국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE - UNII:1ZK20VI6TY)
H.J. Harkins Company, Inc.
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 preparations.
Triamcinolone Acetonide Cream USP, 0.025% is available as follows: 15 g tube (NDC 45802-063 -35) 80 g tube (NDC 45802-063 -36) 454 g jar (NDC 45802-063 -05) Triamcinolone Acetonide Cream USP, 0.1% is available as follows: 15 g tube (NDC 45802-064 -35) 80 g tube (NDC 45802-064 -36) 454 g jar (NDC 45802-064 -05) Triamcinolone Acetonide Cream USP, 0.5% is available as follows: 15 g tube (NDC 45802-065 -35)
Abbreviated New Drug Application
TRIAMCINOLONE ACETONIDE - TRIAMCINOLONE ACETONIDE CREAM H.J. HARKINS COMPANY, INC. ---------- TRIAMCINOLONE ACETONIDE, USP CREAM FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE _RX ONLY_ DESCRIPTION The topical corticosteriods constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic 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 , and M.W. of 434.51; CAS Reg. No.76-25-5. Each gram of 0.025%, 0.1% and 0.5% Triamcinolone Acetonide Cream USP contains 0.25 mg, 1 mg, or 5 mg triamcinolone acetonide respectively, in a washable cream base of cetyl alcohol, cetyl esters wax, glycerin, glyceryl monostearate, isopropyl palmitate, polysorbate-60, propylene glycol, purified water, sorbic acid, and sorbitan monostearate. 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 ha 전체 문서 읽기