Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: 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 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 Ointment USP, 0.025% is available as follows: 80 gram tubes NDC 0168-0005-80 Triamcinolone Acetonide Ointment USP, 0.1% is available as follows: 15 gram tubes NDC 0168-0006-15 80 gram tubes NDC 0168-0006-80 453.6 gram (1lb) jars NDC 0168-0006-16 Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I20515K/IF20515K R05/13 #221 Or 46171939A R10/15 #94
Abbreviated New Drug Application
TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE OINTMENT E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC. ---------- TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.025%, 0.1% RX ONLY FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. DESCRIPTION: The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone Acetonide Ointment USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis-(oxy)]-, (11β,16α)-], with the molecular formula C H FO and molecular weight 434.51. CAS 76-25-5. Triamcinolone Acetonide Ointment USP, 0.025% contains: 0.25 mg of triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil. Triamcinolone Acetonide Ointment USP, 0.1% contains: 1 mg triamcinolone acetonide per gram in a base containing white petrolatum and 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 therapeutic adjunct for treatment of resistant dermatoses (See DOSAGE AND ADMINISTRATION). Once Perskaitykite visą dokumentą