RVP

Drug Catalog - Product Detail

NYSTATIN W/TRIAMCINOLONE 100MU/GM OINT 30GM

NDC Mfr Size Str Form
45802-0244-94 PADAGIS 30 100000-0.1UNIT/GM-% OINTMENT
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PACKAGE FILES

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Generic Name
NYSTATIN AND TRIAMCINOLONE ACETONIDE
Substance Name
NYSTATIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA207380
Description
DESCRIPTION: Nystatin and Triamcinolone Acetonide Ointment 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: Triamcinolone acetonide is designated chemically as 9-fluoro-11ß, 16α, 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: Each gram of Nystatin and Triamcinolone Acetonide Ointment provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an ointment base of mineral oil and white petrolatum. chemical structure image 1 chemical structure image 2
How Supplied
HOW SUPPLIED: Nystatin and Triamcinolone Acetonide Ointment is supplied in 15 g, 30 g, and 60 g tubes. STORAGE: Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid freezing. Manufactured by Padagis ® Yeruham, Israel www.padagis.com Rev 03-23 5Y400 RC PH2
Indications & Usage
INDICATIONS AND USAGE: Nystatin and Triamcinolone Acetonide Ointment 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION: A thin film of Nystatin and Triamcinolone Acetonide Ointment is usually applied to the affected areas twice daily in the morning and evening. The preparation should be discontinued if symptoms persist after 25 days of therapy (see PRECAUTIONS , Laboratory Tests). Nystatin and Triamcinolone Acetonide Ointment should not be used with occlusive dressings.