국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
Triamcinolone Acetonide (UNII: F446C597KA) (Triamcinolone Acetonide - UNII:F446C597KA)
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Triamcinolone Acetonide
Triamcinolone Acetonide 0.25 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
Triamcinolone Acetonide Lotion USP, 0.025% and 0.1% are indicated for 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 Lotion USP, 0.025%; plastic squeeze bottles containing 60 mL NDC 0168-0336-60 Triamcinolone Acetonide Lotion USP, 0.1%; plastic squeeze bottles containing 60 mL NDC 0168-0337-60 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. AVOID FREEZING. SHAKE WELL BEFORE USING. E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I2337D R05/15 #69
Abbreviated New Drug Application
TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE LOTION E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC. ---------- TRIAMCINOLONE ACETONIDE LOTION USP, 0.025%, 0.1% RX ONLY DESCRIPTION: Triamcinolone Acetonide USP is a topical corticosteroid designated chemically as 9-Fluoro- 11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Structural formula: Each mL of 0.025% and 0.1% Triamcinolone Acetonide Lotion USP, provides 0.25 mg and 1 mg triamcinolone acetonide USP, respectively, in a lotion base containing propylene glycol, cetyl alcohol, stearyl alcohol, sorbitan monopalmitate, polysorbate 20, simethicone, 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 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 pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily 전체 문서 읽기