Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
ONDANSETRON (UNII: 4AF302ESOS) (ONDANSETRON - UNII:4AF302ESOS)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
Ondansetron orally disintegrating tablets are 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 Ondansetron orally disintegrating tablets also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron orally disintegrating tablets are 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 i
Ondansetron Orally Disintegrating Tablets USP ,4 mg are white to off-white, round tablets debossed with ‘5’ on one side and ‘E’ on the other side with an embossed circular edge. NDC: 71335-1314-1: 30 Tablets in a BOTTLE NDC: 71335-1314-2: 20 Tablets in a BOTTLE NDC: 71335-1314-3: 10 Tablets in a BOTTLE NDC: 71335-1314-4: 6 Tablets in a BOTTLE NDC: 71335-1314-5: 60 Tablets in a BOTTLE NDC: 71335-1314-6: 9 Tablets in a BOTTLE NDC: 71335-1314-7: 5 Tablets in a BOTTLE NDC: 71335-1314-8: 15 Tablets in a BOTTLE NDC: 71335-1314-9: 3 Tablets in a BOTTLE NDC: 71335-1314-0: 90 Tablets in a BOTTLE Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Abbreviated New Drug Application
ONDANSETRON- ONDANSETRON TABLET, ORALLY DISINTEGRATING BRYANT RANCH PREPACK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ONDANSETRON ORALLY DISINTEGRATING TABLETS, SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON ORALLY DISINTEGRATING TABLETS INITIAL U.S. APPROVAL: 1991 RECENT MAJOR CHANGES Warnings and Precautions, Myocardial Ischemia (5.4) 10/2021 INDICATIONS AND USAGE Ondansetron orally disintegrating tablets are 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 Orally Disintegrating Tablets: 4 mg and 8 mg. (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 ondansetron 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 ondansetron in patients with congenital long QT syndrome; monitor with electrocardiograms (ECGs) if concomitant electrolyte abnormalities, cardiac failure or arrhythmias, or use of other QT prolonging drugs. (5.2) Serotonin Syn Olvassa el a teljes dokumentumot