Nystatin Oral Suspension USP [100,000 units per mL]

Rx Only

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

nystatin chemical structure

C ₄₇H ₇₅NO ₁₇     MW 926.13

Nystatin Oral Suspension USP, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), artificial peppermint flavor, cherry flavor, citric acid, D&C Yellow No. 10, FD&C Red No. 40, glycerin, magnesium aluminum silicate, methylparaben, potassium phosphate dibasic, propylene glycol, propylparaben, purified water and sucrose.

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

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

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 non-specific myalgia have also been rarely reported.

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).

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.

Nystatin Oral Suspension USP, 100,000 USP Nystatin Units per mL, is available in a cherry, peppermint flavored, light creamy yellow, ready-to-use suspension, supplied in the following oral dosage forms:

NDC 17856-0811-01 NYSTATIN 100,000 UNITS/ML 0.5ML ENFIT SYRINGE 120 ct UD 

NDC 17856-0811-02 NYSTATIN 100,000 UNITS/ML 1ML ENFIT SYRINGE 120 ct UD

NDC 17856-0811-03 NYSTATIN 100,000 UNITS/ML 2ML ENFIT SYRINGE 120 ct UD

NDC 17856-0811-04 NYSTATIN 100,000 UNITS/ML 5ML ENFIT SYRINGE 48 ct UD

NDC 17856-0811-05 NYSTATIN 100,000 UNITS/ML 5ML CUP 72 ct UD 

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP

20101 N.E 16TH PLACE 

MIAMI, FL 33179

NDC 17856-0811

NYSTATIN
ORAL
SUSPENSION, USP

[100,000 units per mL]

Alcohol ≤ 1% v/v SHAKE WELL

Rx ONLY

FOR INSTITUTIONAL USE ONLY

SEE INSERT

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