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NYSTATIN and TRIAMCINOLONE ACETONIDE CREAM USP

Rx ONLY

FOR DERMATOLOGIC USE ONLY

NOT FOR OPHTHALMIC USE

DESCRIPTION

Nystatin and triamcinolone acetonide cream 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 (CAS Registry Number 1400-61-9).

Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11β,16α)-. 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 (CAS Registry Number 76-25-5).

Each gram of nystatin and triamcinolone acetonide cream USP contains 100,000 USP Nystatin Units and 1 mg of triamcinolone acetonide in a cream base containing polyoxyethylene fatty alcohol ether, white petrolatum, glyceryl monostearate, polyethylene glycol 400 monostearate, sorbitol solution, si-methicone emulsion, propylene glycol, aluminum hydroxide gel, polysorbate 60, titanium dioxide, and purified water with benzyl alcohol as a preservative. Hydrochloric acid or sodium hydroxide to adjust pH.

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 it 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.

NYSTATIN and TRIAMCINOLONE ACETONIDE

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

INDICATIONS AND USAGE

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.

CONTRAINDICATIONS

This preparation is contraindicated in those patients with a history of hypersensitivity to any of its components.

PRECAUTIONS

ADVERSE REACTIONS

A single case (approximately one percent of patients studied) of acneiform eruption occured with the 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. These reactions are uled in the approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

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.

DOSAGE AND ADMINISTRATION

Nystatin and triamcinolone acetonide cream is usually applied to the affected areas twice daily in the morning and the 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.

HOW SUPPLIED

Nystatin and triamcinolone acetonide cream USP, a yellow to tan cream supplied in:

15 gram tubeNDC 0168-0081-15
30 gram tubeNDC 0168-0081-30
60 gram tubeNDC 0168-0081-60

Store at controlled room temperature 15°-30°C (59°-86°F). Avoid freezing.

E. FOUGERA & CO.
a division of Altana Inc.
MELVILLE, NEW YORK 11747
www.fougera.com

Nystatin and Triamcinolone Acetonide Cream

I28115F
R2/00
#176

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