País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
ONDANSETRON HYDROCHLORIDE (UNII: NMH84OZK2B) (ONDANSETRON - UNII:4AF302ESOS)
McKesson Corporation dba RX Pak
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/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 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. Risk Summary Available data do not reliably inform the association of ondansetron tablets and adverse fetal outcomes. Published epidemiological studies on the association between ondansetron and fetal outcomes
Ondansetron Tablets Ondansetron Tablets USP, 4 mg (ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron), are white, oval, film-coated tablets engraved with "4" on one side and “NO” on another side. They are supplied as follows: NDC 71930-017-30 Bottles of 30 Ondansetron Tablets USP, 8 mg (ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron), are yellow, oval, film-coated tablets engraved with "8" on one side and "NO" on the other side. They are supplied as follows: NDC 71930-018-30 Bottles of 30 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
Abbreviated New Drug Application
ONDANSETRON - ONDANSETRON TABLET MCKESSON CORPORATION DBA RX PAK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ONDANSETRON TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ONDANSETRON TABLETS, USP. ONDANSETRON TABLETS USP, 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. (2.1) 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 tablets 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 tablets and initiate su Leer el documento completo