Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
clobetasol propionate (UNII: 779619577M) (clobetasol - UNII:ADN79D536H)
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
clobetasol propionate
clobetasol propionate 0.5 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
Clobetasol propionate topical solution USP, 0.05% 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 bottle as follows: NDC 0168-0269-50 50 mL plastic bottle Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. Do not refrigerate. Do not use near an open flame. KEEP OUT OF THE REACH OF CHILDREN. E. FOUGERA & CO. A division of FOUGERA PHARMACEUTICALS INC. Melville, New York 11747 46258829A R10/2019 #244
Abbreviated New Drug Application
CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE SOLUTION E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS 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 21-chloro-9-fluoro-11β,17-dihydroxy-16β- methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula: Clobetasol propionate has the molecular formula C H ClFO and a molecular weight of 466.98. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate topical solution USP, 0.05% contains: 0.5 mg/g clobetasol propionate in a base composed of purified water, isopropyl alcohol (39.3%), carbomer 934P and sodium hydroxide (for pH adjustment). 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 25 32 5 corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions. However, while the physiologic, 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 corticoste Прочетете целия документ