Dexlansoprazole Pregnancy and Breastfeeding Warnings

Dexlansoprazole is also known as: Dexilant, Kapidex

Dexlansoprazole Pregnancy Warnings

There were no fetal adverse effects in animal reproduction studies of dexlansoprazole in rabbits. Reproduction studies performed in pregnant rats with oral lansoprazole at doses up to 40 times the recommended human dose revealed no evidence of impaired fertility or harm to the fetus. There are no adequate and well-controlled studies with dexlansoprazole in pregnant women. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

This drug should be used during pregnancy only if clearly needed. US FDA pregnancy category: B

Dexlansoprazole Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue this drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes (lansoprazole) Comments: The effects in the nursing infant are unknown.

Carcinogenicity studies in rats had shown the potential of lansoprazole for tumorigenicity. No information is available on the use of dexlansoprazole during breastfeeding.

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