País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
fluocinolone acetonide (UNII: 0CD5FD6S2M) (fluocinolone acetonide - UNII:0CD5FD6S2M)
Glenmark Pharmaceuticals Inc., USA
AURICULAR (OTIC)
PRESCRIPTION DRUG
Fluocinolone acetonide oil, 0.01% (ear drops) 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 1 fluid ounce bottles containing 20 mL, net weight (Dropper Included) (NDC # 68462-185-56). Keep tightly closed. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. CAUTION: Rx only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Kishanpura, Baddi Nalagarh Road District: Solan, Himachal Pradesh – 173205, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1(888)721-7115 www.glenmarkpharma.com/usa October 2018
Abbreviated New Drug Application
FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL GLENMARK PHARMACEUTICALS INC., USA ---------- FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) RX ONLY For Otic Use Only Not for Ophthalmic Use DESCRIPTION Fluocinolone Acetonide Oil, 0.01% (Ear Drops) contain fluocinolone acetonide, USP {(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. Chemically, fluocinolone acetonide, USP is C H F O . It has the following structural formula: Fluocinolone acetonide, USP in Fluocinolone Acetonide Oil, 0.01% (Ear Drops) has a molecular weight of 452.49. It is a white or almost white, crystalline powder and melts at 270°C with decomposition; practically insoluble in water and heptane, soluble in methanol, anhydrous ethanol and acetone, slightly soluble in ether and chloroform. Each gram of Fluocinolone Acetonide Oil, 0.01% (Ear Drops) contains approximately 0.11 mg of fluocinolone acetonide, USP 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 membrane phospholipids by phospholipase A . PHARMACOKINETICS The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusion of topical corticosteroids can enhance penetra Leer el documento completo