Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
Fluocinolone Acetonide (UNII: 0CD5FD6S2M) (Fluocinolone Acetonide - UNII:0CD5FD6S2M)
Taro Pharmaceuticals U.S.A., Inc.
TOPICAL
PRESCRIPTION DRUG
Fluocinolone acetonide topical oil is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. This product contains refined peanut oil NF (see PRECAUTIONS section).
Fluocinolone acetonide topical oil is supplied in bottles containing 4 fluid ounces. It is labeled as Scalp Oil (NDC #51672-1357-8). Scalp Oil is supplied with 2 shower caps. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep tightly closed.
Abbreviated New Drug Application
FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL TARO PHARMACEUTICALS U.S.A., INC. ---------- FLUOCINOLONE ACETONIDE TOPICAL OIL, 0.01% (SCALP OIL) RX ONLY NDC 51672-1357-8 For Topical Use Only Not for Oral, Ophthalmic, or Intravaginal Use DESCRIPTION Fluocinolone Acetonide Topical Oil, 0.01% contains fluocinolone acetonide {(6α, 11β, 16α)-6,9- difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid for topical dermatologic use. This formulation is also marketed as Fluocinolone Acetonide Topical Oil, 0.01% for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older and as fluocinolone acetonide oil, 0.01% for chronic eczematous external otitis. Chemically, fluocinolone acetonide is C H F O . It has the following structural formula: Fluocinolone acetonide in Fluocinolone Acetonide Topical Oil, 0.01% has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of fluocinolone acetonide topical oil contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, and refined peanut oil. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic. CLINICAL PHARMACOLOGY Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in 24 30 2 6 general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent Olvassa el a teljes dokumentumot