RVP

Drug Catalog - Product Detail

NYSTATIN W/TRIAMCINOLONE OINTMENT OINT 100MU/GM 30GM

NDC Mfr Size Str Form
68462-0799-35 GLENMARK PHARMACEUTICALS 30 100000-0.1UNIT/GM-% OINTMENT
Product Image

PACKAGE FILES

Package Image
Package Image
Package Image
Package Image
Generic Name
NYSTATIN AND TRIAMCINOLONE ACETONIDE
Substance Name
NYSTATIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA208300
Description
DESCRIPTION Nystatin and Triamcinolone Acetonide Ointment USP for dermatologic use contains the antifungal agent nystatin, USP and the synthetic corticosteroid triamcinolone acetonide, USP. Nystatin, USP is a polyene antimycotic obtained from Streptomyces noursei . It is a yellow to light tan powder, having an odor suggestive of cereals. Is hygroscopic, and is affected by long exposure to light, heat, and air. It freely soluble in dimethylformamide and in dimethyl sulfoxide, slightly to sparingly soluble in methanol, in n-propyl alcohol, and in n-butyl alcohol, practically insoluble in water and in alcohol; insoluble in chloroform and in ether. Structural formula: C 47 H 75 NO 17 MW = 926.11 g/mol Triamcinolone acetonide, USP is designated chemically as Pregna-1, 4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11β,16α)-9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16, 17-acetal with acetone. The white to cream colored, crystalline powder, having not more than a slight odor, is practically insoluble in water, sparingly soluble in dehydrated alcohol, in chloroform and in methanol. Structural formula: C 24 H 31 FO 6 MW = 434.50 g/mol Each gram of Nystatin and Triamcinolone Acetonide Ointment provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide, USP in an ointment base of mineral oil and white petrolatum. nystatin-image triamcinolone-structure
How Supplied
HOW SUPPLIED Nystatin and Triamcinolone Acetonide Ointment, USP is supplied as follows: NDC 68462-799-17 15g tube (1 tube per carton) NDC 68462-799-35 30g tube (1 tube per carton) NDC 68462-799-65 60g tube (1 tube per carton) STORAGE Store at 20°C to 25°C (68°F to 77°F); [see USP Controlled Room Temperature]. Do not refrigerate and avoid freezing.
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.