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In December 2012the FDA notified health care professionals that the 32 mgsingle intravenous dose of Zofran would no longer be marketed because of the potential for serious cardiac risksThe FDA said in its Drug Safety Communication that it was working with the manufacturers of all 32 mg dose ondansetron injectable productsbrand and genericto recall them from the marketThe drugs were sold pre-mixed in solutions of either dextrose or sodium chloride in plastic containers.<\/p>\n
The most common adverse reactions reported in greater than or equal to 4of 300 adults receiving a single 24mg dose of ZOFRAN orally in 2 trials for the prevention of nausea and vomiting associated with highly emetogenic chemotherapycisplatin greater than or equal to 50 mg\/m 2wereheadache11and diarrhea4<\/p>\n
Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liversee CLINICAL PHARMACOLOGYBecause ondansetron is metabolized by hepatic cytochrome P450 drug-metabolizing enzymesCYP3A4CYP2D6CYP1A2inducers or inhibitors of these enzymes may change the clearance andhencethe half-life of ondansetronIn patients treated with potent inducers of CYP3A4i.ephenytoincarbamazepineand rifampinthe clearance of ondansetron was significantly increased and ondansetron blood concentrations were decreasedHoweveron the basis of available datano dosage adjustment for ZOFRAN is recommended for patients on these drugssee CLINICAL PHARMACOLOGY<\/p>\n
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