Drug Catalog - Product Detail
CLOBETASOL PROPIONATE OINT 0.05% 60GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-8190-60 | MYLAN | 60 | 0.05% | OINTMENT |
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Description
DESCRIPTION Clobetasol propionate ointment USP, 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 is (11ß,16ß)-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, USP has the molecular formula C 25 H 32 CIFO 5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate ointment USP, 0.05% contains clobetasol propionate 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum. Clobetasol Propionate Structural Formula
How Supplied
HOW SUPPLIED Clobetasol Propionate Ointment USP, 0.05% contains 0.5 mg per gram of clobetasol propionate, USP. The translucent, unctuous ointment is available as follows: NDC 0378-8190-15 carton containing one 15 g tube NDC 0378-8190-30 carton containing one 30 g tube NDC 0378-8190-45 carton containing one 45 g tube NDC 0378-8190-60 carton containing one 60 g tube Store between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Do not be refrigerate. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: DPT Laboratories, Ltd. San Antonio, TX 78215 U.S.A. 140898-0517 Revised: 5/2017 DPT:CLOPOT:R1
Indications & Usage
INDICATIONS AND USAGE Clobetasol propionate ointment 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/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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Apply a thin layer of clobetasol propionate ointment to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE ). Clobetasol propionate ointment is a super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/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 ointment should not be used with occlusive dressings. Geriatric Use In studies where geriatric patients (65 years of age or older, see PRECAUTIONS ) have been treated with clobetasol propionate ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.