Sulpiride


Generic Medicine Info
Indications and Dosage
Oral
Schizophrenia
Adult: Dosage is individualised according to patient response and the predominant symptoms manifested. In patients with mainly positive symptoms: Initially, 400 mg bid, increased as necessary. Max: 1,200 mg bid. In patients with mainly negative symptoms: 200-400 mg bid. Max: 800 mg daily. In patients with mixed positive and negative symptoms (neither predominating): 400-600 mg bid.
Child: ≥14 years Same as adult dose.
Renal Impairment
Dosage adjustment may be necessary. Severe: Contraindicated.
Hepatic Impairment
Severe: Contraindicated.
Administration
May be taken with or without food.
Contraindications
Known or suspected phaeochromocytoma, acute porphyria, severe haematologic disorders including bone marrow suppression, CNS depression, prolactin-dependent tumours (e.g. pituitary gland prolactinomas, breast cancer), alcohol intoxication. Severe renal and hepatic impairment. Concomitant use with levodopa or antiparkinsonian drugs.
Special Precautions
Patient with hypomania, risk factors for blood dyscrasias (e.g. pre-existing low WBC, history of drug induced leucopenia or neutropenia); pre-existing abnormal lipid profile; predisposition to aspiration pneumonia (e.g. Alzheimer disease); risk factors for tardive dyskinesia (e.g. pseudoparkinsonism symptoms, major depressive disorder, previous brain damage, postmenopausal women, alcoholism); history of impulse control disorder; CV disease, risk factors for Qt prolongation (e.g. family history, congenital prolongation of QT interval, bradycardia, hypokalaemia); Lewy body dementia, Parkinson’s disease; current or risk factors for diabetes mellitus, hypertension, history of jaundice, ileac or pyloric stenosis, current or family history of angle-closure glaucoma, myasthenia gravis; prostatic hyperplasia or urinary retention; severe respiratory disorder; unstable epilepsy or history of seizures. Avoid abrupt withdrawal. Renal and hepatic impairment. Elderly particularly in those with dementia-related psychosis. Pregnancy and lactation.
Adverse Reactions
Significant: Blood dyscrasias (e.g. leucopenia, neutropenia, agranulocytosis), dyslipidaemia, oesophaegeal dysmotility/aspiration, extrapyramidal symptoms (e.g. akathisia, tardive dyskinesia, pseudoparkinsonism, acute dystonic reactions), hyperglycaemia, hyperprolactinaemia, impulse control disorders (e.g. pathological gambling, uncontrolled sexual urges, uncontrolled spending, binge eating), photosensitivity, weight gain, lowered seizure threshold, hypertensive crisis; somnolence, orthostatic hypotension, motor or sensory instability leading to an increased risk of falls. Rarely, agitation/mania, venous thromboembolism.
Gastrointestinal disorders: Constipation.
Investigations: Increased liver enzymes.
Musculoskeletal and connective tissue disorders: Tremor.
Nervous system disorders: Sedation, drowsiness.
Psychiatric disorders: Insomnia.
Reproductive system and breast disorders: Galactorrhoea, mastalgia
Skin and subcutaneous tissue disorders: Maculopapular rash.
Potentially Fatal: Significant hyperglycaemia associated with ketoacidosis or hyperosmolar coma; QT prolongation and ventricular arrhythmias (e.g. torsades de pointes). Rarely, neuroleptic malignant syndrome.
Patient Counseling Information
This drug may cause drowsiness, dizziness, or slowing of reaction time, if affected, do not drive or operate machinery. Avoid or minimise exposure to sunlight (including sunlamps), if exposure cannot be avoided, use sunscreens or protective clothing.
Monitoring Parameters
Monitor mental status; vital sign as clinically indicated; blood pressure (at baseline and after 3 months of therapy, then annually); weight, height, BMI, waist circumference (at baseline, then at 4, 8, 12 weeks after initiating or changing therapy, then quarterly); CBC as clinically indicated; electrolytes and LFT (annually or as needed); fasting glucose, HBA1C, lipid profile (at baseline, then after 3 months from initiation, and as necessary). Monitor changes in menstruation, reproductive function. Monitor for signs and symptoms of Parkinson's and tardive dyskinesia.
Overdosage
Symptoms: Restlessness, clouding of consciousness, extrapyramidal symptoms, agitation, confusion, low blood pressure, coma. Management: Symptomatic and supportive treatment. Sulpiride may be partially removed by haemodialysis or treated with alkaline osmotic diuresis. May administer anti-parkinsonian drugs, if necessary.
Drug Interactions
Increased risk of torsades de pointes with β-blockers, some Ca channel blockers (e.g. diltiazem, verapamil, clonidine); diuretics, stimulant laxatives, amphotericin B; Class Ia antiarrhythmic drugs (e.g. quinidine, disopyramide); Class III antiarrhythmic drugs (e.g. amiodarone, sotalol); pimozide, haloperidol, imipramine, antidepressants. Enhanced postural hypotension with other antihypertensive drugs. Decreased bioavailability with antacids or sucralfate. Increased risk of extrapyramidal side effects with lithium. May reduce effectiveness of ropinirole. Antagonism of effects of dopaminergic agents (e.g. bromocriptine, amantadine, cabergoline, lisuride). Potentiated sedative and hypotensive effects with opioid analgesics.
Potentially Fatal: Reciprocal antagonism of effects between levodopa and neuroleptics.
Food Interaction
Enhanced sedative effects with alcohol.
Action
Description: Sulpiride is a substituted benzamide antipsychotic. It is a selective antagonist of central dopamine (D2, D3, D4) receptors.
Onset: Schizophrenia: Within 1-2 weeks.
Pharmacokinetics:
Absorption: Moderately well absorbed from the gastrointestinal tract. Time to peak plasma concentration: 3-6 hours. Bioavailability: 25-40%
Distribution: Rapidly distributed to the tissues; poorly distributed to the blood-brain barrier; crosses the placenta, enters breast milk (low concentration). Plasma protein binding: Approx 40%.
Metabolism: Not significantly metabolised (5% as the inactive metabolite 5-oxypyrrolidinyl sulpiride).
Excretion: Via urine and faeces (95%, as unchanged drug). Elimination half-life: Approx 3-10 hours.
Chemical Structure

Chemical Structure Image
Sulpiride

Source: National Center for Biotechnology Information. PubChem Database. Sulpiride, CID=5355, https://pubchem.ncbi.nlm.nih.gov/compound/Sulpiride (accessed on Jan. 23, 2020)

Storage
Store below 25°C.
MIMS Class
Antipsychotics
ATC Classification
N05AL01 - sulpiride ; Belongs to the class of benzamides antipsychotics.
References
Anon. Sulpiride. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/06/2021.

Buckingham R (ed). Sulpiride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/06/2021.

Joint Formulary Committee. Sulpiride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/06/2021.

Sulpin F.C. Tablet (Averroes Pharmaceuticals Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 01/06/2021.

Sulpiride Rosemont 200 mg/5 mL Oral Solution (Rosemont Pharmaceuticals Ltd). MHRA. https://products.mhra.gov.uk. Accessed 01/06/2021.

Sulpiride Tablets 400 mg (Generics [UK] Ltd). MHRA. https://products.mhra.gov.uk. Accessed 01/06/2021.

Disclaimer: This information is independently developed by MIMS based on Sulpiride 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 © 2021 MIMS. All rights reserved. Powered by MIMS.com
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