Nystatin

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

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. To report SUSPECTED ADVERSE REACTIONS, contact VistaPharm, LLC, at 1-888-655-1505 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

DESCRIPTION Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei . Structural formula: Nystatin Oral Suspension, USP, for oral administration, contains 100,000 Nystatin Units per mL. Inactive ingredients (cherry flavor): alcohol (­ 1% v/v), methylparaben, NF; dibasic sodium phosphate, USP; monobasic sodium phosphate, USP; saccharin sodium, USP; sucrose (50% w/v), NF; glycerin, USP; carboxy-methylcellulose sodium, USP; propylparaben, NF; artificial wild cherry flavor # 14783 and purified water, USP. Inactive ingredients (bubblegum flavor): Alcohol (0.5% v/v), USP, Alcohol free Bubblegum Flavoring, Carboxymethylcellulose Sodium, USP, Dibasic Sodium Phosphate, USP, Glycerin Natural 99.5%, USP, Methylparaben, NF, (Preservative), Monobasic Sodium Phosphate, USP, Propylparaben, NF, (Preservative), Purified Water, USP, Saccharin Sodium, USP, and Sucrose, NF. Nystatin Structure

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 to 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 .

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 of superinfections (see CLINICAL PHARMACOLOGY: Pharmacokinetics ).

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.

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.

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Nystatin Nystatin NYSTATIN NYSTATIN METHYLPARABEN SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE GLYCERIN SACCHARIN SODIUM SUCROSE CARBOXYMETHYLCELLULOSE SODIUM ALCOHOL PROPYLPARABEN Light yellow Nystatin Nystatin NYSTATIN NYSTATIN ALCOHOL CARBOXYMETHYLCELLULOSE SODIUM SODIUM PHOSPHATE, DIBASIC GLYCERIN METHYLPARABEN SODIUM PHOSPHATE, MONOBASIC PROPYLPARABEN WATER SACCHARIN SODIUM SUCROSE Light yellow

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.

ANDA064142

Nystatin

Nystatin

66689-008

HUMAN PRESCRIPTION DRUG

ORAL

PRINCIPAL DISPLAY PANEL - Unit Dose Cup Nystatin Oral Suspension, USP 500,000 units/5 mL Alcohol not more than 1% v/v SHAKE WELL. AVOID FREEZING. Delivers 5 mL Store at 20°–25°C (68°–77°F); see USP CRT conditions. Manufactured by: Largo, FL 33771, USA Xact DOSE™ VistaPharm Rx Only VP2052R2 06/18 NDC 66689-037-01 lidding

Rx Only Manufactured by: Parsippany, NJ 07054 VP2053R3 07/24 Logo

Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. AVOID FREEZING.

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 .

Pregnancy: Teratogenic Effects 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.

HOW SUPPLIED Nystatin Oral Suspension, USP, 100,000 Nystatin Units per mL, cherry flavored, light creamy yellow, ready-to-use suspension, is available as follows: NDC 66689-037-01: 5 mL unit dose cup. NDC 66689-037-50: Case contains 50 unit dose cups of 5 mL (NDC 66689-037-01), packaged in 5 trays of 10 unit dose cups each. NDC 66689-037-99: Case contains 100 unit dose cups of 5 mL (NDC 66689-037-01), packaged in 10 trays of 10 unit dose cups each. Nystatin Oral Suspension, USP, 100,000 Nystatin units per mL, bubblegum flavored, yellow opaque, ready-to-use suspension is available as follows: NDC 66689-008-02: 2 fl. oz. bottle (60 mL): supplied in individual carton with calibrated dropper. NDC 66689-008-08: 8 fl. oz. bottle (237 mL). NDC 66689-008-16: 16 fl. oz. bottle (480 mL).

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

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 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 .