Last update: March 21, 2018

(RS)-5-Methoxy-2-(4-methoxy-3,5-dimethyl-2-pyridylmethylsulphinyl)benzimidazole

Very Low Risk for breastfeeding


Safe. Compatible.
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).


See below the information of this related product:

Alternatives

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.

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Other names

(RS)-5-Methoxy-2-(4-methoxy-3,5-dimethyl-2-pyridylmethylsulphinyl)benzimidazole is Omeprazole in Chemical name.

Is written in other languages:

(RS)-5-Methoxy-2-(4-methoxy-3,5-dimethyl-2-pyridylmethylsulphinyl)benzimidazole is also known as

Group

(RS)-5-Methoxy-2-(4-methoxy-3,5-dimethyl-2-pyridylmethylsulphinyl)benzimidazole belongs to this group or family:

Tradenames

Main tradenames from several countries containing (RS)-5-Methoxy-2-(4-methoxy-3,5-dimethyl-2-pyridylmethylsulphinyl)benzimidazole in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 40 - 60 %
Molecular weight 345 daltons
Protein Binding 95 - 97 %
VD 0,3 l/Kg
Tmax 1 - 2 hours
T1/2 0,5 - 1 hours
Theoretical Dose 0,003 mg/Kg/d
Relative Dose 0,9 %
Relat.Ped.Dose 0,3 %

References

  1. AEMPS. Omeprazol Kern Pharma Ficha técnica 2017 Full text (in our servers)
  2. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  3. FDA. Omeprazol Drug Summary 2012 Full text (in our servers)
  4. Jabbar A, Khan R, Farrukh SN. Hyperprolactinaemia induced by proton pump inhibitor. J Pak Med Assoc. 2010 Abstract
  5. Esplugues JV, Martí-Cabrera M. [Safety and interactions of proton pump inhibitors: lessons learned in millions of patients]. Gastroenterol Hepatol. 2010 Abstract
  6. Nava-Ocampo AA, Velázquez-Armenta EY, Han JY, Koren G. Use of proton pump inhibitors during pregnancy and breastfeeding. Can Fam Physician. 2006 Abstract Full text (link to original source) Full text (in our servers)
  7. Richter JE. Review article: the management of heartburn in pregnancy. Aliment Pharmacol Ther. 2005 Nov 1;22(9):749-57. Review. Abstract Full text (in our servers)
  8. Plante L, Ferron GM, Unruh M, Mayer PR. Excretion of pantoprazole in human breast. J Reprod Med. 2004 Abstract
  9. Marshall JK, Thompson AB, Armstrong D. Omeprazole for refractory gastroesophageal reflux disease during pregnancy and lactation. Can J Gastroenterol. 1998 Abstract
  10. Cederberg C, Andersson T, Skånberg I. Omeprazole: pharmacokinetics and metabolism in man. Scand J Gastroenterol Suppl. 1989 Abstract

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