Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)
Cosette Pharmaceuticals, Inc.
TOPICAL
PRESCRIPTION DRUG
Fluocinolone Acetonide Cream 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 preparation.
Fluocinolone Acetonide Cream USP, 0.025% is supplied in 15 g Tube - NDC 0713-0324-15 60 g Tube - NDC 0713-0324-60
New Drug Application
FLUOCINOLONE ACETONIDE - FLUOCINOLONE ACETONIDE CREAM COSETTE PHARMACEUTICALS, INC. ---------- FLUOCINOLONE ACETONIDE CREAM USP, 0.025% RX ONLY DESCRIPTION Fluocinolone Acetonide Creatm USP, 0.025% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4- diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6ą,11ß,16ą)-. It has the following chemical structure: Fluocinolone Acetonide Cream USP contains fluocinolone acetonide 0.25 mg/g in a water-washable aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid, edetate disodium, methylparaben and propylparaben (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, simethicone, stearyl alcohol, water (purified) and white wax. 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 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 pathwa Les hele dokumentet