Nystatin Oral Suspension, USP 100,000 units per mL

Nystatin is obtained from Streptomyces noursei. It is known to be a mixture, but the composition has not been completely elucidated. Nystatin A is closely related to amphotericin B. Each is a macro-cyclic lactone containing a ketal ring, an all-trans polyene system, and a mycosamine (3-amino-3-deoxyrhamose) moiety.

Its structural formula is:

C₄₇H₇₅NO₁₇ M.W. 926.13

Nystatin oral suspension, USP is a cherry-mint flavored, ready-to-use suspension. Each mL of nystatin oral suspension, USP contains 100,000 units of nystatin in a vehicle containing 50% w/v sucrose with the following inactive ingredients: alcohol (less than 1% v/v), carboxymethylcellulose sodium, cherry flavor, citric acid, glycerin, peppermint flavor, purified water, and sodium citrate. Citric acid and/or sodium hydroxide may be used to adjust pH (5.3-7.5).

PRESERVATIVES ADDED: Methylparaben 0.12%, Propylparaben 0.03%

Nystatin acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin is absorbed very sparingly following oral administration, with no detectable blood levels when given in the recommended doses.

Nystatin oral suspension, USP is indicated for the treatment of infections of the oral cavity caused by Candida albicans.

Nystatin is contraindicated in patients with a history of hypersensitivity to nystatin or any of the suspension components.

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Gastrointestinal symptoms including diarrhea, gastrointestinal distress, nausea, vomiting and burning of the mouth have been reported. Hypersensitivity reactions including rash, pruritus, and anaphylactoid reaction have also been reported.

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

Infants: 2 mL (200,000 units) four times daily (1 mL in each side of mouth).

Pediatric patients and adults: 4 to 6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth).

NOTE: Limited clinical studies in neonates, including premature and low-birth weight neonates, indicate that 1 mL (100,000 units) four times daily is effective.

Local treatment should be continued at least 48 hours after perioral symptoms have disappeared and/or cultures returned to normal. It is recommended that the drug be retained in the mouth as long as possible before swallowing.

Nystatin Oral Suspension USP, 100,000 units per mL, is available as a yellow, milky, ready-to-use suspension with a cherry-mint flavor in the following sizes:

60 mL bottles (with child-resistant calibrated dropper)

473 mL bottles

A 2 mL calibrated dropper with 1 mL calibrations is provided with the 60 mL container.

SHAKE WELL BEFORE USING.

Storage: Store between 15°-30°C (59°-86°F). PROTECT FROM FREEZING.

Dispense in a tight, light resistant container when dispensing from the original container.

KEEP OUT OF REACH OF CHILDREN.

Manufactured by:

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev. 587:02 08/17

AKORN

NDC 50383-587-16

Nystatin Oral Suspension, USP

100,000 units per mL

Rx only

SHAKE WELL BEFORE USING

WARNING- NOT FOR INJECTION

473 mL