Nystatin And Triamcinolone Acetonide
Nystatin And Triamcinolone Acetonide Prescribing Information
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.
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
Nystatin and triamcinolone acetonide cream should not be used with occlusive dressings.
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.
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
Structural formula:
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:
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 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
Nystatin is not absorbed from intact skin or mucous membranes.