Nystatin and Triamcinolone Ointment

Name: Nystatin and Triamcinolone Ointment

Nystatin and Triamcinolone Ointment Description

Nystatin and triamcinolone acetonide ointment, USP 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. It has a molecular formula of C47H75NO17 and a molecular weight of 926.13.

Triamcinolone acetonide is designated chemically as 9-fluoro-11β, 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. It has a molecular formula of C24H31FO6 and a molecular weight of 434.50.

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.

Nystatin and Triamcinolone Ointment - Clinical Pharmacology

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, anti-pruritic and

vasoconstrictive actions, characteristic of the topical corticosteroid class of drugs. The

pharmacological 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 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 pruritis than patients treated with nystatin or triamcinolone acetonide alone.

Indications and Usage for Nystatin and Triamcinolone Ointment

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.

Nystatin and Triamcinolone Ointment 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 ointment 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.

How Supplied

Nystatin and triamcinolone acetonide ointment, USP, a yellow ointment, is supplied as follows:

15 Gram Tube - NDC 61748-425-15

30 Gram Tube - NDC 61748-425-30

60 Gram Tube - NDC 61748-425-60

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid freezing.

Marketed by:

VersaPharm Inc. – An Akorn Company

Lake Forest, IL 60045

Manufactured by:

Halo Pharmaceutical

Mirabel, QC, J7J 1P3 Canada

NTO00N

Revised: 08/2016

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