to transplantation and at 0.15-0.3
conventional immunosuppressive agents. It is recommended mg/kg/day for kidney transplantation
to be used concomitantly with adrenal corticosteroids. administered as 2 divided doses.
Because of the risk of anaphylaxis. Injection should be
reserved for patients unable to take capsules only.

Tacrolimus 1mg Prolonged-Release Hard L04AD02000C2201XX No A* i) Prophylaxis of transplant rejection in adult kidney or liver i) Prophylaxis of kidney transplant
Capsule allograft recipients. ii) Treatment of kidney or liver allograft rejection: Tacrolimus PR therapy should
rejection resistant to treatment with other commence at dose of 0.20-0.30
immunosuppressive medicinal products in adult. mg/kg/day administered once daily in
the morning. Administration should
commence within 24 hours after
completion of surgery. ii) Prophylaxis of
liver transplant rejection: Tacrolimus PR
therapy should commence at a dose of
0.10-0.20 mg/kg/day administered once
daily in the morning. Administration
should commence within 12-18 hours
after completion of surgery. iii)
Treatment of allograft rejection:
Increased doses of tacrolimus,
supplemental corticosteroid therapy,
and introduction of short courses of
mono-/polyclonal antibodies have all
been used to manage rejection episodes.
If signs of toxicity such as severe adverse
reactions are noted, the dose of
Tacrolimus PR might need to be
reduced. iv) Treatment of allograft
rejection after kidney or liver
transplantation: For conversion from
other immunosuppressants to once daily
Tacrolimus 5 mg Capsule L04AD02000C1002XX No A* i) Primary immunosuppression in liver and kidney allograft 0.1-0.2 mg/kg/day for liver
recipients. ii) Liver and kidney allograft rejection resistant to transplantation and at 0.15-0.3
conventional immunosuppressive agents. It is recommended mg/kg/day for kidney transplantation
to be used concomitantly with adrenal corticosteroids. administered as 2 divided doses.
Because of the risk of anaphylaxis. Injection should be
reserved for patients unable to take capsules only.

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Tacrolimus 5mg Prolonged-Release Hard L04AD02000C2202XX No A* i) Prophylaxis of transplant rejection in adult kidney or liver i) Prophylaxis of kidney transplant
Capsule allograft recipients. ii) Treatment of kidney or liver allograft rejection: Tacrolimus PR therapy should
rejection resistant to treatment with other commence at dose of 0.20-0.30
immunosuppressive medicinal products in adult. mg/kg/day administered once daily in
the morning. Administration should
commence within 24 hours after
completion of surgery. ii) Prophylaxis of
liver transplant rejection: Tacrolimus PR
therapy should commence at a dose of
0.10-0.20 mg/kg/day administered once
daily in the morning. Administration
should commence within 12-18 hours
after completion of surgery. iii)
Treatment of allograft rejection:
Increased doses of tacrolimus,
supplemental corticosteroid therapy,
and introduction of short courses of
mono-/polyclonal antibodies have all
been used to manage rejection episodes.
If signs of toxicity such as severe adverse
reactions are noted, the dose of
Tacrolimus PR might need to be
reduced. iv) Treatment of allograft
rejection after kidney or liver
transplantation: For conversion from
other immunosuppressants to once daily
Tacrolimus 5mg/ml Injection L04AD02000P3001XX No A* i) Primary immunosuppression in liver and kidney allograft 0.01-0.05 mg/kg for liver transplant and
recipients. ii) Liver and kidney allograft rejection resistant to 0.05-0.1 mg/kg for kidney transplant as
conventional immunosuppressive agents. It is recommended 24-hours continuous infusion.
to be used concomitantly with adrenal corticosteroids.
Because of the risk of anaphylaxis. Injection should be
reserved for patients unable to take capsules only.

Tamoxifen Citrate 20 mg Tablet L02BA01136T1001XX Yes A Breast cancer 20 mg in 1-2 divided doses. Max: 40
mg/day
Tamsulosin HCl 400 mcg Extended G04CA02110T5001XX No A* Second line treatment of functional symptoms of benign 400 mcg once daily
Release Tablet prostatic hyperplasia (BPH) in patients who do not tolerate
first line drugs or when first line drugs are inappropriate or
contraindicated
Tar, Coal Tar and Oleyl Alcohol Liquid D05AA00952L5001XX No A/KK Dandruff, seborrhoeic dermatitis and atopic dermatitis Massage into wet hair, rinse and repeat.
Use once or twice weekly
Technetium-99m Sterile Generator V09CA01000P3001XX No A* Sodium pertechnetate is used for scintigraphy or nuclear scan Technetium-99m as pertechnetate is
particularly of the brain and thyroid to prepare various obtained by elution with a sterile
technetium-99m labelled injections for selective organ solution of Sodium Chloride 0.9%. The
imaging dosage depend on type of scan i) Thyroid
scintigraphy: 18.5-80 MBq (0.5-2.2 mCi)
Scintigraphy performed 20 minutes after
intravenous injection ii) Salivary gland
scintigraphy: 40 MBq (1.1 mCi)
Scintigraphy performed immediately
after intravenous injection and at regular
intervals up to 15 minutes iii) Meckel?s
diverticulum scintigraphy: 400 MBq
(10.8 mCi) Scintigraphy performed
immediately after intravenous injection
and at regular interval up to 30 minutes
iv) Brain scintigraphy: 370-800 MBq (10-
22 mCi) Rapid sequential images are
taken immediately within the first
minute after intravenous administration,
static images 1 to 4 hours later. Thyroid
and coriod plexus should be blocked to
avoid non-specific 99mTc uptake v)
Cardiac and vascular scintigraphy: 740-
925 MBq (20-25 mCi) Red cells are
labeled in vivo or in vitro by pretreating
with a reducing agent. Dynamic images
Tegafur 100 mg & uracil 224 mg Capsule L01BC53980C1001XX No A* Non small cell lung cancer 300-600 mg daily in 2-3 divided doses

Telbivudine 600 mg Tablet J05AF11000T1001XX No A* Treatment of chronic hepatitis B in patients with evidence of ADULT and CHILD over 16 years: 600 mg
viral replication and active liver inflammation once daily. Renal Dose Adjustment:
600mg every 48hours (30-49ml/min),
600 mg every 72hours. (<30ml/min; not
requiring dialysis); 600mg every 96 days
(ESRD)

Telmisartan 40 mg Tablet C09CA07000T1001XX Yes A/KK Hypertension in patients who cannot tolerate ACE inhibitors 40mg - 80mg once daily
because of cough
Telmisartan 80 mg & C09DA07000T1001XX No A/KK Hypertension in patients who cannot tolerate ACE inhibitors 1 tablet daily
Hydrochlorothiazide 12.5 mg Tablet because of cough
Telmisartan 80 mg Tablet C09CA07000T1002XX Yes A/KK i)Hypertension in patients who cannot tolerate ACE inhibitors i) 40mg - 80mg once daily ii) 80mg once
because of cough ii)Reduction of the risk of myocardial daily
infarction, stroke, or death from cardiovascular causes in
patients 55 years or older at high risk of developing major
cardiovascular events who are unable to take ACE inhibitors

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Temozolomide 100 mg Capsule L01AX03000C1003XX No A* In patients with glioblastoma multiforme who fulfill all the Concomitant phase : 75mg/m2 daily
following criteria: i. Total /near total resection ii. ECOG/WHO with radiotherapy for 42 days, followed
performance status 0-2 iii. Age less than 60 years by 6 cycle of adjuvant treatment.
Adjuvant phase: Additional 6 cycles of
adjuvant phase. Cycle 1- 150mg/m2
once daily for 5 days followed by 23 days
without treatment. Cycle 2-6 :
200mg/m2 once daily for 5 days per 28-
day cycle

Temozolomide 20 mg Capsule L01AX03000C1001XX No A* In patients with glioblastoma multiforme who fulfill all the Concomitant phase : 75mg/m2 daily
following criteria : i. total /near total resection ii. ECOG/WHO with radiotherapy for 42 days, followed
performance status 0-2 iii. Age less than 60 years by 6 cycle of adjuvant treatment.
Adjuvant phase: Additional 6 cycles of
adjuvant phase. Cycle 1- 150mg/m2
once daily for 5 days followed by 23 days
without treatment. Cycle 2-6 :
200mg/m2 once daily for 5 days per 28-
day cycle

Tenecteplase 10,000 unit (50 mg) B01AD11000P4001XX No A* Acute myocardial reinfarction where streptokinase is Less than 60 kg: 30 mg, 60 - 69 kg: 35
Injection contraindicated due to previous streptokinase induced mg, 70 - 79 kg: 40 mg; 80 -90 kg: 45 mg,
antibodies. [Indicated when antibodies was given more than 5 90 kg or above: 50 mg. Administer single
days and less than 12 months] IV bolus over 5-10 seconds

Tenofovir Disoproxil Fumarate 300 mg & J05AR03964T1001XX Yes A/KK Treatment of HIV-1 infection in adults in combination with 1 tablet once daily.
Emtricitabine 200 mg Tablet other antiretroviral agents (such as non-nucleoside reverse
transcriptase inhibitors or protease inhibitors).
Tenofovir Disoproxil Fumarate 300 mg J05AF07138T1001XX Yes A* i)Treatment of HIV-1 infected adults in combination with other 300mg once daily. Renal Dose
Tablet antiretroviral agents. ii)Use as first line monotherapy for Adjustment: 300mg every 48hours (30-
chronic hepatitis B or as a rescue therapy for patients with 49ml/min); 300mg every 72hours (10-
drug resistance hepatitis B virus (according to resistant profile 29ml/min); 300mg every 7 days after
or treatment guidelines). dialysis (Hemodialysis)

Terazosin HCl 1 mg Tablet G04CA03110T1001XX Yes A/KK Only for treatment of Benign Prostatic Hyperplasia. Not to be Initially 1 mg at night, increased in a
used for treatment of hypertension stepwise fashion to 2 mg, 5 mg or 10 mg
once daily
Terazosin HCl 2 mg Tablet G04CA03110T1002XX Yes A/KK i) Treatment of Benign Prostatic Hyperplasia. ii)Hypertension i)Initially 1 mg at night, increased in a
stepwise fashion to 2 mg, 5 mg or 10 mg
once daily. ii)Initial: 1mg once daily at
bedtime, Maintenance: 1-5mg once
(morning or evening) or twice daily.
Max: 20-40mg/day
Terazosin HCl 5 mg Tablet G04CA03110T1003XX Yes A/KK i) Treatment of Benign Prostatic Hyperplasia. ii)Hypertension i) Initially 1 mg at night, increased in a
stepwise fashion to 2 mg, 5 mg or 10 mg
once daily. ii) Initial: 1mg once daily at
bedtime, Maintenance: 1-5mg once
(morning or evening) or twice daily.
Max: 20-40mg/day
Terbinafine 1% gel D01AE15110G3001XXX No A/KK Skin infections caused by dermatophytes, mould and candida. Apply topically twice daily for 1 week
Prescribing restriction: Second line treatment (interdigital); apply topically twice
(plantar) daily for 2 weeks. Children
must be aged above 2 years old.
Terbinafine HCl 250 mg Tablet D01BA02110T1001XX No A/KK Fungal infections especially onchomycosis caused by 250 mg once daily for 6 weeks for
dermatophytes fingernails: 12 weeks for toenails
Terbutaline Sulphate 0.5 mg/ml Injection R03CC03183P3001XX No B Bronchial asthma, chronic bronchitis, emphysema and other SC, IM or slow IV : 250-500 mcg up to 4
lung diseases where broncoconstriction is a complicating times daily. CHILD 2 - 15 years 10mcg/kg
factor to a maximum of 300 mcg. Continuous
IV infusion, as a solution containing 3 - 5
mcg/ml, 1.5 - 5 mcg/minute for 8 - 10
hours; reduce dose for children

Terbutaline Sulphate 10 mg/ml R03AC03183A3001XX No B Asthma and other conditions associated with reversible ADULT : 5 - 10 mg 2 -4 times daily,
Nebulizer Solution airways obstruction additional doses may be necessary in
severe acute asthma. CHILD up to 3
years : 2 mg, 3 - 6 years : 3 mg, 6 - 8
years : 4 mg, over 8 years : 5 mg 2 - 4
times daily
Terlipressin 1mg/5mg Injection H01BA04000P4001XX No A* Acute oesophageal variceal bleeding 2 mg IV bolus over 1 minute.
Maintenance: 1 - 2 mg IV bolus 4 - 6
hourly until bleeding is controlled, up to
24 - 36 hours. The maximum daily
dosage is 120-150 mcg/kg body weight.

Testosterone 250 mg/ml Injection G03BA03000P3001XX Yes A* Only for treatment of male infertility, protein deficiency By IM only. Hypogonadism 250 mg every
during convalescence after surgery and wasting disorder. In 2-3 weeks. To maintain an adequate
women, supplementary therapy of progressive mammary androgenic effect 250 mg every 3-6
carcinoma weeks. Potency disorders 250 mg every
4 weeks. Male climateric disorders: 250
mg every 3-4 weeks. Repeated 6-8 weeks
courses at 2-3 months interval

Tetanus Toxoid Injection J07AM01000P3001XX Yes C+ Immunization against tetanus infection 2 doses of 0.5 mL IM at an interval of 4-8
wk, followed by the 3rd dose 6-12 mth
later. Booster: 0.5 mL IM every 10 yr.

Tetracycline HCl 250 mg Capsule J01AA07110C1001XX Yes B Infections caused by susceptible pathogens "Adult: 250-500 mg 6 hrly. Max: 4 g/day.
Child: ≥12 yr Max: 2 g daily"

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Tetracycline HCl 250 mg Tablet J01AA07110T1001XX No B Infections caused by susceptible pathogens "Adult: 250-500 mg 6 hrly. Max: 4 g/day.
Child: ≥12 yr Max: 2 g daily"
Thalidomide 50 mg Capsule L04AX02000C1001XX No A* First line induction therapy in newly diagnosed multiple 50 mg to 200 mg daily
myeloma, salvage therapy in relapsed multiple myeloma and
maintenance therapy in multiple myeloma (contraindicated
for pregnant women; pregnancy test for females in
reproductive age group before starting treatment should be
done).
Thallous Chloride (Thallium-201) V09GX01100P3001XX No A* Used in myocardial perfusion scintigraphy, acute myocardial As IV infusion
Injection infarction and post-surgical assessment of coronary artery
bypass graft patency, muscle perfusion scintigraphy,
visualisation of brain and thyroid tumours and metastases

Theophylline 125 mg Tablet R03DA04000T1001XX Yes B Reversible airways obstruction, acute severe asthma ADULT: 125 mg 3 - 4 times daily after
food, increased to 250 mg if required.
CHILD: 1 - 15 years : 5 mg/kg/dose (up to
600 mg/ day) every 3 - 4 times daily

Theophylline 250 mg Long Acting Tablet R03DA04000T5001XX Yes B Reversible airways obstruction and acute severe asthma ADULT: 250 mg 2 times daily. CHILD
under 12 years : Up to 10 mg/kg body
weight 2 times daily
Theophylline 80 mg/15 ml Syrup R03DA04000L9001XX Yes B Reversible airways obstruction and acute severe asthma ADULT : 125 mg 3 - 4 times daily after
food, increased to 250 mg if required.
CHILD 1 - 15 years : 5 mg/kg/dose (up to
600 mg/day) every 3 - 4 times per day

Thiamine HCl 100 mg/ml Injection A11DA01110P3001XX No B i) For the prevention or treatment of Vitamin B1 deficiency i) Mild to chronic deficiency: 10-25 mg
syndromes including beri-beri and peripheral neuritis daily. Severe deficiency: 200- 300 mg
associated with pellagra ii) Wernicke-Korsakoff Syndrome daily ii) 500 mg every 8 hours for 2 days,
followed by 100 mg 2 times daily until
patient can take oral dose
Thiamine Mononitrate 10 mg Tablet A11DA01221T1002XX No C For the prevention or treatment of Vitamin B1 deficiency i) Mild to chronic deficiency: 10-25 mg
syndromes including beri-beri and peripheral neuritis daily ii) Severe deficiency: 200- 300 mg
associated with pellagra daily
Thiamine Mononitrate 3 mg Tablet A11DA01221T1001XX No C For the prevention or treatment of Vitamin B1 deficiency i) Mild to chronic deficiency: 10-25 mg
syndromes including beri-beri and peripheral neuritis daily ii) Severe deficiency: 200 - 300 mg
associated with pellagra daily
Thioguanine 40 mg Tablet L01BB03000T1001XX Yes A For acute leukaemia and chronic granulocytic leukaemia Refer to specific protocols. Usually 100
mg/m2 for 5 - 7 days (acute myeloid
leukaemia) or up to 2 weeks (chronic
myeloid leukaemia for accelerated/
advanced disease). CHILD: 40 - 60 g/m2
daily according to protocol

Thiopental Sodium 500 mg Injection N05CA19520P3001XX Yes B i) General anaesthesia, induction ii) Anticonvulsant for cases i) ADULT : For induction 200 - 400 mg.
resistant to conventional anticonvulsants in the ICU For repeat injection 3 - 5 mg/kg over 10 -
15 seconds until desired depth of
anaesthesia is obtained. Not FDA
approved for use in pediatric patients ii)
75 - 125 mg IV single dose; for local-
anaesthetic induced convulsion: 125 -
250 mg IV over 10 minutes

Thymol Compound Gargle A01AD11985M2001XX No C For sore throat and minor mouth inflammation To be gargled 3-4 times daily

Thyrotropin alfa 0.9mg/ml Injection H01AB01000P3002XX No A* Thyrogen (thyrotropin alfa) is indicated for use as an A two-injection regimen is
adjunctive treatment for radioiodine ablation of thyroid tissue recommended for thyrotropin
remnants in patients who have undergone a near-total or total administration.The two-injection
thyroidectomy for well-differentiated thyroid cancer and who regimen is thyrotropin 0.9 mg
do not have evidence of distant metastatic thyroid cancer. intramuscularly (IM), followed by a
second 0.9 mg IM injection 24 hours
later. After reconstitution with 1.2 mL
Sterile Water for Injection, 1.0 mL
solution (0.9 mg thyrotropin alfa) is
administered by intramuscular injection
to the buttock. For radioiodine imaging
or treatment, radioiodine administration
should be given 24 hours following the
final Thyrogen injection. Diagnostic
scanning should be performed 48 hours
after radioiodine administration,
whereas post-therapy scanning may be
delayed additional days to allow
background activity to decline.

Tibolone 2.5 mg Tablet G03CX01000T1001XX No A* Treatment of complaints resulting from the natural or surgical 2.5mg daily
menopause & in cases at high risk for breast carcinomas
where general hormone replacement therapy is
contraindicated
Ticagrelor 90 mg Tablet B01AC24000T1001XX No A* a)Patient who failed clopidogrel readmitted to hospital with Initially, 180mg as single dose followed
recurrent atherothrombotic event while patients are on by 90mg bd with maintenance dose of
clopidogrel. b) ACS patients with:i) STEMI - going for invasive ASA 75-150 mg daily.
(PCI), ii) NSTEMI/UA - intermediate to high risk (based on TIMI
score). iii) Other complicated ACS cases treated either
medically or invasively via PCI or CABG (risk of Stent
thrombosis, 3VD etc.)

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Ticlopidine HCl 250 mg Tablet B01AC05110T1001XX No A/KK i) Prevention of thrombotic stroke for patients who are 250 mg twice daily taken with food
sensitive /intolerant to Acetysalicylic Acid ii) Maintenance of
coronary bypass surgery or angioplasty iii) Maintenance of
patency of access in patients on chronic haemodialysis

Timolol Maleate 0.5% Eye Drops S01ED01253D2002XX Yes A Elevated intraocular pressure, chronic open angle glaucoma 1 drop for once daily or 2 times daily
depending on manufacturer's
recommendation.
Tinidazole 500 mg Tablet P01AB02000T1001XX No B i) Amoebiasis ii) Urogenital trichomoniasis and giardiasis i) ADULT : 2 g as a single dose for 2 - 3
days. CHILD 3 years and older : 50 mg/kg
daily for 3 days ii) ADULT : 2 g as a single
dose (repeated once if necessary). Sexual
partners should be treated
concomitantly with the same dose.
CHILD 6 years and older : single dose of 1
gram
Tinzaparin sodium 10,000 anti-Factor Xa B01AB10520P5001XX No A* i)Treatment of deep vein thrombosis (DVT) and pulmonary i)Treatment of DVT and PE, in
IU/ml Injection in Prefilled embolism (PE), not amounting to hemodynamic instability. conjunction with warfarin: 175 anti-
syringe/cartridge ii)Prevention of post-operative DVT in patients undergoing Factor Xa IU/kg SC once daily for at least
general and orthopaedic surgery. 6 days. ii)Thromboprophylaxis in
patients with:Moderate risk of
thrombosis (general surgery):3,500 anti-
Factor Xa IU SC 2 hrs before surgery and
postoperatively, 3,500 anti-Factor Xa IU
once daily for 7-10 days. High risk of
thrombosis (eg. total hip
replacement):4,500 anti-Factor Xa IU SC
or 50 anti-Factor Xa IU/kg body weight
SC 2 hrs before surgery and then once
daily until the patients has been
mobilized.
Tinzaparin sodium 20,000 anti-Factor Xa B01AB10520P5002XX No A* i)Treatment of deep vein thrombosis (DVT) and pulmonary i)Treatment of DVT and PE, in
IU/ml Injection in Prefilled embolism (PE), not amounting to hemodynamic instability. conjunction with warfarin: 175 anti-
syringe/cartridge ii)Prevention of post-operative DVT in patients undergoing Factor Xa IU/kg SC once daily for at least
general and orthopaedic surgery. 6 days. ii)Thromboprophylaxis in
patients with:Moderate risk of
thrombosis (general surgery):3,500 anti-
Factor Xa IU SC 2 hrs before surgery and
postoperatively, 3,500 anti-Factor Xa IU
once daily for 7-10 days. High risk of
thrombosis (eg. total hip
replacement):4,500 anti-Factor Xa IU SC
or 50 anti-Factor Xa IU/kg body weight
SC 2 hrs before surgery and then once
daily until the patients has been
mobilized.
Tioconazole 100 mg Vaginal Tablet G01AF08000S1001XX No A Vulvovaginal candidiasis Adult & Child > 12yr: Insert nightly on
retiring for 3-6 or 14 days
Tiotropium 2.5mcg/puff solution for R03BB04320A3001XX No A/KK i) Maintenance bronchodilator treatment to relieve symptoms 5 mcg (2 puff) once daily, at the same
inhalation of patients with chronic obstructive pulmonary disease (COPD) time of the day
in which the diagnosis of COPD is confirmed by spirometry. ii)
As add-on maintenance bronchodilator treatment in adult
patients with asthma who are currently treated with the
maintenance combination of inhaled corticosteroids (≥800µg
budesonide/day or equivalent) and long-acting β2-agonist and
who experienced one or more severe exacerbations in the
previous year.

Tiotropium Bromide 18 mcg Inhalation R03BB04320C9901XX No A/KK Long term maintenance treatment of bronchospasm and Contents of one capsule is inhaled once
Capsules dypsnoea associated with COPD. Tiotropium has usually been daily with the Handihaler inhalation
added to standard therapy (e.g. inhaled steroids, theophylline, device at the same time of the day.
albuterol rescue)
Tirofiban HCl 0.25 mg/ml Injection B01AC17110P9901XX No A* Unstable angina or non-ST segment elevation myocardial By IV infusion, 0.4 mcg/kg/min for 30
infarction with the following: elevated cardiac markers, minutes, then 0.1 mcg/kg/min for at
refractory chest pain, ST-segment changes and thrombolysis in least 48 hours, maximum 108 hours
myocardial infarction (TIMI) risk score 4
Tocilizumab 162mg/0.9ml solution for L04AC07000P3003XX No A* Indicated for the treatment of moderate to severe active Adult patients: 162mg given once every
injection in prefilled syringe (for rheumatoid arthritis (RA) in adult patients: i) with inadequate week as a subcutaneous injection.
subcutaneous injection) respond or intolerance to conventional disease- modifying
antirheumatic drugs (DMARDS) ii) who has failed antitumour
necrosis factors (antiTNFs) iii) where TNF is contraindicated
(patients with history of pulmonary tuberculosis [PTB]) It also
can be used as monotherapy or with combination with
methotrexate (MTX) and/ or other DMARDS.

Tocilizumab 20 mg/ml Injection L04AC07000P3001XX No A* Indicated for the treatment of moderate to severe active Recommended dose for rheumatoid
rheumatoid arthritis (RA) in adult patients: i) with inadequate arthritis of tocilizumab for adult patients
respond or intolerance to conventional disease- modifying is 8mg/kg given once every 4 weeks as a
antirheumatic drugs (DMARDS) ii) who has failed antitumour single-drip IV infusion over 1 hour. It
necrosis factors (antiTNFs) iii) where TNF is contraindicated should be diluted to 100 ml by a
(patients with history of pulmonary tuberculosis [PTB]) It also healthcare professional with sterile 0.9%
can be used as monotherapy or with combination with w/v sodium chloride solution over 1
methotrexate (MTX) and/ or other DMARDS. hour. For patients whose body weight is
more than 100kg, doses exceeding
800mg per infusion are not
recommended

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Tofacitinib citrate 5mg film coated tablet L04AA29136T3201XX No A* Indicated for the treatment of adult patients with moderately One tablet twice daily
to severely active rheumatoid arthritis who have had an
inadequate response or intolerance to methotrexate. It may
be used as monotherapy or in combination with methotrexate
or other non-biologic disease-modifying anti-rheumatic drugs
(DMARDs).
Tolterodine Tartrate ER 4 mg Capsule G04BD07123C2002XX No A* Treatment of overactive bladder with symptoms of urinary, 4 mg once daily. May decrease to 2 mg
frequency or urge incontinence once daily depending on response and
tolerability
Topiramate 100 mg Tablet N03AX11000T1003XX Yes A* Add-on therapy for intractable partial epilepsy ADULT: Initially 25-50mg nightly for 1
week. Subsequently at wkly or bi-wkly
intervals, increase dose by 25-50 to
100mg/day in 2 divided doses. CHILD
aged 2 and above: Approx 5-9
mg/kg/day in 2 divided doses. Titrate at
25mg (or less, based on a range of 1-
3mg/kg/day) nightly for the 1st week.
Subsequently at 1 or 2 wkly intervals,
with increments of 1-3 mg/kg/day in 2
divided dose.
Topiramate 15 mg Capsule Sprinkle N03AX11000C1001XX Yes A* Add-on therapy for intractable partial epilepsy ADULT: Initially 25-50mg nightly for 1
week. Subsequently at wkly or bi-wkly
intervals, increase dose by 25-50 to
100mg/day in 2 divided doses. CHILD
aged 2 and above: Approx 5-9
mg/kg/day in 2 divided doses. Titrate at
25mg (or less, based on a range of 1-
3mg/kg/day) nightly for the 1st week.
Subsequently at 1 or 2 wkly intervals,
with increments of 1-3 mg/kg/day in 2
divided dose.
Topiramate 25 mg Capsule Sprinkle N03AX11000C1002XX Yes A* Add-on therapy for intractable partial epilepsy ADULT: Initially 25-50mg nightly for 1
week. Subsequently at wkly or bi-wkly
intervals, increase dose by 25-50 to
100mg/day in 2 divided doses. CHILD
aged 2 and above: Approx 5-9
mg/kg/day in 2 divided doses. Titrate at
25mg (or less, based on a range of 1-
3mg/kg/day) nightly for the 1st week.
Subsequently at 1 or 2 wkly intervals,
with increments of 1-3 mg/kg/day in 2
divided dose.
Topiramate 25 mg Tablet N03AX11000T1001XX Yes A* Add-on therapy for intractable partial epilepsy ADULT: Initially 25-50mg nightly for 1
week. Subsequently at wkly or bi-wkly
intervals, increase dose by 25-50 to
100mg/day in 2 divided doses. CHILD
aged 2 and above: Approx 5-9
mg/kg/day in 2 divided doses. Titrate at
25mg (or less, based on a range of 1-
3mg/kg/day) nightly for the 1st week.
Subsequently at 1 or 2 wkly intervals,
with increments of 1-3 mg/kg/day in 2
divided dose.
Topiramate 50 mg Tablet N03AX11000T1002XX Yes A* Add-on therapy for intractable partial epilepsy ADULT: Initially 25-50mg nightly for 1
week. Subsequently at wkly or bi-wkly
intervals, increase dose by 25-50 to
100mg/day in 2 divided doses. CHILD
aged 2 and above: Approx 5-9
mg/kg/day in 2 divided doses. Titrate at
25mg (or less, based on a range of 1-
3mg/kg/day) nightly for the 1st week.
Subsequently at 1 or 2 wkly intervals,
with increments of 1-3 mg/kg/day in 2
divided dose.
Trace Elements and Electrolytes (Adult) B05XA30905P3001XX No A* Only to be used to cover daily loss of electrolyte and trace 10 ml added to 500-1000 ml solution,
Solution elements for patient on parenteral nutrition given by IV infusion
Trace Elements and Electrolytes B05XA30905P3002XX No A* Only to be used to cover daily loss of electrolyte and trace According to the needs of the patient.
(Paediatric) Solution elements for patient on parenteral nutrition INFANT and CHILD weighing 15 kg or
less: Basal requirements of the included
trace elements are covered by 1
ml/kg/day to a maximum dose of 15 ml.
CHILD weighing 15 kg or more, a daily
dose of 15 ml, should meet basic trace
element requirements. However, for
patients weighing more than 40 kg the
adult preparation trace element should
be used

Tramadol HCl 100 mg Suppository N02AX02110S2001XX No A Post-operative pain, chronic cancer pain, analgesia/pain relief 100mg rectally up to qds
for patients with impaired renal function
Tramadol HCl 100 mg/ml Drops N02AX02110D5001XX Yes A Post-operative pain, chronic cancer pain, analgesia/pain relief 50 - 100 mg every 4 hours. Max : 400 mg
for patients with impaired renal function. daily. Not recommended in children

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Tramadol HCl 50 mg Capsule N02AX02110C1001XX Yes A/KK Moderate to severe acute or chronic pain (eg. Post-operative ADULT: 50mg initially, can take another
pain, chronic cancer pain and analgesia/pain relief for patients 50mg after 30 - 60 min if pain not
with impaired renal function) relieved. Max 400 mg daily. CHILD:
1mg/kg/dose repeated every 6 hours
(Max: 2mg/kg/dose and 100mg/dose)

Tramadol HCl 50 mg/ml Injection N02AX02110P3001XX Yes A Moderate to severe acute or chronic pain (eg. Post-operative ADULT: IV/IM/SC 50 - 100mg. (IV inj over
pain, chronic cancer pain and analgesia/pain relief for patients 2-3 min or IV infusion). Initially 100 mg
with impaired renal function) then 50 - 100 mg every 4 - 6 hours. .
Max: 400 mg daily. CHILD (1 year and
above): 1 - 2mg/kg/dose
Tranexamic Acid 100 mg/ml Injection B02AA02000P3001XX Yes B Haemorrhage associated with excessive fibrinolysis ADULT: Slow IV 0.5-1 g (10 - 15 mg/kg) 3
times daily. Continuous infusion at a rate
of 25 - 50 mg/kg daily. CHILD: slow IV 10
mg/kg/day 2-3 times daily

Tranexamic Acid 250 mg Capsule B02AA02000C1001XX Yes B Haemorrhage associated with excessive fibrinolysis ADULT: 1-1.5 g (15-25 mg/kg) 2-4 times
daily. CHILD: 25 mg/kg/day 2-3 times
daily. Menorrhagia (initiated when
menstruation has started), 1 g 3 times
daily for up to 4 days; maximum 4 g daily

Trastuzumab 440 mg Injection L01XC03000P4001XX No A* Used only in adjuvant setting for patients with HER2 over- Initial loading dose is 4 mg/kg
expressed breast cancer, that is HER2 3+ by administered as a 90 minutes IV
immunohistochemistry and over-expressed by FISH infusion. Subsequent doses is 2 mg/kg
(Fluorescence in situ hybridization) and high risk group administered as 30 minutes IV infusion
weekly for 51 weeks
Trastuzumab 600mg/5ml Solution for L01XC03000P3001XX No A* Used only in adjuvant setting for patients with HER2 over- The recommended fixed dose of
Injection (for subcutaneous) expressed breast cancer, that is HER2 3+ by trastuzumab 600mg is 600mg
immunohistochemistry and over-expressed by FISH irrespective of the patient?s body
(Fluorescence in situ hybridization) and high risk group. weight. No loading dose is required. This
dose should be administered over 2-5
minutes every three weeks.
Travoprost 0.004% & Timolol 0.5% Eye S01ED51990D2003XX No A* To decrease intraocular pressure (IOP) in patients with open- 1 drop in the affected eye(s) once daily
Drops angle glaucoma or ocular hypertension who are insufficiently
responsive to other topical anti glaucomas
Tretinoin 0.01% Gel D10AD01000G3001XX No A/KK Acne vulgaris, recalcitrant cases of acne (comedonal type) Apply thinly to the affected area once
daily or twice daily. Avoid exposure to
sunlight. Duration of treatment: 8-12
weeks is required before any noticeable
response
Tretinoin 0.05% Cream D10AD01000G1001XX No A/KK Acne vulgaris and recalcitrant cases of acne (comedonal type) Apply thinly to the affected area once
daily or twice daily. Avoid exposure to
sunlight. Duration of treatment: 8 - 12
weeks is required before any noticeable
response
Tretinoin 0.1% Cream D10AD01000G1002XX No A Acne vulgaris and recalcitrant cases of acne (comedonal type) Apply thinly to the affected area once
daily or twice daily. Avoid exposure to
sunlight. Duration of treatment: 8 - 12
weeks is required before any noticeable
response
Triamcinolone Acetonide 0.1% Oral A01AC01351G3101XX No B Oral and perioral lesions Apply a thin layer to affected area 2-4
Paste times daily
Triamcinolone Acetonide 10 mg/ml H02AB08351P3001XX No A Inflammation of joints, bursae and tendon sheaths Smaller joints: 2.5 - 5 mg and larger
Injection joints: 5 - 15 mg. Treatment should be
limited to 1 mg/injection site to prevent
cutaneous atrophy
Triamcinolone Acetonide 40 mg/ml H02AB08351P3002XX No A/KK Allergies, dermatoses, rheumatoid arthritis and inflammatory 40-80 mg deep into the gluteal muscle
Injection opthalmic diseases
Trifluoperazine HCI 5 mg Tablet N05AB06110T1001XX No B Psychotic disorder ADULT: Initially 5 mg twice daily,
increase by 5 mg after 1 week, then at 3-
day intervals. Maximum 40 mg/day.
CHILD up to 12 years: Initially up to 5 mg
daily in divided doses adjusted to
response, age and body weight

Trimetazidine 20 mg Tablet C01EB15110T1001XX No B Prophylactic treatment of episodes of angina pectoris 20 mg 3 times daily
Trimetazidine 35 mg MR Tablet C01EB15110T5001XX No B Prophylactic treatment of episodes of angina pectoris 35 mg twice daily in the morning and
evening with meals
Trimethoprim 100 mg Tablet J01EA01000T1001XX No B Treatment of urinary tract infections due to susceptible ADULT: 200 mg daily in 1 or 2 divided
pathogens doses or 300 mg daily as a single dose.
Acute infection: 200 mg twice daily.
CHILD: 6-8 mg/kg/day in 2 divided doses.
6 - 12 years: 100 mg twice daily; 6
months - 5 years: 50 mg twice daily. 6
weeks - 5 months: 25mg twice daily

Trimethoprim 300 mg Tablet J01EA01000T1002XX No B Treatment of urinary tract infections due to susceptible ADULT: 200 mg daily in 1 or 2 divided
pathogens doses or 300 mg daily as a single dose.
Acute infection: 200 mg twice daily.
CHILD: 6 - 12 years: 100 mg twice daily; 6
months - 5 years: 50 mg twice daily. 6
weeks - 5 months: 25mg twice daily

Trioxsalen 5 mg Tablet D05BA01000T1001XX No A Vitiligo 5 - 10 mg daily, 2 - 4 hours before

exposure to sunlight. To increase
pigmentation: 10 mg daily, 2 hours prior
to UV irradiation

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Triprolidine HCl 1.25 mg and R01BA52110L9001XX Yes B Decongestion of the upper respiratory tract in common cold, ADULT and CHILD more than 12 year : 10
Pseudoephedrine HCl 30 mg per 5 ml hay fever, allergic and vasomotor rhinitis and sinusitis. Doses ml. CHILD 6 - 12 years : 5 ml 2 - 5 years :
Syrup to be taken twice daily or three times daily 2.5 ml

Triprolidine HCl 2.5 mg and R01BA52988T1002XX Yes B Decongestion of the upper respiratory tract in common cold, ADULT 2.5 mg every 4 - 6 hours;
Pseudoephedrine HCl 60 mg Tablet hay fever, allergic and vasomotor rhinitis and aerotitis maximum dose 10 mg/day. CHILD
(syrup) 6 - 12 years : 1.25 mg every 4 - 6
hours; maximum dose 5 mg/day 4 - 6
years : 0.938 mg every 4 - 6 hours;
maximum dose 3.744 mg/day 2 - 4 years
: 0.625 mg every 4 - 6 hours; maximum
dose 2.5 mg/day
Triptorelin 3.75 mg Injection L02AE04000P2001XX No A i) Treatment of confirmed central precocious puberty 1 intramuscular injection every 4 weeks.
(preterm sexual development) in girls under 9 years, boys The treatment must be started in the
under 10 years of age ii) Genital and extragenital first 5 days of the menstrual cycle. The
endometriosis (stage I to stage IV). Treatment should not be duration of treatment depends on the
administered for more than 6 months. It is not recommended initial severity of the endometriosis and
to start a second treatment course with triptorelin or another the changes observed in the clinical
GnRH analogue. features. In principle, the treatment
should be administered for at least 4
months and for at most 6 months. It is
not recommended to start a second
treatment course with triptorelin or
another GnRH analogue.

Tropicamide 1% Eye Drops S01FA06000D2002XX Yes A/KK Topical use to produce cycloplegic refraction for diagnostic 1 - 2 drops several times a day
purposes
Trospium Chloride 20mg coated tablet G04BD09100C1001XX No A* Symptomatic treatment for urge incontinence and/or 1 tablet twice daily. Tablet should be
increased urinary frequency and urgency as may occur in swallowed whole with a glass of water
patients with overactive bladder (eg. Idiopathic or neurologic before meals on empty stomach. Severe
detrusor overactivity) Place in therapy: As first line treatment renal impairment (CrCl between 10 & 30
for overactive bladder in patients with Parkinsonism, mL/min/1.73 m2): 1 tab daily or every
Alzheimer?s or other cognitive disease other day

Tuberculine PPD Injection V04CF01000P3001XX Yes B For routine Mantoux (tuberculin sensitivity) test 10 units is injected intradermally
Typhoid Vaccine Capsule J07AP01000C1001XX No B Active immunization against typhoid fever in adult and child 6 ADULT and CHILD 6 years of age or older,
years of age or older 1 capsule on days 1, 3 and 5
Typhoid Vaccine Injection (20 doses) J07AP02000P3001XX Yes B Active immunization against typhoid fever in adult and child 0.5 ml single IM injection into the
more than 2 years deltoid or vastus lateralis, may
reimmunize with 0.5 ml IM every 3 years
if needed.
Ulipristal Acetate 30mg Tablet G03AD02122T1001XX No A Emergency contraception within 4-5 days of unprotected Dosage is one tablet to be taken orally as
sexual intercourse for sexual assault victim. soon as possible, but no later than 120
hours (5 days) after unprotected sexual
intercourse or contraceptive failure.

Umeclidinium 62.5 mcg and vilanterol R03AL03989A2001XXX No A* Indicated as a maintenance bronchodilator treatment to One inhalation daily
25mcg inhalation relieve symptoms in adult patients with chronic obstructive
pulmonary disease (COPD).
Urofollitropin (FSH) 150 IU Injection G03GA04000P3002XX No A* Stimulation of follicular growth in infertile women To be individualized. 75 IU-150 IU daily
and maybe increased or decreased by up
to 75 IU/day at 7 or 14 day intervals if
necessary
Urofollitropin (FSH) 75 IU Injection G03GA04000P3001XX No A* Stimulation of follicular growth in infertile women To be individualized. 75 IU-150 IU daily
and maybe increased or decreased by up
to 75 IU/day at 7 or 14 day intervals if
necessary
Urokinase 250,000 IU Injection B01AD04-000-P40-04- No A Treatment of thromboembolic disease such as mycocardial ADULT: Acute pulmonary embolism: IV
XXX infarction, peripheral artery occlusion, pulmonary embolism, loading dose 4400 iu/kg over 10 mins,
retinal artery thrombosis and other ophthalmologic use maintenance 4400 iu/kg/hour for 12
hours. Peripheral vascular occlusion:
infuse 2500 iu/ml into clot at a rate of
4000 iu/min for 2 hours. This may be
repeated up to 4 times. Hyphaema: 5000
IU in 2 ml saline solution is injected and
withdrawn repeatedly over the iris. If
residual clot remains, leave 0.3ml in the
anterior chambers for 24-48 hours to
facilitate futher dissolution

Ursodeoxycholic Acid 250 mg Capsule A05AA02000C1001XX No A Cholestatic liver diseases (eg. primary biliary cirrhosis, primary 10-15 mg/kg daily in 2 to 4 divided doses
cholangitis etc) usually for 3 months to 2 years. If there
is no decrease in stone size after 18
months, further treatment seems not to
be useful
Ustekinumab 90 mg/ml Injection L04AC05000P3002XX No A* Treatment of moderate to severe plaque psoriasis in adults Body weight less than 100kg: Initial dose
who failed to, or who have contraindication to, or are of 45 mg SC, followed by 45 mg 4 weeks
intolerant to conventional systemic therapies including later, then every 12 weeks thereafter.
ciclosporin, methotrexate and photochemotherapy (PUVA). Body weight more than 100 kg: initial
dose 90 mg SC, followed by 90 mg 4
weeks later, & then every 12 weeks
thereafter.

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Valganciclovir 450 mg Tablet J05AB14110T1001XX No A* For the prevention of cytomegalovirus (CMV) disease in CMV- For adult patients who have received
negative patients who have received a solid organ transplant other than kidney transplant, the
from a CMV-positive donor recommended dose is 900 mg (two 450
mg tablets) once a day starting within 10
days of transplantation until 100 days
post-transplantation. For adult patients
who have received a kidney transplant,
the recommended dose is 900 mg (two
450 mg tablets) once a day starting
within 10 days of transplantation until
200 days post-transplantation.

Valproic Acid and Sodium Valproate (ER) N03AG01520T5001XX Yes B i) In the treatment of generalized or partial epilepsy, i) Adults: Dosage should start at 500mg
500mg Tablet particularly with the following patterns of seizures:absence, daily increasing by 200mg at three-day
myoclonic, tonic-clonic, atonic-mixed as well as, for partial intervals until control is achieved. This is
epilepsy:simple or complex seizures, secondary generalized generally within the dosage range
seizures, specific syndrome (West, Lennox-Gastatut). ii) 1000mg to 2000mg per day. Children:
Treatment and prevention of mania associated with bipolar >20KG: 500mg/day (irrespective of
disorders. weight) with spaced increases until
control is achieved. ii) Initial dose of
1000mg/day, to be increase rapidly as
possible to achieve lowest therapeutic
dose, which produce desired clinical
effects. Recommend initial dose is
1000mg & 2000mg daily. Max dose
3000mg daily.

Valsartan 160 mg and C09DA03935T1005XX No A/KK Treatment of essential hypertension 1 tablet once daily
Hydrochlorothiazide 12.5 mg Tablet
Valsartan 160 mg Tablet C09CA03000T1002XX No A/KK Patients who cannot tolerate ACE inhibitors because of cough, i) 40 mg twice daily. Uptitration to 80 mg
in i) Heart failure ii) Post myocardial infarction and 160mg twice daily. Max: 320 mg in
divided doses. ii) 20 mg twice daily
increased over several weeks to 160mg
twice daily if tolerated.
Valsartan 80 mg and C09DA03935T1001XX No A/KK Hypertension in patients who cannot tolerate ACE inhibitors 1 tablet once daily
Hydrochlorothiazide 12.5 mg Tablet because of cough
Valsartan 80 mg Tablet C09CA03000T1001XX No A/KK Patients who cannot tolerate ACE inhibitors because of cough, i) 40 mg twice daily. Uptitration to 80 mg
in i) Heart failure; ii) Post myocardial infarction and 160mg twice daily. Max: 320 mg in
divided doses. ii) 20 mg twice daily
increased over several weeks to 160mg
twice daily if tolerated.
Vancomycin HCl 500 mg Injection J01XA01110P4001XX No A* Only for the treatment of MRSA and CAPD peritonitis Slow IV infusion, ADULT: 500 mg over at
least 60 minutes every 6 hours or 1 g
over at least 100 minutes every 12
hours. NEONATE up to 1 week, 15 mg/kg
initially, then 10 mg/kg every 12 hours.
INFANT 1 - 4 weeks, 15 mg/kg initially
then 10 mg/kg every 8 hours. CHILD over
1 month, 10 mg/kg every 6 hours

Varenicline Tartrate 0.5 mg and 1 mg N07BA03123T1001XX No A/KK Smoking cessation treatment 0.5 mg once daily for Day 1-3, then 0.5
Tablet mg twice daily for Day 4-7, then 1 mg
twice daily; duration of treatment is 12
weeks
Varenicline Tartrate 1 mg Tablet N07BA03123T1002XX No A/KK Smoking cessation treatment 0.5 mg once daily for Day 1-3, then 0.5
mg twice daily for Day 4-7, then 1 mg
twice daily; duration of treatment is 12
weeks
Varicella Virus Vaccine Live Attenuated J07BK01000P4001XX No A* i) Health staff working with children, pregnant women, ADULT and CHILD 13 years or more: 2
Injection transplant, cancer and immunocompromised patients who are doses of 0.5 ml SC injection separated by
at high risk of contacting varicella and transmitting it to at risk 4 - 8 weeks apart. CHILD 12 months - 12
patients ii) Transplant patients or candidates who are: a) years: 0.5ml SC as a single dose
Immunocompetent and not receiving immunosuppressant
drugs, do not have graft versus host disease 2 years or more
after transplant b) Susceptible to Varicella-Zoster virus at least
3 weeks before grafting iii) Children: a) with impaired humoral
immunity b) HIV-infected children more than 12 months of
age, in CDC class N1 (asymptomatic) or A1 (mildly
symptomatic) with age specific CD4 more than 25% c) with
conditions that require systemic steroid therapy less than 2
mg/kg body weight or a total of 20 mg/day of prednisolone or
its equivalent. [Those receiving high doses of systemic steroids
at 2 mg/kg body weight or more of prednisolone for more
than 2 weeks may be vaccinated after steroid therapy has
been discontinued for at least three months] iv) Acute
lymphoblastic leukemia (ALL) patients with negative history of
varicella who:- a) are 12 months to 17 years of age b) have
leukemia in remission for at least 12 months c) have a
peripheral blood lymphocyte count 700 cells/ mm3 or more.
[If platelet count of greater 100,000/mm3 within 24 hours of
vaccination are not being submitted to radiotherapy.
Chemotherapy should be withheld for seven days before and
after immunisation] v) Susceptible subjects in clinical trials
who will be submitted for chemotherapy vi) Children and

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Vasopressin 20 units/ml Injection H01BA01000P3001XX No A i) Pituitary diabetes insipidus ii) Oesophageal variceal bleeding i) 5 - 20 units SC or IM every 4 hours ii)
20 units in 100 - 200 ml 5% dextrose
saline over 15 minutes as infusion which
may be repeated after at intervals of 1 -
2 hours. Maximum: 4 doses

Vecuronium Bromide 10 mg/10 ml M03AC03320P3001XX No A* As an adjunct in anaesthesia to produce skeletal muscle ADULT & NEONATES > 5 MONTHS Initial:
Injection relaxation 80-100 mcg/kg as inj. Maintenance: 20-
30 mcg/kg, adjust according to response.
Alternatively, as continuous infusion at
0.8-1.4 mcg/kg/min after initial IV dose
of 40-100 mcg/kg. NEONATE and INFANT
up to 4 months: Initially 10 - 20 mcg/kg,
then incremental dose to achieve
response

Vecuronium Bromide 4 mg/ml Injection M03AC03320P3002XX No A* As an adjunct in anaesthesia to produce skeletal muscle ADULT & NEONATES > 5 MONTHS Initial:
relaxation 80-100 mcg/kg as inj. Maintenance: 20-
30 mcg/kg, adjust according to response.
Alternatively, as continuous infusion at
0.8-1.4 mcg/kg/min after initial IV dose
of 40-100 mcg/kg. NEONATE and INFANT
up to 4 months: Initially 10 - 20 mcg/kg,
then incremental dose to achieve
response.

Venlafaxine HCl 150 mg Extended N06AX16110C2002XX No A* i) Depression ii) Generalized anxiety disorder iii) Social anxiety i), ii) & iii) ADULT: 75 mg once daily. May
Release Capsule disorder (social phobia) iv) Panic disorder increase dose by 75 mg/day every 4 days
to a maximum dose of 225 mg/day,
(severe depression: max: 375mg/day) iv)
37.5 mg/day for the first 4-7 days after
which the dose should be increased to
75 mg once daily. CHILD and
ADOLESCENT under 18 years not
recommended.
Venlafaxine HCl 75 mg Extended Release N06AX16110C2001XX No A* i) Depression ii) Generalized anxiety disorder iii) Social anxiety i), ii) & iii) ADULT: 75 mg once daily. May
Capsule disorder (social phobia) iv) Panic disorder increase dose by 75 mg/day every 4 days
to a maximum dose of 225 mg/day,
(severe depression: max: 375mg/day) iv)
37.5 mg/day for the first 4-7 days after
which the dose should be increased to
75 mg once daily. CHILD and
ADOLESCENT under 18 years not
recommended
Verapamil HCl 2.5 mg/ml Injection C08DA01110P3001XX Yes A/KK Supraventricular tachycardia Initially 5-10mg given by slow IV over at
least 2 minutes. The dose can be
repeated 10mg 30 minutes after the first
dose if the initial response is not
adequate.
Verapamil HCl 40 mg Tablet C08DA01110T1001XX Yes B i) Supraventricular tachyarrhythmias (SVT) prophylaxis ii) ADULT: 40 - 80 mg 3-4 times daily. In
angina oral long term therapy, max: 480 mg
daily
Vildagliptin 50 mg and Metformin HCl A10BD08926T1002XX No A* FUKKM restriction: As add-on therapy for patient who failed 50 mg/850 mg or 50 mg/1000 mg twice
1000 mg Tablet therapy and/or contraindicated/unable to tolerate metformin daily. Maximum daily dose is 100 mg
and/or sulphonylurea. - Treatment of type 2 diabetes mellitus vildagliptin plus 2000 mg metformin
patients who are unable to achieve sufficient glycaemic hydrochloride.
control at their maximally tolerated dose of oral metformin
alone or who are already treated with the combination of
vildagliptin and metformin as separate tablets.

Vildagliptin 50 mg and Metformin HCl A10BD08926T1003XX No A* FUKKM restriction: As add-on therapy for patient who failed 50/500mg or 50/850mg or 50/1000mg
500 mg Tablet therapy and/or contraindicated/unable to tolerate metformin twice daily. Maximum daily dose is
and/or sulphonylurea. - Treatment of type 2 diabetes mellitus 100mg vildagliptin and 2000mg
patients who are unable to achieve sufficient glycaemic metformin.
control at their maximally tolerated dose of oral metformin
alone or who are already treated with the combination of
vildagliptin and metformin as separate tablets.

Vildagliptin 50 mg and Metformin HCl A10BD08926T1001XX No A* FUKKM restriction: As add-on therapy for patient who failed 50 mg/850 mg or 50 mg/1000 mg twice
850 mg Tablet therapy and/or contraindicated/unable to tolerate metformin daily. Maximum daily dose is 100 mg
and/or sulphonylurea. - Treatment of type 2 diabetes mellitus vildagliptin plus 2000 mg metformin
patients who are unable to achieve sufficient glycaemic hydrochloride.
control at their maximally tolerated dose of oral metformin
alone or who are already treated with the combination of
vildagliptin and metformin as separate tablets.

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KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Vildagliptin 50 mg Tablet A10BH02000T1001XX No A* FUKKM restriction: As add-on therapy for patient who failed ADULT over 18 years: 50mg bd when
therapy and/or contraindicated/unable to tolerate metformin combine with metformin, 50 mg od
and/or sulphonylurea. i) As second line therapy in type 2 when combine with sulphonylurea
diabetes patients inadequately controlled on maximal
tolerated dose of metformin monotherapy and high risk of
hypoglycaemia. ii) As second line therapy in type 2 diabetes
patients inadequately controlled on maximal tolerated dose of
sulphonylurea and intolerant/contraindicated for metformin
therapy. iii) As third line therapy in type 2 diabetes patients
inadequately controlled with dual OAD combination therapy
with sulphonylurea and metformin iv) As a monotherapy in
type 2 diabetes mellitus patients inadequately controlled by
diet and exercise alone and for whom metformin is
inappropriate due to contraindications or intolerance. v) An
adjunct to diet and exercise to improve glycaemic control in
patients with type 2 diabetes mellitus: As a dual therapy in
combination with insulin in patients with insufficient
glycaemic control. Insulin dose and regimen should be
optimized before addition of vildagliptin.

Vinblastine Sulphate 10 mg Injection L01CA01183P3002XX Yes A Hodgkin's disease, choriocarcinoma resistant to other Adult: Initially, 3.7 mg/m2, increase dose
chemotherapeutic agents, non-small cell lung cancer, weekly based on WBC counts in
Langerhans cell histiocytosis increments of about 1.8 mg/m2 until
leukocyte count decreases to about
3000/mm3, or maximum weekly dose of
18.5 mg/m2 reached. Usual dose: 5.5-
7.4 mg/m2 per week. Do not administer
next dose, even though 7 days have
lapsed unless the leukocyte count has
returned to at least 4000/mm3. Child:
Initial 2.5 mg/m2 of BSA, increased dose
at weekly intervals in increments of
about 1.25 mg/m2 until leukocyte count
decreases to about 3000/ mm3, or
maximum weekly dose of 12.5 mg/m2
reached. Do not increase dose once
leukocyte count reaches approximately
3000 cells/mm3, instead, a dose of 1
increment smaller to be admin at wkly
intervals for maintenance. Do not
administer next dose, even though 7
days have lapsed unless the leukocyte
count has returned to at least
4000/mm3.

Vincristine Sulphate 1 mg Injection L01CA02183P3001XX Yes A i) Solid tumours ii) Gestational trophoblastic disease iii) Non- i) ADULT: 1.4 mg/m2 weekly (maximum
Hodgkin's lymphoma iv) Multiple myeloma v) Acute 2 mg weekly) ii) Refer to protocol iii) 1.4
lymphoblastic leukemia mg/m2 weekly (maximum 2 mg weekly)
iv) 0.4 mg/m2 IV continuous infusion on
days 1 - 4 v) Refer to protocol. CHILD: 1
mg/m2 to 2 mg/m2 weekly according to
protocol (0.05 mg/kg for infants less
than 10kg)

Vinorelbine 10 mg Injection L01CA04000P4001XX No A* i) First line treatment in non-small cell lung cancer in i) Single agent: Adult 30mg/m2 IV
combination with cisplatin/ifosfomide ii) Metastatic breast administered over 6-10 minutes once
cancer weekly Combination with cisplatin :
30mg/m2 IV administered over 6-
10mintes once weekly combination with
cisplatin IV on days and 29 and then
every 6 weeks or Vinolrebine
administered at a dose of 25mg/m2 IV
weekly in combination with cisplatin
given every 4 weeks at a dose of
100mg/m2 ii) 25 - 30 mg/m2 diluted in
saline solution, infused over 6 - 10
minutes, administered weekly or
vinolrebine maybe given as an 8mg/m2
IV BOLUS followed by 8mg/m2 as a 96-
hour intravenous infusion

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Vinorelbine 50 mg Injection L01CA04000P4002XX No A* i) First line treatment in non-small cell lung cancer in i) Single agent: Adult 30mg/m2 IV
combination with cisplatin/ifosfomide ii) Metastatic breast administered over 6-10 minutes once
cancer weekly Combination with cisplatin :
30mg/m2 IV administered over 6-
10mintes once weekly combination with
cisplatin IV on days and 29 and then
every 6 weeks or Vinolrebine
administered at a dose of 25mg/m2 IV
weekly in combination with cisplatin
given every 4 weeks at a dose of
100mg/m2 ii) 25 - 30 mg/m2 diluted in
saline solution, infused over 6 - 10
minutes, administered weekly or
vinolrebine maybe given as an 8mg/m2
IV BOLUS followed by 8mg/m2 as a 96-
hour intravenous infusion.

Vitamin A & D (Cod Liver Oil) A11CB00901L5001XX No C Prevention of ricketts Not more than 10 ml daily, allowance
being made for Vitamin D obtained from
other sources
Vitamin A & D Concentrate 25,000 A11CB00901L5002XX No B Prevention of ricketts 0.06 - 0.6ml (2,500-25,000 IU of Vitamin
units/0.6ml Liquid A and 250-2,500 IU of D) daily,
allowance being made for A and D
obtained from other sources
Vitamin A 50,000 IU Capsule A11CA01000C1001XX No C Children with measles malnutrition and serious infections. i) 0-5 months, 50,000 IU ii) 6-11 months,
Category C can use this drug for Orang Asli and in Sabah 100,000 IU iii) 1-5 years, 200,000 IU.
Frequency twice daily
Vitamin B Complex 10 ml Injection A11EX00901P3001XX No B Prophylaxis and treatment of vitamin B deficiency 1-2 ml daily by IM
Vitamin B Complex Tablet A11EA00901T1001XX Yes C+ Prophylaxis and treatment of vitamin B deficiency 1-2 tablets daily
Vitamin B1, B6, B12 Injection A11DB00901P3001XX No B For deficiency or raised requirement of Vitamin B1, B6, B12 Mild cases: 1 ampoule given by IM 2-3
times weekly. Severe cases: 1 ampoule
daily
Vitamin B1, B6, B12 Tablet A11DB00901T1001XX Yes B For deficiency or raised requirement of Vitamin B1, B6, B12 1 - 3 tablets 3 times daily swallowed
unchewed.
Vitamin E, B12, B6, Nicotinamide Tablet A11E000901T1001XX No A To improve appetite and growth. Neurasthenia, nausea and 1 - 2 tablet daily
vomiting in pregnancy, radiation sickness and neuritis due to
isoniazid therapy and alcoholism
Vitamin K1 1 mg/ml Injection B02BA01000P3001XX Yes C+ Vitamin K deficiency in neonates Prophylaxis of vitamin K deficiency
bleeding in neonates Child: Neonate: 0.5-
1 mg, given as a single dose via IM inj.
Alternatively, 2 mg may be given orally,
followed by a 2nd dose of 2 mg after 4-7
days. Intravenous Vitamin K deficiency
bleeding in neonates Child: Infant: 1 mg
by IV/IM/SC inj, further doses may be
given if necessary

Vitamin K1 10 mg/ml Injection B02BA01000P3002XX Yes B Haemorrhage associated with hypoprothrombinaemia caused 0.5 - 20 mg by very slow IV at a rate not
by overdose of anticoagulants exceeding 1 mg per minute
Vitamin K1 Mixed Micelle 2 mg/0.2 ml B02BA01000P3004XX No B Prevention of bleeding in neonates Healthy neonate 2 mg orally at birth or
Injection soon after followed by 2 mg at 4 - 7
days. Exclusively breastfed baby, in
addition, 2 mg orally at monthly
intervals until end of breastfeeding
period. Neonate at special risk, 1 mg
IM/IV at birth or soon after if oral route
is not suitable. Treatment: 1 mg IV
initially. Further doses depend on clinical
picture and coagulation status

Voriconazole 200 mg Injection J02AC03000P3001XX No A* i) Treatment of immunocompromised patients with Adult and Children 12 years and greater:
progressive, possibly life-threatening infections such as Loading dose: 6 mg/kg 12 hourly for first
invasive aspergillosis, fluconazole-resistant serious invasive 24 hours. Maintenance: i) 4 mg/kg 12
candidiasis, serious fungal infections caused by Scedosporium hourly ii) 3 mg/kg 12 hourly. Dose may
species and Fusarium species ii)Prevention of breakthrough be increased to 4 mg/kg 12 hourly if
fungal infections in febrile high-risk neutropenic patients response is inadequate. Children aged
2years to <12years with normal hepatic
and renal function: No loading dose
needed; 7mg/kg 12hourly

Voriconazole 200 mg Tablet J02AC03000T1002XX No A* i) Treatment of immunocompromised patients with Adult and Children 12 years and greater
progressive, possibly life-threatening infections such as and over 40 kg: Loading dose: 400 mg 12
invasive aspergillosis, fluconazole-resistant serious invasive hourly for first 24 hours. Maintenance:
candidiasis, candidiasis of the oesophagus, serious fungal 200 - 300 mg 12 hourly. Less than 40 kg:
infections caused by Scedosporium species and Fusarium Loading dose: 200 mg 12 hourly for first
species ii) Prevention of breakthrough fungal infections in 24 hours. Maintenance: 100 - 150 mg 12
febrile high-risk neutropenic patients hourly. Children aged 2years to <12years
with normal hepatic and renal function:
No loading dose needed; 200mg
12hourly

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Voriconazole 50 mg Tablet J02AC03000T1001XX No A* i) Treatment of immunocompromised patients with ADULT and CHILDREN 12 years and
progressive, possibly life-threatening infections such as greater and over 40 kg: Loading dose:
invasive aspergillosis, fluconazole-resistant serious invasive 400 mg 12 hourly for first 24 hours.
candidiasis, candidiasis of the oesophagus, serious fungal Maintenance: 200 - 300 mg 12 hourly.
infections caused by Scedosporium species and Fusarium Less than 40 kg: Loading dose: 200 mg
species ii) Prevention of breakthrough fungal infections in 12 hourly for first 24 hours.
febrile high-risk neutropenic patients Maintenance: 100 - 150 mg 12 hourly

Warfarin Sodium 1 mg Tablet B01AA03520T1001XX Yes B Treatment and prophylaxis of thromboembolic disorders Initially 10 mg daily for 2 days.
Maintenance dose, 3-9 mg daily
according to the INR (taken at the same
time each day)
Warfarin Sodium 2 mg Tablet B01AA03520T1002XX Yes B Treatment and prophylaxis of thromboembolic disorders Initially 10 mg daily for 2 days.
Maintenance dose, 3-9 mg daily
according to the INR (taken at the same
time each day)
Warfarin Sodium 3 mg Tablet B01AA03520T1003XX Yes B Treatment and prophylaxis of thromboembolic disorders Initially 10 mg daily for 2 days.
Maintenance dose, 3-10 mg daily
according to the INR (taken at the same
time each day)
Warfarin Sodium 5 mg Tablet B01AA03520T1004XX Yes B Treatment and prophylaxis of thromboembolic disorders Initially 10 mg daily for 2 days.
Maintenance dose, 3-10 mg daily
according to the INR (taken at the same
time each day)
Water for Injection V07AB00000P3001XX Yes C+ As a diluent and vehicle for the administration of medications According to the needs of the patient

Zidovudine 1% Injection J05AF01000P3001XX Yes A To reduce the rate of maternal-foetal transmission of HIV in: i) i) Prophylaxis of maternal-foetal HIV
HIV-positive pregnant women over 14 weeks of gestation ii) transmission during labour and delivery
Their newborn infants Adult: Loading dose: 2 mg/kg, followed
by continuous infusion of 1 mg/kg/hr
until umbilical cord is clamped. If
caesarean section is planned, start the IV
infusion 4 hr before the operation. Renal
and Hepatic impairment: Dose reduction
may be needed. HIV infection (to be
discuss: not in indication) Adult: 1-2
mg/kg every 4 hr, given as 2-4 mg/ml
infusion over 1 hr. Child: As continuous
infusion: 20 mg/m2/hr. Alternatively, as
intermittent infusion: 120 mg/m2 every
6 hr. Renal impairment: Haemodialysis
or peritoneal dialysis: 1 mg/kg every 6-8
hr. ii) Prophylaxis of HIV infection in
neonates Child: Neonates: 1.5 mg/kg
every 6 hr. Start treatment within 12 hr
after birth and continue for 1st 6 wk of
life. Dose to be given via IV infusion over
30 minutes. Renal impairment: Dose
adjustment may be needed.

Zidovudine 10 mg/ml Syrup J05AF01000L9001XX Yes A* i) Management of patients with asymptomatic and i) HIV infection Adult: 600 mg daily in
symptomatic (early or advanced) HIV infections with CD4 cell divided doses, in combination with other
counts less than 500 cu. mm. ii) Neonatal prophylaxis antiretroviral agents. Child: 6 wk - 12 yr:
160 mg/m2 every 8 hr. Max: 200 mg
every 8 hr. May be used in combination
with other anti-retrovirals. Renal and
Hepatic impairment: Dose reduction
may be needed. ii) Prophylaxis of HIV
infection in neonates Child: Neonates: 2
mg/kg every 6 hr for 1st 6 wk of life,
starting within 12 hr after birth. Renal
and hepatic impairment: Dose
adjustment may be needed.

Zidovudine 100 mg Capsule J05AF01000C1001XX Yes A/KK i) Management of patients with asymptomatic and i) HIV infection Adult: 600 mg daily in
symptomatic (early or advanced) HIV infections with CD4 cell divided doses, in combination with other
counts less than 500 cu. mm ii) Neonatal prophylaxis antiretroviral agents. Child: 6 wk - 12 yr:
160 mg/m2 every 8 hr. Max: 200 mg
every 8 hr. May be used in combination
with other anti-retrovirals. Renal and
Hepatic impairment: Dose reduction
may be needed. ii) Prophylaxis of HIV
infection in neonates Child: Neonates: 2
mg/kg every 6 hr for 1st 6 wk of life,
starting within 12 hr after birth. Renal
and hepatic impairment: Dose
adjustment may be needed.

Zidovudine 300 mg & Lamivudine 150 J05AR01964T1001XX Yes A/KK HIV infection in combination with at least one other ADULT and CHILD over 12 years: 1 tablet
mg Tablet antiretroviral drug twice daily

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Zidovudine 300 mg Tablet J05AF01000T1001XX Yes A* i) Management of patients with asymptomatic and HIV infection Adult: 600 mg daily in
symptomatic (early or advanced) HIV infections with CD4 cell divided doses, in combination with other
counts < 500 cu. mm ii) HIV positive pregnant mothers antiretroviral agents. Child: 6 wk - 12 yr:
160 mg/m2 every 8 hr. Max: 200 mg
every 8 hr. May be used in combination
with other anti-retrovirals. ii)Prophylaxis
of maternal-foetal HIV transmission
Adult: 100 mg 5 times daily or 200 mg
tid or 300 mg bid. Start treatment after
14th wk of gestation until the start of
labour. Haemodialysis or peritoneal
dialysis (CrCl <10 ml/min: 100 mg every
6-8 hr.

Zinc Oxide Cream D02AB00000G1001XX Yes C+ Skin protective in various skin conditions such as nappy rash, Apply 3 times daily or as required
eczema and problem skin
Zinc Oxide Ointment D02AB00240G5001XX Yes C Skin protective in various skin conditions such as nappy rash Apply 3 times daily or as required
and eczema
zinc oxide, benzyl benzoate and balsam C05AX04931S1001XX No C For relief of pruritus, burning and soreness in patients with Insert 1 suppository night and morning
peru suppository haemorrhoids and perianal conditions after bowel movements; do not use for
longer than 7 days OR please refer to the
product insert.
Ziprasidone 20 mg/ml Injection N05AE04110P3001XX No A* Acute agitation in schizophrenia ADULT: Initially 10 mg (every 2 hour) or
20 mg (every 4 hour). Maximum: 40
mg/day. IM administration more than 3
days has not been studied
Zoledronic Acid 4 mg Injection M05BA08000P3001XX No A* i) Treatment of hypercalcaemia of malignancy ii) Prevention of 4 mg reconstituted and should be given
skeletal related events in patients with multiple myeloma as a 15 minutes IV infusion every 3-4
involving multiple bone lesions weeks
Zolpidem Tartrate 10 mg Tablet N05CF02123T1001XX No A For treatment of insomnia 10-mg tablet daily. Stilnox should always
be taken just before going to bed. In
elderly patients or patients with hepatic
insufficiency: Dosage should be halved
ie, 5 mg. Dosage must never exceed 10
mg/day.
Zonisamide 100mg tablet N03AX15000T1001XX No A* As adjunctive therapy in the treatment of partial seizures in For adults, usually 100 to 200mg of
adults with epilepsy. Restrictions: As adjunctive therapy in the zonisomide is to be administered orally 1
treatment of partial seizures in adults with epilepsy when 1st to 3 times a day initially. The dose is
line and 2nd line therapy failed. gradually increased at every one to two
weeks up to 200-400mg daily, in 1 to 3
divided dose. The maximum daily dose
should not exceed 600mg per day.

Zuclopenthixol 20 mg/ml Drops N05AF05000D5001XX No A* Only for psychoses with insight or compliance Acute Schizophrenia and Other Acute
Psychoses; Severe Acute States of
Agitation; Mania: Oral treatment:
Usually 10-50 mg/day. In moderate to
severe cases initially 20 mg/day
increased, if necessary, by 10-20 mg/day
every 2-3 days to ≥75 mg daily.

Zuclopenthixol Acetate 100 mg/2 ml N05AF05122P3002XX No A* Only for treatment of agitated and violent patients suffering Clopixol-Acuphase: Clopixol-Acuphase is
Injection from schizophrenia who are not responding to the available administered by IM injection. The
standard drugs dosage range should normally be 50-150
mg (1-3 mL) IM repeated if necessary,
preferably with a time interval of 2-3
days. In a few patients, an additional
injection may be needed 24-48 hrs
following the 1st injection. In the
maintenance therapy, treatment should
be continued with oral Clopixol or
Clopixol Depot IM after the following
guidelines: Change to Oral Clopixol: 2-3
days after the last injection of Clopixol-
Acuphase, a patient who has been
treated with 100 mg Clopixol-Acuphase,
oral treatment should be started at a
dosage of about 40 mg daily, possibly in
divided dosages. If necessary, the dose
can be further increased by 10-20 mg
every 2-3 days up to 75 mg or more.

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 FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (FUKKM)
KEMASKINI PADA DISEMBER 2017

Generic Name MDC NEML Category Indications Dosage

Zuclopenthixol Acetate 50 mg/ml N05AF05122P3001XX No A* Only for treatment of agitated and violent patients suffering Clopixol-Acuphase: Clopixol-Acuphase is
Injection from schizophrenia who are not responding to the available administered by IM injection. The
standard drugs dosage range should normally be 50-150
mg (1-3 mL) IM repeated if necessary,
preferably with a time interval of 2-3
days. In a few patients, an additional
injection may be needed 24-48 hrs
following the 1st injection. In the
maintenance therapy, treatment should
be continued with oral Clopixol or
Clopixol Depot IM after the following
guidelines: Change to Oral Clopixol: 2-3
days after the last injection of Clopixol-
Acuphase, a patient who has been
treated with 100 mg Clopixol-Acuphase,
oral treatment should be started at a
dosage of about 40 mg daily, possibly in
divided dosages. If necessary, the dose
can be further increased by 10-20 mg
every 2-3 days up to 75 mg or more.

Zuclopenthixol Decanoate 200 mg/ml N05AF05135P2001XX No B Only for treatment of agitated and violent patients suffering By deep IM injection test dose 100 mg
Injection from schizophrenia who are not responding to the available followed after 7 - 28 days by 100 - 200
standard drugs mg or more followed by 200 - 400 mg at
intervals of 2 - 4 weeks adjusted
according to response. Maximum 600
mg weekly. Child not recommended

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