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Nystatin Oral Suspension

Last reviewed on RxList: 1/29/2016
Drug Description

Nystatin
(nystatin) Oral Suspension, USP

DESCRIPTION

Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula:

NYSTATIN ORAL SUSPENSION Structural Formula Illustration

Nystatin Oral Suspension is a cherry-mint flavored suspension for oral administration. It contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol ( ≤ 1% v/v), carboxymethylcellulose sodium, flavor, glycerin, methylparaben, propylparaben, purified water, saccharin sodium, sodium citrate, and sucrose (50% w/v). May also contain citric acid for pH adjustment.

For Consumers

What are the possible side effects of nystatin (Bio-Statin, Mycostatin, Mycostatin Pastilles, Nilstat)?

Stop taking nystatin and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Side effects are not likely to occur with nystatin. Continue to take nystatin and talk to your doctor if you experience

  • nausea or stomach upset,
  • vomiting, or
  • diarrhea.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially...

Indications & Dosage

INDICATIONS

Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.

DOSAGE AND ADMINISTRATION

Infants: 2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes). NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective.

Children and Adults: 4–6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). The preparation should be retained in the mouth as long as possible before swallowing.

Continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans.

HOW SUPPLIED

Nystatin Oral Suspension, USP, 100,000 USP Nystatin Units per mL, is available as a cherry-mint flavored, light creamy yellow, ready-to-use suspension in 60 mL bottles with calibrated dropper and 473 mL bottles.

Storage

Store at 20°-25°C (68°-77°F) with excursions permitted between 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]; avoid freezing.

Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811. Revised: Apr 2015

Side Effects & Drug Interactions

SIDE EFFECTS

Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported (See PRECAUTIONS: General).

Gastrointestinal

Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.

Dermatologic

Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.

Other

Tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been reported.

DRUG INTERACTIONS

No information provided.

Warnings & Precautions

WARNINGS

No information provided.

PRECAUTIONS

General

This medication is not to be used for the treatment of systemic mycoses.

Discontinue treatment if sensitization or irritation is reported during use.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.

Pregnancy

Teratogenic Effects - Category C

Animal reproduction studies have not been conducted with nystatin oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin oral suspension should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman.

Pediatric Use

See DOSAGE AND ADMINISTRATION.

Overdosage & Contraindications

OVERDOSE

Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset.

There have been no reports of serious toxic effects or superinfections (See CLINICAL PHARMACOLOGY: Pharmacokinetics ).

CONTRAINDICATIONS

The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.

Clinical Pharmacology

CLINICAL PHARMACOLOGY

Pharmacokinetics

Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur.

Microbiology

Nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. Candida albicans demonstrates no significant resistance to nystatin in vitro on repeated subculture in increasing levels of nystatin; other Candida species become quite resistant. Generally, resistance does not develop in vivo. Nystatin acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

Medication Guide

PATIENT INFORMATION

No information provided. Please refer to the PRECAUTIONS section.

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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