Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
fluocinolone acetonide (UNII: 0CD5FD6S2M) (fluocinolone acetonide - UNII:0CD5FD6S2M)
Quagen Pharmaceuticals LLC
TOPICAL
PRESCRIPTION DRUG
Fluocinolone acetonide topical oil, 0.01% 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, 0.01% (scalp oil) is supplied in bottles containing 4 fluid ounces. It is labeled as fluocinolone acetonide topical oil, 0.01% (scalp oil) (NDC # 70752-158-06) . Fluocinolone acetonide topical oil, 0.01% (scalp oil) is supplied with 2 shower caps. Keep tightly closed. Store at 25°C (68° to 77°F); excursions permitted to 15°–30°C (59°–86° F) [see USP Controlled Room Temperature]. CAUTION: Rx Only Manufactured for: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 52026 Rev. 04/21
Abbreviated New Drug Application
FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL QUAGEN PHARMACEUTICALS LLC ---------- FLUOCINOLONE ACETONIDE TOPICAL OIL, 0.01% (SCALP OIL) For Topical Use Only- Not for Oral, Ophthalmic, or Intravaginal Use DESCRIPTION Fluocinolone acetonide topical oil, 0.01% (scalp oil) 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% (body oil) 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% (ear drops) for chronic eczematous external otitis. Chemically, fluocinolone acetonide is C H F O . It has the following structural formula: Fluocinolone acetonide 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% (scalp oil) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contain 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 24 30 2 6 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 inflamma Przeczytaj cały dokument