Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Nystatin Tablets USP, 500,000 Units are brown, film-coated tablets debossed "HP51" on one side and plain on the other side are packaged in: bottles of 30: NDC 71205-575-30 bottles of 60: NDC 71205-575-60 bottles of 90: NDC 71205-575-90 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 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Rev: 06/2020 logo; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Nystatin Tablets USP, 500,000 Units, 30 count bottles 500,000 Units, 30 ct 71205-575-30
- HOW SUPPLIED Nystatin Tablets USP, 500,000 Units are brown, film-coated tablets debossed "HP51" on one side and plain on the other side are packaged in: bottles of 30: NDC 71205-575-30 bottles of 60: NDC 71205-575-60 bottles of 90: NDC 71205-575-90 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 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Rev: 06/2020 logo
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Nystatin Tablets USP, 500,000 Units, 30 count bottles 500,000 Units, 30 ct 71205-575-30
Overview
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, hydroxypropyl cellulose, dibasic calcium phosphate, microcrystalline cellulose, talc, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, FD&C yellow #6, FD&C red #40, FD&C blue # 2 and polysorbate 80. Image
Indications & Usage
Nystatin Tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.
Dosage & 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.
Warnings & Precautions
No warnings available yet.
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 .
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