Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)
NuCare Pharmaceuticals,Inc.
TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE 1 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Triamcinolone Acetonide Ointment is 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 Ointment USP, 0.1% is supplied in the following sizes: NDC 68071-1784-5 Bottles of 15g Store at 20° - 25°C (68° - 77°F). [see USP Controlled Room Temperature] Teligent Pharma, Inc. Buena, New Jersey 08310 Rev. 04/16
Abbreviated New Drug Application
TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE OINTMENT NUCARE PHARMACEUTICALS,INC. ---------- TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.1% DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti- inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide is designated chemically as 9-Fluoro-11β, 16α, 17,21-tetrahydroxypregna-1,4-diene-3,20- dione cyclic 16,17-acetal with acetone. C H FO . M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.1% contains 1mg triamcinolone acetonide in an ointment base of light mineral oil and white petrolatum. CLINICAL PHARMACOLOGY Topicalcorticosteroids share anti- inflammatory, antipruritic 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 corticosteroidsis 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 metaboliz Preberite celoten dokument