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Full Prescribing Info
Clobetasol propionate.
Composition: Clobetasol propionate 0.05% w/w.
Pharmacology: Clobetasol propionate is a highly active corticosteroid with topical anti-inflammatory activity. The major effect of clobetasol propionate on skin is a non-specific anti-inflammatory responses, as a result of vasoconstriction and decrease in collagen synthesis.
Percutaneous penetration of clobetasol propionate varies among individuals and can be increased by the use of occlusive dressings, or when the skin is inflamed or diseased.
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 30g clobetasol propionate 0.05% ointment to normal individuals with healthy skin.
Following the application of a second dose of 30g clobetasol propionate cream 0.05% mean peak plasma concentration were slightly higher than the ointment and occured 10 h after application. In a separate study, mean peak plasma concentration of approximately 2.3 nanograms/ml and 4.6 nanograms/ml occured respectively in patients with psoriasis and eczema three hours after a single application of 25g clobetasol propionate ointment.
Following percutaneous absorption of clobetasol propionate the drug probably follows the metabolic pathway of systemically administered corticosteroids, i.e. metabolised primarily by the liver and then excreted by the kidneys. However, systemic metabolism of clobetasol has never been fully characterised or quantified.
It is used for the short-term relief of the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses.
Dosage/Direction for Use
Apply the cream to the affected areas twice a day, preferably in the morning and evening. Generally, the dosage should not exceed 50gm of Clobetasol propionate 0.05% cream per week and duration of a course of Clobetasol therapy should not exceed 14 days.
Topically applied corticosteroids can be absorbed in sufficient amount to produce systemic effect.
Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressings should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favourable response does not occur promptly, the corticosteroids should be discontinued until the infection has been adequately controlled.
It is contraindicated in patient who are hypersensitive to Clobetasol propionate or other corticosteroids.
Special Precautions
Clobetasol propionate is one of the most potent topical corticosteroid preparations. It can suppress the hypothalamic-pituitary-adrenal axis following topical application, and HPA axis suppression has occurred following topical dosages as low as 2gm of the 0.05% cream daily. Because of the drug's potency and potential for causing adverse systemic effect during topical therapy, the usual dosage should not be exceeded and occlusive dressings should not be applied to areas of Clobetasol propionate application.
Use in children: It is not recommended to use in children under 12 years of age.
Use In Pregnancy & Lactation
Pregnant women and nursing mother should seek the advice of a physician before using this product. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development.
The relevance of this finding to human beings has not been established; however, topical steroids should not be used extensively in pregnancy, ie large amounts or for prolonged periods.
Side Effects
The side effects are itching, burning, stinging, dryness, folliculitis, hypertrichosis, acne form eruption, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atropy, striae, miliaria.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal axis suppression, manisfestation of cushing’s syndrome, hyperglycemia, and glucosuria in some patients.
Store at or below 25°C. Protect from light.
Shelf-life: 3 years.
ATC Classification
D07AD01 - clobetasol ; Belongs to the class of very potent (group IV) corticosteroids. Used in the treatment of dermatological diseases.
Cream 0.05% w/w (white and smooth) x 400 g.
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