Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
ONDANSETRON HYDROCHLORIDE (UNII: NMH84OZK2B) (ONDANSETRON - UNII:4AF302ESOS)
Mylan Institutional Inc.
ONDANSETRON HYDROCHLORIDE
ONDANSETRON 4 mg
ORAL
PRESCRIPTION DRUG
Ondansetron 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/m 2 . - 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 tablets are also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron 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. Available data do not reliably inform the association of ondansetron and adverse fetal outcomes. Published epidemiological studies on the association between ondansetron and fetal outcomes have reported inconsist
Ondansetron Tablets, USP are available containing ondansetron hydrochloride, USP equivalent to 4 mg or 8 mg of ondansetron. The 4 mg tablets are white, film-coated, round, unscored tablets debossed with 315 on one side of the tablet and M on the other side. They are available as follows: NDC 51079-524-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 8 mg tablets are orange, film-coated, round, unscored tablets debossed with 344 on one side of the tablet and M on the other side. They are available as follows: NDC 51079-525-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.
Abbreviated New Drug Application
ONDANSETRON- ONDANSETRON TABLET, FILM COATED MYLAN INSTITUTIONAL INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ONDANSETRON TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ONDANSETRON TABLETS. ONDANSETRON TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1991 INDICATIONS AND USAGE Ondansetron 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 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 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 Syndrome: Reported with 5-HT receptor antagonists alone but particularly with concomitant use of serotonergic drugs. If such symptoms occur, discontinue ondansetron and initiate supportive trea read_full_document