![]() ![]() Including cisplatin greater than or equal to 50 mg/m 2 The start of single-day highly emetogenic chemotherapy, (5.4)įULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Dosage 2.2 Dosage in Hepatic Impairment 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity Reactions 5.2 QT Prolongation 5.3 Serotonin Syndrome 5.4 Masking of Progressive Ileus and Gastric Distension 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Serotonergic Drugs 7.2 Drugs Affecting Cytochrome P-450 Enzymes 7.3 Tramadol 7.4 Chemotherapy 7.5 Alfentanil and Atracurium 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Hepatic Impairment 8.7 Renal Impairment 9 DRUG ABUSE AND DEPENDENCE 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1 Prevention of Chemotherapy-Induced Nausea and Vomiting 14.2 Radiation-Induced Nausea and Vomiting 14.3 Postoperative Nausea and Vomiting 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed.Ī single 24 mg dose administered 30 minutes before Masking of progressive ileus and/or gastric distention following abdominal surgery or chemotherapy induced nausea and vomiting: Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction.If concomitant use of ondansetron tablets with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome. If such symptoms occur, discontinue ondansetron tablets and initiate supportive treatment. Serotonin syndrome: Reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs.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.Monitor and treat promptly per standard of care until signs and symptoms resolve. ![]() Hypersensitivity reactions including anaphylaxis and bronchospasm: Discontinue ondansetron tablets if suspected. ![]()
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