Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
ONDANSETRON HYDROCHLORIDE (UNII: NMH84OZK2B) (ONDANSETRON - UNII:4AF302ESOS)
Novartis Pharmaceuticals Corporation
ONDANSETRON
ONDANSETRON 4 mg
ORAL
PRESCRIPTION DRUG
ZOFRAN is indicated for the prevention of nausea and vomiting associated with: - highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 - initial and repeat courses of moderately emetogenic cancer chemotherapy - radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen ZOFRAN is also indicated for the prevention of postoperative nausea and/or vomiting. ZOFRAN is contraindicated in patients: - known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any of the components of the formulation [see Adverse Reactions (6.2)] - receiving concomitant apomorphine due to the risk of profound hypotension and loss of consciousness Risk Summary Published epidemiological studies on the association between ondansetron use and major birth defects have reported inconsistent findings and have important methodological limitations that preclude conclusions about the safety of ondansetron use in pre
ZOFRAN Tablets Store between 2°C and 30°C (36°F and 86°F). Protect from light. Dispense in tight, light-resistant container as defined in the USP. Store between 2°C and 30°C (36°F and 86°F). Protect from light. Dispense in tight, light-resistant container as defined in the USP. ZOFRAN ODT Orally Disintegrating Tablets Store between 2°C and 30°C (36°F and 86°F). ZOFRAN Oral Solution Store upright between 15°C and 30°C (59°F and 86°F). Protect from light. Store bottles upright in cartons.
New Drug Application
ZOFRAN- ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED NOVARTIS PHARMACEUTICALS CORPORATION ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ZOFRAN TABLETS, ZOFRAN ODT, AND ZOFRAN ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOFRAN TABLETS, ZOFRAN ODT, AND ZOFRAN ORAL SOLUTION. ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLETS, FOR ORAL USE ZOFRAN ODT (ONDANSETRON) ORALLY DISINTEGRATING TABLETS ZOFRAN (ONDANSETRON HYDROCHLORIDE) ORAL SOLUTION INITIAL U.S. APPROVAL: 1991 RECENT MAJOR CHANGES Warnings and Precautions, Myocardial Ischemia (5.4) 10/2021 INDICATIONS AND USAGE ZOFRAN is a 5-HT receptor antagonist indicated for the prevention of: nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m . (1) nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. (1) nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. (1) postoperative nausea and/or vomiting. (1) DOSAGE AND ADMINISTRATION See full prescribing information for the recommended dosage in adults and pediatrics. (2) Patients with severe hepatic impairment: do not exceed a total daily dose of 8 mg. (2.2, 8.6) DOSAGE FORMS AND STRENGTHS Tablets: 4 mg and 8 mg. (3) ODT Orally Disintegrating Tablets: 4 mg and 8 mg. (3) Oral Solution: 4 mg/5 mL. (3) CONTRAINDICATIONS Patients known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any components of the formulation. (4) Concomitant use of apomorphine. (4) WARNINGS AND PRECAUTIONS Hypersensitivity Reactions, Including Anaphylaxis and Bronchospasm: Discontinue ZOFRAN if suspected. Monitor and treat promptly per standard of care until signs and symptoms resolve. (5.1) QT Interval Prolongation and Torsade de Pointes: Avoid ZOFRAN in patients with congenital long QT syndrome Olvassa el a teljes dokumentumot