Sulpiride oral formulations
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations containing sulpiride
Schizophrenia (acute+chronic) predominantly with negative symptoms
Schizophrenia (acute+chronic) predominantly with positive symptoms
Gilles de la Tourette syndrome
Initial dose: 400mg to 800mg daily, given in two divided doses (morning and early evening).
Predominantly positive symptoms (formal thought disorder, hallucinations, delusions, incongruity of affect) respond to higher doses, and a starting dose of at least 400mg twice daily is recommended, increasing if necessary up to a suggested maximum 1200 mg twice daily. Increasing the dose beyond this level has not been shown to produce any further improvement.
Predominantly negative symptoms (flattening of affect, poverty of speech, anergia, apathy), as well as depression, respond to doses below 800mg daily; therefore a starting dose of 400mg twice daily is recommended. Reducing this dose towards 200mg twice daily will normally increase the alerting effect of sulpiride.
Patients with mixed positive and negative symptoms, with neither predominating, will normally respond to dosage of 400mg to 600mg twice daily.
(See Dosage; Adult)
Elderly patients are usually more sensitive to centrally-acting drugs, therefore a lower starting dose is recommended, increasing gradually to the normal adult dose according to response.
Sulpiride is not licensed in children under 14 years.
Children aged 14 to 18 years
Initial dose: 200mg to 400mg, twice daily.
In predominantly positive symptoms, the dose may be increased to a maximum of 2.4g daily if necessary.
In predominantly negative symptoms, the dose may be increased to a maximum of 800mg if necessary.
Gilles de la Tourette syndrome (unlicensed)
Children aged 12 to 18 years
100mg to 400mg, given twice daily.
Children aged 2 to 12 years
50mg to 400mg, given twice daily.
Patients with Renal Impairment
Some manufacturers contraindicate sulpiride in severe renal impairment.
The Renal Drug Handbook states that sulpiride may be used throughout all stages of renal impairment if the following dosage adjustments are used:
Patients with GFR between 20ml/minute and 50ml/minute: The dose should be reduced to 66% of the normal dose or the dosage interval increased by a factor of 1.5.
Patients with GFR between 10ml/minute and 20ml/minute: The dose should be 50% of the normal dose, or the dosing interval should be multiplied by 2.
Patients with GFR below 10ml/minute: The dose should be lowered to 30% of the normal dose, alternatively the dosing interval may be increased by a factor of 3.
Acute alcohol intoxication
Children under 2 years
Bone marrow aplasia
Central nervous system depression
Long QT syndrome
Torsade de pointes
Precautions and Warnings
Children aged 2 to 14 years
Family history of breast cancer
Family history of long QT syndrome
Family history of narrow angle glaucoma
Predisposition to venous thromboembolism
Risk of cerebrovascular accident
Benign prostatic hyperplasia
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
History of cerebrovascular disorder
History of jaundice
History of seizures
History of torsade de pointes
Narrow angle glaucoma
Predominant excitation or agitation
Severe respiratory disease
Correct electrolyte disorders before treatment
Reduce dose in patients with renal impairment
Advise ability to drive/operate machinery may be affected by side effects
May reduce seizure threshold
Patients at risk of arrhythmias perform ECG prior to initiating therapy
Oral solution with maltitol unsuitable in hereditary fructose intolerance
Some formulations contain hydroxybenzoate
Some formulations contain lactose
Perform ECG before and during treatment
Monitor closely patient with strong family history of breast cancer
Monitor patients at risk for signs & symptoms of venous thromboembolism
Monitor patients with epilepsy while taking this treatment
Monitor serum electrolytes
Neonate exposed in utero: Monitor for neonatal withdrawal syndrome
Perform blood counts if unexplained infection or fever develops
Risk of cerebrovascular events
May cause convulsions
May cause or exacerbate extrapyramidal symptoms
May cause postural hypotension especially in elderly
Potential for withdrawal symptoms
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Reduce dose +/or add antiparkinsonian drug if extrapyramidal symptoms occur
Avoid abrupt withdrawal
Discontinue if patient develops neuroleptic malignant syndrome
Advise patient to avoid alcohol during treatment
Advise patient that photosensitivity possible
Data from observational studies showed a small increased risk of death in elderly patients with dementia when treated with antipsychotics. A 3 fold increase in the risk of cerebrovascular events has been observed in patients with dementia treated with atypical antipsychotic drugs. Sulpiride should therefore be used with caution in patients with risk factors for stroke.
Increased motor agitation has been reported at high dosage in a small number of patients: in aggressive, agitated or excited phases of the disease process, low doses of sulpiride may aggravate symptoms. Sulpiride may be given with a sedative in patients with aggressive behaviour or agitation with impulsiveness. Care should be exercised where mania or hypomania is present.
Pregnancy and Lactation
Use sulpiride with caution in pregnancy
The manufacturers recommend that sulpiride should not be taken during pregnancy.
Use in the third trimester of pregnancy may result in extrapyramidal effects, lethargy and hypotonia in the neonate.
Schaefer and co-workers remark that pregnancy alone is not a justification for stopping treatment and that the benefits of maintaining therapy may well outweigh the risks, particularly for patients stabilised on benzamide antipsychotics. Similarly, for the authors the intentional, or inadvertent use of sulpiride during pregnancy does not warrant termination. Rather, detailed foetal ultrasonography (after its use in the first trimester) and regular obstetric care should be offered in order to allow for the timely diagnosis of possible complications.
When neuroleptics have been used up to delivery, observation of the neonate for at least 2 days is recommended. In order to prevent neonatal adaptation disorders, prescribers are advised to reduce the dose or even interrupt treatment in the days immediately preceding delivery.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Sulpiride is contraindicated in breastfeeding.
Sulpiride is excreted into breast milk and breastfeeding is not recommended during treatment. No side-effects had been observed in nursing infants whose mothers were taking sulpiride.
NICE advises that Infants of mothers who are breastfeeding while taking psychotropic medication should be monitored for adverse reactions.
As a dopamine antagonist, sulpiride may increase prolactin levels and thus lead to increased production of breast milk.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Changes in libido
Deep vein thrombosis (DVT)
Difficulty in micturition
Increases in hepatic enzymes
Neuroleptic malignant syndrome
Prolongation of QT interval
Purplish pigmentation of cornea, conjunctiva, retina
Purplish pigmentation of skin
Sudden death reported
Torsades de pointes
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: November 2016
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Handbook on Injectable Drugs, 15th Edition, Trissel, L. American Society of Health-System Pharmacists.
Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.
Summary of Product Characteristics: Dolmatil Tablets. Sanofi-Aventis. Revised July 2016
Summary of Product Characteristics: Sulpor 200mg/5ml oral solution. Rosemont Pharmaceuticals Ltd. Revised March 2010
Summary of Product Characteristics: Sulpiride 200mg/5ml oral solution. Rosemont Pharmaceuticals Ltd. Revised February 2016
Summary of Product Characteristics: Sulpiride Tablets 200mg, 400mg. Wockhardt UK Ltd. Revised January 2010
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 04 September 2017
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Sulpiride Last revised: 07 September 2016
Last accessed: 14 November 2016
The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.org
Last revised: 10 June 2010
Last accessed: 14 November 2016
Already a member? Log in
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.