Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
fluticasone propionate (UNII: O2GMZ0LF5W) (fluticasone - UNII:CUT2W21N7U)
PharmaDerm a division of Fougera Pharmaceuticals Inc.
TOPICAL
PRESCRIPTION DRUG
CUTIVATE® Cream is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CUTIVATE® Cream may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of CUTIVATE® Cream in pediatric patients below 3 months of age have not been established. CUTIVATE® Cream is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.
CUTIVATE® (fluticasone propionate cream) Cream 0.05% is supplied in: Store between 2° and 30°C (36° and 86° F). PharmaDerm® A division of Fougera Pharmaceuticals Inc. Melville, NY 11747 US www.pharmaderm.com I8332E Rev. 06/12 #142
New Drug Application
CUTIVATE - FLUTICASONE PROPIONATE CREAM PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC. ---------- CUTIVATE (FLUTICASONE PROPIONATE CREAM) CREAM, 0.05% RX ONLY FOR DERMATOLOGIC USE ONLY—NOT FOR OPHTHALMIC USE. DESCRIPTION CUTIVATE (fluticasone propionate cream) Cream, 0.05% contains fluticasone propionate [(6α,11β,16α,17α)-6,9,-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene- 17-carbothioic acid, S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Chemically, fluticasone propionate is C H F O S. It has the following structural formula: Fluticasone propionate has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water. Each gram of CUTIVATE Cream contains fluticasone propionate 0.5 mg in a base of propylene glycol, mineral oil, cetostearyl alcohol, Ceteth-20, isopropyl myristate, dibasic sodium phosphate, citric acid, purified water, and imidurea as preservative. CLINICAL PHARMACOLOGY Like other topical corticosteroids, fluticasone propionate 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 . ® ® 25 31 3 5 ® 2 2 Fluticasone propionate is lipophilic and has a strong affinity for the glucocorticoid receptor. It has weak affinity for the progesterone receptor, and virtually no affinity for the mineralocorticoid, estrogen, or androgen receptors. The the Preberite celoten dokument