Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Nystatin Tablets USP, 500,000 Units are round, convex, brown, film-coated tablet debossed with 93 on one side and 983 on the reverse and are packaged in bottles of 90 tablets (NDC 42291-651-90). Store at 20° and 25°C (68° and 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured For: AvKARE Pulaski, TN 38478 Mfg. Rev. 11/22 AV Rev. 09/25(M); PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1
- HOW SUPPLIED Nystatin Tablets USP, 500,000 Units are round, convex, brown, film-coated tablet debossed with 93 on one side and 983 on the reverse and are packaged in bottles of 90 tablets (NDC 42291-651-90). Store at 20° and 25°C (68° and 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured For: AvKARE Pulaski, TN 38478 Mfg. Rev. 11/22 AV Rev. 09/25(M)
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1
Overview
Nystatin, USP is an antimycotic polyene antibiotic obtained from Streptomyces noursei . Its structural formula: C 47 H 75 NO 17 M.W. 926.13 Nystatin tablets USP contain the inactive ingredients: Corn Starch, Povidone, Compressible Sugar, Microcrystalline Cellulose, Sodium Starch Glycolate, Talc, Magnesium Stearate, Purified Water, and Coloring. Structural formula for nystatin
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 AvKARE at 1-855-361-3993; email [email protected]; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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