red tramadol more frequently, leading to an increased cumulative dose in patient controlled administration (PCA) of tramadol. 4,5
Chemotherapy
In humans, carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron.
In a crossover study in 76 pediatric patients, intravenous ondansetron did not increase blood levels of high-dose methotrexate.
Temazepam
The coadministration of ondansetron had no effect on the pharmacokinetics and pharmacodynamics of temazepam.
Antacids
Bioavailability of ondansetron is unaffected by antacids.
Alfentanil and Atracurium
Ondansetron does not alter respiratory depressant effects produced by alfentanil or the degree of neuromuscular blockade produced by atracurium. Interactions with general or local anesthetics have not been studied.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category B. Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg/day, respectively, (approximately 8 and 30 times the human dose of 16mg/day, based on body surface area), and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Zuplenz (ondansetron) oral soluble film should be used during pregnancy only if clearly needed.
Nursing Mothers
Ondansetron is excreted in the milk of rats. It is not known whether ondansetron is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Zuplenz oral soluble film is administered to a nursing woman.
Pediatric Use
Little information is available about dosage in pediatric patients less than 4 years of age. For dosage recommendations in the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy for patients 4 years of age and older [see Dosage and Administration (2.2)]. The safety and effectiveness in pediatric patients have not been established for the following indications: prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, prevention of nausea and vomiting associated with radiotherapy, and prevention of postoperative nausea and/or vomiting.
Geriatric Use
Of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting in US- and foreign-controlled clinical trials, for which there were subgroup analyses, 938 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 experience 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 the age of 65 [see Clinical Pharmacology (12.3)].
Renal Impairment
The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.
Hepatic Impairment
In patients with severe hepatic impairment (Child-Pugh score of 10 or greater) 2, clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life [see Clinical Pharmacology (12.3)]. In such patients, a total daily dose of 8 mg should no |
