Country: United States
Language: English
Source: NLM (National Library of Medicine)
TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)
Aidarex Pharmaceuticals LLC
TOPICAL
PRESCRIPTION DRUG
Triamcinolone acetonide cream 0.025% and 0.1% 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%: tubes containing 15 g. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid freezing.
Abbreviated New Drug Application
TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE CREAM AIDAREX PHARMACEUTICALS LLC ---------- TRIAMCINOLONE ACETONIDE CREAM, USP 0.025% AND 0.1% RX ONLY 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. Graphic formula: Each gram of 0.025% and 0.1% triamcinolone acetonide cream provides 0.25 mg or 1 mg of triamcinolone acetonide, respectively, in a cream base containing cetyl alcohol, isopropyl palmitate, methyl paraben, mineral oil/lanolin alcohol, polysorbate 40, propyl paraben, propylene glycol, propylene glycol monostearate, purified water, sorbic acid, sorbitan monopalmitate, stearyl alcohol and xanthan gum. 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 Read the complete document