Last update: March 21, 2018
Minimal risk for breastfeeding and infant.
Proton pump inhibitor, reducing gastric acid secretion.
Oral administration once or twice a day.
Its pharmacokinetic data (very high percentage of plasma protein binding and short half-life) explain the negligible passage to milk observed (AEMPS 2017, FDA 2012, Nava 2006, Marshall 1998).
No problems have been observed in infants of mothers who took omeprazole (Marshall 1998).
Possible adverse reactions are rare and not serious (AEMPS 2017, FDA 2012).
Shown to be labile in acid-pH environment must be administered in the form of micro-granules within an enteric-coated capsule (AEMPS 2017). Any small quantity reaching the infant's stomach would be readily inactivated.
Authorized use in children from one year of age.
A similar product, pantoprazole, also has negligible excretion in breast milk and did not cause problems in the infant (Plante 2004).
The manufacturer (AEMPS 2017) and expert authors (Rowe 2013) consider that the risk of affecting the infant is very unlikely.
A case of hyperprolactinemia and galactorrhea has been reported in a 13-year-old girl who took it (Jabbar 2010).
Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
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