Nystatin

ADVERSE REACTIONS Nystatin is virtually nontoxic and nonsensitizing and is well tolerated by all age groups including debilitated infants, even on prolonged administration. If irritation on topical application should occur, discontinue medication.

CONTRAINDICATIONS Nystatin Cream USP is contraindicated in patients with a history of hypersensitivity to any of its components.

DESCRIPTION EACH GRAM OF NYSTATIN CREAM USP CONTAINS: 100,000 units in an aqueous cream base of aluminum hydroxide gel, cetearyl alcohol (and) ceteareth-20, citric acid, glyceryl stearate, methylparaben, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, sodium citrate, sorbic acid, sorbitol solution, titanium dioxide and white petrolatum.

DOSAGE AND ADMINISTRATION Nystatin Cream USP should be applied liberally to the affected areas twice a day or as indicated until healing is complete. Nystatin cream is usually preferred to nystatin ointment in candidiasis involving intertriginous areas; very moist lesions however are best treated with nystatin topical powder. The cream does not stain the skin or mucous membranes and it provides a simple, convenient means of treatment.

INDICATIONS AND USAGE Nystatin Cream USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida (Monilia) albicans and other Candida species.

CLINICAL PHARMACOLOGY Nystatin is an antifungal antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. It probably acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin is a polyene antibiotic of undetermined structural formula that is obtained from Streptomyces noursei , and is the first well tolerated antifungal antibiotic of dependable efficacy for the treatment of cutaneous, oral and intestinal infections caused by Candida (Monilia) albicans and other Candida species. It exhibits no appreciable activity against bacteria. Nystatin provides specific therapy for all localized forms of candidiasis. Symptomatic relief is rapid, often occurring within 24 to 72 hours after the initiation of treatment. Cure is effected both clinically and mycologically in most cases of localized candidiasis.

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Nystatin Nystatin NYSTATIN NYSTATIN ALUMINUM HYDROXIDE CETOSTEARYL ALCOHOL CITRIC ACID MONOHYDRATE GLYCERYL MONOSTEARATE POLYOXYL 40 STEARATE PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SORBIC ACID SORBITOL TITANIUM DIOXIDE PETROLATUM METHYLPARABEN

ANDA062949

Nystatin

Nystatin

63187-422

HUMAN PRESCRIPTION DRUG

TOPICAL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 63187-422-15

(100,000 units/g) Rx Only

HOW SUPPLIED Nystatin Cream USP 100,000 units/g 15 g tube (0 . 53 oz) Store at controlled room temperature 15°-30°C (59°-86°F). Avoid exposure to excessive heat, 40°C (104°F). Manufactured by: Actavis Mid Atlantic LLC 1877 Kawai Road Lincolnton, NC 28092 USA FORM NO. 0163 Rev. 1/06 VC2751 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

PRECAUTIONS Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken. This preparation is not for ophthalmic use.