Exposure Summary
Esomeprazole is the S-isomer of omeprazole. Offered epidemiologic investigation fail to have indicated an increased danger of biggest congenital malformations or other unfavorable maternity consequences that have first trimester omeprazole play with.
Teratogenicity was not noticed in animal breeding knowledge having administration out-of dental esomeprazole magnesium during the rats and you may rabbits which have dosages throughout the 68 moments and you may 42 moments, correspondingly, a dental human dosage off 40 milligrams (centered on a body surface cause for a good sixty kg person). However, alterations in limbs morphology was indeed observed in little ones regarding rats dosed as a consequence of most of pregnancy and you may lactation on dosage comparable to or more than just as much as 34 moments an oral people dosage out-of 40 milligrams (pick Creature Data). By noticed impression on large doses out-of esomeprazole magnesium toward developing limbs into the rat training, esomeprazole magnesium delayed-release capsules will be put during pregnancy only when the possibility benefit justifies the potential exposure toward fetus.
Human Study
Esomeprazole is the S-isomer away from omeprazole. Four epidemiological studies compared brand new frequency away from congenital irregularities certainly one of babies produced to help you women who utilized omeprazole while pregnant toward volume regarding abnormalities one of infants of women confronted with H2 -receptor antagonists or any other control.