Onzet Special Precautions

Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT₃ receptor antagonists.
Electrocardiographic Changes: Rarely and predominantly with intravenous ondansetron, transient electrocardiogram (ECG) changes including QT/QTc interval prolongation have been reported.
Masking of Progressive Ileus and Gastric Distension: The use of Ondansetron Injection in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and gastric distention.
Effect on Peristalsis: Ondansetron Injection is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction.
Keep away from children.
Drug Abuse and Dependence: Animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.
Hepatic Impairment: In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.
Renal Impairment: Although plasma clearance is reduced in patients with severe renal impairment (creatinine clearance < 30 mL/min), no dosage adjustment is recommended.
Use in Children: Little information is available about the use of ondansetron in pediatric surgical patients younger than 1 month of age. Little information is available about the use of ondansetron in pediatric cancer patients younger than 6 months of age.
The clearance of ondansetron in pediatric patients 1 month to 4 months of age is slower and the half-life is ~2.5 fold longer than patients who are > 4 to 24 months of age. As a precaution, it is recommended that patients less than 4 months of age receiving this drug be closely monitored.
Use in Elderly: Of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting in US and foreign controlled clinical trials, 862 were 65 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experiences has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dosage adjustment is not needed in patients over age of 65.