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CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)
Actavis Pharma, Inc.
Clobetasol Propionate
Clobetasol Propionate 0.5 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
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. Clobetasol propionate topical solution is contraindicated in patients with primary infections of the scalp, or in patients who are hypersensitive to clobetasol propionate, other corticosteroids, or any ingredient in this preparation.
Clobetasol Propionate Topical Solution, USP 0.05% is supplied in plastic squeeze bottles. 25 mL (NDC 0472-0402-25) 50 mL (NDC 0472-0402-50) Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Do not refrigerate. Do not use near an open flame. Rx only Manufactured by: Cosette Pharmaceuticals, Inc. 111 Coolidge St., South Plainfield, NJ 07080 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. 08/2019 8-0323ACT4
Abbreviated New Drug Application
CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE SOLUTION ACTAVIS PHARMA, INC. ---------- CLOBETASOL PROPIONATE TOPICAL SOLUTION USP, 0.05% RX ONLY FOR TOPICAL DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE 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 (11β, 16β)-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 H CIFO and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate Topical solution,USP 0.05% contains clobetasol propionate 0.5 mg/g in a base of carbomer 974P, isopropyl alcohol (40% w/w), purified water, and sodium hydroxide. CLINICAL PHARMACOLOGY The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects. Topical corticosteroids such as clobetasol propionate are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions. However, while the physiologic, 25 32 5 pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. Clobetasol propionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs. PHARMACOKINETICS The extent of percutaneous absorption of topical corticosteroids, including clobetasol propionate, is determined by many facto 전체 문서 읽기