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Previous versions of the ondansetron labels included a warning about QT interval prolongationThe FDA added a new warning to avoid the use of ondansetron in patients with congenital long QT syndrome because these patients are at particular risk for developing Torsade.
It is not known whether ondansetron passes into breast milk or if it could harm a nursing babyDo not use this medication without telling your doctor if you are breast-feeding a baby.
Table 5Pharmacokinetics in Male and Female Healthy Subjects after a Single Dose of a ZOFRAN 8-mg Tablet.
ElectrocardiogramECGchanges including QT interval prolongation have been seen in patients receiving ondansetronIn additionpostmarketing cases of Torsade de Pointes have been reported in patients using ZOFRANAvoid ZOFRAN in patients with congenital long QT syndromeECG monitoring is recommended in patients with electrolyte abnormalitiese.ghypokalemia or hypomagnesemiacongestive heart failurebradyarrhythmiasor patients taking other medicinal products that lead to QT prolongationsee CLINICAL PHARMACOLOGY
Liver failure and death has been reported in cancer patients receiving concurrent medicationsincluding potentially hepatotoxic cytotoxic chemotherapy and antibioticsThe etiology of the liver failure is unclear.
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use zofran as directed by your healthcare professional.
