Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 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 0121-0810-02: 2 fl oz (60mL) bottle with calibrated dropper NDC 0121-0810-16: 16 fl oz (473mL) bottle NDC 0121-4810-05: 5mL unit dose cup NDC 0121-4810-40: Case contains 40 unit dose cups of 5mL (0121-4810-05) packaged in 4 trays of 10 unit dose cups each. Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing.; PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label 60 mL NDC 0121-0810-02 Nystatin Oral Suspension, USP 100,000 units per mL SHAKE WELL BEFORE USING Packaged with Calibrated Dropper DO NOT USE IF TAMPER EVIDENT SEAL IS BROKEN OR MISSING. Rx ONLY Pharmaceutical Associates, Inc. Greenville, SC 29605 Each mL of cherry, peppermint flavored oral suspension contains 100,000 units Nystatin, USP and alcohol (≤ 1% v/v). USUAL DOSAGE: For Infants: 2 mL(200,000 units) four times daily (in infants andyoung children, use dropper to place one half of dose in each side of the mouth and avoid feeding feeding for 5 to 10 minutes). See insert. WARNINGS: Keep this and all drugs out of reach of children. In case of accidental overdose, seek professional assistance orcontact a Poison Control Center immediately. Keep tightly closed. Protect from light. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature}. AVOID FREEZING R04/17 X01810020417 60 mL bottle label; PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label Delivers 5 mL NDC 0121-4810-05 N YSTATIN O RAL S USPENSION , USP 500,000 units / 5 mL Alcohol ≤ 1% v/v SHAKE WELL Rx ONLY FOR INSTITUTIONAL USE ONLY PHARMACEUTICAL ASSOCIATES, INC., GREENVILLE, SC 29605 SEE INSERT A48100500 5 mL unit dose cup label
- HOW SUPPLIED 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 0121-0810-02: 2 fl oz (60mL) bottle with calibrated dropper NDC 0121-0810-16: 16 fl oz (473mL) bottle NDC 0121-4810-05: 5mL unit dose cup NDC 0121-4810-40: Case contains 40 unit dose cups of 5mL (0121-4810-05) packaged in 4 trays of 10 unit dose cups each. Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing.
- PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label 60 mL NDC 0121-0810-02 Nystatin Oral Suspension, USP 100,000 units per mL SHAKE WELL BEFORE USING Packaged with Calibrated Dropper DO NOT USE IF TAMPER EVIDENT SEAL IS BROKEN OR MISSING. Rx ONLY Pharmaceutical Associates, Inc. Greenville, SC 29605 Each mL of cherry, peppermint flavored oral suspension contains 100,000 units Nystatin, USP and alcohol (≤ 1% v/v). USUAL DOSAGE: For Infants: 2 mL(200,000 units) four times daily (in infants andyoung children, use dropper to place one half of dose in each side of the mouth and avoid feeding feeding for 5 to 10 minutes). See insert. WARNINGS: Keep this and all drugs out of reach of children. In case of accidental overdose, seek professional assistance orcontact a Poison Control Center immediately. Keep tightly closed. Protect from light. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature}. AVOID FREEZING R04/17 X01810020417 60 mL bottle label
- PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label Delivers 5 mL NDC 0121-4810-05 N YSTATIN O RAL S USPENSION , USP 500,000 units / 5 mL Alcohol ≤ 1% v/v SHAKE WELL Rx ONLY FOR INSTITUTIONAL USE ONLY PHARMACEUTICAL ASSOCIATES, INC., GREENVILLE, SC 29605 SEE INSERT A48100500 5 mL unit dose cup label
Overview
Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei . Structural formula: C 47 H 75 NO 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 chemical structure
Indications & Usage
Nystatin oral suspension is indicated for the treatment of candidiasis in the oral cavity.
Dosage & Administration
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 .
Warnings & Precautions
No warnings available yet.
Contraindications
The preparation is contraindicated in patients with a history of hypersensitivity to any of its 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 non-specific myalgia have also been rarely reported.
Storage & Handling
Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing.
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