Clobetasol propionate

Dermovate
500mcg/g Cream
500mcg/g Ointment
Corticosteroids

Formulation:
Each gram contains:
Clobetasol propionate, Ph. Eur. ……. 500 mcg

PRODUCT DESCRIPTION
Each Clobetasol propionate (Dermovate) Cream and Ointment contains 500 mcg/g (0.05 % w/w) clobetasol propionate.
The water-miscible cream and paraffin-based ointment are both white in appearance.

PHARMACOLOGIC PROPERTIES
Pharmacodynamics
ATC code
D07AD Corticosteroids, very potent (group IV)
Mechanism of action
Topical corticosteroids act as anti-inflammatory agents via multiple mechanisms to inhibit late phase allergic reactions
including decreasing the density of mast cells, decreasing chemotaxis and activation of eosinophils, decreasing cytokine
production by lymphocytes, monocytes, mast cells and eosinophils, and inhibiting the metabolism of arachidonic acid.
Pharmacodynamic effects
Topical corticosteroids, have anti-inflammatory, antipruritic, and vasoconstrictive properties.
Pharmacokinetics
Absorption
Topical corticosteroids can be systemically absorbed from intact healthy skin. The extent of percutaneous absorption of
topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier.
Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption.
Mean peak plasma clobetasol propionate concentrations of 0.63 nanograms/ml occurred in one study eight hours after the
second application (13 h after an initial application) of 30 g clobetasol propionate 0.05 % ointment to normal individuals
with healthy skin. Following the application of a second dose of 30 g clobetasol propionate cream 0.05 %, mean peak
plasma concentrations were slightly higher than the ointment and occurred 10 h after application. In a separate study,
mean peak plasma concentrations of approximately 2.3 nanograms/ml and 4.6 nanograms/ml occurred respectively in
patients with psoriasis and eczema three hours after a single application of 25 g clobetasol propionate 0.05 % ointment.
Distribution
The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary due
to the fact that circulating levels are well below the level of detection.
Metabolism
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to
systemically administered corticosteroids. They are metabolised, primarily in the liver.
Elimination
Topical corticosteroids are excreted by the kidneys. In addition, some corticosteroids and their metabolites are also
excreted in the bile.
Non-Clinical Information
Carcinogenesis / Mutagenesis
Carcinogenesis
Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate.
Genotoxicity
Clobetasol propionate was not mutagenic in a range of in vitro bacterial cell assays.
Reproductive Toxicology
Fertility
In fertility studies, subcutaneous administration of clobetasol propionate to rats at doses of 6.25 to 50 micrograms/kg/day
produced no effects on mating, and fertility was only decreased at 50 micrograms/kg/day.
Pregnancy
Subcutaneous administration of clobetasol propionate to mice (100 micrograms/kg/day), rats (400 micrograms/kg/day) or
rabbits (1 to 10 micrograms/kg/day) during pregnancy produced foetal abnormalities including cleft palate and intrauterine
growth retardation.
In the rat study, where some animals were allowed to litter, developmental delay was observed in the F1 generation at
100 micrograms/kg/day and survival was reduced at 400 micrograms/kg/day. No treatment-related effects were observed
in F1 reproductive performance or in the F2 generation.

INDICATIONS
Clobetasol propionate (Dermovate) is a very potent topical corticosteroid indicated for adults, elderly and children over 1
year for the relief of the inflammatory and pruritic manifestations of steroid responsive dermatoses.
These include the following:
- Psoriasis (excluding widespread plaque psoriasis).
- Recalcitrant dermatoses
- Lichen planus
- Discoid lupus erythematosus
- Other skin conditions which do not respond satisfactorily to less potent steroids

DOSAGE AND ADMINISTRATION

Ointment
Ointments are especially appropriate for dry, lichenified or scaly lesions.
Cream
Creams are especially appropriate for moist or weeping surfaces.
Adults, Elderly and Children over 1 year
Apply thinly and gently rub in using only enough to cover the entire affected area once or twice a day for up to 4 weeks
until improvement occurs, then reduce the frequency of application or change the treatment to a less potent preparation.
Allow adequate time for absorption after each application before applying an emollient.
Repeated short courses of Clobetasol propionate (Dermovate) may be used to control exacerbations.
In more resistant lesions, especially where there is hyperkeratosis, the effect of Clobetasol propionate (Dermovate) can be
enhanced, if necessary, by occluding the treatment area with polythene film.
Overnight occlusion only is usually adequate to bring about a satisfactory response. Thereafter improvement can usually
be maintained by application without occlusion.
If the condition worsens or does not improve within 2-4 weeks, treatment and diagnosis should be re-evaluated. Treatment
should not be continued for more than 4 weeks. If continuous treatment is necessary, a less potent preparation should be
used.
The maximum weekly dose should not exceed 50 gms/week.
Atopic dermatitis (eczema)
Therapy with Clobetasol propionate (Dermovate) cream and ointment should be gradually discontinued once control is
achieved and an emollient continued as maintenance therapy.
Rebound of pre-existing dermatoses can occur with abrupt discontinuation of Clobetasol propionate (Dermovate).
Recalcitrant dermatoses
Patients who frequently relapse
Once an acute episode has been treated effectively with a continuous course of topical corticosteroid, intermittent dosing
(once daily, twice weekly, without occlusion) may be considered. This has been shown to be helpful in reducing the
frequency of relapse.
Application should be continued to all previously affected sites or to known sites of potential relapse. This regime should
be combined with routine daily use of emollients. The condition and the benefits and risks of continued treatment must be
re-evaluated on a regular basis.
Children
Clobetasol propionate (Dermovate) is contraindicated in children under one year of age.
Children are more likely to develop local and systemic side effects of topical corticosteroids and, in general, require
shorter courses and less potent agents than adults.
Care should be taken when using Clobetasol propionate (Dermovate) to ensure the amount applied is the minimum that
provides therapeutic benefit.
Elderly
Clinical studies have not identified differences in responses between the elderly and younger patients. The greater
frequency of decreased hepatic or renal function in the elderly may delay elimination if systemic absorption occurs.
Therefore, the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.
Renal / Hepatic Impairment
In case of systemic absorption (when application is over a large surface area for a prolonged period) metabolism and
elimination may be delayed therefore increasing the risk of systemic toxicity. Therefore, the minimum quantity should be
used for the shortest duration to achieve the desired clinical benefit.

CONTRAINDICATIONS
The following conditions should not be treated with Clobetasol propionate (Dermovate):
 Untreated cutaneous infections
 Rosacea
 Acne vulgaris
 Pruritus without inflammation.
 Perianal and genital pruritus
 Perioral dermatitis
Clobetasol propionate (Dermovate) is contraindicated in dermatoses in children under one year of age, including
dermatitis.

WARNINGS AND PRECAUTIONS

Clobetasol propionate (Dermovate) should be used with caution in patients with a history of local hypersensitivity to
corticosteroids or to any of the excipients in the preparation. Local hypersensitivity reactions (see Adverse Effects) may
resemble symptoms of the condition under treatment.
Manifestations of hypercortisolism (Cushing’s syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis
suppression, leading to glucocorticosteroid insufficiency, can occur in some individuals as a result of increased systemic
absorption of topical steroids. If either of the above are observed, withdraw the drug gradually by reducing the frequency
of application, or by substituting a less potent corticosteroid. Abrupt withdrawal of treatment may result in
glucocorticosteroid insufficiency (see Adverse Effects).
Risk factors for increased systemic effects are:
• Potency and formulation of topical steroid
• Duration of exposure
• Application to a large surface area
• Use on occluded areas of skin (e.g. on intertriginous areas or under occlusive dressings (in infants the nappy may act
as an occlusive dressing)
• Increasing hydration of the stratum corneum
• Use on thin skin areas such as the face
• Use on broken skin or other conditions where the skin barrier may be impaired
• In comparison with adults, children and infants may absorb proportionally larger amounts of topical corticosteroids
and thus be more susceptible to systemic adverse effects. This is because children have an immature skin barrier
and a greater surface area to body weight ratio compared with adults.
Visual disturbance has been reported by patients using systemic and/or topical corticosteroids. If a patient has blurred vision
or other visual disturbances, consider evaluation of possible causes which may include cataract, glaucoma or central serous
chorioretinopathy.
Children
In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided
where possible, as adrenal suppression can occur
Children are more susceptible to develop atrophic changes with the use of topical corticosteroids. If Clobetasol propionate
(Dermovate) is required for use in children, it is recommended that the treatment should be limited to only a few days
and reviewed weekly.
Infection risk with occlusion
Bacterial infection is encouraged by the warm, moist conditions within skin folds or caused by occlusive dressings. When
using occlusive dressings, the skin should be cleansed before a fresh dressing is applied.
Use in Psoriasis
Topical corticosteroids should be used with caution in psoriasis as rebound relapses, development of tolerances, risk of
generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin
have been reported in some cases. If used in psoriasis careful patient supervision is important.
Concomitant infection
Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected.
Any spread of infection requires withdrawal of topical corticosteroid therapy and administration of appropriate antimicrobial
therapy.
Chronic leg ulcers
Topical corticosteroids are sometimes used to treat the dermatitis around chronic leg ulcers. However, this use may be
associated with a higher occurrence of local hypersensitivity reactions and an increased risk of local infection.
Application to the face
Application to the face is undesirable as this area is more susceptible to atrophic changes. If used on the face, treatment
should be limited to only a few days.
Application to the eyelids
If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as cataract and glaucoma
might result from repeated exposure.
Effects on Ability to Drive and Use Machines
There have been no studies to investigate the effect of Clobetasol propionate (Dermovate) on driving performance or the
ability to operate machinery. A detrimental effect on such activities would not be anticipated from the adverse reaction profile
of topical Clobetasol propionate (Dermovate).
Cream and Ointment
DERMOVATE cream and ointment contain paraffin. Instruct patients not to smoke or go near naked flames due to the risk of
severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with these products burns more easily and is
a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

DRUG INTERACTIONS
Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir and itraconazole) have been shown to inhibit the metabolism
of corticosteroids leading to increased systemic exposure. The extent to which this interaction is clinically relevant
depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor.

PREGNANCY AND LACTATION

Fertility
There are no data in humans to evaluate the effect of topical corticosteroids on fertility. Clobetasol administered
subcutaneously to rats had no effect upon mating performance; however, fertility was decreased at the highest dose (see
Non-Clinical Information).
Pregnancy
There are limited data from the use of Clobetasol propionate (Dermovate) in pregnant women.
Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development (see Non-
Clinical Information)
The relevance of this finding to humans has not been established. Administration of Clobetasol propionate (Dermovate)
during pregnancy should only be considered if the expected benefit to the mother outweighs the risk to the foetus. The
minimum quantity should be used for the minimum duration.
Lactation
The safe use of topical corticosteroids during lactation has not been established.
It is not known whether the topical administration of corticosteroids could result in sufficient systemic absorption to
produce detectable amounts in breast milk. Administration of Clobetasol propionate (Dermovate) during lactation should
only be considered if the expected benefit to the mother outweighs the risk to the infant.
If used during lactation Clobetasol propionate (Dermovate) should not be applied to the breasts to avoid accidental
ingestion by the infant.

ADVERSE EFFECTS
Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are
defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and
<1/1,000) and very rare (<1/10,000), including isolated reports.
Post-marketing data
Infections and Infestations
Very rare Opportunistic infection
Immune System Disorders
Very rare Local Hypersensitivity
Endocrine Disorders
Very rare Hypothalamic-pituitary adrenal (HPA) axis suppression:
 Cushingoid features: (e.g. moon face, central obesity),
delayed weight gain/growth retardation in children,
osteoporosis, hyperglycaemia/glucosuria, hypertension,
increased weight/obesity, decreased endogenous cortisol
levels, alopecia, trichorrhexis
Eye Disorders
Very rare Cataract, central serous chorioretinopathy, glaucoma
Skin and Subcutaneous Tissue Disorders
Common Pruritus, local skin burning /skin pain
Uncommon Skin atrophy*, striae*, telangiectasias*
Very rare Skin thinning*, skin wrinkling*, skin dryness*,
pigmentation changes*, hypertrichosis, exacerbation of
underlying symptoms, allergic contact dermatitis/dermatitis,
pustular psoriasis, erythema, rash, urticaria, acne
General Disorders and Administration Site Conditions
Very rare Application site irritation/pain

*Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.

OVERDOSE AND TREATMENT

Symptoms and signs
Topically applied Clobetasol propionate (Dermovate) may be absorbed in sufficient amounts to produce systemic
effects. Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse the features of
hypercortisolism may occur (see Adverse Effects).
Treatment
In the event of overdose, Clobetasol propionate (Dermovate) should be withdrawn gradually by reducing the frequency of
application or by substituting a less potent corticosteroid because of the risk of glucocorticosteroid insufficiency.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.

STORAGE CONDITION
Store at temperatures not exceeding 30C.

INCOMPATIBILITIES
No incompatibilities have been identified.

USE AND HANDLING

There are no special requirements for use or handling of this product.

AVAILABILITY
Clobetasol propionate (Dermovate) Cream: 5 g Aluminum Tube (Box of 1’s)
Clobetasol propionate (Dermovate) Ointment: 5 g Aluminum Tube (Box of 1’s)

CAUTION
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription. Keep
all medicines out of reach of children.

For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph

Seek medical attention at the first sign of any adverse drug reaction.

Clobetasol propionate (Dermovate) cream

Registration number: DR-10074
Date of first authorization: 05 December 2003

Clobetasol propionate (Dermovate) ointment

Registration number: DR-10073
Date of first authorization: 05 December 2003

Trademarks are owned by or licensed to the GSK group of companies.

©2023, GSK. All rights reserved.

Version number: GDS16/IPI10 Revision date: 25 May 2022

Marketing Authorization Holder:

GlaxoSmithKline Philippines Inc
23F The Finance Centre, 26th St. cor. 9th Ave.
Bonifacio Global City, Taguig City

Manufactured By:
Delpharm Poznań S.A.
ul. Grunwaldzka 189, 60-322,
Poznan, Poland