Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)
Ascend Laboratories, LLC
TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE 1 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 Cream USP, 0.025% is supplied in: 15 grams tube NDC 67877-317-15 80 grams tube NDC 67877-317-80 454 grams jar NDC 67877-317-45 Triamcinolone Acetonide Cream USP, 0.1% is supplied in: 15 grams tube NDC 67877-251-15 30 grams tube NDC 67877-251-30 80 grams tube NDC 67877-251-80 454 grams jar NDC 67877-251-45 Triamcinolone Acetonide Cream USP, 0.5% is supplied in: 15 grams tube NDC 67877-318-15 Store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. PRINTED IN USA Manufactured for: Ascend Laboratories, LLC, Parsippany, NJ 07054 Manufactured by: Crown Laboratories, Inc., Johnson City, TN 37604 P1810.02 Revised: DEC 2016
Abbreviated New Drug Application
TRIAMCINOLONE ACETONIDE - TRIAMCINOLONE ACETONIDE CREAM ASCEND LABORATORIES, LLC ---------- DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti- inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21- dihydroxy-16, 17-[(1-methylethylidene) bis(oxy)]-(11β16α) Its structural formula is: Each gram of Triamcinolone Acetonide Cream USP, 0.025% contains 0.25 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triamcinolone Acetonide Cream USP, 0.5% contains 5 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. 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 o Izlasiet visu dokumentu