Nystatin

Nystatin
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Black Box Warning

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

Overview

Nystatin is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Nystatin Cream USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.

Nystatin Cream USP is not indicated for systemic, oral, intravaginal or ophthalmic use.

Candidal vulvovaginitis

• Dosing Information

• Dosage

Candidiasis of skin, Cutaneous and mucocutaneous infections

• Dosing Information

• Dosage

Gastrointestinal candidiasis, Non-esophageal

• Dosing Information

• Dosage

Oropharyngeal candidiasis

• Dosing Information

• Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Nystatin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Candidiasis of skin, Cutaneous and mucocutaneous infections

• Dosing Information

• Dosage

Oropharyngeal candidiasis

There is limited information regarding FDA-Labeled Use of Nystatin in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Nystatin in pediatric patients.

Contraindications

• Condition1

Warnings

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Nystatin in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Nystatin in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nystatin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Nystatin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Nystatin with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Nystatin with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Nystatin with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Nystatin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Nystatin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Nystatin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Nystatin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Nystatin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Nystatin in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Nystatin in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Nystatin in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Nystatin in the drug label.

Pharmacology

Mechanism of Action

Structure

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula is C47H75NO17, and the molecular weight is 926.13.

Structural formula:

Nystatin Cream USP is for dermatologic use.

Nystatin Cream USP for topical use, contains 100,000 USP nystatin units per gram. Inactive ingredients: emulsifying wax, glycerin, isopropyl myristate, lactic acid, purified water, sodium hydroxide, and sorbic acid.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Nystatin in the drug label.

Pharmacokinetics

Nystatin Cream USP is not absorbed from intact skin or mucous membrane.

Microbiology

Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsisglabrata, Tricophytonrubrum, T. mentagrophytes.

Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components. On repeated subculturing with increasing levels of nystatin, Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of Candida (C. tropicalis, C. guilliermondi, C. krusei, and C. stellatoides) become quite resistant on treatment with nystatin and simultaneously become cross resistant to amphotericin as well. This resistance is lost when the antibiotic is removed.

Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Nystatin in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Nystatin in the drug label.

How Supplied

Storage

There is limited information regarding Nystatin Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Nystatin in the drug label.

Precautions with Alcohol

• Alcohol-Nystatin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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