ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. 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 rarely reported.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

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-Pregnancy 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 pregnant woman or can affect reproduction capacity. Nystatin oral suspension should be given to pregnant woman only if clearly needed.

CLINICAL PHARMACOLOGY SECTION.

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 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 resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

CONTRAINDICATIONS SECTION.

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

DESCRIPTION SECTION.

DESCRIPTION. Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. The structural formula is: Molecular Formula: C47 H75 NO17 Molecular Weight: 926.13Nystatin Oral Suspension, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol USP (not more than 1% by volume), mint blend flavoring, dibasic sodium phosphate USP, glycerin USP, purified water USP, colloidal silicon dioxide, sucrose NF (50%), methylparaben NF (0.12%) and propylparaben NF (0.03%) as preservatives.. Structural Formula.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. INFANTS: mL (approximately 1/2 teaspoon)(200,000 units) four times daily mL (approximately 1/4/ teaspoon) (one-half of dose) in each side of mouth and avoid feeding for to 10 minutes.NOTE: Limited clinical studies in premature and low birth weight infants indicate that mL four times daily is effective.. CHILDREN AND ADULTS: - mL (approximately teaspoon)(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.

GENERAL PRECAUTIONS SECTION.

General:. This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Nystatin Oral Suspension, USP (100,000 USP Nystatin Units per mL) is available as mint-flavored, light yellow, ready-to-use suspension in the following sizes:NDC 0168-0037-60 60 mL bottle (with calibrated dosing cup)NDC 0168-0037-61 60 mL bottle (with calibrated dropper)NDC 0168-0037-74 Pint bottleShake well before using. Wash cup before and after each use.Before dispensing, replace cap with safety cap dropper.Store at 20-25C (68-77F); excursions permitted between 15-30C (59-86F)[see USP Controlled Room Temperature].WARNING: Keep out of reach of children.This product sealed for your protection. If the seal is missing or broken return to place of purchase.E. FOUGERA CO.A division of Nycomed US Inc.Melville, New York 11747I237C/IF237ER11/07276.

INDICATIONS & USAGE SECTION.

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

MICROBIOLOGY SECTION.

Microbiology:. Nystatin is both fungistatic and fungicidal in vitro against 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 resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

NURSING MOTHERS SECTION.

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 nursing woman.

OVERDOSAGE SECTION.

OVERDOSAGE. 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).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE LABEL PRINCIPAL DISPLAY PANEL 60ML CONTAINER. NDC 0168-0037-60FOUGERA(R) NYSTATIN ORALSUSPENSION USP100,000 USP Nystatin Units per mLRx only60mL. PACKAGE LABEL PRINCIPAL DISPLAY PANEL 60ML CONTAINER.

PHARMACOKINETICS SECTION.

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.

PRECAUTIONS SECTION.

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-Pregnancy 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 pregnant woman or can affect reproduction capacity. Nystatin oral suspension should be given to 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 nursing woman.. Pediatric Use:. See DOSAGE AND ADMINISTRATION.

TERATOGENIC EFFECTS SECTION.

Pregnancy: Teratogenic Effects-Pregnancy 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 pregnant woman or can affect reproduction capacity. Nystatin oral suspension should be given to pregnant woman only if clearly needed.