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Clobetasol Propionate Gel Clobetasol Propionate Recall
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Questions & Answers
Side Effects & Adverse Reactions
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Clobetasol propionate gel, cream and ointment are super-high potency corticosteroid formulations 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 potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. 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 the diagnosis may be necessary.
History
There is currently no drug history available for this drug.
Other Information
Clobetasol propionate gel, cream and ointment contain 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.
Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, it is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula:
C25H32CIFO5 Molecular Weight: 467
Each gram of the 0.05% gel contains 0.5 mg clobetasol propionate in a base of carbomer 934P, propylene glycol, purified water, and sodium hydroxide.
Each gram of the 0.05% cream contains clobetasol propionate 0.5 mg in a cream base of cetyl alcohol, chlorocresol, citric acid, glyceryl monostearate, glyceryl stearate/polyethylene glycol 100 stearate, propylene glycol, purified water, sodium citrate, stearyl alcohol, and white wax.
Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.
Sources
Clobetasol Propionate Gel Clobetasol Propionate Manufacturers
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Taro Pharmaceuticals U.s.a., Inc.
Clobetasol Propionate Gel Clobetasol Propionate | Taro Pharmaceuticals U.s.a., Inc.
Apply a thin layer of clobetasol propionate gel, cream or ointment to the affected skin areas twice daily and rub in gently and completely. (See INDICATIONS AND USAGE.)
Clobetasol propionate gel, cream and ointment are super-high potency topical corticosteroids; 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, cream or ointment should not be used with occlusive dressings.
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