Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE - UNII:1ZK20VI6TY)
STAT RX LLC USA
TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE 1 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 Cream USP and Triamcinolone Acetonide Ointments USP are supplied as follows: 0.025%: 15 and 80 g tubes and 1 lb and 5 lb jars. 0.1%: 15 and 80 g tubes and 1 lb and 5 lb jars. 0.5%: 15 g tubes Store at controlled room temperature 15° to 30°C (59° to 86°F). DISTRIBUTED BY PERRIGO, ALLEGAN, MI 49010 4B400 RC J1
Abbreviated New Drug Application
TRIAMCINOLONE ACETONIDE - TRIAMCINOLONE ACETONIDE CREAM STAT RX LLC USA ---------- DESCRIPTION RX ONLY DESCRIPTION The topical corticosteriods constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3, 20-dione, 9-fluoro-11, 21- dihydroxy-16, 17-[(1-methylethylidene)bis (0xy)]-, (11β, 16α)-. C H FO ,M.W.:434.51; CAS Reg.No.:76-25-5. Each gram of 0.025%, 0.1% and 0.5% Triamcinolone Acetonide Cream USP provides 0.25 mg, 1 mg, or 5 mg triamcinolone acetonide respectively in a washable cream base of : Purified Water, Cetyl Alcohol, Propylene Glycol, Glyceryl Monostearate, Glycerin, Cetyl Esters Wax, Polysorbate-60, Sorbitan Monostearate, Isopropyl Palmitate and Sorbic Acid. Each gram of 0.025%, 0.1% and 0.5% Triamcinolone Acetonide Ointment USP provides 0.25 mg, 1 mg, or 5 mg triamcinolone acetonide respectively in an ointment base of White Petrolatum and Light 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 24 31 6 therapeutic adjunct for trea Przeczytaj cały dokument