Last update: May 11, 2019

Dextropropoxyphene

High Risk for breastfeeding


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

An opioid analgesic with a similar structure to methadone indicated for mild to moderate pain relief.
Oral administration every 4 hours.
It is metabolized to norpropoxyphene, which has a very long elimination half-life (30 to 36 hours).

It is excreted in breastmilk in very small quantities (Mylan 2009, Kunka 1985 and 1984), but potentially serious side effects have been reported (hypotonia, lack of weight gain, apneas, bradycardia, cyanosis) in newborns whose breastfeeding mothers were taking it. (Soasan 2014, Rigourd 2008, Naumburg 1988). It is believed that this may be due to the slow elimination of the norpropoxyphene metabolite in adults, which is still much slower in newborns, so there may be accumulation in young infants (Mylan 2009, Spigset 2000).

The American Academy of Pediatrics initially considered it to be a medication which is usually compatible with breastfeeding (AAP 2001). Subsequently, it does not recommend its use during breastfeeding (Sachs 2013),

During breastfeeding, safer known alternatives are preferable, especially during the neonatal period and in cases of prematurity.

It has been withdrawn from sale due to lack of efficacy and potentially serious side effects (EMA 2010, FDA 2010).

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

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.

Group

Dextropropoxyphene belongs to this group or family:

Tradenames

Main tradenames from several countries containing Dextropropoxyphene in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 35 %
Molecular weight 340 daltons
Protein Binding 80 %
VD 16 l/Kg
Tmax 2 - 2,5 hours
T1/2 6 -12 (Norp: 30 - 36) hours
M/P ratio 0,5 -

References

  1. Soussan C, Gouraud A, Portolan G, Jean-Pastor MJ, Pecriaux C, Montastruc JL, Damase-Michel C, Lacroix I. Drug-induced adverse reactions via breastfeeding: a descriptive study in the French Pharmacovigilance Database. Eur J Clin Pharmacol. 2014 Abstract
  2. 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)
  3. FDA Drug Safety Communication. FDA recommends against the continued use of propoxyphene. 2010 Full text (link to original source) Full text (in our servers)
  4. EMA. Questions and answers on the withdrawal of the marketing authorisations for medicines containing dextropropoxyphene. 2010 Full text (link to original source) Full text (in our servers)
  5. Mylan. Dextropropoxyphene. Drug Summary. 2009 Full text (in our servers)
  6. Rigourd V, Amirouche A, Tasseau A, Kintz P, Serreau R. Retrospective diagnosis of an adverse drug reaction in a breastfed neonate: liquid chromatography-tandem mass spectrometry quantification of dextropropoxyphene and norpropoxyphene in newborn and maternal hair. J Anal Toxicol. 2008 Abstract
  7. Spigset O, Hägg S. Analgesics and breast-feeding: safety considerations. Paediatr Drugs. 2000 Abstract
  8. Naumburg EG, Meny RG. Breast milk opioids and neonatal apnea. Am J Dis Child. 1988 Abstract
  9. Kunka RL, Yong CL, Ladik CF, Bates TR. Liquid chromatographic determination of propoxyphene and norpropoxyphene in plasma and breast milk. J Pharm Sci. 1985 Abstract
  10. Kunka RL, Venkataramanan R, Stern RM, Ladik CF. Excretion of propoxyphene and norpropoxyphene in breast milk. Clin Pharmacol Ther. 1984 Abstract

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