Last update: Dec. 10, 2019

Ранитидин

Very Low Risk for breastfeeding


Safe. Compatible.
Minimal risk for breastfeeding and infant.

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.

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.

Other anti H2s from the same family are excreted less in breastmilk and may be preferred (Hagemann 1998).

Several medical assocoations, experts and expert consensus consider its use to be safe during breastfeeding (Hale 2019, Briggs 2017, Rowe 2013, Mahadevan 2006, Richter 2005, Nice 2000).

It can produce hyperprolactinemia (Petit 2003).

***
*** Since 10/2019, oral preparations (not intravenous) of Ranitidine have been withdrawn from the market in several countries because some of them have detected contamination with Nitrosamine (N-Nitrosodimethylamine, NDMA) a carcinogenic product.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 or famotidine (AEMPS 2019).

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.

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

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Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Ранитидин is Ranitidine in Cyrillic.

Is written in other languages:

Ранитидин is also known as

Tradenames

Main tradenames from several countries containing Ранитидин 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
T1/2 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 %
Relat.Ped.Dose 3,8 - 19,5 %

References

  1. Hale TW. Hale's Medications & Mothers' Milk. Springer Publishing Company. 2019
  2. AEMPS. Retirada del mercado de medicamentos que contienen ranitidina vía oral. Nota informativa. 2019 Full text (in our servers)
  3. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. 11th edition (acces on line) 2017
  4. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  5. 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)
  6. 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)
  7. Petit A, Piednoir D, Germain ML, Trenque T. [Drug-induced hyperprolactinemia: a case-non-case study from the national pharmacovigilance database]. Therapie. 2003 Abstract
  8. 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
  9. Hagemann TM. Gastrointestinal medications and breastfeeding. J Hum Lact. 1998 Sep;14(3):259-62. Review. Abstract
  10. Bennett PN. Drugs and human lactation, 2nd ed. Amsterdam. Elsevier. 1996. 1996
  11. Kearns GL, McConnell RF Jr, Trang JM, Kluza RB. Appearance of ranitidine in breast milk following multiple dosing. Clin Pharm. 1985 Abstract
  12. Roberts CJ. Clinical pharmacokinetics of ranitidine. Clin Pharmacokinet. 1984 Abstract
  13. 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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