País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)
Quagen Pharmaceuticals LLC
AURICULAR (OTIC)
PRESCRIPTION DRUG
Fluocinolone acetonide 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).
Fluocinolone acetonide oil, 0.01% (ear drops) is supplied in a 1 fluid ounce bottle containing 20 mL net content (Dropper Included). (NDC # 70752-159-20). Keep tightly closed. Store at 20°-25° C (68° to 77° F); excursions permitted to 15°-30° C (59°-86°F.) [see USP Controlled Room Temperature]. Discard fluocinolone acetonide oil, 0.01% (ear drops) 2 months after initial use. CAUTION: Rx only Manufactured for: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 52027 Rev. 04/21
Abbreviated New Drug Application
FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL QUAGEN PHARMACEUTICALS LLC ---------- FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) For Otic Use Only Not for Ophthalmic Use DESCRIPTION Fluocinolone acetonide oil, 0.01% (ear drops) contain 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. This formulation is also marketed as fluocinolone acetonide topical oil, 0.01% (body oil) for the treatment of atopic dermatitis and fluocinolone acetonide topical oil, 0.01% (scalp oil) for the treatment of psoriasis of scalp. 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 oil, 0.01% (ear drops) 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. 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 24 30 2 6 2 membrane phospholipids by phospholipase A . PHARMACOKINETICS: The extent of percutaneous absorption of topical corticosteroids is determined by many Leer el documento completo