Country: United States
Language: English
Source: NLM (National Library of Medicine)
TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)
Glenmark Pharmaceuticals Inc., USA
TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE 1 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Triamcinolone Acetonide Ointment 0.1% and 0.5% 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 Ointment USP, 0.1% is available as follows: Triamcinolone Acetonide Ointment USP, 0.5% is available as follows: Storage Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature] Manufactured by: Glenmark Pharmaceuticals Limited Village Kishanpura, Baddi Nalagarh Road, District: Solan, Himachal Pradesh 173205, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888)721-7115 www.glenmarkpharma.com/usa December 2016
Abbreviated New Drug Application
TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE OINTMENT GLENMARK PHARMACEUTICALS INC., USA ---------- TRIAMCINOLONE ACETONIDE OINTMENT USP 0.1%, 0.5% FOR DERMATOLOGIC USE ONLY RX ONLY NOT FOR OPHTHALMIC USE 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 USP is designated chemically as 9-Fluoro-11 , 16 , 17,21-tetrahydroxypregna-1,4-diene- 3,20-dione cyclic 16,17-acetal with acetone. Structural Formula: C H FO , MW 434.50 Each gram of 0.1% and 0.5% Triamcinolone Acetonide Ointment USP contains 1 mg or 5 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum. CLINICAL PHARMACOLOGY Topical corticosteroids 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 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 corticosteroid Read the complete document