Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)
Lyne Laboratories, Inc.
FLUOCINOLONE ACETONIDE
FLUOCINOLONE ACETONIDE 0.11 mg in 1 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
FLUOCINOLONE ACETONIDE OIL- FLUOCINOLONE ACETONIDE OIL OIL LYNE LABORATORIES, INC. ---------- FLUOCINOLONE ACETONIDE TOPICAL OIL, 0.01% (SCALP OIL) NDC 0374-5090-01 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. 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, 0.01% 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 NF. 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 general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A . PHARMACOKINETICS: The extent of percutaneous absorption of topical corticosteroids is determ Prečítajte si celý dokument