Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
Triamcinolone Acetonide (UNII: F446C597KA) (Triamcinolone - UNII:1ZK20VI6TY)
Rebel Distributors Corp
Triamcinolone Acetonide
Triamcinolone Acetonide 0.25 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.
Triamcinolone Acetonide Ointment USP, 0.025% 80 gram tubes NDC 21695-503-80 Triamcinolone Acetonide Ointment USP, 0.1% 15 gram tubes NDC 21695-504-15 80 gram tubes NDC 21695-504-80 Store at controlled room temperature 15°-30°C (59°-86°F). March 2008 E. FOUGERA & CO. A division of Nycomed US Inc. MELVILLE, NEW YORK 11747 Repackaged by: REBEL DISTRIBUTORS CORP Thousand Oaks, CA 91320
Abbreviated New Drug Application
TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE OINTMENT REBEL DISTRIBUTORS CORP ---------- TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.025%, 0.1% RX ONLY DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone Acetonide Ointment USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis-(oxy)]-, (11β,16α)-], with the molecular formula C H FO and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Ointment USP, 0.025% contains: 0.25 mg of triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil. Triamcinolone Acetonide Ointment USP, 0.1% contains: 1 mg triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil. 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 dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (See DOSAGE AND ADMINISTRATION). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pa Olvassa el a teljes dokumentumot