Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)
Tasman 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).
Fluocinolone acetonide oil, 0.01% (ear drops) is supplied in 1 fluid ounce bottles containing 20 mL, net weight (Dropper Included) (NDC # 72641-002-20). 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]. Discard fluocinolone acetonide oil, 0.01% 2 months after initial use.
Abbreviated New Drug Application
FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) - FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) OIL TASMAN PHARMA INC. ---------- 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, 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% has a molecular weight of 452.49. 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, 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 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 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 th Đọc toàn bộ tài liệu