Drug StuDy

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Legalon® [cap]

Madaus [ Zuellig / Invida ]


MIMS Class : Cholagogues, Cholelitholytics & Hepatic Protectors

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Contents Silymarin
Indications Supportive treatment of chronic inflammatory diseases of the liver and
cirrhosis.
Dosage Initially and In Serious Cases: 70-mg capsule: 2 caps 3 times daily.

140-mg capsule: 1 cap 3 times daily.


Administration Should be taken with food (Take after meals.).
Side Effects A mild laxative action has been observed in occasional instances.
Storage Store at temperatures not exceeding 30°C.

Shelf-Life: 70 mg: 60 months. 140 mg: 48 months.


Description Each 70-mg capsule contains silymarin 70 mg (calculated as silibinin) in
dried extract of milk thistle fruits 86.5-93.3 mg while the 140-mg
capsule contains silymarin 140 mg (calculated as silibinin) in dried
extract of milk thistle fruits 173-186.6 mg.
Mechanism of Hepatic protector.
Action
The liver has several vital functions in the human body; it plays a major
role in metabolism (sugar, proteins and fats), digestion (bile secretion)
and in the detoxification of metabolic wastes. Any form of damage to the
liver affects the membranes of the liver cells and hence impairs
functional capacity.

Silymarin is of plant origin. It acts as a stabilizer of cell membranes and


is hence capable of protecting the liver from noxious influences and of
restoring or revitalizing liver cells which have previously been damaged.
Its effects are reflected in improvement in general condition, lessening of
digestive symptoms and increase in appetite and body weight in patients
whose general condition and nutritional state have been impaired by
liver disease. It also ameliorates the signs of liver disease and normalizes
laboratory tests of liver function.
MIMS Class Cholagogues, Cholelitholytics & Hepatic Protectors
ATC Classification A05BA03 - Silymarin ; Belongs to the class of drugs used in liver
therapy.
Poison Schedule Rx
Presentation/Packing Cap 70 mg x 20's. 140 mg x 20's.

Nasathera® [cap]
Morishita-Seggs [ Metro Drug ]
MIMS Class : Cough & Cold Preparations

See related Nasathera cap information


Contents Per cap Paracetamol 325 mg, phenylpropanolamine 25 mg. paracetamol
250 mg, Per 5 mL syr Phenylpropanolamine HCl 12.5 mg
Indications Nasal congestion, headache & fever associated w/ sinusitis, rhinitis,
common cold & flu.
Dosage Cap Adult 1 cap 8 hrly. Childn 6-12 yr 1 cap bid. Syr Childn 6-12 yr 1-2
tsp, 1-5 yr ½-1 tsp. Infant ¼-½ tsp. To be taken tid-qid.
Administration May be taken with or without food
Contraindications Hyperthyroidism; HTN, coronary disease; MAOIs; nephropathy; benign
prostatic hypertrophy & closed-angle glaucoma.
Special Cardiac disease or decompensation, angina, diabetes; hepatic or renal
Precautions impairment; pregnancy.
Adverse Drug Giddiness, headache; GI upsets; sweating, thirst; tachycardia, precordial
Reactions pain, palpitations; difficulty in micturition; muscle weakness; tremors,
anxiety, insomnia; skin eruptions.
View ADR Monitoring Website
Drug Interactions Phenobarb & phenytoin potentiate paracetamol-induced hepatotoxicity.
Daily use of paracetamol may potentiate oral anticoagulants. Caution in
digitalis therapy.
View more drug interactions with Nasathera
MIMS Class Cough & Cold Preparations
ATC R01BA51 - Phenylpropanolamine, combinations ; Belongs to the class of
Classification systemic sympathomimetic preparations used as nasal decongestants.
Poison Schedule Rx
Presentation/Packing
Form Packing/Price Photo
Nasathera capsule Nasathera 325 mg/25 mg x 100's (P383.85)
Nasathera syrup Nasathera 250 mg/12.5 mg x 60 mL (P53.76)

Nexium® [granules]
AstraZeneca [ Zuellig ]
MIMS Class : Antacids, Antireflux Agents & Antiulcerants
 

See related Nexium granules information


Contents Esomeprazole
Indications Listed in Dosage.
Dosage MUPS tab Adult & childn 12-18 yr Erosive reflux esophagitis 40 mg once
daily for 4-8 wk. Long-term management of patients w/ healed
esophagitis to prevent relapse 20 mg once daily. Symptomatic treatment
of GERD 20 mg once daily for 4 wk. Maintenance: 20 mg once daily.
Adult Treatment of upper GI symptoms associated w/ NSAID therapy
20 mg daily for 4 wk. Healing of gastric ulcers associated w/ NSAID
therapy 20-40 mg once daily for 4-8 wk. Prevention of gastric &
duodenal ulcers associated w/ NSAID therapy in patients at risk 20-40
mg once daily. Maintenance of hemostasis & prevention of rebleeding of
gastric or duodenal ulcers following treatment with IV esomeprazole 40
mg once daily for 4 wk. In combination w/ an appropriate antibacterial
therapeutic regimen for the eradication of H pylori & H pylori-
associated duodenal ulcer & prevention of relapse of peptic ulcers in
patients w/ H pylori-associated ulcers disease 20 mg Nexium w/ 1 g
amoxicillin & 500 mg clarithromycin, all bid for 7 days. Pathological
hypersecretory conditions including Zollinger-Ellison syndrome &
idiopathic hypersecretion Initially, 40-120 mg bid. Granules Childn 1-11
yr GERD BW ≥10-<20 kg 10 mg once daily for 8 wk. BW ≥20kg 10 or 20
mg once daily for 8 wk. Maitenance: 10 mg once daily. Symptomatic
treatment 10 mg once daily for up to 8 wk.
Administration May be taken with or without food (For patients w/ swallowing difficulties,
the tab may also be dispersed in a glass containing 15 mL of non-carbonated
water. No other liqds should be used. Stir gently & leave for a few mins to
thicken. Stir again & drink the liqd w/ the pellets immediately or within 30
mins. Rinse the glass w/ 15 mL of water & drink. Do not chew/crush the tab
or the pellets. The dispersion may also be administered via a nasogastric
tube.).
Contraindications Hypersensitivity to substituted benzimidazoles. Childn <1 yr.
Special Exclude gastric malignancy, severe renal or hepatic impairment. Long-term
Precautions treatment for >1 yr. Pregnancy, lactation. Fructose intolerance, glucose-
galactose malabsorption or sucrose-maltase insufficiency (granules only).
Adverse Drug Headache, abdominal pain, diarrhea, flatulence, nausea, vomiting,
Reactions constipation.
View ADR Monitoring Website
Drug Interactions Ketoconazole, itraconazole, diazepam, warfarin, atazanavir, nelfinavir,
saquinavir, clarithromycin, voriconazole, ritonavir.
View more drug interactions with Nexium
Pregnancy
Category (US
FDA) Category B: Either animal-reproduction studies have not demonstrated a
foetal risk but there are no controlled studies in pregnant women or animal-
reproduction studies have shown an adverse effect (other than a decrease in
fertility) that was not confirmed in controlled studies in women in the 1st
trimester (and there is no evidence of a risk in later trimesters).
MIMS Class Antacids, Antireflux Agents & Antiulcerants
ATC A02BC05 - Esomeprazole ; Belongs to the class of proton pump inhibitors.
Classification Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease
(GERD).
Poison Schedule Rx
Presentation/Packing
Form Packing/Price Photo
Nexium granules Nexium 10 mg x 28's (P2636)
Nexium 20 mg x 14's (P1274)
Nexium MUPS tablet
Nexium 40 mg x 14's (P1401)
Generic NameDrug Interactioncetirizine
vs
pilsicainideAdverse Effect :
cetirizine has its effect increased by, and increases the effect of pilsicainide

Severity Level :

Moderate - These medications may interact resulting in the potential deterioration of the patient's
condition. The patient should be monitored for the possible manifestations of the interaction.
Medical intervention or a change in therapy may be required.

Documentation Level :
Limited - Few reports of this interaction exist. These few reports usually consist of limited case
reports where clinically sound justification of the interaction is found.

Probable Mechanism :
The concomitant use of cetirizine and pilsicainide may increase the serum concentration of both
drugs which may lead to drug toxicities. A small study indicates this might be due to the
decrease in renal clearance of both drugs when given concurrently. Monitor the ECG, especially
in patients with renal insufficiency, and adjust treatment in patients with signs of drug toxicity.

Actions to be Taken :
1. Use combination with extreme caution.
2. Monitor cardiac function.

cetirizine belongs to the class of Cetirizine


Cetirizine is a nonsedating antihistamine.

pilsicainide belongs to the class of Pilsicainide


Pilsicainide hydrochloride is an antiarrhythmic with class Ic activity.

Allergy
Test:
RAST (+), S.IgE (H), intradermal skin test (+)

Sign:
Dermographia, geographic tongue

Physiology:
Allergy reactions may present in any major system depending on allergen and site of entry. Clinical
diagnosis is more important than tests. Diseases with an allergic component include asthma,
bronchitis, coryza, colitis, dermatitis, eczema, hay fever, cluster headaches, migraine, diarrhoea

Polynerv 500® [tab]


Pharma Nutria [ Pharma Nutria ]
MIMS Class : Vitamin B-Complex / with C

See related Polynerv 500 tab information


Contents Vit B1 500 mg, vit B6 250 mg, vit B12 1 mg
Indications Treatment of vit B deficiencies. Nutritional support in painful neurological
manifestations of neuritis & neuropathy eg cervical & shoulder-arm
syndrome, lumbago, ischialgia & sciatica. Neuropathies caused by disease
states eg diabetes, RA, TB, leprosy & cardiac disorders. Alcoholic
neuropathy due to INH or phenothiazine intoxication. Pregnancy,
hyperemesis gravidarum.
Dosage Prophylaxis 1-2 tab daily. Therapy 2-4 tab daily.
Administration May be taken with or without food (May be taken w/ meals to reduce GI
discomfort.).
MIMS Class Vitamin B-Complex / with C
ATC A11DB - Vitamin B1 in combination with vitamin B6 and/or vitamin B12 ;
Classification Used as dietary supplements.
Poison Schedule Rx
Presentation/Packing
Form Packing/Price Photo
Polynerv 500 tablet Polynerv 500 50's (P1174.22)
Plasil® [amp]
Duncan [ Zuellig ]
MIMS Class : Antiemetics, GIT Regulators, Antiflatulents & Anti-Inflammatories
 

See related Plasil amp information


Contents Metoclopramide
Indications Disturbances of gastrointestinal motility, including gastroesophageal
reflux and diabetic gastroparesis (diabetic gastric stasis). Nausea and
vomiting of central and peripheral origin associated with surgery,
metabolic diseases, infectious diseases, migraine headache, or drugs
including cancer chemotherapy. To facilitate small bowel intubation and
radiological procedures of gastrointestinal tract.
Dosage Adults: Tablet: 1 tab orally 3 times a day 10 min before meals.

Syrup: 2 tsp (10 mL containing 10 mg) orally 3 times a day, 10 min


before meals.

Ampule: 1 amp every 8 hrs (IM or IV).

Children 5-14 years: 2.5-5 mg orally 3 times daily; 3-5 years: 2 mg


orally 2-3 times daily; 1-3 years: 1 mg orally 2-3 times daily; <1 year: 1
mg orally twice daily.

Dosage should not exceed 0.5 mg/kg/day. Treatment of children should


begin with the lower dosage.

Radiological Examination of Gastrointestinal Tract: 1-2 amps IM or


IV, 10 min before starting the procedure.
Overdosage Symptoms of overdosage may include drowsiness, disorientation and
extrapyramidal reactions. Anticholinergic or antiparkinson drugs and
antihistamines with anticholinergic properties may be helpful in
controlling the extrapyramidal reactions. Symptoms are self-limiting and
usually disappear within 24 hrs. Dialysis is not likely to be an effective
method of drug removal in overdose situations.
Contraindications Patients with a history of hypersensitivity to metoclopramide or any of
the components of Plasil.
Metoclopramide should not be used whenever stimulation of
gastrointestinal motility might be dangerous eg, in the presence of
gastrointestinal hemorrhage, mechanical obstruction or perforation.

Metoclopramide is contraindicated in patients with pheochromocytoma


because the drug may cause a hypertensive crisis, probably due to
release of catecholamines from the tumor. Such hypertensive crises may
be controlled by phentolamine.

Metoclopramide should not be used in epileptics or patients receiving


other drugs which are likely to cause extrapyramidal reactions, since the
frequency and severity of seizures or extrapyramidal reactions may be
increased.
Special Precautions Extrapyramidal symptoms may occur in patients treated with
metoclopramide. These occur more frequently in children and young
adults and may occur after a single dose. These most often consist of
feelings of restlessness; occasionally, they may include involuntary
movements of limbs and facial grimacing; rarely, torticollis, oculogyric
crisis, rhythmic protrusion of tongue, bulbar type of speech or trismus.
The development of tardive dyskinesia has been reported in elderly
patients when treated for extended periods.

Plasil ampules contain sodium metabisulfite which may cause allergic-


type reactions, including anaphylactic symptoms and life-threatening or
less severe asthmatic episodes in certain susceptible people. The overall
prevalence of sulfite sensitivity in the general population is unknown and
probably low. Sulfite sensitivity is seen more frequently in asthmatic
than in non-asthmatic people.

IV injections of metoclopramide should be made slowly over a 1- to 2-


min period since a transient but intense feeling of anxiety and
restlessness, followed by drowsiness, may occur with rapid
administration.

Diabetic Patients: Gastroparesis (gastric stasis) may be responsible for


poor diabetic control in some patients. Exogenously administered insulin
may begin to act before food has left the stomach and lead to
hypoglycemia. Because the action of metoclopramide may quicken the
delivery of food to the intestines and thus the rate of absorption, insulin
dose or timing of administration may require adjustment.

Renal Impairment: Since metoclopramide is excreted principally through


the kidneys, in those patients whose creatinine clearance is <40 mL/min,
therapy should be initiated at approximately ½ the recommended dosage.
Depending upon clinical efficacy and safety considerations, the dosage
may be increased or decreased as appropriate.

Breast Cancer: Metoclopramide can increase prolactin levels and should


be considered in patients with previously detected breast cancer.

Effects on the Ability to Drive or Operate Machinery: Patients should be


cautioned about engaging in activities requiring mental alertness for a
few hours after the drug has been administered.

Use in pregnancy & lactation: Reproduction studies performed in rats,


mice and rabbits by IV, IM, SC and oral routes at maximum levels
ranging from 12-250 times the human dose have demonstrated no
impairment of fertility or significant harm to the fetus due to
metoclopramide. There are, however, no adequate and well-controlled
studies in pregnant women. Because animal reproductive studies are not
always predictive of human response, Plasil should be used during
pregnancy only if clearly needed.

Metoclopramide is secreted in breast milk and infants should not be


breastfed by a patient receiving metoclopramide unless in the physician's
judgement, the potential benefit to the patient outweighs the potential
risk to the infant.
Adverse Drug The most frequent adverse reactions to metoclopramide are restlessness,
Reactions drowsiness, fatigue and lassitude which occur in approximately 10% of
patients. Less frequently, extrapyramidal symptoms, insomnia,
headache, dizziness, nausea, galactorrhea, gynecomastia, rash including
urticaria, or bowel disturbances may occur.
Click to view ADR Monitoring Website
Drug Interactions The effects of metoclopramide on gastrointestinal motility are
antagonized by anticholinergic drugs and narcotic analgesics. Additive
sedative effects can occur when metoclopramide is given with alcohol,
sedatives, hypnotics, narcotics or tranquilizers. The finding that
metoclopramide releases catecholamines in patients with essential
hypertension suggests that it should be used cautiously, if at all, in
patients receiving MAOIs. Absorption of drugs from the stomach may
be diminished (eg, digoxin) by metoclopramide, whereas absorption of
drugs from the small bowel may be accelerated (eg, acetaminophen,
tetracycline, levodopa, ethanol).
View more drug interactions for Plasil
Pregnancy Category
(US FDA)
Category B: Either animal-reproduction studies have not demonstrated a
foetal risk but there are no controlled studies in pregnant women or
animal-reproduction studies have shown an adverse effect (other than a
decrease in fertility) that was not confirmed in controlled studies in
women in the 1st trimester (and there is no evidence of a risk in later
trimesters).
Storage Store below 30°C.
Mechanism of Pharmacology: Metoclopramide, a dopamine antagonist, stimulates
Action motility of the upper gastrointestinal tract without stimulating gastric,
biliary or pancreatic secretions. Its mode of action is unclear. It seems to
sensitize tissues to the action of acetylcholine. The effect of
metoclopramide on motility is not dependent on intact vagal innervation
but it can be abolished by anticholinergic drugs. Metoclopramide
increases the tone and amplitude of gastric (especially antral)
contractions, relaxes the pyloric sphincter and the duodenum and
jejunum, resulting in accelerated gastric emptying and intestinal transit.
It increases the resting tone of the lower esophageal sphincter.

Pharmacokinetics: Peak plasma levels are reached 30-60 min following


an oral dose. Excretion is primarily in the urine. The plasma half-life is
about 3 hrs. Metoclopramide undergoes minimal hepatic metabolism,
except for simple conjugation. Its safe use has been described in patients
with advanced liver disease whose renal function was normal.
MIMS Class Antiemetics / GIT Regulators, Antiflatulents & Anti-Inflammatories
ATC Classification A03FA01 - Metoclopramide ; Belongs to the class of propulsives. Used
in the treatment of functional gastrointestinal disorders.
Poison Schedule Rx
Presentation/Packing Tab 10 mg x 100's. Syrup 5 mg/5 mL x 60 mL. Amp 10 mg/2 mL x 5's.

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