nystatin

INDICATIONS AND USAGE Nystatin tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.

DOSAGE AND ADMINISTRATION The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units nystatin) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.

CONTRAINDICATIONS Nystatin tablets are contraindicated in patients with a history of hypersensitivity to any of their components.

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 Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

DESCRIPTION Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei . Its structural formula: C 47 H 75 NO 17 M.W. 926.13 Nystatin tablets are for oral administration and contain 500,000 units of nystatin per tablet. Nystatin tablets contain the inactive ingredients: corn starch, confectioner sugar, dibasic calcium phosphate, FD&C yellow #6, FD&C red #40, FD&C blue # 2, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, polysorbate 80, talc and titanium dioxide. Image

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 ).

HOW SUPPLIED Nystatin Tablets USP, 500,000 Units are round brown, film-coated tablets debossed "HP51" on one side and plain on the other side are packaged in: Bottles of 120: NDC 68788-8690-1 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Manufactured by: Strides Pharma Science Limited Puducherry- 605 014, India. PON/DRUGS/16 13 4193 Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) 1041073 Rev: 06/2020 OR Manufactured by: Strides Alathur Private Limited Alathur, Chengalpattu – 603 110, Tamilnadu, India. M.L. No.: TN00002327 Manufactured for: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG(3784) 1049633 Revised: 01/2024 Repackaged By: Preferred Pharmaceuticals Inc. logo Avet logo