Last update Aug. 4, 2022

Indomethacin; Indometacin

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

It is a non-steroidal anti-inflammatory drug (NSAID), derived from indole acetic acid, which is used for the symptomatic treatment of chronic musculoskeletal pain, to induce closure of a patent ductus arteriosus in premature babies and, topically, in certain ophthalmological processes. Oral, rectal or eye drop administration in three daily doses.

It is excreted into breast milk in non-significant clinically amounts. Usually, breast milk and infant plasma levels have been found to be undetectable. (Beaulac 1993, Lebedevs 1991)

There has not been side-effects described in children from treated mothers (Li 1994, Lebedevs 1991), except for a case reported in 1978 with convulsions in a newborn infant whose mother received a higher dose than recommended (Eeg 1978). However, a causal relationship was questioned by other author in the same publication.

It has been successfully used with no side-effects on treated mothers who had high levels of Prostaglandin E (PGE) whose infants were suffering of “physiologic diarrhea. (Li 1994)

This drug is used in neonates. Expert authors consider the use of this medication probably compatible during breastfeeding. (Hale, LactMed, Bordini 2016, Briggs 2015, Risser 2009, Østensen 2007, Nice 2004, Lee 1993). The American Academy of Pediatrics rates it as usually compatible with breastfeeding. (AAP 2001)

Until more published data is known about this drug in relation to breastfeeding, known safer alternatives are preferable, especially during the neonatal period and in the event of prematurity.

Alternatives

  • Ibuprofen ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Paracetamol ( 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

Indomethacin; Indometacin is also known as


Indomethacin; Indometacin in other languages or writings:

Tradenames

Main tradenames from several countries containing Indomethacin; Indometacin in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 90 %
Molecular weight 358 daltons
Protein Binding 90 - 99 %
VD 0.34 - 1.57 l/Kg
pKa 3.79 -
Tmax 1 - 2 hours
4.5 (2.6 - 11.2) hours
M/P ratio 0.4 -
Theoretical Dose 0.017 mg/Kg/d
Relative Dose 2.1 %
Ped.Relat.Dose 0.9 - 1.7 %

References

  1. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on March 17, 2022 Full text (link to original source)
  2. LactMed. Drugs and Lactation Database (LactMed). Internet. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/ 2006 - Consulted on March 15, 2022 Full text (link to original source)
  3. Bordini CA, Roesler C, Carvalho Dde S, Macedo DD, Piovesan É, Melhado EM, Dach F, Kowacs F, Silva Júnior HM, Souza JA, Maciel JA Jr, Carvalho JJ, Speciali JG, Barea LM, Queiroz LP, Ciciarelli MC, Valença MM, Lima MM, Vincent MB. Recommendations for the treatment of migraine attacks - a Brazilian consensus. Arq Neuropsiquiatr. 2016 Abstract Full text (link to original source) Full text (in our servers)
  4. 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
  5. Risser A, Donovan D, Heintzman J, Page T. NSAID prescribing precautions. Am Fam Physician. 2009 Abstract Full text (link to original source) Full text (in our servers)
  6. Østensen M, Motta M. Therapy insight: the use of antirheumatic drugs during nursing. Nat Clin Pract Rheumatol. 2007 Abstract
  7. Nice FJ, De Eugenio D, Dimino TA, Freeny IC, Rovnack MB, Gromelski JS. Medications and Breast-Feeding: A Guide for Pharmacists, Pharmacy Technicians, and Other Healthcare Professionals. Part I. J Pharm Technol 2004;20:17-27. doi: 10.1177/875512250402000106.
  8. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Abstract Full text (link to original source) Full text (in our servers)
  9. Janssen NM, Genta MS. The effects of immunosuppressive and anti-inflammatory medications on fertility, pregnancy, and lactation. Arch Intern Med. 2000 Abstract Full text (link to original source) Full text (in our servers)
  10. Li SY, Geng ZC, Wang AZ, Gao YL, Li M, Wang HD, Wang WY. The relationship between PGE2 level in mothers' milk and physiological diarrhea of the baby and the treatment. Chin Med J (Engl). 1994 Abstract
  11. Lee JJ, Rubin AP. Breast feeding and anaesthesia. Anaesthesia. 1993 Jul;48(7):616-25. Review. Abstract Full text (link to original source) Full text (in our servers)
  12. Beaulac-Baillargeon L, Allard G. Distribution of indomethacin in human milk and estimation of its milk to plasma ratio in vitro. Br J Clin Pharmacol. 1993 Abstract Full text (link to original source) Full text (in our servers)
  13. Lebedevs TH, Wojnar-Horton RE, Yapp P, Roberts MJ, Dusci LJ, Hackett LP, Ilett KF. Excretion of indomethacin in breast milk. Br J Clin Pharmacol. 1991 Abstract Full text (link to original source) Full text (in our servers)
  14. Helleberg L. Clinical Pharmacokinetics of indomethacin. Clin Pharmacokinet. 1981 Abstract
  15. Eeg-Olofsson O, Malmros I, Elwin CE, Steen B. Convulsions in a breast-fed infant after maternal indomethacin. Lancet. 1978 Abstract
  16. Fairhead FW. Convulsions in a breast-fed infant after maternal indomethacin. Lancet. 1978 Abstract

Total visits

75,784

Help us improve this entry

How to cite this entry

Do you need more information or did not found what you were looking for?

   Write us at elactancia.org@gmail.com

e-lactancia is a resource recommended by Asociación Española de Bancos de Leche Humana of Spain

Would you like to recommend the use of e-lactancia? Write to us at corporate mail of APILAM