Last update April 25, 2022

A02BA02

High Risk

Poorly safe. Evaluate carefully. Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives). Read the Comment.

Histamine H2 receptor antagonist that inhibits gastric acid secretion. Indicated in the treatment of gastric and duodenal ulcer and peptic esophagitis. Oral or intravenous administration in one or two daily doses.

Since 10/2019, preparations of Ranitidine have been withdrawn from the market in several countries because some of them have detected contamination with Nitrosamine (N-Nitrosodimethylamine, NDMA) a carcinogenic product. It is advised, until the situation has cleared up, to switch to omeprazole, cimetidine or famotidine. (RCPCH 2021, FDA 2020, AEMPS 2019)

It is concentrated in breastmilk and is excreted in moderate quantities (Kearns 1985, Riley 1982 cited in Bennet 1996 p329), but is 5 to 25 times lower than the dose used in newborns and infants (2-4 mg/kg/day).

No side effects have been observed in infants whose mothers were taking ranitidine. (Kearns 1985)

It is commonly used in Pediatrics, even in premature newborns.

It can produce hyperprolactinemia. (Petit 2003)

Other anti H2s from the same family, like Famotidine or Nizatidine, are excreted less in breastmilk and are preferred. (Hagemann 1998)

Several medical societies, experts and expert consensus, consider the use of this medication to be safe or very probably safe during breastfeeding. (Hale 2019, Briggs 2017, Rowe 2013, Mahadevan 2006, Richter 2005, Nice 2000)

 

Alternatives

  • Cimetidine (Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)
  • Famotidine ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Nizatidine ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Omeprazole ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

A02BA02 is Ranitidine in ATC Code/s.

Is written in other languages:

A02BA02 is also known as

Tradenames

Main tradenames from several countries containing A02BA02 in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 50 - 60 %
Molecular weight 351 daltons
Protein Binding 15 %
VD 1.4 - 2.0 l/Kg
pKa 8.1 -
Tmax 1 - 3 hours
1.5 - 3 hours
M/P ratio 6.8 - 26.8 -
Theoretical Dose 0.15 - 0.39 mg/Kg/d
Relative Dose 6.1 - 8.5 %
Ped.Relat.Dose 3.8 - 19.5 %

References

  1. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on April 10, 2024 Full text (link to original source)
  2. RCPCH. Medicine safety alert - ranitidine (withdrawn). News. 2021 Consulted on Feb. 15, 2021 Full text (link to original source)
  3. FDA FDA Requests Removal of All Ranitidine Products (Zantac) from the Market FDA Advises Consumers, Patients and Health Care Professionals After New FDA Studies Show Risk to Public Health. News & Events. 2020 Consulted on April 20, 2020 Full text (link to original source)
  4. AEMPS. Retirada del mercado de medicamentos que contienen ranitidina vía oral. Nota informativa. 2019 Full text (in our servers)
  5. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. Tenth edition (acces on line) 2015
  6. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  7. Mahadevan U, Kane S. American gastroenterological association institute technical review on the use of gastrointestinal medications in pregnancy. Gastroenterology. 2006 Jul;131(1):283-311. Review. Abstract Full text (link to original source) Full text (in our servers)
  8. 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)
  9. Petit A, Piednoir D, Germain ML, Trenque T. [Drug-induced hyperprolactinemia: a case-non-case study from the national pharmacovigilance database]. Therapie. 2003 Abstract
  10. Nice FJ, Snyder JL, Kotansky BC. Breastfeeding and over-the-counter medications. J Hum Lact. 2000 Nov;16(4):319-31. Review. Erratum in: J Hum Lact 2001 Feb;17(1):90. Abstract
  11. Hagemann TM. Gastrointestinal medications and breastfeeding. J Hum Lact. 1998 Sep;14(3):259-62. Review. Abstract
  12. Bennett PN. Drugs and human lactation, 2nd ed. Amsterdam. Elsevier. 1996. 1996
  13. Kearns GL, McConnell RF Jr, Trang JM, Kluza RB. Appearance of ranitidine in breast milk following multiple dosing. Clin Pharm. 1985 Abstract
  14. Roberts CJ. Clinical pharmacokinetics of ranitidine. Clin Pharmacokinet. 1984 Abstract
  15. Riley AJ, Crowley P, Harrison C. Transfer of ranitidine to biological fluids: milk and semen. In: Misiewicz JJ, Wormsley KG eds. The clinical use of ranitidine. Medicine Publishing Foundation Symposium series 5. Oxford. Medicine Publishing Foundation, 1982: 78-81. 1982

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