Last update June 18, 2022

塩酸ドキセピン

Very High Risk

Very unsafe. Contraindicated. Use of an alternative or cessation of breastfeeding. Read the Comment.

A tricyclic antidepressant dibenzoxepine with actions and uses similar to amitriptyline with major antihistaminic, antimuscarinic and sedative properties. Indicated in the treatment of certain states of depression, anxiety and psychosis. Oral administration in one or two daily doses.

Although it is concentrated in breastmilk rather than in plasma (Weissman 2004), the amount in breastmilk is very small (Frey 1999, Matheson 1985, Kemp 1985), but in two recorded cases the infants, 9 days (Frey 1999) and 8 weeks of age (Matheson 1985), presented hypotonia, vomiting and weight loss (Frey 1999) as well as pallor, drowsiness and respiratory depression (Matheson 1985).

An infant whose mother started treatment with doxepin a month postpartum did not have any problems during the little more than three months she continued with breastfeeding. (Kemp 1985)

Plasma levels of doxepin in these three infants ranged from undetectable in the 9-day-old infant (Frey 1999), undetectable to very low in the one-and-a-half-month-old infant (Kemp 1985) and high, similar to those of maternal plasma in the 8 week-old infant. (Sachs 2013, Matheson 1985).

It is believed that the ability to metabolize and excrete doxepin is minimal before 15 days of age and improves after 2 - 3 months of age. (Wisner 1996, Pons 1994) 

Until there is more published data on this drug in relation to breastfeeding, safer known alternatives are preferable (Uguz 2021, Gjerdingen 2003, Håberg 1997), especially during the neonatal period (first month) and in case of prematurity.

Women suffering from depression during pregnancy need more breastfeeding support due to their increased risk of breastfeeding problems and early weaning. (Grzeskowiak 2018, Leggett 2017, Venkatesh 2017, Gorman 2012)


See below the information of these related products:

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

塩酸ドキセピン is Doxepin Hydrochloride in Japanese.

Is written in other languages:

Groups

塩酸ドキセピン belongs to these groups or families:

Tradenames

Main tradenames from several countries containing 塩酸ドキセピン in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 30 %
Molecular weight 316 daltons
Protein Binding 76 - 80 %
VD 170 l/Kg
pKa 9.76 -
Tmax 1 - 3.5 hours
31 hours
M/P ratio 1.4 -
Theoretical Dose 0.01 - 0.03 mg/Kg/d
Relative Dose 0.8 - 2.5 %

References

  1. Govindan K, Mandadi GD. Alopecia in Breastfed Infant Possibly Due to Mother Getting Valproate. Indian J Pediatr. 2021 May;88(5):519-520. Abstract
  2. Uguz F. A New Safety Scoring System for the Use of Psychotropic Drugs During Lactation. Am J Ther. 2021 Jan-Feb 01;28(1):e118-e126. Abstract
  3. Grzeskowiak LE, Leggett C, Costi L, Roberts CT, Amir LH. Impact of serotonin reuptake inhibitor use on breast milk supply in mothers of preterm infants: a retrospective cohort study. Br J Clin Pharmacol. 2018 Jun;84(6):1373-1379. Abstract Full text (link to original source)
  4. Venkatesh KK, Castro VM, Perlis RH, Kaimal AJ. Impact of antidepressant treatment during pregnancy on obstetric outcomes among women previously treated for depression: an observational cohort study. J Perinatol. 2017 Sep;37(9):1003-1009. Abstract
  5. Leggett C, Costi L, Morrison JL, Clifton VL, Grzeskowiak LE. Antidepressant Use in Late Gestation and Breastfeeding Rates at Discharge from Hospital. J Hum Lact. 2017 Nov;33(4):701-709. Abstract
  6. 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)
  7. Gorman JR, Kao K, Chambers CD. Breastfeeding among women exposed to antidepressants during pregnancy. J Hum Lact. 2012 Abstract
  8. Gjerdingen D. The effectiveness of various postpartum depression treatments and the impact of antidepressant drugs on nursing infants. J Am Board Fam Pract. 2003 Abstract Full text (link to original source) Full text (in our servers)
  9. Frey OR, Scheidt P, von Brenndorff AI. Adverse effects in a newborn infant breast-fed by a mother treated with doxepin. Ann Pharmacother. 1999 Jun;33(6):690-3. Abstract
  10. Wisner KL, Perel JM, Findling RL. Antidepressant treatment during breast-feeding. Am J Psychiatry. 1996 Sep;153(9):1132-7. Review. Abstract
  11. Pons G, Rey E, Matheson I. Excretion of psychoactive drugs into breast milk. Pharmacokinetic principles and recommendations. Clin Pharmacokinet. 1994 Abstract
  12. Matheson I, Pande H, Alertsen AR. Respiratory depression caused by N-desmethyldoxepin in breast milk. Lancet. 1985 Nov 16;2(8464):1124. No abstract available. Abstract
  13. Kemp J, Ilett KF, Booth J, Hackett LP. Excretion of doxepin and N-desmethyldoxepin in human milk. Br J Clin Pharmacol. 1985 Nov;20(5):497-9. Abstract

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