Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
BETAMETHASONE VALERATE (UNII: 9IFA5XM7R2) (BETAMETHASONE - UNII:9842X06Q6M)
Actavis Pharma, 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 NDC 0472-0370-15 45 g (1. 59 oz) tubes NDC 0472-0370-45 Betamethasone Valerate Ointment USP, 0. 1% is supplied in: 15 g (0. 53 oz) tubes NDC 0472-0371-15 45 g (1. 59 oz) tubes NDC 0472-0371-45 Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street South Plainfield, NJ 07080 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised – November 2016 I600-5531/34 GW7148
Abbreviated New Drug Application
BETAMETHASONE VALERATE- BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE- BETAMETHASONE VALERATE OINTMENT ACTAVIS PHARMA, INC. ---------- BETAMETHASONE VALERATE CREAM USP, 0.1% BETAMETHASONE VALERATE OINTMENT USP, 0.1% FOR EXTERNAL USE ONLY – NOT FOR OPHTHALMIC USE RX ONLY DESCRIPTION Betamethasone Valerate Cream, USP and Betamethasone Valerate Ointment, USP contain betamethasone valerate, USP (9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-valerate); its molecular 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, USP (equivalent to 1.0 mg betamethasone) in a hydrophilic cream base consisting of purified water, mineral oil, white petrolatum, polyethylene glycol 1,000 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, USP (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 absorptio Διαβάστε το πλήρες έγγραφο