Nystatin (ointment)

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# Overview
Nystatin (ointment) is an antifungal,  polyene antibiotic that is FDA approved for the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other Candida species.   Common adverse reactions include irritation on topical application.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Nystatin Ointment is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other Candida species.

### Dosing Information
- 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.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Nystatin (ointment) in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Nystatin (ointment) in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Nystatin (ointment) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Nystatin (ointment) in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Nystatin (ointment) in pediatric patients.

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

# Warnings

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- Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.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

## Clinical Trials Experience
- 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.

## Postmarketing Experience
There is limited information regarding Nystatin (ointment) Postmarketing Experience in the drug label.

# Drug Interactions
There is limited information regarding Nystatin (ointment) Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): 
There is no FDA guidance on usage of Nystatin (ointment) in women who are pregnant.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nystatin (ointment) in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Nystatin (ointment) during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Nystatin (ointment) in women who are nursing.

### Pediatric Use
There is no FDA guidance on the use of Nystatin (ointment) in pediatric settings.

### Geriatic Use
There is no FDA guidance on the use of Nystatin (ointment) in geriatric settings.

### Gender
There is no FDA guidance on the use of Nystatin (ointment) with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Nystatin (ointment) with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Nystatin (ointment) in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Nystatin (ointment) in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Nystatin (ointment) in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Nystatin (ointment) in patients who are immunocompromised.

# Administration and Monitoring

### Administration
There is limited information regarding Nystatin (ointment) Administration in the drug label.

### Monitoring
There is limited information regarding Nystatin (ointment) Monitoring in the drug label.

# IV Compatibility
There is limited information regarding the compatibility of Nystatin (ointment) and IV administrations.

# Overdosage
There is limited information regarding Nystatin (ointment) overdosage.  If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

# Pharmacology

## Mechanism of Action
- 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.

## Structure
- 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:

## Pharmacodynamics

### 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 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.

## Pharmacokinetics
There is limited information regarding Nystatin (ointment) Pharmacokinetics in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nystatin (ointment) Nonclinical Toxicology in the drug label.

# Clinical Studies
There is limited information regarding Nystatin (ointment) Clinical Studies in the drug label.

# 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
E. FOUGERA & CO. 
A division of Fougera Pharmaceuticals Inc.
Melville, New York 11747
I20715H
R08/11

## Storage
- Store at controlled room temperature 15- 30C (59-86F).

# Images

## Drug Images

## Package and Label Display Panel
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
NDC 0168-0007-15
FOUGERA    Rx only
NYSTATIN OINTMENT USP
100,000 USP Nystatin Units Per Gram
WARNING: Keep this and all
drugs out of reach of children.
For Topical Use Only.
Not for Ophthalmic Use.
NET WT 15 grams

# Patient Counseling Information
There is limited information regarding Nystatin (ointment) Patient Counseling Information in the drug label.

# Precautions with Alcohol
Alcohol-Nystatin (ointment) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
There is limited information regarding Nystatin (ointment) Brand Names in the drug label.

# Look-Alike Drug Names
There is limited information regarding Nystatin (ointment) Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price