国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
TRIAMCINOLONE (UNII: 1ZK20VI6TY) (TRIAMCINOLONE - UNII:1ZK20VI6TY)
Ascend Laboratories, LLC
TRIAMCINOLONE
TRIAMCINOLONE 0.25 mg
TOPICAL
PRESCRIPTION DRUG
Triamcinolone Acetonide Cream USP is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Triamcinolone Acetonide Cream USP is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Triamcinolone Acetonide Cream USP, 0.025% 15 gram tubes: NDC67877-470-75 30 gram tubes: NDC67877-470-76 80 gram tubes: NDC67877-470-77 Triamcinolone Acetonide Cream USP, 0.1 % 15 gram tubes: NDC67877-471-75 30 gram tubes: NDC67877-471-76 80 gram tubes: NDC67877-471-77 Triamcinolone Acetonide Cream USP, 0.5 % 15 gram tubes: NDC67877-472-75 30 gram tubes: NDC67877-472-76 80 gram tubes: NDC67877-472-77 Store at controlled room temperature 15°-30 °C (59°-86°F). Avoid excessive heat. Protect from freezing. Manufactured by: Torrent Pharmaceuticals Ltd. Pithampur-454775, INDIA Distributed by : Ascend Laboratories, LLC Parsippany, NJ 07054 Revised: October, 2017 PT 2326
Abbreviated New Drug Application
TRIAMCINOLONE ACETONIDE - TRIAMCINOLONE ACETONIDE CREAM ASCEND LABORATORIES, LLC ---------- TRIAMCINOLONE ACETONIDE CREAM USP 0.025%,0.1%,0.5% RX ONLY DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4 -diene-3,20 -dione,9 -fluoro - 11,21-dihydro xy-16 ,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16 α)-], with the empirical formula C24H31FO6 and molecular weight 434.50 .CAS 76-25-5. The structural formula is: Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Glycerin, Cetyl Alcohol,Isopropyl Palmitate,Noncrystallizing sorbitol solution,Emulsifying Wax,Lactic Acid,Benzyl Alcohol andPurified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1mg of Triamcinolone Acetonide per gram in a base containing Glycerin, Cetyl Alcohol, Isopropyl Palmitate, Noncrystallizing sorbitol solution, Emulsifying Wax, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Glycerin, Cetyl Alcohol, Isopropyl Palmitate, Noncrystallizing sorbitol solution, Emulsifying Wax, Lactic Acid, Benzyl Alcohol and Purified Water. 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 阅读完整的文件