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The potential effects of esomeprazole on fertility and reproductive performance were assessed using omeprazole studies. Omeprazole at oral doses up to 138 mg/ kg/ day in rats (about 56 times the human dose on a body surface area basis) was found to have no effect on reproductive performance of parental animals. Pregnancy Teratogenic Effects. Text Continues Below
Pregnancy Category B Teratology studies have been performed in rats at oral doses up to 280 mg/ kg/ day (about 57 times the human dose on a body surface area basis) and in rabbits at oral doses up to 86 mg/ kg/ day (about 35 times the human dose on a body surface area basis) and have revealed no evidence of impaired fertility or harm to the fetus due to esomeprazole. 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. Teratology studies conducted with omeprazole in rats at oral doses up to 138 mg/ kg/ day (about 56 times the human dose on a body surface area basis) and in rabbits at doses up to 69 mg/ kg/ day (about 56 times the human dose on a body surface area basis) did not disclose any evidence for a teratogenic potential of omeprazole. In rabbits, omeprazole in a dose range of 6.9 to 69.1 mg/ kg/ day (about 5.5 to 56 times the human dose on a body surface area basis) produced dose-related increases in embryo-lethality, fetal resorp-tions, and pregnancy disruptions. In rats, dose-related embryo/ fetal toxicity and postnatal developmental toxicity were observed in offspring resulting from parents treated with omeprazole at 13.8 to 138.0 mg/ kg/ day (about 5.6 to 56 times the human doses on a body surface area basis). There are no adequate and well-controlled studies in pregnant women. Sporadic reports have been received of congenital abnormalities occurring in infants born to women who have received omeprazole during pregnancy. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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