Ezoprole IV Use In Pregnancy & Lactation

Pregnancy: Clinical data on exposed pregnancies with esomeprazole are insufficient. With the racemic mixture, omeprazole data on a larger number of exposed pregnancies from epidemiological studies indicate no malformative nor fetotoxic effect. Animal studies with esomeprazole does not indicate direct or indirect harmful effects with respect to embryonal/fetal development. Animal studies with the racemic mixture does not indicate direct or indirect harmful effects with respect to pregnancy, parturition or post-natal development. Caution should be exercised when prescribing esomeprazole to pregnant women. A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicated no malformities or feto/neonatal toxicity of esomeprazole. Use is recommended only if clearly needed and the benefit outweighs the risk.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Breastfeeding: It is not known whether esomeprazole is excreted in human breast milk, there is insufficient information on the effects of esomeprazole in newborns/infants. Esomeprazole should not be used during breastfeeding.