However, this association could be a chance finding, given the large number of drugs-birth defect comparisons in this study. 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 development of serotonin syndrome has been reported with 5-HTSymptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Copy the URL below and paste it into your RSS Reader application.DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. With the exception of a slight decrease in maternal body weight gain in the rabbits, there were no significant effects of ondansetron on the maternal animals or the development of the offspring. Mean bioavailability in healthy subjects, following administration of a single 8-mg tablet, is approximately 56%. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X.If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Each 4-mg and 8-mg orally disintegrating tablet contains less than 0.03 mg phenylalanine.Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.The following adverse reactions have been reported in clinical trials of patients treated with ondansetron, the active ingredient of ZOFRAN. In this study, the 8-mg dose infused over 15 minutes did not prolong the QT interval to any clinically relevant extent.Ondansetron is absorbed from the gastrointestinal tract and undergoes some first-pass metabolism. Following infusion of 32 mg over only a 4-minute period, a vasovagal episode with transient second-degree heart block was observed. If you are a consumer or patient please visit Severe Interactions.


At doses of 15 mg/kg/day in rats and 30 mg/kg/day in rabbits, the maternal exposure margin was approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, respectively, based on body surface area.In a pre- and postnatal developmental toxicity study, pregnant rats received oral doses of ondansetron up to 15 mg/kg/day from Day 17 of pregnancy to litter Day 21. Get The Lowest Prices With Free Home Delivery. No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger subjects. Protect from light. In single-arm trials, 148 patients receiving cyclophosphamide-based chemotherapy were re-treated with ZOFRAN 8 mg three times daily during subsequent chemotherapy for a total of 396 re-treatment courses. Zofran is medication that is often prescribed to patients who underwent surgery or chemotherapy. Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of ZOFRAN and other serotonergic drugs. In one study with 1,349 infants born to women who reported the use of ondansetron or received an ondansetron prescription in the first trimester, no increased risk for major congenital malformations was seen in aggregate analysis. In these trials, 58% of the 170 evaluable patients had a complete response (no emetic episodes) on Day 1. Using the established exposure-response relationship, 24 mg infused intravenously over 15 minutes had a mean predicted (95% upper prediction interval) ΔΔQTcF of 14.0 (16.3) milliseconds. A significant exposure-response relationship was identified between ondansetron concentration and ΔΔQTcF. If symptoms of serotonin syndrome occur, discontinue ZOFRAN and initiate supportive treatment. Patients received 3 fractions for 3 days, then 2 fractions on Day 4.In an active-controlled, double-blind trial in 105 patients receiving single high-dose radiotherapy (800 to 1,000 cGy) over an anterior or posterior field size of greater than or equal to 80 cmIn an active-controlled, double-blind trial in 135 patients receiving a 1- to 4- week course of fractionated radiotherapy (180 cGy doses) over a field size of greater than or equal to 100 cmIn 2 placebo-controlled, double-blind trials (one conducted in the US and the other outside the US) in 865 females undergoing inpatient surgical procedures, ZOFRAN 16 mg as a single dose or placebo was administered one hour before the induction of general balanced anesthesia (barbiturate, opioid, nitrous oxide, neuromuscular blockade, and supplemental isoflurane or enflurane), ZOFRAN tablets was significantly more effective than placebo in preventing postoperative nausea and vomiting.Store upright between 15°C and 30°C (59°F and 86°F).
Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation.These medications may interact and cause very harmful effects. The medicine treats vomiting and nausea that may result because of the different procedures.

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