País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
BETAMETHASONE VALERATE (UNII: 9IFA5XM7R2) (BETAMETHASONE - UNII:9842X06Q6M)
Preferred Pharmaceuticals, Inc.
BETAMETHASONE VALERATE
BETAMETHASONE VALERATE 1.2 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Betamethasone Valerate Cream USP, 0. 1% is supplied in: 15 g (0. 53 oz) tubes - 68788-0597-1 45 g (1. 59 oz) tubes - 68788-0597-4 Manufactured by Actavis Mid Atlantic LLC 1877 Kawai Road Lincolnton, NC 28092 USA FORM NO. 0370/0371 VC2795 Rev. 2/06 Repackaged by Preferred Pharmaceuticals, Inc.
Abbreviated New Drug Application
BETAMETHASONE VALERATE- BETAMETHASONE VALERATE CREAM PREFERRED PHARMACEUTICALS, INC. ---------- BETAMETHASONE VALERATE CREAM, USP 0.1% BETAMETHASONE VALERATE OINTMENT, USP 0.1% DESCRIPTION Betamethasone Valerate Cream and Betamethasone Valerate Ointment contain Betamethasone Valerate USP (9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-valerate); its empirical formula is C H FO ; its molecular weight is 476.59 (CAS Registry Number 2152-44-5); its structural formula is: Each gram of the 0.1% cream contains 1.2 mg betamethasone valerate (equivalent to 1.0 mg betamethasone) in a hydrophilic cream base consisting of purified water, mineral oil, white petrolatum, polyethylene glycol 1000 monocetyl ether, cetostearyl alcohol, monobasic sodium phosphate, phosphoric acid or sodium hydroxide and 4-chloro-m-cresol as a preservative. Each gram of the 0.1% ointment contains 1.2 mg betamethasone valerate (equivalent to 1.0 mg betamethasone) in an ointment base consisting of mineral oil, white petrolatum and hydrogenated lanolin. CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. PHARMACOKINETICS The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressin Leer el documento completo