Use in Pregnancy: Teratogenic Effects: Pregnancy Category B: There are no adequate and well-controlled studies in pregnant women because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.
Use in Lactation: Pantoprazole and its metabolites are excreted in milk of rats. Pantoprazole excretion in human milk has been detected in as study of a single nursing mother after a single 40 mg oral dose. The clinical relevance of this findings is not known. Many drugs which excreted in human milk have a potential for serious adverse reactions in nursing infants. Based on the potential for tumorigenicity shown for pantoprazole in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the benefit of the drug to the mother.
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