Last update Aug. 15, 2022

Methadone Hydrochloride

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

It is an opioid analgesic used to treat moderate to severe pain, opioid dependence, and neonatal opioid withdrawal syndrome. Oral, intramuscular, intravenous and subcutaneous administration.

It is excreted in breast milk in clinically non-significant amount. (Bogen 2011, Nikolaou 2008, Jansson 2008 & 2007, Begg 2001, McCarthy 2000, Wojnar 1997, Geraghty 1997, Pond 1985, Kreek 1979 & 1974, Blinick 1975)

No problems in the short or long term have been observed in infants whose mothers were treated. (Malpas 1999, Wojnar 1997, Blinick 1975)

Plasma levels of these infants were undetectable or very low. (Jansson 2008 & 2008, Wojnar 1997)

Exposure of the newborn to methadone through breast milk is insufficient to prevent the development of a neonatal withdrawal syndrome  (Wojnar 1997). The dose that gets the infant through the mother's milk, even when taking 70-150 mg a-day, is much lower than that used to treat neonatal abstinence syndrome. This is a reason for not using it as a solely measure of treatment.

Neonatal methadone withdrawal syndrome is less common, less severe, with less need for pharmacological treatment, and occurs later in breastfed infants than in non-breastfed infants (McQueen 2019, Wachman 2017, Short 2016, Liu 2015, Bagley 2014, Sutter 2014, Welle 2013, Pritham 2012, Hodgson 2012, McQueen 2011, Isemann 2011, Dryden 2009, Jansson 2008, Miles 2007, Abdel 2006, Arlettaz 2005, Malpas 1997). Neonatal abstinence syndrome can occur after abrupt weaning in infants of mothers on methadone maintenance. Weaning should be gradual to avoid its appearance. (Isemann 2011, Malpas 1999)

Methadone can cause galactorrhea due to increased prolactin secretion. (Bennett 2006, Tolis 1978)

The frequency and duration of breastfeeding are very low in opiate-dependent mothers. (Wachman 2010, Jansson 2004). Many newborns of mothers with drug addiction are either premature or underweight infants, and over 60% develop withdrawal syndrome at about one post-natal month. Breastfeeding with regard to the entire context of addictive behavior is neither easy nor frequently achieved. Much help is needed on supporting addicted mothers by health and social services in the community.

Expert authors consider the use of this medication compatible during breastfeeding (Hale, ACOG 2017, ABM 2015, Briggs 2015, Schaefer 2015, Kocherlakota 2014, Bagley 2014, Sachs 2013, Logan 2013, Rowe 2013, D'Apolito 2013, Nice 2004, Moretti 2000). American Academy of Pediatrics: medication usually compatible with breastfeeding.(AAP 2001)

It should be reinforced that it is observed a non-polydrug behavior and adequacy of maternal care is maintained.

...

 

 

Alternatives

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

Methadone Hydrochloride is also known as


Methadone Hydrochloride in other languages or writings:

Groups

Methadone Hydrochloride belongs to these groups or families:

Tradenames

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

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 50 (35 - 90) %
Molecular weight 346 daltons
Protein Binding 85 - 90 %
VD 4.1 (2 -7) l/Kg
Tmax 1.5 - 5 hours
7 - 59 hours
M/P ratio 0.7 - 1.2 -
Theoretical Dose 0.02 - 0.08 mg/Kg/d
Relative Dose 1.2 - 7 %
Ped.Relat.Dose 8 %

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. McQueen K, Taylor C, Murphy-Oikonen J. Systematic Review of Newborn Feeding Method and Outcomes Related to Neonatal Abstinence Syndrome. J Obstet Gynecol Neonatal Nurs. 2019 Jul;48(4):398-407. Abstract
  3. ACOG Committee on Health Care for Underserved Women; American Society of Addiction Medicine. ACOG Committee Opinion No. 711: Opioid Use and Opioid Use Disorder in Pregnancy. Obstet Gynecol. 2017 Abstract Full text (link to original source) Full text (in our servers)
  4. 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)
  5. 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
  6. 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)
  7. 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)
  8. Liu A, Juarez J, Nair A, Nanan R. Feeding modalities and the onset of the neonatal abstinence syndrome. Front Pediatr. 2015 Feb 26;3:14. Abstract Full text (link to original source)
  9. Schaefer C, Peters P, Miller RK. Drugs During Pregnancy and Lactation. Treatment options and risk assessment. Elsevier, Third Edition. 2015
  10. 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
  11. Sutter MB, Leeman L, Hsi A. Neonatal opioid withdrawal syndrome. Obstet Gynecol Clin North Am. 2014 Abstract
  12. Kocherlakota P. Neonatal abstinence syndrome. Pediatrics. 2014 Abstract Full text (link to original source) Full text (in our servers)
  13. 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)
  14. Logan BA, Brown MS, Hayes MJ. Neonatal abstinence syndrome: treatment and pediatric outcomes. Clin Obstet Gynecol. 2013 Abstract Full text (link to original source) Full text (in our servers)
  15. 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)
  16. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  17. D'Apolito K. Breastfeeding and substance abuse. Clin Obstet Gynecol. 2013 Mar;56(1):202-11. Abstract
  18. 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
  19. Pritham UA, Paul JA, Hayes MJ. Opioid dependency in pregnancy and length of stay for neonatal abstinence syndrome. J Obstet Gynecol Neonatal Nurs. 2012 Abstract Full text (link to original source) Full text (in our servers)
  20. Hodgson ZG, Abrahams RR. A rooming-in program to mitigate the need to treat for opiate withdrawal in the newborn. J Obstet Gynaecol Can. 2012 Abstract
  21. Isemann B, Meinzen-Derr J, Akinbi H. Maternal and neonatal factors impacting response to methadone therapy in infants treated for neonatal abstinence syndrome. J Perinatol. 2011 Abstract
  22. Bogen DL, Perel JM, Helsel JC, Hanusa BH, Thompson M, Wisner KL. Estimated infant exposure to enantiomer-specific methadone levels in breastmilk. Breastfeed Med. 2011 Abstract Full text (link to original source) Full text (in our servers)
  23. McQueen KA, Murphy-Oikonen J, Gerlach K, Montelpare W. The impact of infant feeding method on neonatal abstinence scores of methadone-exposed infants. Adv Neonatal Care. 2011 Abstract
  24. Wachman EM, Byun J, Philipp BL. Breastfeeding rates among mothers of infants with neonatal abstinence syndrome. Breastfeed Med. 2010 Abstract
  25. Dryden C, Young D, Hepburn M, Mactier H. Maternal methadone use in pregnancy: factors associated with the development of neonatal abstinence syndrome and implications for healthcare resources. BJOG. 2009 Abstract Full text (link to original source) Full text (in our servers)
  26. Jansson LM, Choo R, Velez ML, Lowe R, Huestis MA. Methadone maintenance and long-term lactation. Breastfeed Med. 2008 Abstract Full text (link to original source) Full text (in our servers)
  27. Nikolaou PD, Papoutsis II, Maravelias CP, Spiliopoulou CA, Pistos CM, Calokerinos AC, Atta-Politou J. Development and validation of an EI-GC-MS method for the determination of methadone and its major metabolites (EDDP and EMDP) in human breast milk. J Anal Toxicol. 2008 Sep;32(7):478-84. Abstract Full text (link to original source)
  28. Jansson LM, Choo R, Velez ML, Harrow C, Schroeder JR, Shakleya DM, Huestis MA. Methadone maintenance and breastfeeding in the neonatal period. Pediatrics. 2008 Abstract
  29. Miles J, Sugumar K, Macrory F, Sims DG, D'Souza SW. Methadone-exposed newborn infants: outcome after alterations to a service for mothers and infants. Child Care Health Dev. 2007 Abstract
  30. Jansson LM, Choo RE, Harrow C, Velez M, Schroeder JR, Lowe R, Huestis MA. Concentrations of methadone in breast milk and plasma in the immediate perinatal period. J Hum Lact. 2007 Abstract Full text (link to original source) Full text (in our servers)
  31. Bennett J, Whale R. Galactorrhoea may be associated with methadone use. BMJ. 2006 Abstract Full text (link to original source) Full text (in our servers)
  32. Abdel-Latif ME, Pinner J, Clews S, Cooke F, Lui K, Oei J. Effects of breast milk on the severity and outcome of neonatal abstinence syndrome among infants of drug-dependent mothers. Pediatrics. 2006 Abstract
  33. Arlettaz R, Kashiwagi M, Das-Kundu S, Fauchère JC, Lang A, Bucher HU. Methadone maintenance program in pregnancy in a Swiss perinatal center (II): neonatal outcome and social resources. Acta Obstet Gynecol Scand. 2005 Abstract
  34. 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.
  35. Jansson LM, Velez M, Harrow C. Methadone maintenance and lactation: a review of the literature and current management guidelines. J Hum Lact. 2004 Abstract
  36. Begg EJ, Malpas TJ, Hackett LP, Ilett KF. Distribution of R- and S-methadone into human milk during multiple, medium to high oral dosing. Br J Clin Pharmacol. 2001 Abstract Full text (link to original source) Full text (in our servers)
  37. 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)
  38. McCarthy JJ, Posey BL. Methadone levels in human milk. J Hum Lact. 2000 Abstract
  39. Moretti ME, Lee A, Ito S. Which drugs are contraindicated during breastfeeding? Practice guidelines. Can Fam Physician. 2000 Sep;46:1753-7. Review. Abstract Full text (link to original source) Full text (in our servers)
  40. Malpas TJ, Darlow BA. Neonatal abstinence syndrome following abrupt cessation of breastfeeding. N Z Med J. 1999 Abstract
  41. Wojnar-Horton RE, Kristensen JH, Yapp P, Ilett KF, Dusci LJ, Hackett LP. Methadone distribution and excretion into breast milk of clients in a methadone maintenance programme. Br J Clin Pharmacol. 1997 Abstract Full text (link to original source) Full text (in our servers)
  42. Geraghty B, Graham EA, Logan B, Weiss EL. Methadone levels in breast milk. J Hum Lact. 1997 Abstract
  43. Pond SM, Kreek MJ, Tong TG, Raghunath J, Benowitz NL. Altered methadone pharmacokinetics in methadone-maintained pregnant women. J Pharmacol Exp Ther. 1985 Apr;233(1):1-6. Abstract
  44. Kreek MJ. Methadone disposition during the perinatal period in humans. Pharmacol Biochem Behav. 1979 Abstract
  45. Tolis G, Dent R, Guyda H. Opiates, prolactin, and the dopamine receptor. J Clin Endocrinol Metab. 1978 Jul;47(1):200-3. Abstract
  46. Blinick G, Inturrisi CE, Jerez E, Wallach RC. Methadone assays in pregnant women and progeny. Am J Obstet Gynecol. 1975 Mar 1;121(5):617-21. Abstract
  47. Kreek MJ, Schecter A, Gutjahr CL, Bowen D, Field F, Queenan J, Merkatz I. Analyses of methadone and other drugs in maternal and neonatal body fluids: use in evaluation of symptoms in a neonate of mother maintained on methadone. Am J Drug Alcohol Abuse. 1974 Abstract

Total visits

21,199

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 IHAN of Spain

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