For the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting.
The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron.
ZUPLENZ (ondansetron) oral soluble film is contraindicated for patients known to have hypersensitivity to the drug. Anaphylactic reactions have been reported in patients taking ondansetron.
Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists.
Avoid ZUPLENZ in patients with congenital long QT syndrome. Monitor ECG 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.
Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs.
The use of ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.
The most common adverse drug events (≥5%) in chemotherapy-induced nausea and vomiting and radiotherapy-induced nausea and vomiting were: headache, malaise/fatigue, constipation, and diarrhea. The most common adverse event (≥5%) in postoperative nausea and vomiting was headache.
ZUPLENZ is available by prescription only. Please click here for complete Prescribing Information.
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Visit www.FDA.gov/medwatch, or call 1-800-FDA-1088.
For more information about ZUPLENZ, call 1-855-636-5710.