Nystatin Ointment

Dosage Form: ointment
Nystatin Ointment USP

For Dermatologic Use Only

Not For Ophthalmic Use

Rx Only

Nystatin Ointment Description

Nystatin Ointment USP for topical use only, contains 100,000 USP Nystatin units per gram, in an ointment base of light mineral oil and white petrolatum. The structural formula is as follows:

Molecular Weight 926.13

Molecular Formula C47H75NO17

Nystatin Ointment - 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 Ointment USP 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.

Indications and Usage for Nystatin Ointment

Nystatin Ointment USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia]albicans and other Candida species.

Contraindications

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Should a reaction of hypersensitivity occur, the drug should be immediately withdrawn and appropriate measures taken.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

Adverse Reactions

Nystatin Ointment USP 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 Ointment Dosage and Administration

Nystatin Ointment USP 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 is Nystatin Ointment Supplied

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

15 g tube (NDC 45802-048-35)

30 g tube (NDC 45802-048-11)

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

MANUFACTURED BY

PERRIGO

BRONX, NY 10457

DISTRIBUTED BY

PERRIGO®

ALLEGAN, MI 49010

Rev. 08/09

2K800RCJ3

Principal Display Panel - 15 g Carton

Nystatin Ointment USP

(100,000 USP Nystatin Units)

Rx Only

Nystatin Ointment USP Carton

Principal Display Panel - 15 g Tube

Nystatin Ointment USP

(100,000 USP Nystatin Units)

Rx Only

Nystatin Ointment USP Tube

NYSTATIN  nystatin  ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 45802-048 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NYSTATIN (NYSTATIN) NYSTATIN 100000 [USP'U]  in 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 45802-048-35 1 TUBE In 1 CARTON contains a TUBE 1 15 g In 1 TUBE This package is contained within the CARTON (45802-048-35) 2 45802-048-11 1 TUBE In 1 CARTON contains a TUBE 2 30 g In 1 TUBE This package is contained within the CARTON (45802-048-11)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA062472	09/15/2006

Labeler - Perrigo New York Inc (078846912)

Revised: 04/2010Perrigo New York Inc

More Nystatin Ointment resources

• Nystatin Ointment Use in Pregnancy & Breastfeeding
• Nystatin Ointment Support Group
• 6 Reviews for Nystatin - Add your own review/rating

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