Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)
Padagis Israel Pharmaceuticals Ltd
FLUOCINOLONE ACETONIDE
FLUOCINOLONE ACETONIDE 0.11 mg in 1 mL
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 45802-009 -10). 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 By Padagis Yeruham, Israel Distributed By PadagisTM Allegan, MI 49010 • www.padagis.com Rev 07-22 0N300 RC J3
Abbreviated New Drug Application
FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE SOLUTION/ DROPS PADAGIS ISRAEL PHARMACEUTICALS LTD ---------- FLUOCINOLONE ACETONIDE OIL, 0.01% EAR DROPS For Otic Use Only- Not for Ophthalmic Use NDC 45802-009-10 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 the scalp. Chemically, fluocinolone acetonide is C H F O . It has the following structural formula: Fluocinolone acetonide in Fluocinolone Acetonide Oil, 0.01% Ear Drops 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 24 30 2 6 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 ex read_full_document