Pantoprazole at oral doses up to 500 mg/ kg/ day in male rats (98 times the recommended human dose based on body surface area) and 450 mg/ kg/ day in female rats (88 times the recommended human dose based on body surface area) was found to have no effect on fertility and reproductive performance. Pregnancy Teratogenic Effects Pregnancy Category B Teratology studies have been performed in rats at oral doses up to 450 mg/ kg/ day (88 times the recommended human dose based on body surface area) and rabbits at oral doses up to 40 mg/ kg/ day (16 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole. There are, however, 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 during pregnancy only if clearly needed. Nursing Mothers Pantoprazole and its metabolites are excreted in the milk of rats. It is not known whether pantoprazole is excreted in human milk. Many drugs which are 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. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Use in Women Erosive esophagitis healing rates in the 221 women treated with PROTONIX (pantoprazole sodium) Delayed-Release Tablets in U. S. clinical trials were similar to those found in men. In the 122 women treated long-term with PROTONIX 40 mg or 20 mg, healing was maintained at a rate similar to that in men. The incidence rates of adverse events were also similar for men and women. | ||||
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