Amisulpride


Concise Prescribing Info
Indications/Uses
Acute psychosis.
Dosage/Direction for Use
Adult : PO 400-800 mg bid. Max: 1.2 g/day. Patients w/ predominantly negative symptoms: 50-300 mg/day.
Dosage Details
Oral
Acute psychosis
Adult: 400-800 mg bid. Max: 1.2 g daily. Patients w/ predominantly negative symptoms: 50-300 mg daily.
Renal Impairment
CrCl (mL/min) Dosage
10-30 One-third of the usual dose.
31-60 Half the usual dose.
Administration
Should be taken on an empty stomach. Preferably taken before meals.
Contraindications
Phaeochromocytoma, concomitant prolactin-dependent tumours (e.g. pituitary gland prolactinomas or breast cancer). Pre-pubertal childn. Combination w/ levodopa.
Special Precautions
Patient w/ history of epilepsy; Parkinson's disease, CV disease. Avoid abrupt withdrawal. Renal impairment. Elderly. Pregnancy and lactation.
Adverse Reactions
Insomnia, anxiety, agitation, drowsiness, wt gain, acute dystonia, parkinsonism, akathisia, tardive dyskinesia, QT prolongation, hypotension, bradycardia, GI disorders (e.g. constipation, nausea, vomiting, dry mouth), hyperglycaemia; breast pain, erectile dysfunction, amenorrhoea, gynaecomastia, galactorrhoea. Rarely, allergic reactions, abnormal LFTs, seizures.
Potentially Fatal: Neuroleptic malignant syndrome.
Patient Counseling Information
This drug may cause somnolence, if affected, may impair ability to drive or operate machinery.
Overdosage
Symptoms: Generalised convulsions, coma, motor restlessness, tachycardia, slight prolongation of the QT interval, drowsiness, sedation, hypotension, extrapyramidal symptoms. Management: Symptomatic and supportive treatment. Institute close supervision of vital functions including continuous cardiac monitoring until patient recovers. Perform gastric lavage. In case severe extrapyramidal symptoms occur, administer anticholinergic agents.
Drug Interactions
Increased risk of arrhythmias w/ cisapride, thioridazine, halofantrine, erythromycin, some antiarrhythmics, pimozide, haloperidol, TCAs, β-blockers, some Ca channel blockers, clonidine, guanfacine, digoxin, K-depleting diuretics, lithium, antimalarials. May enhance effects of antihypertensives and CNS depressants (e.g. sedative H1-antihistamines, narcotics, anaesthetics, analgesics, barbiturates, benzodiazepines, other anxiolytics, clonidine and derivatives).
Potentially Fatal: Reciprocal antagonism between levodopa and neuroleptics.
Food Interaction
May enhance central effects of alcohol.
Action
Description: Amisulpride is a substituted benzamide atypical antipsychotic which binds selectively w/ a high affinity to human dopaminergic D2 and D3 receptor subtypes.
Pharmacokinetics:
Absorption: Absorbed from GI tract. Bioavailability: Approx 48%. Time to peak plasma concentration: 1 hr (initial); 3-4 hr (2nd).
Distribution: Volume of distribution: 5.8 L/kg. Plasma protein binding: Approx 16%.
Metabolism: Limited metabolism.
Excretion: Mainly via urine as unchanged drug. Terminal elimination half-life: Approx 12 hr.
Chemical Structure

Chemical Structure Image
Amisulpride

Source: National Center for Biotechnology Information. PubChem Database. Amisulpride, CID=2159, https://pubchem.ncbi.nlm.nih.gov/compound/Amisulpride (accessed on Jan. 20, 2020)

Storage
Store below 25°C.
MIMS Class
References
Buckingham R (ed). Amisulpride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 17/11/2014.

Joint Formulary Committee. Amisulpride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 17/11/2014.

Disclaimer: This information is independently developed by MIMS based on Amisulpride from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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