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2Further dilute with 100 mL of 5Dextrose InjectionUSP0.9Sodium Chloride InjectionUSPor Lactated Ringer’s InjectionUSPto a final concentration of approximately 0.4 mg/mL.
In a 24-month carcinogenicity studySprague-Dawley rats were treated orally with pantoprazole doses of 0.5 to 200 mg/kg/dayabout 0.1 to 40 times the exposure on a body surface area basis of a 50-kg person dosed at 40 mg/dayIn the gastric fundustreatment with 0.5 to 200 mg/kg/day produced enterochromaffin-likeECLcell hyperplasia and benign and malignant neuroendocrine cell tumors in a dose-related mannerIn the forestomachtreatment with 50 and 200 mg/kg/dayabout 10 and 40 times the recommended human dose on a body surface area basisproduced benign squamous cell papillomas and malignant squamous cell carcinomasRare gastrointestinal tumors associated with pantoprazole treatment included an adenocarcinoma of the duodenum with 50 mg/kg/day and benign polyps and adenocarcinomas of the gastric fundus with 200 mg/kg/dayIn the livertreatment with 0.5 to 200 mg/kg/day produced dose-related increases in the incidences of hepatocellular adenomas and carcinomasIn the thyroid glandtreatment with 200 mg/kg/day produced increased incidences of follicular cell adenomas and carcinomas for both male and female rats.
For Injection40 mg of pantoprazole white to off-white freeze-dried powder in a single-dose vial for reconstitution.
In a 24-month carcinogenicity studyB6C3F1 mice were treated orally with pantoprazole doses of 5 to 150 mg/kg/day0.5 to 15 times the recommended human dose based on body surface areaIn the livertreatment with 150 mg/kg/day produced increased incidences of hepatocellular adenomas and carcinomas in female miceTreatment with 5 to 150 mg/kg/day also produced gastric fundic ECL cell hyperplasia.
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.
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