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).
See below the information of this related product:
- Pantoprazole (Very Low Risk)
Very Low Risk
Compatible. Not risky for breastfeeding or infant.
Moderately safe. Mild risk possible. Follow up recommended. Read the Comment.
Poorly safe. Evaluate carefully. Use a safer alternative. Read the Comment.
Very High Risk
Not recommended. Cessation of breastfeeding or alternative.
- Omeprazole Magnesium
- Omeprazole Sodium
- Ομεπραζόλη (Greek)
- أوميبرازول (Arabic)
- Омепразол (Cyrillic)
- 奥美拉唑 (Chinese)
- オメプラゾール (Japanese)
- C17 H19 N3 O3 S (Molecular formula)
- (RS)-5-Methoxy-2-(4-methoxy-3,5-dimethyl-2-pyridylmethylsulphinyl)benzimidazole (Chemical name)
- A02BC01 (ATC Code/s)
Drug trade names
- Heartburn Relief™ (United Kingdom)
- Losec (Лосек)™
- Losec (洛赛克)™
- ОМЕЗ ІНСТА
- ОМЕПРАЗОЛ -ТЕВА
- ОМЕПРАЗОЛ 20 АНАНТА
- ОМЕПРАЗОЛ АНАНТА
- ОМЕПРАЗОЛ КРКА
- ОМЕПРАЗОЛ НАТРІЮ
- ОМЕПРАЗОЛ ПЕЛЕТИ
- ОМЕПРАЗОЛ ПЕЛЕТИ 8,5 %
- ОМЕПРАЗОЛУ ПЕЛЕТИ
- AEMPS. Omeprazol Kern Pharma Ficha técnica 2017 Full text (in our servers)
- Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. 2013Abstract
- FDA. Omeprazol Drug Summary 2012 Full text (in our servers)
- Esplugues JV, Martí-Cabrera M. [Safety and interactions of proton pump inhibitors: lessons learned in millions of patients]. Gastroenterol Hepatol. 2010Abstract
- Jabbar A, Khan R, Farrukh SN. Hyperprolactinaemia induced by proton pump inhibitor. J Pak Med Assoc. 2010Abstract
- Nava-Ocampo AA, Velázquez-Armenta EY, Han JY, Koren G. Use of proton pump inhibitors during pregnancy and breastfeeding. Can Fam Physician. 2006Abstract Full text (link to original source) Full text (in our servers)
- Richter JE. Review article: the management of heartburn in pregnancy. Aliment Pharmacol Ther. 2005Abstract Full text (in our servers)
- Plante L, Ferron GM, Unruh M, Mayer PR. Excretion of pantoprazole in human breast. J Reprod Med. 2004Abstract
- Marshall JK, Thompson AB, Armstrong D. Omeprazole for refractory gastroesophageal reflux disease during pregnancy and lactation. Can J Gastroenterol. 1998Abstract
- Cederberg C, Andersson T, Skånberg I. Omeprazole: pharmacokinetics and metabolism in man. Scand J Gastroenterol Suppl. 1989Abstract