Nystatin and Triamcinolone Acetonide

INDICATIONS AND USAGE Nystatin and Triamcinolone Acetonide Ointment, USP 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 A thin film of Nystatin and Triamcinolone Acetonide Ointment, USP 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, USP should not be used with occlusive dressings.

CONTRAINDICATIONS These preparations are contraindicated in those patients with a history of hypersensitivity to any of their components.

ADVERSE REACTIONS: A single case (approximately one percent of patients studied) of acneiform eruption occurred with use of combined nystatin and triamcinolone acetonide in clinical studies. Nystatin is virtually nontoxic and nonsensitizing and is well tolerated by all age groups, even during prolonged use. Rarely, irritation may occur. The following local adverse reactions are reported infrequently with topical corticosteroids (reactions are listed in an approximate decreasing order of occurrence): burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, perioral secondary infection, skin atrophy, striae and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS , General ); however, acute overdosage and serious adverse effects with dermatologic use are unlikely.

HOW SUPPLIED Nystatin and Triamcinolone Acetonide Ointment, USP is supplied in 15g (NDC 21922-031-04), 30g (NDC 21922-031-05) and 60g (NDC 21922-031-07) tubes. STORAGE Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid freezing. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-844-369-4671 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Rx only Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202, Durham, NC 27713, USA Rev 01 November 2022