Drug Catalog - Product Detail
CLOBETASOL PROPIONATE TOPICAL SOL. SOL 0.0005 50ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 50383-0266-50 | AKORN | 50 | 0.05% | SOLUTION |
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Description
DESCRIPTION Clobetasol Propionate Topical Solution, 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 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 topical solution contains clobetasol propionate 0.5 mg/g in a base of carbomer 974P, isopropyl alcohol (40% w/w), purified water, and sodium hydroxide. Chemical Structure
How Supplied
HOW SUPPLIED Clobetasol Propionate Topical Solution, USP, 0.05% is supplied in plastic squeeze bottles, 25 mL (NDC 50383-266-25), and 50 mL (NDC 50383-266-50). Store between 15° and 30°C (59° and 86°F). Do not use near an open flame. Rx only Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Rev. 266:01 2/10
Indications & Usage
INDICATIONS AND USAGE Clobetasol propionate topical solution is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.
Dosage and Administration
DOSAGE AND ADMINISTRATION Clobetasol propionate topical solution should be applied to the affected scalp areas twice daily, once in the morning and once at night. Clobetasol propionate topical solution is potent; therefore, treatment must be limited to 2 consecutive weeks and amounts greater than 50 mL/week should not be used. Clobetasol propionate topical solution is not to 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 topical solution, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.