Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E), TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)
NuCare Pharmaceuticals,Inc.
TOPICAL
PRESCRIPTION DRUG
Nystatin and Triamcinolone Acetonide Cream is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment. This preparation is contraindicated in those patients with a history of hypersensitivity to any of its components.
Nystatin and Triamcinolone Acetonide Cream is supplied in 15 g (NDC 68071-2478-5) tubes. STORAGE: Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid freezing. Made in Israel Manufactured By Perrigo Yeruham, Israel Distributed By Perrigo® Allegan, MI 49010 • www.perrigo.com Rev 04-17 7M900 RC J1
Abbreviated New Drug Application
NYSTATIN AND TRIAMCINOLONE ACETONIDE- NYSTATIN, TRIAMCINOLONE ACETONIDE CREAM NUCARE PHARMACEUTICALS,INC. ---------- NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM, USP RX ONLY FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. DESCRIPTION: Nystatin and Triamcinolone Acetonide Cream for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. Structural formula: C H N0 MW = 926.13 Triamcinolone acetonide is designated chemically as 9-fluoro-11ß, 16ɑ, 17, 21- tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. Structural formula: 47 75 17 C H F0 MW = 434.50 Nystatin and Triamcinolone Acetonide Cream is a soft, smooth cream having a light yellow to buff color. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in a cream base with aluminum hydroxide, cetearyl alcohol and ceteareth 20, glyceryl monostearate, methylparaben, polyethylene glycol monostearate, polysorbate 60, propylene glycol, propylparaben, purified water, simethicone emulsion, sodium hydroxide, sorbic acid, sorbitol, titanium dioxide, and white petrolatum. CLINICAL PHARMACOLOGY: NYSTATIN: Nystatin exerts its antifungal activity against a variety of pathogenic and nonpathogenic yeasts and fungi by binding to sterols in the cell membrane. The binding process renders the cell membrane incapable of functioning as a selective barrier. Nystatin provides specific anticandidal activity to _Candida_ (Monilia) _albicans_ and other Candida species, but is not active against bacteria, protozoa, trichomonads, or viruses. Nystatin is not absorbed from intact skin or mucous membranes. TRIAMCINOLONE ACETONIDE: Triamcinolone acetonide is prima Przeczytaj cały dokument