Nystatin (oral)

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# Overview
Nystatin (oral) is an antifungal agent that is FDA approved for the treatment of candidal vulvovaginitis, candidiasis of skin, cutaneous and mucocutaneous infections, gastrointestinal candidiasis(non-esophageal), oropharyngeal candidiasis.   Common adverse reactions include skin irritation, hypersensitivity reaction.

# 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.
- Dosing Information
- 1 tablet (100,000 units) INTRAVAGINALLY daily for 2 weeks.
- Dosing Information
- ointment or cream, apply liberally to affected areas TOPICALLY twice daily until healing complete.
- powder, apply to candidal lesions TOPICALLY 2 to 3 times daily until healing complete; for fungal infections of the feet, footwear should be dusted as well.
- Dosing Information
- Tablet, 1 to 2 tablets (500,000 to 1,000,000 units) ORALLY 3 times per day; continue treatment for at least 48 hr after clinical cure
- Dosing Information
- Oral suspension, 4 to 6 mL (400,000 to 600,000 units) ORALLY (retained in mouth as long as possible prior to swallowing) 4 times daily; continue treatment for at least 48 hr after perioral symptoms disappear
- (HIV patients, duration): treat for 7 to 14 days (guideline dosing).

## Off-Label Use and Dosage (Adult)

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

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

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
- Dosing Information
- Ointment or cream, apply liberally to affected areas TOPICALLY twice daily until healing complete.
- Powder, apply to candidal lesions TOPICALLY 2 to 3 times daily until healing complete; for fungal infections of the feet, footwear should be dusted as well.
- Oral suspension, infants; 2 mL (200,000 units) ORALLY 4 times/day; continue treatment for at least 48 hr after perioral symptoms disappear.
- Oral suspension, children; 4 to 6 mL (400,000 to 600,000 units) ORALLY (retained in mouth as long as possible prior to swallowing) 4 times daily; continue treatment for at least 48 hr after perioral symptoms disappear.
- (HIV patients, duration) treat for 7 to 14 days (guideline dosing).

## Off-Label Use and Dosage (Pediatric)

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

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

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

# Warnings

### Precautions
- General -
- Nystatin Cream USP should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections.
- If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.
Information for Patients
- Patients using this medication should receive the following information and instructions:
- The patient should be instructed to use this medication as directed (including the replacement of missed doses). This medication is not for any disorder other than that for which it is prescribed.
- Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed.
- If symptoms of irritation develop, the patient should be advised to notify the physician promptly.
- Laboratory Tests -
- If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated.

# Adverse Reactions

## Clinical Trials Experience
- The frequency of adverse events reported in patients using Nystatin Cream USP is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application (see PRECAUTIONS-General).

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

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

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): C
- Pregnancy Category C
Teratogenic Effects:
Category C -
- Animal reproduction studies have not been conducted with any Nystatin topical preparation. It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin topical preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
- There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nystatin (oral) in women who are pregnant.

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

### Nursing Mothers
- It is not known whether Nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.

### Pediatric Use
- Safety and effectiveness have been established in the pediatric population from birth to 16 years.

### Geriatic Use
- Clinical studies with nystatin cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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

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

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

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

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

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

# Administration and Monitoring

### Administration
- Very moist lesions are best treated with nystatin topical dusting powder.
Adults and Pediatric Patients (Neonates and Older):
- Apply liberally to affected areas twice daily or as indicated until healing is complete.

### Monitoring
- There is limited information regarding Monitoring of Nystatin (oral) in the drug label.
- Description

# IV Compatibility
- There is limited information regarding IV Compatibility of Nystatin (oral) in the drug label.

# Overdosage
- There is limited information regarding Chronic Overdose of Nystatin (oral) 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 (oral) 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
Carcinogenesis, Mutagenesis, Impairment of Fertility
- No long-term animal studies have been performed to evaluate the carcinogenic potential of Nystatin. No studies have been performed to determine the mutagenicity of Nystatin or its effects on male or female fertility.

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

# How Supplied
- Nystatin Cream USP (100,000 USP Nystatin Units per gram) is a yellow cream available as follows:
- 15 g tube (NDC 45802-059-35)
- 30 g tube (NDC 45802-059-11)

## Storage
- Store at 20-25C (68-77F) .

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
Information for Patients
- Patients using this medication should receive the following information and instructions:
- The patient should be instructed to use this medication as directed (including the replacement of missed doses). This medication is not for any disorder other than that for which it is prescribed.
- Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed.
- If symptoms of irritation develop, the patient should be advised to notify the physician promptly.

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

# Brand Names
Bio-Statin,
Mycostatin,
Nystop,
Pedi-Dri.

# Look-Alike Drug Names
- A  B

# Drug Shortage Status

# Price