Drugs List

Therapeutic Indications

Uses

Acute psychotic episodes
Schizophrenia (acute+chronic) predominantly with negative symptoms
Schizophrenia (acute+chronic) with positive and negative symptoms

Contraindications

Children under 15 years
Breastfeeding
Long QT syndrome
Phaeochromocytoma
Prolactin-dependent neoplasm
Torsade de pointes

Precautions and Warnings

Children aged 15 to 18 years
Elderly
Family history of breast cancer
Family history of long QT syndrome
Females of childbearing potential
Predisposition to venous thromboembolism
Restricted sodium intake
Risk of cerebrovascular accident
Bradycardia
Cardiac disorder
Dementia
Diabetes mellitus
Electrolyte imbalance
Epileptic disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
History of breast cancer
History of torsade de pointes
Lactose intolerance
Parkinson's disease
Pregnancy
Renal impairment - creatinine clearance 10-60ml/minute

Adjustment of hypoglycaemic therapy may be necessary in diabetes mellitus
Correct electrolyte disorders before treatment
Reduce dose in patients with creatinine clearance of 10-60ml/min
Advise ability to drive/operate machinery may be affected by side effects
May reduce seizure threshold
Not all available products are licensed for all age groups
Some formulations contain hydroxybenzoate
Some formulations contain lactose
Consider ECG before treatment
Monitor serum electrolytes before and during treatment
Monitor ECG in patients at risk of QT prolongation
Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
Monitor liver function if anorexia,nausea,vomiting,abdominal pain develop
Monitor patients at risk for signs & symptoms of venous thromboembolism
Monitor patients with epilepsy while taking this treatment
Monitor serum electrolytes
Advise patient to seek urgent medical advice if blood dyscrasias suspected
Potential for withdrawal symptoms
Withdraw gradually after long-term use
Discontinue if hyperthermia occurs
Discontinue if patient develops neuroleptic malignant syndrome
Advise patient that the effects of alcohol may be potentiated
Advise patient to avoid alcohol during treatment
Female: Ensure adequate contraception during treatment

If patients display very high levels of prolactin or clinical signs of pituitary tumour (such as visual field defect and headache), pituitary imaging should be performed. Amisulpride treatment must be discontinued if the diagnosis of pituitary tumour is confirmed.

Pregnancy and Lactation

Pregnancy

Use amisulpride with caution during pregnancy.

The manufacturer does not recommend using amisulpride during pregnancy or in women not using effective contraception unless the benefits outweigh the potential risks.

Amisulpride crosses the placenta. Animal studies have shown reproductive toxicity, however, human data is limited and as such a potential risk cannot be ruled out.

Antipsychotics exposure to neonates during the third trimester of pregnancy increases the risk of adverse reactions such as extrapyramidal and/or withdrawal symptoms. Cases of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder have been reported. Newborns should be monitored carefully.

Lactation

Amisulpride is contraindicated in breastfeeding.

The manufacturer advises either discontinuing breastfeeding or discontinuing amisulpride therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Amisulpride is excreted into breast milk in large amounts, although there is limited information regarding the effects of amisulpride in newborns/infants. LactMed (2021) suggests using an alternative drug whilst breastfeeding, due to the lack of information available.

Side Effects

Acute dystonias
Acute hepatic injury
Agitation
Agranulocytosis
Akathisia
Allergic reaction
Amenorrhoea
Angioedema
Anxiety
Blurred vision
Bradycardia
Breast pain
Cardiac arrest
Confusion
Constipation
Deep vein thrombosis (DVT)
Diabetes
Dizziness
Drowsiness
Dry mouth
Dyskinesia
Erectile dysfunction
Extrapyramidal effects
Galactorrhoea
Gynaecomastia
Hypercholesterolaemia
Hyperglycaemia
Hyperprolactinaemia
Hypersalivation
Hypertriglyceridaemia
Hypokinesia
Hyponatraemia
Hypotension
Inappropriate secretion of antidiuretic hormone
Increased blood pressure
Increases in hepatic enzymes
Insomnia
Leukopenia
Muscle spasm
Nasal congestion
Nausea
Neuroleptic malignant syndrome
Neutropenia
Oculogyric crisis
Orgasmic dysfunction
Osteopenia
Osteoporosis
Parkinsonism
Photosensitivity
Pneumonia aspiration
Postural hypotension
Prolactinoma
Prolongation of QT interval
Pulmonary embolism
Reflex tachycardia
Restless legs
Rigidity
Seizures
Somnolence
Sudden death reported
Syncope
Tardive dyskinesia
Thromboembolism
Torsades de pointes
Torticollis
Tremor
Trismus
Urinary retention
Urticaria
Venous thrombosis
Ventricular arrhythmias
Ventricular fibrillation
Ventricular tachycardia
Vomiting
Weight gain
Withdrawal symptoms

Presentation

Oral formulations of amisulpride.

Drugs List

Therapeutic Indications

Uses

Acute psychotic episodes
Schizophrenia (acute+chronic) predominantly with negative symptoms
Schizophrenia (acute+chronic) with positive and negative symptoms

Dosage

Doses should be adjusted to individual response, and the minimum effective dose should be used.

Once daily dosing is suitable for doses up to 300mg, higher doses should be administered twice a day.

Adults

Children

Patients with Renal Impairment

Contraindications

Children under 15 years
Breastfeeding
Long QT syndrome
Phaeochromocytoma
Prolactin-dependent neoplasm
Torsade de pointes

Precautions and Warnings

Children aged 15 to 18 years
Elderly
Family history of breast cancer
Family history of long QT syndrome
Females of childbearing potential
Predisposition to venous thromboembolism
Restricted sodium intake
Risk of cerebrovascular accident
Bradycardia
Cardiac disorder
Dementia
Diabetes mellitus
Electrolyte imbalance
Epileptic disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
History of breast cancer
History of torsade de pointes
Lactose intolerance
Parkinson's disease
Pregnancy
Renal impairment - creatinine clearance 10-60ml/minute

Adjustment of hypoglycaemic therapy may be necessary in diabetes mellitus
Correct electrolyte disorders before treatment
Reduce dose in patients with creatinine clearance of 10-60ml/min
Advise ability to drive/operate machinery may be affected by side effects
May reduce seizure threshold
Not all available products are licensed for all age groups
Some formulations contain hydroxybenzoate
Some formulations contain lactose
Consider ECG before treatment
Monitor serum electrolytes before and during treatment
Monitor ECG in patients at risk of QT prolongation
Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
Monitor liver function if anorexia,nausea,vomiting,abdominal pain develop
Monitor patients at risk for signs & symptoms of venous thromboembolism
Monitor patients with epilepsy while taking this treatment
Monitor serum electrolytes
Advise patient to seek urgent medical advice if blood dyscrasias suspected
Potential for withdrawal symptoms
Withdraw gradually after long-term use
Discontinue if hyperthermia occurs
Discontinue if patient develops neuroleptic malignant syndrome
Advise patient that the effects of alcohol may be potentiated
Advise patient to avoid alcohol during treatment
Female: Ensure adequate contraception during treatment

If patients display very high levels of prolactin or clinical signs of pituitary tumour (such as visual field defect and headache), pituitary imaging should be performed. Amisulpride treatment must be discontinued if the diagnosis of pituitary tumour is confirmed.

Pregnancy and Lactation

Pregnancy

Use amisulpride with caution during pregnancy.

The manufacturer does not recommend using amisulpride during pregnancy or in women not using effective contraception unless the benefits outweigh the potential risks.

Amisulpride crosses the placenta. Animal studies have shown reproductive toxicity, however, human data is limited and as such a potential risk cannot be ruled out.

Antipsychotics exposure to neonates during the third trimester of pregnancy increases the risk of adverse reactions such as extrapyramidal and/or withdrawal symptoms. Cases of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder have been reported. Newborns should be monitored carefully.

Lactation

Amisulpride is contraindicated in breastfeeding.

The manufacturer advises either discontinuing breastfeeding or discontinuing amisulpride therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Amisulpride is excreted into breast milk in large amounts, although there is limited information regarding the effects of amisulpride in newborns/infants. LactMed (2021) suggests using an alternative drug whilst breastfeeding, due to the lack of information available.

Side Effects

Acute dystonias
Acute hepatic injury
Agitation
Agranulocytosis
Akathisia
Allergic reaction
Amenorrhoea
Angioedema
Anxiety
Blurred vision
Bradycardia
Breast pain
Cardiac arrest
Confusion
Constipation
Deep vein thrombosis (DVT)
Diabetes
Dizziness
Drowsiness
Dry mouth
Dyskinesia
Erectile dysfunction
Extrapyramidal effects
Galactorrhoea
Gynaecomastia
Hypercholesterolaemia
Hyperglycaemia
Hyperprolactinaemia
Hypersalivation
Hypertriglyceridaemia
Hypokinesia
Hyponatraemia
Hypotension
Inappropriate secretion of antidiuretic hormone
Increased blood pressure
Increases in hepatic enzymes
Insomnia
Leukopenia
Muscle spasm
Nasal congestion
Nausea
Neuroleptic malignant syndrome
Neutropenia
Oculogyric crisis
Orgasmic dysfunction
Osteopenia
Osteoporosis
Parkinsonism
Photosensitivity
Pneumonia aspiration
Postural hypotension
Prolactinoma
Prolongation of QT interval
Pulmonary embolism
Reflex tachycardia
Restless legs
Rigidity
Seizures
Somnolence
Sudden death reported
Syncope
Tardive dyskinesia
Thromboembolism
Torsades de pointes
Torticollis
Tremor
Trismus
Urinary retention
Urticaria
Venous thrombosis
Ventricular arrhythmias
Ventricular fibrillation
Ventricular tachycardia
Vomiting
Weight gain
Withdrawal symptoms

Withdrawal Symptoms and Signs

Withdrawal symptoms including nausea, vomiting and insomnia may occur after abrupt cessation of treatment. The emergence of involuntary movement disorders like, akathisia, dystonia and dyskinesia have been reported. Gradual withdrawal is advisable.

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 2014

Reference Sources

Summary of Product Characteristics: Amisulpride 100mg/ml oral solution. Advanz Pharma. Revised April 2020.
Summary of Product Characteristics: Amisulpride 50mg, 100mg, 200mg, 400mg tablets. Accord Healthcare. Revised January 2012.

Summary of Product Characteristics: Solian 50mg Tablets. SANOFI. Revised July 2019.
Summary of Product Characteristics: Solian 100mg Tablets. SANOFI. Revised July 2019.
Summary of Product Characteristics: Solian 200mg Tablets. SANOFI. Revised July 2019.
Summary of Product Characteristics: Solian 400mg Tablets. SANOFI. Revised July 2019.
Summary of Product Characteristics: Solian Solution. SANOFI. Revised July 2016.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 13 December 2021

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Amisulpride Last revised: 15 November 2021
Last accessed: 13 December 2021