Drugs List

Therapeutic Indications

Uses

Schizophrenia (acute+chronic) predominantly with negative symptoms
Schizophrenia (acute+chronic) predominantly with positive symptoms

Unlicensed Uses

Gilles de la Tourette syndrome

Contraindications

Acute alcohol intoxication
Children under 2 years
Bone marrow aplasia
Breast neoplasm
Breastfeeding
Central nervous system depression
Coma
Long QT syndrome
Phaeochromocytoma
Pituitary neoplasm
Prolactin-dependent neoplasm
Torsade de pointes

Precautions and Warnings

Children aged 2 to 14 years
Elderly
Extrapyramidal disturbances
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
Aggression
Benign prostatic hyperplasia
Cardiovascular disorder
Dementia
Electrolyte imbalance
Epileptic disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
Haematological disorder
Hepatic impairment
Hereditary fructose intolerance
History of cerebrovascular disorder
History of jaundice
History of seizures
History of torsade de pointes
Hypertension
Hypomania
Lactose intolerance
Mania
Myasthenia gravis
Narrow angle glaucoma
Parkinson's disease
Porphyria
Predominant excitation or agitation
Pregnancy
Renal impairment
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

Pregnancy

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 ).

Lactation

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

Side Effects

Agitation
Agranulocytosis
Akathisia
Amenorrhoea
Blurred vision
Breast enlargement
Breast pain
Cardiac arrest
Catatonia
Changes in libido
Confusion
Constipation
Contact sensitisation
Convulsions
Corneal opacities
Deep vein thrombosis (DVT)
Delirium
Depression
Diarrhoea
Difficulty in micturition
Drowsiness
Dry mouth
Dyskinesia
Dystonia
ECG changes
Erectile dysfunction
Exfoliative dermatitis
Extrapyramidal effects
Galactorrhoea
Gynaecomastia
Haemolytic anaemia
Hepatitis
Hyperglycaemia
Hyperprolactinaemia
Hypersalivation
Hypersensitivity reactions
Hyperthermia
Hypertonia
Hypokinesia
Hypotension
Hypothermia
Impotence
Increases in hepatic enzymes
Insomnia
Jaundice
Lassitude
Lens opacities
Leucopenia
Maculopapular rash
Nasal congestion
Neuroleptic malignant syndrome
Oculogyric crisis
Oligomenorrhoea
Orgasmic dysfunction
Parkinsonism
Photosensitivity
Postural hypotension
Prolongation of QT interval
Pulmonary embolism
Purplish pigmentation of cornea, conjunctiva, retina
Purplish pigmentation of skin
Rash
Sedation
Sexual disturbances
Skin reactions
Sleep disturbances
Somnolence
Sudden death reported
Tachycardia
Tardive dyskinesia
Thrombocytopenic purpura
Torsades de pointes
Torticollis
Tremor
Trismus
Urticaria
Venous thrombosis
Ventricular arrhythmias
Ventricular fibrillation
Ventricular tachycardia
Weight gain

Presentation

Oral formulations containing sulpiride

Drugs List

Therapeutic Indications

Uses

Schizophrenia (acute+chronic) predominantly with negative symptoms
Schizophrenia (acute+chronic) predominantly with positive symptoms

Unlicensed Uses

Gilles de la Tourette syndrome

Dosage

Adults

Elderly

Children

Patients with Renal Impairment

Contraindications

Acute alcohol intoxication
Children under 2 years
Bone marrow aplasia
Breast neoplasm
Breastfeeding
Central nervous system depression
Coma
Long QT syndrome
Phaeochromocytoma
Pituitary neoplasm
Prolactin-dependent neoplasm
Torsade de pointes

Precautions and Warnings

Children aged 2 to 14 years
Elderly
Extrapyramidal disturbances
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
Aggression
Benign prostatic hyperplasia
Cardiovascular disorder
Dementia
Electrolyte imbalance
Epileptic disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
Haematological disorder
Hepatic impairment
Hereditary fructose intolerance
History of cerebrovascular disorder
History of jaundice
History of seizures
History of torsade de pointes
Hypertension
Hypomania
Lactose intolerance
Mania
Myasthenia gravis
Narrow angle glaucoma
Parkinson's disease
Porphyria
Predominant excitation or agitation
Pregnancy
Renal impairment
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

Pregnancy

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 ).

Lactation

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

Side Effects

Agitation
Agranulocytosis
Akathisia
Amenorrhoea
Blurred vision
Breast enlargement
Breast pain
Cardiac arrest
Catatonia
Changes in libido
Confusion
Constipation
Contact sensitisation
Convulsions
Corneal opacities
Deep vein thrombosis (DVT)
Delirium
Depression
Diarrhoea
Difficulty in micturition
Drowsiness
Dry mouth
Dyskinesia
Dystonia
ECG changes
Erectile dysfunction
Exfoliative dermatitis
Extrapyramidal effects
Galactorrhoea
Gynaecomastia
Haemolytic anaemia
Hepatitis
Hyperglycaemia
Hyperprolactinaemia
Hypersalivation
Hypersensitivity reactions
Hyperthermia
Hypertonia
Hypokinesia
Hypotension
Hypothermia
Impotence
Increases in hepatic enzymes
Insomnia
Jaundice
Lassitude
Lens opacities
Leucopenia
Maculopapular rash
Nasal congestion
Neuroleptic malignant syndrome
Oculogyric crisis
Oligomenorrhoea
Orgasmic dysfunction
Parkinsonism
Photosensitivity
Postural hypotension
Prolongation of QT interval
Pulmonary embolism
Purplish pigmentation of cornea, conjunctiva, retina
Purplish pigmentation of skin
Rash
Sedation
Sexual disturbances
Skin reactions
Sleep disturbances
Somnolence
Sudden death reported
Tachycardia
Tardive dyskinesia
Thrombocytopenic purpura
Torsades de pointes
Torticollis
Tremor
Trismus
Urticaria
Venous thrombosis
Ventricular arrhythmias
Ventricular fibrillation
Ventricular tachycardia
Weight gain

Overdosage

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 ).

Further Information

Last Full Review Date: November 2016

Reference Sources

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