Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1095
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Clobetasol Propionate (Gel)
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| dailymed-instance:dosage |
Apply a thin layer of clobetasol propionate gel to the affected skin areas twice daily and rub in gently and completely . Clobetasol propionate gel is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 g per week should not be used. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Clobetasol propionate gel should not be used with occlusive dressings.
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| dailymed-instance:descripti... |
Clobetasol Propionate Gel, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate (11��,16��)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula: Clobetasol propionate has the molecular formula CHClFOand a molecular weight of 466.98. It is a white to cream-colored crystalline powder insoluble in water. Each gram, for topical administration, contains clobetasol propionate 0.5 mg in a base of propylene glycol, carbomer 934P, sodium hydroxide, and purified water.
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| dailymed-instance:clinicalP... |
Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase Ainhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A.<br/>Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressing with hydrocortisone for up to 24 hours has not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin, while inflammation and/or other disease processes in the skin may increase percutaneous absorption. Greater absorption was observed for the clobetasol propionate gel formulation as compared to the cream formulation in in vitro human skin penetration studies. Studies performed with clobetasol propionate gel indicate that it is in the super-high range of potency as compared with other topical corticosteroids.
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| dailymed-instance:contraind... |
Clobetasol propionate gel is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
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| dailymed-instance:supply |
Clobetasol Propionate Gel, 0.05% is supplied in 15 g, 30 g, and 60 g tubes. Store at 20��- 25��C (68��- 77��F) [see USP Controlled Room Temperature]. Do not refrigerate.
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Topically applied clobetasol propionate gel can be absorbed in sufficient amounts to produce systemic effects .
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| dailymed-instance:genericMe... |
Clobetasol Propionate
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| dailymed-instance:fullName |
Clobetasol Propionate (Gel)
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| dailymed-instance:adverseRe... |
In a controlled trial with clobetasol propionate gel, the only reported adverse reaction that was considered to be drug related was a report of burning sensation (1.8% of treated patients). In larger controlled clinical trials with other clobetasol propionate formulations, the most frequently reported adverse reactions have included burning, stinging, irritation, pruritis, erythema, folliculitis, cracking and fissuring of the skin, numbness of fingers, skin atrophy and telangiectasia (all less than 2%). Cushing's syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations. The following additional local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with super-high potency corticosteroids such as clobetasol propionate gel. These reactions are listed in approximate decreasing order of occurrence: dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.
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| dailymed-instance:indicatio... |
Clobetasol propionate gel is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potentialfor the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric petients under 12 years of age is not recommended.
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| dailymed-instance:name |
Clobetasol Propionate
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