Nystatin

ADVERSE REACTIONS Nystatin is virtually non-toxic 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 Ointment is contraindicated in patients with a history of hypersensitivity to any of its components.

DESCRIPTION Nystatin Ointment USP, for topical use only, contains 100,000 USP Nystatin Units per gram, in a polyethylene and mineral oil base. The structural formula is as follows: Structural Formula

DOSAGE AND ADMINISTRATION Nystatin Ointment should be applied liberally to 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. This preparation does not stain skin or mucous membranes and provides a simple, convenient means of treatment.

INDICATIONS AND USAGE Nystatin Ointment 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 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 HIGH DENSITY POLYETHYLENE Mineral Oil

ANDA062124

Nystatin

nystatin

0168-0007

HUMAN PRESCRIPTION DRUG

TOPICAL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER NDC 0168-0007-15 FOUGERA ® NYSTATIN OINTMENT USP 100,000 USP Nystatin Units Per Gram For Topical Use Only. Not for Ophthalmic Use. Rx only CONTAINS: 100,000 USP Nystatin Units per gram, in a polyethylene and mineral oil base. NET WT 15 grams 15gtube

R x only

HOW SUPPLIED Nystatin Ointment (100,000 USP Nystatin Units per gram) is a yellow ointment available as follows: NDC 0168-0007-15 15 gram tube NDC 0168-0007-30 30 gram tube Store at controlled room temperature 15°- 30°C (59°-86°F). E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 I20715H R08/11 #21

PRECAUTIONS Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.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