Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)
Physicians Total Care, Inc.
FLUOCINOLONE ACETONIDE
FLUOCINOLONE ACETONIDE 0.1 mg in 1 mL
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.
Fluocinolone Acetonide Topical Solution, USP 0.01% in 60 mL bottles, NDC 54868-2264-1 Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat. Protect from freezing. E. FOUGERA & CO. A division of Nycomed US Inc. Melville, New York 11747 I259C R12/07 Relabeling of "Additional" barcode label by: Physicians Total Care, Inc. Tulsa, OK 74146
Abbreviated New Drug Application
FLUOCINOLONE ACETONIDE - FLUOCINOLONE ACETONIDE SOLUTION PHYSICIANS TOTAL CARE, INC. ---------- FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE RX ONLY DESCRIPTION Fluocinolone Acetonide Topical Solution USP, 0.01% contains fluocinolone acetonide USP (Pregna- 1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α,11β,16α)-); it has an empirical formula of C H F O and a molecular weight of 425.49 (CAS Registry Number 67-73-2). Each mL of the topical solution contains 0.1 mg fluocinolone acetonide in a base containing propylene glycol and citric acid. 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 the 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. (SeeDOSAGE AND ADMINISTRATION ). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are 24 30 2 6 bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and Perskaitykite visą dokumentą