Last update June 18, 2022

Дулоксетина Гидрохлорид

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

It is a selective serotonin and norepinephrine reuptake inhibitor antidepressant. Oral administration once a day.

Excreted into breast milk in clinically non-significant amount (Collin 2018, Andrade 2014, Rowe 2013, Boyce 2011, Berle 2011, Briggs 2009, EMA 2009, Lanza 2009, Lobo 2008) with no side-effects being observed in breastfed infants from treated mothers (Briggs 2009).

Plasma level in those infants was very low or undetectable (Boyce 2011, Briggs 2009).

Galactorrhea has been observed with or without an increase in prolactin (Derle 2021, Özkan 2020, Luo 2019, McGrane 2019, Demirci 2015, Belli 2013, Korkmaz 2011), but less frequently than with other antidepressants. (Trenque 2011)

Expert authors consider the use of this medication possible during breastfeeding. (Hale, Uguz 2021, Larsen 2015)

Because there is less experience published than with other antidepressants of the same pharmacological group, it should be preferred the use of an alternative drug that is known to be safer in the neonatal period or prematurity.

Women who use antidepressant medication during pregnancy are in need of more support for breastfeeding since they are at risk for early weaning (Leggett 2017).


See below the information of this related product:

  • Maternal Depression (Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)

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

Дулоксетина Гидрохлорид is Duloxetine in Cyrillic.

Is written in other languages:

Дулоксетина Гидрохлорид is also known as

Groups

Дулоксетина Гидрохлорид belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Дулоксетина Гидрохлорид in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 50 (32 - 80) %
Molecular weight 334 daltons
Protein Binding 96 %
VD 23.4 l/Kg
pKa 9.5 -
Tmax 6 hours
12 (8- 17) hours
M/P ratio 0.27 - 1.3 -
Theoretical Dose 0.004 - 0.01 mg/Kg/d
Relative Dose 0.3 - 1 %

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. Derle E, Can U. Hyperprolactinemia and galactorrhea with duloxetine in neuropathic pain management. Agri. 2021 Oct;33(4):268-271. Abstract
  3. 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
  4. Özkan HM. [Duloxetine Associated Galactorrhea and Hyperprolactinemia: A Case Report]. Turk Psikiyatri Derg. 2020 Winter;31(4):294-296. Turkish. Abstract
  5. McGrane IR, Morefield CM, Aytes KL. Probable Galactorrhea Associated with Sequential Trials of Escitalopram and Duloxetine in an Adolescent Female. J Child Adolesc Psychopharmacol. 2019 Dec;29(10):788-789. Abstract
  6. Luo T, Liu QS, Yang YJ, Wei B. Aripiprazole for the treatment of duloxetine-induced hyperprolactinemia: A case report. J Affect Disord. 2019 May 1;250:330-332. Abstract
  7. Collin-Lévesque L, El-Ghaddaf Y, Genest M, Jutras M, Leclair G, Weisskopf E, Panchaud A, Ferreira E. Infant Exposure to Methylphenidate and Duloxetine During Lactation. Breastfeed Med. 2018 Abstract
  8. 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
  9. Larsen ER, Damkier P, Pedersen LH, Fenger-Gron J, Mikkelsen RL, Nielsen RE, Linde VJ, Knudsen HE, Skaarup L, Videbech P. Use of psychotropic drugs during pregnancy and breast-feeding. Acta Psychiatr Scand Suppl. 2015 Abstract
  10. Demirci S, Unubol M, Demirci K. Galactorrhea With Normal Prolactin Levels Associated With Duloxetine. J Clin Psychopharmacol. 2015 Abstract
  11. Andrade C. The safety of duloxetine during pregnancy and lactation. J Clin Psychiatry. 2014 Abstract Full text (link to original source) Full text (in our servers)
  12. Belli H, Akbudak M, Ural C. Duloxetine-related galactorrhea and restless legs syndrome: a case report. Psychiatr Danub. 2013 Abstract Full text (link to original source) Full text (in our servers)
  13. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  14. Korkmaz S, Kuloğlu M, Işık U, Sağlam S, Atmaca M. Galactorrhea during duloxetine treatment: a case report. Turk Psikiyatri Derg. 2011 Abstract
  15. Trenque T, Herlem E, Auriche P, Dramé M. Serotonin reuptake inhibitors and hyperprolactinaemia: a case/non-case study in the French pharmacovigilance database. Drug Saf. 2011 Abstract
  16. Boyce PM, Hackett LP, Ilett KF. Duloxetine transfer across the placenta during pregnancy and into milk during lactation. Arch Womens Ment Health. 2011 Abstract
  17. Berle JO, Spigset O. Antidepressant Use During Breastfeeding. Curr Womens Health Rev. 2011 Abstract Full text (link to original source) Full text (in our servers)
  18. EMA. Duloxetina. Ficha técnica. 2009 Full text (in our servers)
  19. Lanza di Scalea T, Wisner KL. Antidepressant medication use during breastfeeding. Clin Obstet Gynecol. 2009 Abstract Full text (link to original source) Full text (in our servers)
  20. EMA. Duloxetine. Drug Summary. 2009 Full text (in our servers)
  21. Briggs GG, Ambrose PJ, Ilett KF, Hackett LP, Nageotte MP, Padilla G. Use of duloxetine in pregnancy and lactation. Ann Pharmacother. 2009 Abstract
  22. Lobo ED, Loghin C, Knadler MP, Quinlan T, Zhang L, Chappell J, Lucas R, Bergstrom RF. Pharmacokinetics of duloxetine in breast milk and plasma of healthy postpartum women. Clin Pharmacokinet. 2008 Abstract

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