Nystatin and triamcinolone acetonide

INDICATIONS AND USAGE Nystatin and triamcinolone acetonide cream, 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.

DOSAGE AND ADMINISTRATION 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.

CONTRAINDICATIONS This preparations is contraindicated in those patients with a history of hypersensitivity to any of their components.

Pregnancy: There are no teratogenic studies with combined nystatin and triamcinolone acetonide. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Therefore, any topical corticosteroid preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Topical preparations containing corticosteroids should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers It is not known whether any component of this preparation is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised during the use of this preparation by a nursing woman.

ADVERSE REACTIONS 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.