Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
FLURANDRENOLIDE (UNII: 8EUL29XUQT) (FLURANDRENOLIDE - UNII:8EUL29XUQT)
Almirall, LLC
FLURANDRENOLIDE
FLURANDRENOLIDE 0.5 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Cordran® (flurandrenolide, USP) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of these preparations.
Cordran® Cream is supplied in aluminum tubes as follows: Cordran® Cream, 0.025%: 120 g (NDC 16110-034-12) Cordran® Cream, 0.05%: 120 g (NDC 16110-035-12) Cordran® Ointment is supplied in aluminum tube as follows: Cordran® Ointment, 0.05%: 60 g (NDC 16110-026-60) 120 g (NDC 16110-026-12) Keep out of reach of children. Storage Keep tightly closed. Protect from light. Store at 20° to 25°C (68° to 77°F) with excursions permitted to 15° to 30°C (59° to 86°F) [See USP controlled room temperature.].
New Drug Application
CORDRAN- FLURANDRENOLIDE CREAM CORDRAN- FLURANDRENOLIDE OINTMENT ALMIRALL, LLC ---------- CORDRAN CREAM AND CORDRAN OINTMENT FLURANDRENOLIDE, USP DESCRIPTION Cordran (flurandrenolide, USP) is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One gram of flurandrenolide dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52. The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21- dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is C H FO . The structure is as follows: Each gram of Cordran Cream (flurandrenolide Cream, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in an emulsified base composed of cetyl alcohol, citric acid, mineral oil, polyoxyl 40 stearate, propylene glycol, sodium citrate, stearic acid, and purified water. Each gram of Cordran Ointment (flurandrenolide Ointment, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in a base composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white petrolatum. CLINICAL PHARMACOLOGY Cordran is primarily effective because of its anti-inflammatory, antipruritic, and vasoconstrictive actions. ® ® ® 24 33 6 ® ® The mechanism of the anti-inflammatory effect of topical corticosteroids is not completely understood. Corticosteroids with anti-inflammatory activity may stabilize cellular and lysosomal membranes. There is also the suggestion that the effect on the membranes of lysosomes prevents the release of proteolytic enzymes and, thus, plays a part in reducing inflammation. _Pharmacokinetics_— The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticost Aqra d-dokument sħiħ