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Sulpiride


Generic Medicine Info
Indications and Dosage
Oral
Schizophrenia
Adult: In patients with mainly positive symptoms: Initially, 400 mg bid; may increase as necessary. Max: 1,200 mg bid. In patients with mainly negative symptoms: Initially, 400 mg bid; may reduce to 200 mg bid to increase alerting effect. In patients with mixed positive and negative symptoms (with neither predominating): 400-600 mg bid. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
Elderly: Use lower initial dose; may increase gradually according to response. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
Child: ≥14 years Same as adult dose. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
What are the brands available for Sulpiride in Malaysia?
  • Dogmatil 200 mg
  • Dogmatil 50 mg
  • Sulpin
Renal Impairment
Dose adjustment may be necessary; increase dose in small increments. Severe: Contraindicated.
Hepatic Impairment
Severe: Contraindicated.
Administration
Sulpiride May be taken with or without food.
Contraindications
Known or suspected phaeochromocytoma, prolactin-dependent tumours (e.g. breast cancer, pituitary gland prolactinomas), acute porphyria; severe haematologic disorders including bone marrow suppression; alcohol intoxication and other disorders that cause CNS depression. Severe renal and hepatic impairment. Concomitant administration with levodopa or other antiparkinsonian drugs (e.g. ropinirole). Contraindications may vary among countries and between individual products (refer to specific product guidelines).
Special Precautions
Patient with hypomania, unstable epilepsy or history of seizures, current or family history of angle-closure glaucoma, prostatic hyperplasia or urinary retention, ileus, congenital digestive stenosis; myasthenia gravis, Parkinson's disease, Lewy body dementia, severe respiratory disorder, current or risk factors for diabetes mellitus, history of jaundice, hypertension, risk factors for QT prolongation (e.g. family history of QT prolongation, congenital QT interval prolongation, CV disease, bradycardia, hypokalaemia), risk factors for stroke, pre-existing abnormal lipid profile, risk factors for blood dyscrasia (e.g. pre-existing low WBC, history of drug-induced leucopenia or neutropenia), personal or family history of breast cancer. Not indicated for the treatment of dementia-related psychosis. Avoid abrupt withdrawal. Mild to moderate renal impairment. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Leucopenia, neutropenia, agranulocytosis, extrapyramidal symptoms (e.g. akathisia, tardive dyskinesia, pseudoparkinsonism, acute dystonic reactions), oesophageal dysmotility/aspiration, hyperglycaemia, hyperprolactinaemia; photosensitivity (high doses); weight gain, seizures, hypertensive crisis; somnolence, orthostatic hypotension which may increase the risk of falls. Rarely, agitation (high doses).
Gastrointestinal disorders: Constipation.
Investigations: Increased liver enzymes.
Nervous system disorders: Sedation.
Psychiatric disorders: Insomnia.
Reproductive system and breast disorders: Breast pain, galactorrhoea.
Skin and subcutaneous tissue disorders: Maculopapular rash.
Potentially Fatal: QT prolongation and serious ventricular arrhythmias (e.g. torsades de pointes), neuroleptic malignant syndrome, venous thromboembolism.
Patient Counseling Information
This drug may cause drowsiness, if affected, do not drive or operate machinery. Avoid exposure to direct sunlight; if exposure cannot be avoided, use sunscreens or protective clothing.
Monitoring Parameters
Correct hypokalaemia before treatment initiation. Evaluate history of metabolic syndrome; mental status, adherence, and fall risk (every visit). Monitor CBC, ECG (as clinically indicated); electrolyte levels, renal and liver function (annually); blood pressure, temperature, pulse rate (every visit and 4 weeks after dose change); weight, height, or BMI (8 and 12 weeks after starting treatment and dose change, then quarterly). Obtain prolactin level (particularly if symptoms are reported); fasting blood glucose or HbA1c, lipid panel (12 weeks after treatment initiation and dose change, then annually; check more frequently than annually if abnormal). Assess for extrapyramidal symptoms (every visit, 4 weeks after starting treatment and dose change, and annually) and tardive dyskinesia (every visit and annually).
Overdosage
Symptoms: Restlessness, clouding of consciousness, extrapyramidal symptoms, agitation, confusion, low blood pressure, coma. Management: Symptomatic and supportive treatment. Overdose may be managed with alkaline osmotic diuresis and, if needed, antiparkinsonian agents. Administer anticholinergics if severe extrapyramidal symptoms occur. Closely monitor vital signs and cardiac function until the patient recovers.
Drug Interactions
Concomitant use with levodopa or other antiparkinsonian drugs (e.g. ropinirole) may result in reciprocal antagonism of effects. May increase the risk of QT prolongation or torsades de pointes with QT-prolonging agents such as β-blockers, calcium channel blockers (e.g. diltiazem, verapamil), class Ia antiarrhythmic drugs (e.g. quinidine, disopyramide), class III antiarrhythmic drugs (e.g. amiodarone, sotalol), diuretics, stimulant laxatives, IV amphotericin B, pimozide, haloperidol, imipramine, pentamidine, thioridazine, and IV erythromycin. Decreased bioavailability with antacids or sucralfate. Increased risk of extrapyramidal adverse effects with lithium. May increase adverse effects with metoclopramide. May increase hypotensive and sedative effects with opioid analgesics.
Food Interaction
Enhanced sedative effects with alcohol.
Action
Description:
Mechanism of Action: Sulpiride is a substituted benzamide atypical antipsychotic with bimodal activity, as it has both neuroleptic and antidepressant properties. Its antipsychotic action is reported to be exerted through selective antagonism of central dopamine (D2, D3, and D4) receptors.
Onset: Schizophrenia: Within 1-2 weeks.
Pharmacokinetics:
Absorption: Slowly absorbed from the gastrointestinal tract. Time to peak plasma concentration: 3-6 hours. Bioavailability: 25-35%.
Distribution: Rapidly distributed to the tissues but poorly penetrates the blood-brain barrier. Crosses the placenta and enters breast milk. Plasma protein binding: Approx 40%.
Metabolism: Not significantly metabolised.
Excretion: Via urine and faeces (95% as unchanged drug). Elimination half-life: Approx 7-8 hours.
Chemical Structure

Chemical Structure Image
Sulpiride

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 5355, Sulpiride. https://pubchem.ncbi.nlm.nih.gov/compound/Sulpiride. Accessed July 28, 2025.

Storage
Store below 25°C. Use the oral solution within 3 months after opening.
MIMS Class
Antipsychotics
ATC Classification
N05AL01 - sulpiride ; Belongs to the class of benzamides antipsychotics.
References
Brayfield A, Cadart C (eds). Sulpiride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/07/2025.

Joint Formulary Committee. Sulpiride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/07/2025.

Negatil Tablet 50 mg and 200 mg (Malaysian Pharmaceutical Industries Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 08/07/2025.

Paediatric Formulary Committee. Sulpiride. BNF for Children [online]. London. BMJ Group, Pharmaceutical Press, and RCPCH Publications. https://www.medicinescomplete.com. Accessed 08/07/2025.

Sulpin F.C. Tablet 200 mg (Averroes Pharmaceuticals Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 14/07/2025.

Sulpiride 200 mg/5 mL Oral Solution (Essential Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 08/07/2025.

Sulpiride Grindeks 100 mg Tablets (AS Grindeks.). MHRA. https://products.mhra.gov.uk. Accessed 08/07/2025.

Sulpiride. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 08/07/2025.

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 © 2025 MIMS. All rights reserved. Powered by MIMS.com
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