Nystatin

Rebel Distributors Corp
PSS World Medical, Inc.

NYSTATIN OINTMENT USP

FULL PRESCRIBING INFORMATION: CONTENTS*

• NYSTATIN DESCRIPTION
• CLINICAL PHARMACOLOGY
• NYSTATIN INDICATIONS AND USAGE
• NYSTATIN CONTRAINDICATIONS
• PRECAUTIONS
• NYSTATIN ADVERSE REACTIONS
• NYSTATIN DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

R_x only

NYSTATIN 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:

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.

NYSTATIN 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.

NYSTATIN CONTRAINDICATIONS

Nystatin Ointment is contraindicated in patients with a history of hypersensitivity to any of its components.

PRECAUTIONS

Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.

This preparation is not for ophthalmic use.

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.

NYSTATIN 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.

HOW SUPPLIED

Nystatin Ointment (100,000 USP Nystatin Units per gram) is a yellow ointment available as follows:

NDC 42254-284-15 15 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

Repackaged by:
REBEL DISTRIBUTORS CORP.
Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL