Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
FLURANDRENOLIDE (UNII: 8EUL29XUQT) (FLURANDRENOLIDE - UNII:8EUL29XUQT)
Almirall, LLC
FLURANDRENOLIDE
FLURANDRENOLIDE 0.5 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
Cordran Lotion is indicated for the relief of the inflammatory and pruritic manifestations of cortico-steroid-responsive dermatoses. Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of these preparations.
Cordran® Lotion, 0.05% is supplied in plastic squeeze bottles as follows: 15 mL (NDC 16110-052-15) 60 mL (NDC 16110-052-60) 120 mL (NDC 16110-052-12) Keep out of reach of children. Storage: Avoid freezing. 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] Rx Only Revised: July 2016 ALMIRALL, LLC Manufactured by DPT Laboratories, San Antonio, TX 78215 For Almirall LLC, 101 Lindenwood Drive, Suite 400, Malvern, PA 19355
New Drug Application
CORDRAN- FLURANDRENOLIDE LOTION ALMIRALL, LLC ---------- CORDRAN® LOTION, 0.05% FLURANDRENOLIDE LOTION, 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 g 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 mL of Cordran Lotion contains 0.5 mg (1.145 µmol) (0.05%) flurandrenolide in an oil-in-water emulsion base composed of glycerin, cetyl alcohol, stearic acid, glyceryl monostearate, mineral oil, polyoxyl 40 stearate, menthol, benzyl alcohol, and purified water. CLINICAL PHARMACOLOGY Cordran is primarily effective because of its anti-inflammatory, antipruritic, and vasoconstrictive actions. The mechanism of the anti-inflammatory effect of topical corticosteroids is not completely understood. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. 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. ® 24 33 6 Evaporation of water from the lotion vehicle produces a cooling effect, which is often desirable in the treatment of acutely inflamed or weeping lesions. _Pharmacokinetics_—The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including t Les hele dokumentet