מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)
Encube Ethicals Private Limited
TOPICAL
PRESCRIPTION DRUG
Triamcinolone Acetonide Ointment 0.05% 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, 0.05%: jar containing 430 g (NDC 21922-024-11) KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. You may report Side effects to FDA at 1-800-FDA-1088. You may also report side effects to Encube Ethicals Private Limited at (1-833-285-4151). DISPENSE IN A WELL-CLOSED CONTAINER CAUTION : Federal law prohibits dispensing without prescription. For external use only. Not for ophthalmic use. Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa-403404, India. Distributed by: Encube Ethicals Inc. 200 Meredith Avenue, Suite101A Durham, NC 27713 USA. Revised : 04/2021
Abbreviated New Drug Application
TRIAMCINOLONE ACETONIDE - TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.05% OINTMENT ENCUBE ETHICALS PRIVATE LIMITED ---------- TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.05% 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: C H FO , MW 434.50 Each gram of 0.05% Triamcinolone Acetonide Ointment USP provides 0.5 mg of Triamcinolone Acetonide in a water in-oil emulsion composed of light mineral oil, purified water, white petrolatum, mineral oil, ceresin wax 155/165, and lanolin alcohols. 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. 24 31 6 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 sim קרא את המסמך השלם