Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
Hydrocortisone Valerate (UNII: 68717P8FUZ) (Hydrocortisone - UNII:WI4X0X7BPJ)
Taro Pharmaceuticals U.S.A., Inc.
TOPICAL
PRESCRIPTION DRUG
Hydrocortisone valerate cream, 0.2% and hydrocortisone valerate ointment, 0.2% are medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients. Hydrocortisone valerate cream, 0.2% and hydrocortisone valerate ointment, 0.2% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
Hydrocortisone valerate cream USP, 0.2%, is supplied in 15 g (NDC 51672-1290-1), 45 g (NDC 51672-1290-6), 60 g (NDC 51672-1290-3) tube sizes. Hydrocortisone valerate ointment USP, 0.2% is supplied in 15 g (NDC 51672-1292-1), 45 g (NDC 51672-1292-6), 60 g (NDC 51672-1292-3) tube sizes. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
HYDROCORTISONE VALERATE- HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE- HYDROCORTISONE VALERATE OINTMENT TARO PHARMACEUTICALS U.S.A., INC. ---------- HYDROCORTISONE VALERATE CREAM USP, 0.2% HYDROCORTISONE VALERATE OINTMENT USP, 0.2% RX ONLY FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. DESCRIPTION Hydrocortisone valerate cream USP, 0.2% and hydrocortisone valerate ointment USP, 0.2%, contain hydrocortisone valerate, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-(11β)- pregn-4-ene-3,20-dione, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti- inflammatory and antipruritic agents. Chemically, hydrocortisone valerate is C H O . It has the following structural formula: Hydrocortisone valerate has a molecular weight of 446.58. It is a white, crystalline solid, soluble in ethanol and methanol, sparingly soluble in propylene glycol and insoluble in water. Each gram of hydrocortisone valerate cream USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer homopolymer type C, dibasic sodium phosphate, methylparaben, polyoxyl 2 stearyl ether, propylene glycol, purified water, sodium lauryl sulfate, steareth-100, stearyl alcohol and white petrolatum. Each gram of hydrocortisone valerate ointment USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer homopolymer type B, dibasic sodium phosphate, methylparaben, mineral oil, polyoxyl 2 stearyl ether, propylene glycol, purified water, sodium lauryl sulfate, steareth-100, stearyl alcohol and 26 38 6 propylene glycol, purified water, sodium lauryl sulfate, steareth-100, stearyl alcohol and white petrolatum. CLINICAL PHARMACOLOGY Like other topical corticosteroids, hydrocortisone valerate has anti-inflammatory, antipruritic and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induct Прочитайте повний документ