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In patients with severe hepatic impairmentclearance is reduced and the apparent volume of distribution is increasedresulting in a significant increase in the half-life of ondansetronThereforedo not exceed a total daily dose of 8 mg in patients with severe hepatic impairmentChild-Pugh score of 10 or greatersee DOSAGE AND ADMINISTRATIONCLINICAL PHARMACOLOGY

The anti-nausea drug Zofran is approved for the prevention of nausea and vomiting caused by cancer chemotherapyradiation and surgeryDoctors also prescribe the medication to treat morning sicknessthough studies offer conflicting results about its potential for causing birth defects.

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.

The development of serotonin syndrome has been reported with 5-HT 3 receptor antagonists aloneMost reports have been associated with concomitant use of serotonergic drugse.gselective serotonin reuptake inhibitorsSSRIsserotonin and norepinephrine reuptake inhibitorsSNRIsmonoamine oxidase inhibitorsmirtazapinefentanyllithiumtramadoland intravenous methylene blueSome of the reported cases were fatalSerotonin syndrome occurring with overdose of ZOFRAN alone has also been reportedThe majority of reports of serotonin syndrome related to 5-HT 3 receptor antagonist use occurred in a post-anesthesia care unit or an infusion center.

Ondansetron is absorbed from the gastrointestinal tract and undergoes some first-pass metabolismMean bioavailability in healthy subjectsfollowing administration of a single 8-mg tabletis approximately 56

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in addition, it can be used in patients who suffer from nausea, since it is a 5ht-3 antagonist, the target of the popular anti-emetic ondansetron zofran .

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In embryo-fetal development studies in rats and rabbitspregnant animals received oral doses of ondansetron up to 15 mg/kg/day and 30 mg/kg/dayrespectivelyduring the period of organogenesisWith the exception of a slight decrease in maternal body weight gain in the rabbitsthere were no significant effects of ondansetron on the maternal animals or the development of the offspringAt doses of 15 mg/kg/day in rats and 30 mg/kg/day in rabbitsthe maternal exposure margin was approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/dayrespectivelybased on body surface area.

Carcinogenic effects were not seen in 2-year studies in rats and mice with oral ondansetron doses up to 10 mg/kg per day and 30 mg/kg per dayrespectivelyapproximately 4 and 6 times the maximum recommended human oral dose of 24 mg per daybased on body surface area

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