281
Views
5
CrossRef citations to date
0
Altmetric
Drug Profile

A pharmacological profile of intravenous amisulpride for the treatment of postoperative nausea and vomiting

&
Pages 331-340 | Received 11 Dec 2019, Accepted 25 Mar 2020, Published online: 15 Apr 2020

References

  • Smith HS, Smith EJ, Smith BR. Postoperative nausea and vomiting. Ann Palliat Med. 2012;1(2):94–102.
  • Koivuranta M, Läärä E, Snare L, et al. A survey of postoperative nausea and vomiting. Anaesthesia. 1997;52(5):443–449.
  • Kovac AL. Prevention and treatment of postoperative nausea and vomiting. Drugs. 2000;59(2):213–243.
  • Apfel CC, Läärä E, Koivuranta M, et al. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999;91(3):693–700.
  • Apfel CC, Roewer N. Risk assessment of postoperative nausea and vomiting. Int Anesthesiol Clin. 2003;41(4):13–32.
  • Macario A, Weinger M, Carney S, et al. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652–658.
  • Lachaine J. Therapeutic options for the prevention and treatment of postoperative nausea and vomiting: a pharmacoeconomic review. Pharmacoeconomics. 2006;24(10):955–970.
  • Hirsch J. Impact of postoperative nausea and vomiting in the surgical setting. Anaesthesia. 1994;49(Suppl):30–33.
  • Eberhart LH, Morin AM, Wulf H, et al. Patient preferences for immediate postoperative recovery. Br J Anaesth. 2002;89(5):760–761.
  • De Winter HL, Verlinde CL, Blaton NM, et al. Structure of the neuroleptic drug 4-amino-N-1-[(1-ethyl-2-pyrrolidinyl)methyl]-5-(ethylsulfonyl)-2- methoxybenzamide (amisulpride). Acta Crystallogr C. 1990 Feb 15;46(Pt 2):313–317.
  • Abbas AI, Hedlund PB, Huang XP, et al. Amisulpride is a potent 5-HT7 antagonist: relevance for antidepressant actions in vivo. Psychopharmacology (Berl). 2009;205(1):119–128.
  • Schoemaker H, Claustre Y, Fage D, et al. Neurochemical characteristics of amisulpride, an atypical dopamine D2/D3 receptor antagonist with both presynaptic and limbic selectivity. J Pharmacol Exp Ther. 1997;280(1):83–97.
  • Casey DE. Neuroleptic-induced acute extrapyramidal syndromes and tardive dyskinesia. Psychiatr Clin North Am. 1993 Sep;16(3):589–610.
  • Barnes TR, McPhillips MA. Novel antipsychotics, extrapyramidal side effects and tardive dyskinesia. Int Clin Psychopharmacol. 1998 Mar;13(Suppl 3):S49–S57.
  • Moller HJ. Amisulpride: limbic specificity and the mechanism of antipsychotic atypicality. Prog Neuropsychopharmacol Biol Psychiatry. 2003;27(7):1101–1111.
  • Seeman P, Tallerico T. Antipsychotic drugs which elicit little or no parkinsonism bind more loosely than dopamine to brain D2 receptors, yet occupy high levels of these receptors. Mol Psychiatry. 1998;3(2):123–134.
  • Coulouvrat C, Dondey-Nouvel L. Safety of amisulpride (Solian): a review of 11 clinical studies. Int Clin Psychopharmacol. 1999 Jul;14(4):209–218.
  • Rein W, Coulouvrat C, Dondey-Nouvel L. Safety profile of amisulpride in short- and long-term use. Acta Psychiatr Scand Suppl. 2000;400:23–27.
  • Borison HL. Area postrema: chemoreceptor circumventricular organ of the medulla oblongata. Prog Neurobiol. 1989;32(5):351–390.
  • Habib AS, Gan TJ. The use of droperidol before and after the Food and Drug Administration black box warning: a survey of the members of the Society of Ambulatory Anesthesia. J Clin Anesth. 2008;20(1):35–39.
  • Yoshida N, Yoshikawa T, Hosoki K. A dopamine D3 receptor agonist, 7-OH-DPAT, causes vomiting in the dog. Life Sci. 1995;57(21):PL347–50.
  • Darmani NA, Zhao W, Ahmad B. The role of D2 and D3 dopamine receptors in the mediation of emesis in Cryptotis parva (the least shrew). J Neural Transm (Vienna). 1999;106(11–12):1045–1061.
  • Horn CC, Wallisch WJ, Homanics GE, et al. Pathophysiological and neurochemical mechanisms of postoperative nausea and vomiting. Eur J Pharmacol. 2014;722:55–66.
  • Kline DD, Takacs KN, Ficker E, et al. Dopamine modulates synaptic transmission in the nucleus of the solitary tract. J Neurophysiol. 2002 Nov;88(5):2736–2744.
  • Sanger GJ, Andrews PLR. A history of drug discovery for treatment of nausea and vomiting and the implications for future research. Front Pharmacol. 2018;9:913.
  • Besser GM, Delitala G, Grossman A, et al. Chlorpromazine, haloperidol, metoclopramide and domperidone release prolactin through dopamine antagonism at low concentrations but paradoxically inhibit prolactin release at high concentrations. Br J Pharmacol. 1980;71(2):569–573.
  • Fox GM, Roffel AF, Hartstra J, et al. Metabolism and excretion of intravenous, radio-labeled amisulpride in healthy, adult volunteers. Clin Pharmacol. 2019;11:161–169.
  • Schwoerer AP, Blutner C, Brandt S, et al. Molecular interaction of droperidol with human ether-a-go-go-related gene channels: prolongation of action potential duration without inducing early afterdepolarization. Anesthesiology. 2007 May;106(5):967–976.
  • Suessbrich H, Schonherr R, Heinemann SH, et al. The inhibitory effect of the antipsychotic drug haloperidol on HERG potassium channels expressed in Xenopus oocytes. Br J Pharmacol. 1997 Mar;120(5):968–974.
  • Silvestre JS, Prous JR. Comparative evaluation of hERG potassium channel blockade by antipsychotics. Methods Find Exp Clin Pharmacol. 2007;29(7):457–465.
  • Charbit B, Albaladejo P, Funck-Brentano C, et al. Prolongation of QTc interval after postoperative nausea and vomiting treatment by droperidol or ondansetron. Anesthesiology. 2005 Jun;102(6):1094–1100.
  • Darpo B. Spectrum of drugs prolonging QT interval and the incidence of torsades de pointes. Eur Heart J Suppl. 2001;3:K70–K80.
  • Yap YG, Camm AJ. Drug induced QT prolongation and torsades de pointes. Heart. 2003 Nov;89(11):1363–1372.
  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Topic E14. The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. 2005. cited 2020 Feb 20. Available from: https://database.ich.org/sites/default/files/E14_Guideline.pdf
  • Taubel J, Ferber G, Fox G, et al. Thorough QT study of the effect of intravenous amisulpride on QTc interval in Caucasian and Japanese healthy subjects. Br J Clin Pharmacol. 2017 Feb;83(2):339–348.
  • Fox GM, Albayaty M, Walker JL, et al. Intravenous amisulpride does not meaningfully prolong the QTc interval at doses effective for the management of postoperative nausea and vomiting. Anesth Analg. 2019. DOI:10.1213/ANE.0000000000004538.
  • Dos Santos Pereira JN, Tadjerpisheh S, Abu Abed M, et al. The poorly membrane permeable antipsychotic drugs amisulpride and sulpiride are substrates of the organic cation transporters from the SLC22 family. Aaps J. 2014 Nov;16(6):1247–1258.
  • Kapur S, Langlois X, Vinken P, et al. The differential effects of atypical antipsychotics on prolactin elevation are explained by their differential blood-brain disposition: a pharmacological analysis in rats. J Pharmacol Exp Ther. 2002 Sep;302(3):1129–1134.
  • Canal M, Espie P, Thenot JP. Amisulpride: metabolic and pharmacokinetic profile after 14C intravenous administration. Eur Neuropsychopharmacol. 2002;12(Supplement 3):310.
  • Gillet G, Dormerque L, Canal M, et al. Amisulpride does not inhibit cytochrome P450 isozymes. Eur Neuropsychopharmacol. 2000;10(Supplement 3):331–332.
  • Dufour A, Desanti C. Pharmacocinétique et métabolisme de l’amisulpride. Ann Gen Psychiatry. 1988;3(3bis):298–305.
  • Fisher DS, van Schalkwyk GI, Seedat S, et al. Plasma, oral fluid, and whole-blood distribution of antipsychotics and metabolites in clinical samples. Ther Drug Monit. 2013 Jun;35(3):345–351.
  • Spina E, de Leon J. Metabolic drug interactions with newer antipsychotics: a comparative review. Basic Clin Pharmacol Toxicol. 2007 Jan;100(1):4–22.
  • Canal M, Fraisse J, Thenot JP. Amisulpride: metabolic and pharmacokinetic profile after 14C oral administration. Eur Neuropsychopharmacol. 2002;12(Supplement 3):319.
  • UKPAR on Amisulpride 50mg, 100mg and 200mg tablets PL 19364/0044-6. Amisulpride 400mg film-coated tablets PL 19364/0047. London: Medicines and Healthcare products Regulatory Agency; 2010.
  • Canal M, MacMahon M, Kwan J, et al. Amisulpride: kinetics in patients with renal failure. Eur Neuropsychopharmacol. 2000;10(Supplement 3):330.
  • Hamon-Vilcot B, Chaufour S, Deschamps C, et al. Safety and pharmacokinetics of a single oral dose of amisulpride in healthy elderly volunteers. Eur J Clin Pharmacol. 1998;54(5):405–409.
  • Apfel CC, Roewer N, Korttila K. How to study postoperative nausea and vomiting. Acta Anaesthesiol Scand. 2002;46(8):921–928.
  • Kranke P, Eberhart L, Motsch J, et al. I.V. APD421 (amisulpride) prevents postoperative nausea and vomiting: a randomized, double-blind, placebo-controlled, multicentre trial. Br J Anaesth. 2013 Dec;111(6):938–945.
  • Gan TJ, Kranke P, Minkowitz HS, et al. Intravenous amisulpride for the prevention of postoperative nausea and vomiting: two concurrent, randomized, double-blind, placebo-controlled trials. Anesthesiology. 2017 Feb;126(2):268–275.
  • Kranke P, Bergese SD, Minkowitz HS, et al. Amisulpride prevents postoperative nausea and vomiting in patients at high risk: a randomized, double-blind, placebo-controlled trial. Anesthesiology. 2018 Jun;128(6):1099–1106.
  • Apfel CC, Korttila K, Abdalla M, et al. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004 Jun 10;350(24):2441–2451.
  • Gan TJ, Diemunsch P, Habib AS, et al. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85–113.
  • Feldheiser A, Aziz O, Baldini G, et al. Enhanced Recovery After Surgery (ERAS) for gastrointestinal surgery, part 2: consensus statement for anaesthesia practice. Acta Anaesthesiol Scand. 2016 Mar;60(3):289–334.
  • Rüsch D, Eberhart LH, Wallenborn J, et al. Nausea and vomiting after surgery under general anesthesia: an evidence-based review concerning risk assessment, prevention, and treatment. Dtsch Arztebl Int. 2010;107(42):733–741.
  • ASPAN’s evidence-based clinical practice guideline for the prevention and/or management of PONV/PDNV. J Perianesth Nurs. 2006;21(4):230–250.
  • McCracken G, Houston P, Lefebvre G, et al. Guideline for the management of postoperative nausea and vomiting. J Obstet Gynaecol Can. 2008 Jul;30(7):600–7, 608–16.
  • Claybon L. Single dose intravenous ondansetron for the 24-hour treatment of postoperative nausea and vomiting. Anaesthesia. 1994;49(Suppl):24–29.
  • Kovac AL, Scuderi PE, Boerner TF, et al. Treatment of postoperative nausea and vomiting with single intravenous doses of dolasetron mesylate: a multicenter trial. Dolasetron mesylate PONV treatment study group. Anesth Analg. 1997;85(3):546–552.
  • Diemunsch P, Conseiller C, Clyti N, et al. Ondansetron compared with metoclopramide in the treatment of established postoperative nausea and vomiting. The French Ondansetron study group. Br J Anaesth. 1997;79(3):322–326.
  • Taylor AM, Rosen M, Diemunsch PA, et al. A double-blind, parallel-group, placebo-controlled, dose-ranging, multicenter study of intravenous granisetron in the treatment of postoperative nausea and vomiting in patients undergoing surgery with general anesthesia. J Clin Anesth. 1997 Dec;9(8):658–663.
  • Kovac AL, O’Connor TA, Pearman MH, et al. Efficacy of repeat intravenous dosing of ondansetron in controlling postoperative nausea and vomiting: a randomized, double-blind, placebo-controlled multicenter trial. J Clin Anesth. 1999;11(6):453–459.
  • Candiotti KA, Nhuch F, Kamat A, et al. Granisetron versus ondansetron treatment for breakthrough postoperative nausea and vomiting after prophylactic ondansetron failure: a pilot study. Anesth Analg. 2007;104(6):1370–1373.
  • Candiotti KA, Ahmed SR, Cox D, et al. Palonosetron versus ondansetron as rescue medication for postoperative nausea and vomiting: a randomized, multicenter, open-label study. BMC Pharmacol Toxicol. 2014;15:45.
  • Candiotti KA, Kranke P, Bergese SD, et al. Randomized, double-blind, placebo-controlled study of intravenous amisulpride as treatment of established postoperative nausea and vomiting in patients who have had no prior prophylaxis. Anesth Analg. 2019 Jun;128(6):1098–1105.
  • Habib AS, Kranke P, Bergese SD, et al. Amisulpride for the rescue treatment of postoperative nausea or vomiting in patients failing prophylaxis: a randomized, placebo-controlled phase III trial. Anesthesiology. 2019 Feb;130(2):203–212.
  • Juruena MF, de Sena EP, de Oliveira IR. Safety and tolerability of antipsychotics: focus on amisulpride. Drug Healthc Patient Saf. 2010;2:205–211.
  • Gan TJ, Meyer TA, Apfel CC, et al. Society for ambulatory anesthesia guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2007;105(6):1615–1628.
  • Gan TJ, Sinha AC, Kovac AL, et al. A randomized, double-blind, multicenter trial comparing transdermal scopolamine plus ondansetron to ondansetron alone for the prevention of postoperative nausea and vomiting in the outpatient setting. Anesth Analg. 2009;108(5):1498–1504.
  • Diemunsch P, Gan TJ, Philip BK, et al. Single-dose aprepitant vs ondansetron for the prevention of postoperative nausea and vomiting: a randomized, double-blind phase III trial in patients undergoing open abdominal surgery. Br J Anaesth. 2007;99(2):202–211.
  • Gan TJ, Apfel CC, Kovac A, et al. A randomized, double-blind comparison of the NK1 antagonist, aprepitant, versus ondansetron for the prevention of postoperative nausea and vomiting. Anesth Analg. 2007 May;104(5):1082–1089. tables of contents.
  • Wang JJ, Ho ST, Tzeng JI, et al. The effect of timing of dexamethasone administration on its efficacy as a prophylactic antiemetic for postoperative nausea and vomiting. Anesth Analg. 2000 Jul;91(1):136–139.
  • Habib AS, Reuveni J, Taguchi A, et al. A comparison of ondansetron with promethazine for treating postoperative nausea and vomiting in patients who received prophylaxis with ondansetron: a retrospective database analysis. Anesth Analg. 2007 Mar;104(3):548–551.
  • Sheth HS, Verrico MM, Skledar SJ, et al. Promethazine adverse events after implementation of a medication shortage interchange. Ann Pharmacother. 2005 Feb;39(2):255–261.
  • Apfelbaum JL, Silverstein JH, Chung FF, et al. Practice guidelines for postanesthetic care: an updated report by the American Society of Anesthesiologists task force on postanesthetic care. Anesthesiology. 2013 Feb;118(2):291–307.
  • Macario A, Claybon L, Pergolizzi JV. Anesthesiologists’ practice patterns for treatment of postoperative nausea and vomiting in the ambulatory post anesthesia care unit. BMC Anesthesiol. 2006;6:6.
  • Franck M, Radtke FM, Apfel CC, et al. Documentation of post-operative nausea and vomiting in routine clinical practice. J Int Med Res. 2010 May-Jun;38(3):1034–1041.
  • Franck M, Radtke FM, Baumeyer A, et al. Adherence to treatment guidelines for postoperative nausea and vomiting. How well does knowledge transfer result in improved clinical care?. Anaesthesist. 2010 Jun;59(6):524–528.
  • Kooij FO, Klok T, Hollmann MW, et al. Decision support increases guideline adherence for prescribing postoperative nausea and vomiting prophylaxis. Anesth Analg. 2008 Mar;106(3):893–898.
  • Kooij FO, Klok T, Hollmann MW, et al. Automated reminders increase adherence to guidelines for administration of prophylaxis for postoperative nausea and vomiting. Eur J Anaesthesiol. 2010 Feb;27(2):187–191.
  • Frenzel JC, Kee SS, Ensor JE, et al. Ongoing provision of individual clinician performance data improves practice behavior. Anesth Analg. 2010 Aug;111(2):515–519.
  • Gan TJ, Meyer T, Apfel CC, et al. Consensus guidelines for managing postoperative nausea and vomiting. Anesth Analg. 2003;97(1):62–71.
  • Kranke P, Diemunsch P. The 2014 consensus guidelines for the management of postoperative nausea and vomiting: a leapfrog towards a postoperative nausea and vomiting-free hospital. Eur J Anaesthesiol. 2014 Dec;31(12):651–653.
  • Kranke P. Effective management of postoperative nausea and vomiting: let us practise what we preach! Eur J Anaesthesiol. 2011 Mar;28(3):152–154.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.