Label: NYSTATIN AND TRIAMCINOLONE ACETONIDE- nystatin and triamcinolone acetonide ointment

Nystatin and Triamcinolone Acetonide Ointment, USP for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide.

Nystatin, USP is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereallike odor, slightly soluble in methanol, and freely soluble in dimethylformamide, dimethyl sulfoxide, and practically insoluble in n-propyl alcohol, n-bulyl alcohol,water, alcohol, chloroform, ether.

Structural formula:

Triamcinolone acetonide, USP is designated chemically as 9-fluoro-11β,16a, 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 sparingly soluble in dehydrated alcohol, chloroform, and slightly soluble in methanol.

Structural formula:

Each gram of Nystatin and Triamcinolone Acetonide Ointment, USP provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an ointment base of mineral oil and white petrolatum.

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 primarily effective because of its anti-inflammatory, antipruritic and vasoconstrictive actions, characteristic of the topical corticosteroid class of drugs. The pharmacologic effects of the topical corticosteroids are well known; however, the mechanisms of their dermatologic actions are unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings (see DOSAGE AND ADMINISTRATION).
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (see DOSAGE AND
ADMINISTRATION ).

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are
then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Nystatin and Triamcinolone Acetonide
During clinical studies of mild to severe manifestations of cutaneous candidiasis, patients treated with nystatin and triamcinolone acetonide showed a faster and more pronounced clearing of erythema and pruritus than patients treated with nystatin or triamcinolone acetonide alone.

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.

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 non sensitizing 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.

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.

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 Avenue,
Suite 101A Durham, NC 27713 USA

Rev 00
June 2019

NDC 21922-031-04 Carton-15g
Nystatin and Triamcinolone Acetonide Ointment USP

FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.
Keep this and all medications out of the reach of children.

NDC 21922-031-05 Carton-30g
Nystatin and Triamcinolone Acetonide Ointment USP

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
Keep this and all medications out of the reach of children.

NDC 21922-031-07 Carton-60g
Nystatin and Triamcinolone Acetonide Ointment USP

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
Keep this and all medications out of the reach of children.