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.
These preparations are contraindicated in those patients with a history of hypersensitivity to any of their components.
These preparations are contraindicated in those patients with a history of hypersensitivity to any of their components.
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.
Nystatin and triamcinolone acetonide cream is usually applied to the affected areas twice daily in the morning and evening by gently and thoroughly massaging the preparation into the skin. The cream should be discontinued if symptoms persist after 25 days of therapy (see PRECAUTIONS, Laboratory Tests ). Nystatin and triamcinolone acetonide cream should not be used with occlusive dressings.
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1053753 | nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Cream | PSN | 3 |
| 1053753 | nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream | SCD | 3 |
| 1053753 | nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream | SY | 3 |
| Class | Version | Type | Effective |
|---|---|---|---|
| NYSTATIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| TRIAMCINOLONE ACETONIDE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68462-314-17 | Nystatin and Triamcinolone Acetonide | 15 g in 1 TUBE | CREAM | 15 | 3 | |
| 68462-314-17 | Nystatin and Triamcinolone Acetonide | 1 in 1 CARTON | CREAM | 1 | 3 | |
| 68462-314-35 | Nystatin and Triamcinolone Acetonide | 1 in 1 CARTON | CREAM | 1 | 3 | |
| 68462-314-35 | Nystatin and Triamcinolone Acetonide | 30 g in 1 TUBE | CREAM | 30 | 3 | |
| 68462-314-65 | Nystatin and Triamcinolone Acetonide | 1 in 1 CARTON | CREAM | 1 | 3 | |
| 68462-314-65 | Nystatin and Triamcinolone Acetonide | 60 g in 1 TUBE | CREAM | 60 | 3 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68462-314-17 | GM - Gram | 68462-314 | d7795ff9-5301-4059-ad65-82348b434e73 | 1 | 2016-11-08 |
| 68462-314-35 | GM - Gram | 68462-314 | a796ac99-e8db-4cf1-9242-fde30f8d8cd2 | 1 | 2016-11-08 |
| 68462-314-65 | GM - Gram | 68462-314 | a6cb7f24-e128-4b63-bd2d-db2a367df6cd | 1 | 2016-11-08 |
| Product NDC | Package NDC |
|---|---|
| 68462-314 | 68462-314-17, 68462-314-35, 68462-314-65 |
| Name | UNII | Kind |
|---|---|---|
| Nystatin | BDF1O1C72E | ACTIB |
| Triamcinolone Acetonide | F446C597KA | ACTIB |
| ALUMINUM HYDROXIDE | 5QB0T2IUN0 | IACT |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POLYOXYL 20 CETOSTEARYL ETHER | YRC528SWUY | IACT |
| POLYSORBATE 60 | CAL22UVI4M | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
Nystatin and Triamcinolone Acetonide Cream, 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, hygroscopic powder, having a bitter taste and an odor suggestive of cereals. It is freely soluble in dimethylformamide and dimethyl sulfoxide; slightly to sparingly soluble in methanol, n-propyl alcohol, and n-butyl alcohol; practically insoluble in water and alcohol; insoluble in chloroform and 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 Nystatin and Triamcinolone Acetonide Cream, USP is a soft, smooth yellow color cream. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide, USP in a cream base with dried aluminum hydroxide gel, glyceryl monostearate, methylparaben, polyethylene glycol 400 monostearate, polyoxyl 20 cetostearyl ether, polysorbate-60, propylene glycol, propylparaben, purified water, simethicone emulsion, sorbic acid, sorbitol, titanium dioxide, and white petrolatum.
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.
These preparations are contraindicated in those patients with a history of hypersensitivity to any of their components.
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.
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.
Nystatin and triamcinolone acetonide cream is usually applied to the affected areas twice daily in the morning and evening by gently and thoroughly massaging the preparation into the skin. The cream should be discontinued if symptoms persist after 25 days of therapy (see PRECAUTIONS, Laboratory Tests ). Nystatin and triamcinolone acetonide cream should not be used with occlusive dressings.
Nystatin and Triamcinolone Acetonide Cream, USP is supplied as follows: NDC 68462-314-17 15g tube (1 tube per carton) NDC 68462-314-35 30g tube (1 tube per carton) NDC 68462-314-65 60g tube (1 tube per carton)
Manufactured by: Glenmark Pharmaceuticals Limited Baddi, Himachal Pradesh 173205, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com January 2021