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Clopidogrel is metabolized to its active metabolite in part by CYP2C19In a crossover clinical study66 healthy subjects were administered clopidogrel300 mg loading dose followed by 75 mg per dayalone and with oral pantoprazole80 mg at the same time as clopidogrelfor 5 daysOn Day 5the mean AUC of the active metabolite of clopidogrel was reduced by approximately 14geometric mean ratio was 86with 90CI of 79 to 93when pantoprazole sodium was coadministered with clopidogrel as compared to clopidogrel administered alonePharmacodynamic parameters were also measured and demonstrated that the change in inhibition of platelet aggregationinduced by 5 micromolar ADPwas correlated with the change in the exposure to clopidogrel active metaboliteThe clinical significance of this finding is not clear.
In neonatal/juvenile animalsrats and dogstoxicities were similar to those observed in adult animalsincluding gastric alterationsdecreases in red cell massincreases in lipidsenzyme induction and hepatocellular hypertrophyAn increased incidence of eosinophilic chief cells in adult and neonatal/juvenile ratsand atrophy of chief cells to serve them to pursue. in adult rats and in neonatal/juvenile dogswas observed in the fundic mucosa of stomachs in repeated-dose studiesFull to partial recovery of these effects were noted in animals of both age groups following a recovery period.
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