Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)
Patrin Pharma, Inc.
AURICULAR (OTIC)
PRESCRIPTION DRUG
Fluocinolone acetonide oil, 0.01% is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older. 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).
Flac® Otic Oil (fluocinolone acetonide oil, 0.01%) Ear Drops is supplied in 1 fluid ounce bottles containing 20 mL, net weight (Dropper Included) (NDC # 39328-079-20) 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]. CAUTION: Rx only Manufactured for: Patrin Pharma Inc, Skokie, IL 60076 1 (800) 936 3088 Oct 2017
Abbreviated New Drug Application
FLAC OTIC OIL- FLUOCINOLONE ACETONIDE OIL PATRIN PHARMA, INC. ---------- FLAC® OTIC OIL (FLUOCINOLONE ACETONIDE OIL, 0.01%) EAR DROPS FOR OTIC USE ONLY- NOT FOR OPHTHALMIC USE NDC 39328-079-20 DESCRIPTION FLAC OIL 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 oil (body oil) for the treatment of atopic dermatitis and fluocinolone acetonide oil (scalp oil) for the treatment of psoriasis of the scalp. Chemically, fluocinolone acetonide is C H F O . It has the following structural formula: Fluocinolone acetonide in Fluocinolone Acetonide 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 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. 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 A2 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 A2. PHARMACOKINETICS The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the Lire le document complet