Each 100 g contains Clobetasol propionate 0.05 g.
Pharmacology: Pharmacodynamics: The primary therapeutic effects of the topical clobetasol propionate are due to their anti-inflammatory activity which is non-specific.
Pharmacokinetics: Absorption: Percutaneous penetration of clobetasol propionate varies among individuals and can be increased by the use of occlusive dressings and by inflammation and/or other diseases of the epidermal barrier. Following topical application of clobetasol propionate to most areas of normal skin, only small amounts of the drug appear to reach the dermis and subsequently the systemic circulation with the usual dosage.
Metabolism: Following percutaneous penetration of clobetasol propionate drug that is systemically absorbed probably follows the metabolic pathways of systemically administered corticosteroids. However, systemic metabolism of clobetasol has not been fully characterized or quantified.
Elimination: Clobetasol and its metabolites are excreted in bile and in urine in animals.
Clobet is used for the short-term relief of the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses, including plaque, psoriasis and dermatoses of the scalp.
Apply sparingly in thin films and rubbed gently into the affected area twice daily, preferably in the morning and evening. Duration of a course of clobetasol therapy generally should not exceed 14 days.
Although clobetasol propionate 0.05% may be used for up to 4 consecutive weeks in the management of plaque psoriasis. Clobetasol therapy should be discontinued and a less potent topical corticosteroid preparation substituted.
Acute overdosage is very unlikely to occur, in the case of chronic overdosage or misuse the features of hypercortisolism may appear. In this situation topical steroids should be reduced or discontinued gradually under medical supervision because of the risk of adrenal insufficiency.
Hypersensitivity to any component; monotherapy in primary bacterial infections such as impetigo, paronychia, erysipelas, cellulitis, angular cheilitis, erythrasma, treatment of rosacea, perioral dermatitis or acne; use on the face, groin or axilla; ophthalmic use (prolonged ocular exposure may cause steroid-induced glaucoma and cataracts).
When applied to the eyelids or skin near the eyes, the drug may enter the eyes.
Local irritation: If local irritation develops, discontinue use and institute appropriate therapy.
Atrophic change: Certain areas of the body, such as the face, groin and axillae, are more prone to atrophic changes than other areas of the body following treatment with corticosteroids.
Psoriasis: Do not use topical corticosteroids as sole therapy in widespread plaque psoriasis.
Infections: In the presence of an infection, institute therapy with an antifungal or antibacterial agent. If a favorable response does not occur promptly, discontinue the corticosteroid until the infection has been controlled.
Use in Children: Children may be more susceptible to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome than adults because of a larger skin surface area to body weight ratio. Limit administration to the least amounts compatible with effective therapy. Chronic corticosteroid therapy may interfere with the growth and development of children.
Because certain areas of the body may be more susceptible to atrophic changes than others following treatment with corticosteroids, clobetasol propionate cream should not be applied to the face or intertriginous areas. Clobetasol propionate cream should not be used with occlusive dressings (including bandages).
Use in pregnancy: Pregnancy category C. There are no adequate and well controlled studies in pregnant woman. Therefore, use during pregnancy only if the potential benefits outweigh the potential hazards to the fetus. In pregnant patients, do not use extensively; do not use in large amounts or for prolonged periods of time.
Use in nursing mother: It is not known whether topical corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Nevertheless, exercise caution when administering topical corticosteroids to a nursing mother.
Local: Burning; itching; irritation; erythema; dryness; folliculitis; hypertrichosis; pruritus; acneiform; eruptions; hypopigmentation; perioral dermatitis; allergic contact dermatitis; numbness of fingers; stinging and cracking/tightening of skin; marceration of the skin; secondary infection; skin atrophy; striae; miliaria; telangiectasia. These may occur more frequently with occlusive dressings.
Systemic: Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia and glycosuria. This is more likely to occur with occlusive dressings and with the more potent steroids. Patients with liver failure or children may be at higher risk. Lightheadedness and hives have been reported rarely. Following prolonged application around the eyes, cataracts, and glaucoma may develop. In diffusely atrophied skin, blood vessels may become visible on the skin surface.
Store at temperature not exceeding 30°C.
D07AD01 - clobetasol ; Belongs to the class of very potent (group IV) corticosteroids. Used in the treatment of dermatological diseases.
Clobet cream 0.05%
10 g x 10 × 1's;450 g x 1's;5 g x 10 × 1's
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