Last update Aug. 3, 2022

Buprenorphine Hydrochloride

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

Buprenorphine is an opioid analgesic, partial opioid agonist, used for relief of moderate to severe pain and as an adjunct to anesthesia. It is also used in the maintenance treatment of opioid dependence. Intramuscular, intravenous, sublingual or subdermal implant administration.

It is excreted in breast milk in clinically insignificant amount. (Jansson 2016, Swortwood 2016, Ilett 2012, Lindemalm 2009, Grimm 2005, Johnson 2001, Marquet 1997)

No problems have been observed in infants whose mothers have taken it. (Gower 2014, Ilett 2012, Johnson 2001, Marquet 1997)

Plasma or urinary levels in these infants were very low or undetectable. (Jansson 2016, Swortwood 2016, Lindemalm 2009)

Extradural buprenorphine after cesarean section decreased breast milk production and infant weight gain. (Hirose 1997)

It has been noticed a mild abstinence syndrome after birth when sudden withdrawn occurred. (Elladki 2011). Gradual weaning from breastfeeding is advised (Kocherlakota 2014). Breastfeeding reduces the need for withdrawal treatment in opioid-exposed infants during pregnancy (Wong 2018, Wachman 2017, Short 2016, Welle 2013, O'Connor 2013), although not always with significant differences. (​Welle 2013, O'Connor 2013)

There are studies that find a higher frequency of breastfeeding with buprenorphine than with methadone (Yonke 2019). In others, the frequency of breastfeeding was similar and very low in mothers treated for opioid dependence with methadone or buprenorphine. (Wachman 2010, Lejeune 2001) 

Several medical societies and experts authors consider the use of this medication to be safe or very probably safe during breastfeeding. (Committee 2017, ABM 2015, Bagley 2014, Kocherlakota 2014, Sachs 2013, Wong 2011)

Alternatives

We do not have alternatives for Buprenorphine Hydrochloride since it is relatively safe.

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

Buprenorphine Hydrochloride in other languages or writings:

Groups

Buprenorphine Hydrochloride belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Buprenorphine Hydrochloride in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 31 %
Molecular weight 504 daltons
Protein Binding 96 %
Tmax 0.5 hours
24 hours
M/P ratio 1.7 -
Theoretical Dose 0.00006 - 0.002 mg/Kg/d
Relative Dose 0.3 - 2.4 %

References

  1. Yonke N, Maston R, Weitzen S, Leeman L. Breastfeeding Intention Compared With Breastfeeding Postpartum Among Women Receiving Medication-Assisted Treatment. J Hum Lact. 2019 Feb;35(1):71-79. Abstract
  2. Wong J, Saver B, Scanlan JM, Gianutsos LP, Bhakta Y, Walsh J, Plawman A, Sapienza D, Rudolf V. Does Maternal Buprenorphine Dose Affect Severity or Incidence of Neonatal Abstinence Syndrome? J Addict Med. 2018 Nov/Dec;12(6):435-441. Abstract
  3. Wachman EM, Hayes MJ, Sherva R, Brown MS, Shrestha H, Logan BA, Heller NA, Nielsen DA, Farrer LA. Association of maternal and infant variants in PNOC and COMT genes with neonatal abstinence syndrome severity. Am J Addict. 2017 Jan;26(1):42-49. Abstract Full text (link to original source)
  4. [No authors listed] Committee Opinion No. 711: Opioid Use and Opioid Use Disorder in Pregnancy. Obstet Gynecol. 2017 Aug;130(2):e81-e94. Abstract
  5. Swortwood MJ, Scheidweiler KB, Barnes AJ, Jansson LM, Huestis MA. Simultaneous quantification of buprenorphine, naloxone and phase I and II metabolites in plasma and breastmilk by liquid chromatography-tandem mass spectrometry. J Chromatogr A. 2016 May 13;1446:70-7. Abstract
  6. Jansson LM, Spencer N, McConnell K, Velez M, Tuten M, Harrow CA, Jones HE, Swortwood MJ, Barnes AJ, Scheidweiler KB, Huestis MA. Maternal Buprenorphine Maintenance and Lactation. J Hum Lact. 2016 Nov;32(4):675-681. Abstract
  7. Short VL, Gannon M, Abatemarco DJ. The Association Between Breastfeeding and Length of Hospital Stay Among Infants Diagnosed with Neonatal Abstinence Syndrome: A Population-Based Study of In-Hospital Births. Breastfeed Med. 2016 Sep;11:343-9. Abstract
  8. ABM Protocolo clínico de la ABM n.º 21: Pautas para la lactancia y el consumo de sustancias o trastorno por consumo de sustancias, revisado en 2015. Breastfeed Med. 2015 Full text (link to original source) Full text (in our servers)
  9. ABM. Reece-Stremtan S, Marinelli KA. ABM Clinical Protocol #21: Guidelines for Breastfeeding and Substance Use or Substance Use Disorder, Revised 2015. Breastfeed Med. 2015 Abstract Full text (link to original source) Full text (in our servers)
  10. Gower S, Bartu A, Ilett KF, Doherty D, McLaurin R, Hamilton D. The wellbeing of infants exposed to buprenorphine via breast milk at 4 weeks of age. J Hum Lact. 2014 May;30(2):217-23. Abstract
  11. Kocherlakota P. Neonatal abstinence syndrome. Pediatrics. 2014 Abstract Full text (link to original source) Full text (in our servers)
  12. Bagley SM, Wachman EM, Holland E, Brogly SB. Review of the assessment and management of neonatal abstinence syndrome. Addict Sci Clin Pract. 2014 Abstract Full text (link to original source) Full text (in our servers)
  13. Sachs HC; Committee On Drugs. The transfer of drugs and therapeutics into human breast milk: an update on selected topics. Pediatrics. 2013 Sep;132(3):e796-809. Abstract Full text (link to original source) Full text (in our servers)
  14. Welle-Strand GK, Skurtveit S, Jansson LM, Bakstad B, Bjarkø L, Ravndal E. Breastfeeding reduces the need for withdrawal treatment in opioid-exposed infants. Acta Paediatr. 2013 Abstract
  15. O'Connor AB, Collett A, Alto WA, O'Brien LM. Breastfeeding rates and the relationship between breastfeeding and neonatal abstinence syndrome in women maintained on buprenorphine during pregnancy. J Midwifery Womens Health. 2013 Jul-Aug;58(4):383-8. Abstract
  16. Ilett KF, Hackett LP, Gower S, Doherty DA, Hamilton D, Bartu AE. Estimated dose exposure of the neonate to buprenorphine and its metabolite norbuprenorphine via breastmilk during maternal buprenorphine substitution treatment. Breastfeed Med. 2012 Aug;7:269-74. Abstract
  17. Elladki H, Thill P. Buprenorphine withdrawal in an infant after cessation of breastfeeding: A case report and review of the literature. Pharmacotherapy. 2011;31:435e. Abstract 453 Full text (link to original source) Full text (in our servers)
  18. Wong S, Ordean A, Kahan M; Society of Obstetricians and Gynecologists of Canada.. SOGC clinical practice guidelines: Substance use in pregnancy: no. 256, April 2011. Int J Gynaecol Obstet. 2011 Aug;114(2):190-202. Abstract
  19. Wachman EM, Byun J, Philipp BL. Breastfeeding rates among mothers of infants with neonatal abstinence syndrome. Breastfeed Med. 2010 Abstract
  20. Lindemalm S, Nydert P, Svensson JO, Stahle L, Sarman I. Transfer of buprenorphine into breast milk and calculation of infant drug dose. J Hum Lact. 2009 May;25(2):199-205. Abstract
  21. Grimm D, Pauly E, Pöschl J, Linderkamp O, Skopp G. Buprenorphine and norbuprenorphine concentrations in human breast milk samples determined by liquid chromatography-tandem mass spectrometry. Ther Drug Monit. 2005 Aug;27(4):526-30. Abstract
  22. OMS. Comité de Expertos de la OMS en Farmacodependencia. Examen crítico de psicofármacos. OMS. Serie de informes técnicos, 33 informe. 2003 Full text (in our servers)
  23. WHO Expert Committee on Drug Dependence. Critical review of psychoactive substances. WHO Technical Report Series. Thirty-third Report 2003 Full text (link to original source) Full text (in our servers)
  24. Johnson RE, Jones HE, Jasinski DR, Svikis DS, Haug NA, Jansson LM, Kissin WB, Alpan G, Lantz ME, Cone EJ, Wilkins DG, Golden AS, Huggins GR, Lester BM. Buprenorphine treatment of pregnant opioid--dependent women: maternal and neonatal outcomes. Drug Alcohol Depend. 2001 Jun 1;63(1):97-103. Abstract
  25. Lejeune C, Aubisson S, Simmat-Durand L, Cneude F, Piquet M, Gourarier L; Groupe d'Etudes Grossesse et addictions.. [Withdrawal syndromes of newborns of pregnant drug abusers maintained under methadone or high-dose buprenorphine: 246 cases]. Ann Med Interne (Paris). 2001 Nov;152 Suppl 7:21-7. French. Abstract
  26. Marquet P, Chevrel J, Lavignasse P, Merle L, Lachâtre G. Buprenorphine withdrawal syndrome in a newborn. Clin Pharmacol Ther. 1997 Nov;62(5):569-71. Abstract
  27. Hirose M, Hosokawa T, Tanaka Y. Extradural buprenorphine suppresses breast feeding after caesarean section. Br J Anaesth. 1997 Abstract Full text (link to original source) Full text (in our servers)

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