In a gender balanced pharmacodynamic trial (n = 56), ondansetron 4 mg administered intravenously or intramuscularly was dynamically similar in the prevention of nausea and vomiting using the ipecacuanha model of emesis.QTc interval prolongation was studied in a double-blind, single intravenous dose, placebo- and positive-controlled, crossover trial in 58 healthy subjects. Injectable solution. All rights reserved. Adults—At first, 8 milligrams (mg) taken 1 to 2 hours before radiation treatment. For patients ages 12 and older, the dosage is the same as for adults. Eighteen patients (25%) received routine prophylactic dexamethasone (i.e., not given as rescue). The results of these trials are summarized in Table 10.In a placebo-controlled trial conducted in 468 males undergoing outpatient procedures, a single 4-mg intravenous ondansetron dose prevented postoperative vomiting over a 24-hour period in 79% of males receiving drug compared with 63% of males receiving placebo (Two other placebo-controlled trials were conducted in 2,792 patients undergoing major abdominal or gynecological surgeries to evaluate a single 4-mg or 8-mg intravenous ondansetron dose for prevention of postoperative nausea and vomiting over a 24-hour period. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy.

The results of the trial are summarized in Table 13.NDC 0173-0442-00         20-mL multiple-dose vial (Singles)Patients should be informed that ZOFRAN may cause serious cardiac arrhythmias such as QT prolongation. In patients in whom nausea and/or vomiting must be avoided postoperatively, Zofran Injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. The role of CYP2D6 in ondansetron in vivo metabolism is relatively minor.The pharmacokinetics of intravenous ondansetron did not differ between subjects who were poor metabolizers of CYP2D6 and those who were extensive metabolizers of CYP2D6, further supporting the limited role of CYP2D6 in ondansetron disposition in vivo.Based on the population pharmacokinetic analysis, cancer patients aged 6 to 48 months who receive a dose of 0.15 mg/kg of intravenous ondansetron every 4 hours for 3 doses would be expected to achieve a systemic exposure (AUC) consistent with the exposure achieved in previous pediatric trials in cancer patients (4 to 18 years) at similar doses.In a trial of 21 pediatric patients (3 to 12 years) who were undergoing surgery requiring anesthesia for a duration of 45 minutes to 2 hours, a single intravenous dose of ondansetron, 2 mg (3 to 7 years) or 4 mg (8 to 12 years), was administered immediately prior to anesthesia induction. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. Fifty-seven percent (57%) were females; 67% were white, 18% were American Hispanic, and 15% were black patients. Interactions with general or local anesthetics have not been studied.Available data do not reliably inform the association of ZOFRAN and adverse fetal outcomes. ZOFRAN is approved for patients aged 6 months and older.Zofran Injection is indicated for the prevention of postoperative nausea and/or vomiting. The 0.30-mg/kg dosing regimen was not shown to be more effective than the 0.15-mg/kg dosing regimen.In a double-blind trial in 28 patients, Zofran Injection (three 0.15-mg/kg doses) was significantly more effective than placebo in preventing nausea and vomiting induced by cisplatin-based chemotherapy. ZOFRAN was administered intravenously over 15 minutes in three doses of 0.15 mg/kg.

In all instances, the events resolved completely.Pediatric cases consistent with serotonin syndrome have been reported after inadvertent oral overdoses of ondansetron (exceeding estimated ingestion of 5 mg/kg) in young children. It is unknown whether ondansetron exposure in utero in the cases of cleft palate occurred during the time of palate formation (the palate is formed between the 6In embryo-fetal development studies in rats and rabbits, pregnant animals received intravenous doses of ondansetron up to 10 mg/kg/day and 4 mg/kg/day, respectively, during the period of organogenesis.