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warnings and cautions
WARNINGS AND PRECAUTIONS Hypersensitivity reactions including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT 3 receptor antagonists. ( 5.1 ) QT prolongation occurs in a dose-dependent manner. Cases of torsade de pointes have been reported. Avoid ondansetron hydrochloride in patients with congenital long QT syndrome. ( 5.2 ) Use in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distention. ( 5.3 )( 5.4 ) Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT 3 receptor antagonists. Ondansetron prolongs the QT interval in a dose-dependent manner [see Clinical Pharmacology ( 12.2 )] . In addition, postmarketing cases of torsade de pointes have been reported in patients using ondansetron. Avoid ondansetron hydrochloride in patients with congenital long QT syndrome. ECG monitoring is recommended in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or patients taking other medicinal products that lead to QT prolongation. The use of ondansetron hydrochloride in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and gastric distention. Ondansetron hydrochloride is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction.
ADVERSE REACTIONS Chemotherapy-Induced Nausea and Vomiting – The most common adverse reactions (≥ 7%) in adults are diarrhea, headache, and fever. ( 6.1 ) Postoperative Nausea and Vomiting – The most common adverse reaction (≥ 10%) which occurs at a higher frequency compared to placebo in adults is headache. ( 6.1 ) The most common adverse reaction (≥ 2%) which occurs at a higher frequency compared to placebo in pediatric patients 1 to 24 months of age is diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or drug.safety@tevapharm.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The following adverse reactions have been reported in clinical trials of adult patients treated with ondansetron, the active ingredient of intravenous ondansetron hydrochloride across a range of dosages. A causal relationship to therapy with ondansetron hydrochloride was unclear in many cases. Chemotherapy-Induced Nausea and Vomiting Table 1. Adverse Reactions Reported in > 5% of Adult Patients Who Received Ondansetron at a Dosage of Three 0.15 mg/kg Doses Number of Adult Patients With Reaction Adverse Reaction Ondansetron Injection 0.15 mg/kg x 3 n = 419 Metoclopramide n = 156 Placebo n = 34 Diarrhea 16% 44% 18% Headache 17% 7% 15% Fever 8% 5% 3% Cardiovascular Rare cases of angina (chest pain), electrocardiographic alterations, hypotension, and tachycardia have been reported. Gastrointestinal Constipation has been reported in 11% of chemotherapy patients receiving multiday ondansetron. Hepatic In comparative trials in cisplatin chemotherapy patients with normal baseline values of aspartate transaminase (AST) and alanine transaminase (ALT), these enzymes have been reported to exceed twice the upper limit of normal in approximately 5% of patients. The increases were transient and did not appear to be related to dose or duration of therapy. On repeat exposure, similar transient elevations in transaminase values occurred in some courses, but symptomatic hepatic disease did not occur. Integumentary Rash has occurred in approximately 1% of patients receiving ondansetron. Neurological There have been rare reports consistent with, but not diagnostic of, extrapyramidal reactions in patients receiving ondansetron injection, and rare cases of grand mal seizure. Other Rare cases of hypokalemia have been reported. Postoperative Nausea and Vomiting The adverse reactions in Table 2 have been reported in ≥ 2% of adults receiving ondansetron at a dosage of 4 mg intravenous over 2 to 5 minutes in clinical trials. Table 2. Adverse Reactions Reported in ≥ 2% (and With Greater Frequency Than the Placebo Group) of Adult Patients Receiving Ondansetron at a Dosage of 4 mg Intravenous Over 2 to 5 Minutes Adverse Reaction * , † Ondansetron Injection 4 mg Intravenous n = 547 patients Placebo n = 547 patients Headache 92 (17%) 77 (14%) Drowsiness/sedation 44 (8%) 37 (7%) Injection site reaction 21 (4%) 18 (3%) Fever 10 (2%) 6 (1%) Cold sensation 9 (2%) 8 (1%) Pruritus 9 (2%) 3 (< 1%) Paresthesia 9 (2%) 2 (< 1%) Adverse Reactions: Rates of these reactions were not significantly different in the ondansetron and placebo groups Patients were receiving multiple concomitant perioperative and postoperative medications Pediatric Use Rates of adverse reactions were similar in both the ondansetron and placebo groups in pediatric patients receiving ondansetron (a single 0.1 mg/kg dose for pediatric patients weighing 40 kg or less, or 4 mg for pediatric patients weighing more than 40 kg) administered intravenously over at least 30 seconds. Diarrhea was seen more frequently in patients taking ondansetron hydrochloride (2%) compared to placebo (< 1%) in the 1 month to 24 month age group. These patients were receiving multiple concomitant perioperative and postoperative medications. The following adverse reactions have been identified during post-approval use of ondansetron. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to ondansetron. Cardiovascular Arrhythmias (including ventricular and supraventricular tachycardia, premature ventricular contractions, and atrial fibrillation), bradycardia, electrocardiographic alterations (including second-degree heart block, QT/QTc interval prolongation, and ST segment depression), palpitations, and syncope. Rarely and predominantly with intravenous ondansetron, transient ECG changes including QT/QTc interval prolongation have been reported [see Warnings and Precautions ( 5.2 )] . General Flushing. Rare cases of hypersensitivity reactions, sometimes severe (e.g., anaphylatic reactions, angioedema, bronchospasm, cardiopulmonary arrest, hypotension, laryngeal edema, laryngospasm, shock, shortness of breath, stridor) have also been reported. A positive lymphocyte transformation test to ondansetron has been reported, which suggests immunologic sensitivity to ondansetron. Hepatobiliary Liver enzyme abnormalities have been reported. Liver failure and death have been reported in patients with cancer receiving concurrent medications including potentially hepatotoxic cytotoxic chemotherapy and antibiotics. Local Reactions Pain, redness, and burning at site of injection. Lower Respiratory Hiccups Neurological Oculogyric crisis, appearing alone, as well as with other dystonic reactions. Transient dizziness during or shortly after intravenous infusion. Skin Urticaria Eye Disorders Cases of transient blindness, predominantly during intravenous administration, have been reported. These cases of transient blindness were reported to resolve within a few minutes up to 48 hours. Transient blurred vision, in some cases associated with abnormalities of accommodation, have also been reported.
adverse reactions table
<table ID="id_94d57357-71f9-4103-83cc-3300bec8079a" border="single" width="400"> <caption>Table 1. Adverse Reactions Reported in > 5% of Adult Patients Who Received Ondansetron at a Dosage of Three 0.15 mg/kg Doses </caption> <col span="1" width="34.2%"/> <col span="1" width="22.3%"/> <col span="1" width="24.5%"/> <col span="1" width="18.9%"/> <tbody> <tr> <td/> <td>Number of Adult Patients With Reaction</td> </tr> <tr> <td>Adverse Reaction</td> <td> <paragraph>Ondansetron Injection</paragraph> <paragraph>0.15 mg/kg x 3</paragraph>n = 419 </td> <td> <paragraph>Metoclopramide</paragraph>n = 156 </td> <td> <paragraph>Placebo</paragraph>n = 34 </td> </tr> <tr> <td>Diarrhea</td> <td>16%</td> <td>44%</td> <td>18%</td> </tr> <tr> <td>Headache</td> <td>17%</td> <td>7%</td> <td>15%</td> </tr> <tr> <td>Fever</td> <td>8%</td> <td>5%</td> <td>3%</td> </tr> </tbody> </table>