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After oral administration there was a modest increase in the AUC and C max of pantoprazole in women compared to menHoweverweight-normalized clearance values are similar in women and men.

Pantoprazole and its metabolites are excreted in the milk of ratsPantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose of pantoprazole sodiumThe clinical relevance of this finding is not knownMany drugs which are excreted in human milk have a potential for serious adverse reactions in nursing infantsBased on the potential for tumorigenicity shown for pantoprazole sodium in rodent carcinogenicity studiesa decision should be made whether to discontinue nursing or to discontinue the drugtaking into account the benefit of the drug to the mother.

In a preand post-natal development toxicity study in ratsthe pups were administered oral doses of pantoprazole at 515and 30 mg/kg/day on postnatal dayPND 4through PND 21in addition to lactational exposure through milkOn PND 21decreased mean femur length and weight and changes in femur bone mass and geometry were observed in the offspring at 5 mg/kg/day and higher dosesChanges in bone parameters were partially reversible following a recovery periodsee Use in Specific Populations8.1

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Applies to pantoprazoleintravenous powder for injectionoral delayed release tabletoral granule enteric coated.

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