Last update June 14, 2022

Amisulpride

Likely Compatibility

Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

It is an atypical substituted benzamide antipsychotic. It is used in the management of psychoses such as schizophrenia and also in depression. Oral administration in two daily doses or intramuscularly.

It is excreted in breast milk in a small amount, but it could become clinically significant (RD 1.8% to 11%). (OʼHalloran 2016, Teoh 2011, Ilett 2010)

No problems have been observed in infants of mothers treated with amisulpride. (Uguz 2016;23, Teoh 2011)

Possibly due to poor passage into milk and low oral bioavailability, low plasma levels were found in these infants: between 4% and 10% of the maternal serum concentration. (OʼHalloran 2016, Ilett 2010)

Like other benzamide-based substances, it may increase serum levels of Prolactin and induce galactorrhea. (Zhenhua 2022, Glocker 2021, Lee 2012, Ružić 2011, Mendhekar 2009, Raj 2008, Paparrigopoulos 2007, Bushe 2007, Kopecek 2004, Kropp 2004, Fric 2003)

Until more data on this drug is available, a safer alternative should be chosen (Uguz 2021 y 2016;36, Pacchiarotti 2016), mostly during neonatal period and with prematurity.


See below the information of these related products:

Alternatives

  • Olanzapine (Safe substance and/or breastfeeding is the best option.)
  • Quetiapine Fumarate (Safe substance and/or breastfeeding is the best option.)
  • Risperidone (Safe substance and/or breastfeeding is the best option.)

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.

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Other names

Amisulpride in other languages or writings:

Groups

Amisulpride belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Amisulpride in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 48 %
Molecular weight 370 daltons
Protein Binding 25 - 30 %
VD 5.8 l/Kg
pKa 14.03 -
Tmax 1 - 4 hours
T½ 12 hours
M/P ratio 19.5 -
Theoretical Dose 0.24 - 0.53 mg/Kg/d
Relative Dose 1.8 - 10.7 %

References

  1. Zhenhua W, Haizhi C, Jing L, Xiaocong F, Jianhua L, Jianjun L, Lilei L, Haiying J. Occurrence of macroprolactinemia in schizophrenia patients treated with risperidone or amisulpride. Asia Pac Psychiatry. 2022 Mar;14(1):e12469. Consulted on May 27, 2022 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. Glocker C, Grohmann R, Engel R, Seifert J, Bleich S, Stübner S, Toto S, Schüle C. Galactorrhea during antipsychotic treatment: results from AMSP, a drug surveillance program, between 1993 and 2015. Eur Arch Psychiatry Clin Neurosci. 2021 Dec;271(8):1425-1435. Abstract
  4. Uguz F. Second-Generation Antipsychotics During the Lactation Period: A Comparative Systematic Review on Infant Safety. Am J Ther. 2016;36(3):244-52. Abstract
  5. Uguz F. Breastfed Infants Exposed to Combined Antipsychotics: Two Case Reports. Am J Ther. 2016;23(6):e1962-e1964. Abstract
  6. Pacchiarotti I, León-Caballero J, Murru A, Verdolini N, Furio MA, Pancheri C, Valentí M, Samalin L, Roigé ES, González-Pinto A, Montes JM, Benabarre A, Crespo JM, de Dios Perrino C, Goikolea JM, Gutiérrez-Rojas L, Carvalho AF, Vieta E. Mood stabilizers and antipsychotics during breastfeeding: Focus on bipolar disorder. Eur Neuropsychopharmacol. 2016 Oct;26(10):1562-78. Abstract
  7. OʼHalloran SJ, Wong A, Joyce DA. A Liquid Chromatography-Tandem Mass Spectrometry Method for Quantifying Amisulpride in Human Plasma and Breast Milk, Applied to Measuring Drug Transfer to a Fully Breast-Fed Neonate. Ther Drug Monit. 2016 Aug;38(4):493-8. Abstract
  8. Lee BH, Kang SG, Kim TW, Lee HJ, Yoon HK, Park YM. Hyperprolactinemia induced by low-dosage amisulpride in Korean psychiatric patients. Psychiatry Clin Neurosci. 2012 Abstract
  9. Ružić K, Grahovac T, Graovac M, Dadić-Hero E, Sepić-Grahovac D, Sabljić V. Hyperprolactinaemia with amisulpride. Psychiatr Danub. 2011 Mar;23(1):92-4. Abstract
  10. Teoh S, Ilett KF, Hackett LP, Kohan R. Estimation of rac-amisulpride transfer into milk and of infant dose via milk during its use in a lactating woman with bipolar disorder and schizophrenia. Breastfeed Med. 2011 Abstract
  11. Ilett KF, Watt F, Hackett LP, Kohan R, Teoh S. Assessment of infant dose through milk in a lactating woman taking amisulpride and desvenlafaxine for treatment-resistant depression. Ther Drug Monit. 2010 Abstract
  12. Mendhekar D, Lohia D. Amisulpride and galactorrhoea: delayed or withdrawal? World J Biol Psychiatry. 2009;10(4 Pt 3):1041-2. Abstract
  13. Raj R, Sidhu BS. Hyperprolactinaemia with amisulpride. Indian J Psychiatry. 2008 Abstract
  14. Paparrigopoulos T, Liappas J, Tzavellas E, Mourikis I, Soldatos C. Amisulpride-induced hyperprolactinemia is reversible following discontinuation. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Abstract
  15. Bushe C, Shaw M. Prevalence of hyperprolactinaemia in a naturalistic cohort of schizophrenia and bipolar outpatients during treatment with typical and atypical antipsychotics. J Psychopharmacol. 2007 Sep;21(7):768-73. Epub 2007 Jul 2. Abstract
  16. Kropp S, Ziegenbein M, Grohmann R, Engel RR, Degner D. Galactorrhea due to psychotropic drugs. Pharmacopsychiatry. 2004 Mar;37 Suppl 1:S84-8. Abstract
  17. Kopecek M, Bares M, Svarc J, Dockery C, Horácek J. Hyperprolactinemia after low dose of amisulpride. Neuro Endocrinol Lett. 2004 Abstract
  18. Fric M, Laux G. [Prolactin Levels and Symptoms of Hyperprolactinemia in Patients Treated with Amisulpride, Risperidone, Olanzapine and Quetiapine] Psychiatr Prax. 2003 Abstract
  19. Rosenzweig P, Canal M, Patat A, Bergougnan L, Zieleniuk I, Bianchetti G. A review of the pharmacokinetics, tolerability and pharmacodynamics of amisulpride in healthy volunteers. Hum Psychopharmacol. 2002 Abstract

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