amisulpride: clinical use

Prescribing considerations

• Assess renal function because amisulpride is predominantly eliminated unchanged in urine.
• Review cardiac disease, bradycardia, family history of sudden death or QT prolongation, electrolyte disturbance and interacting medicines.
• Use particular caution in older people and in Parkinson's disease, epilepsy, diabetes risk, stroke risk or venous-thromboembolism risk.
• Avoid abrupt withdrawal because withdrawal effects, movement disorders and relapse can occur.

Contraindications and cautions

• Hypersensitivity to amisulpride or product excipients
• Known or suspected phaeochromocytoma
• Prolactin-dependent tumours, including prolactinoma or breast cancer
• Concomitant levodopa
• Children below the product-specific licensed age threshold
• For the selected tablet, specified medicines associated with torsades de pointes, including certain antiarrhythmics and QT-prolonging agents

Monitoring

• Renal function and clinical response
• ECG and electrolytes according to product and individual cardiac risk; the selected tablet recommends a baseline ECG
• Weight and glycaemic or lipid parameters where clinically appropriate
• Blood pressure, sedation and extrapyramidal symptoms
• Prolactin-related symptoms; investigate marked elevation, headache or visual-field disturbance
• Urgent blood count for unexplained fever or infection and liver assessment for symptoms of hepatotoxicity

Clinical pharmacology

A selective benzamide antipsychotic with high affinity for dopamine D2 and D3 receptors, little affinity for serotonin, histamine, adrenergic or cholinergic receptors, low protein binding and predominantly renal elimination.

Formulation and product differences

• The selected tablet contains lactose and may be swallowed whole or halved; food does not materially restrict administration.
• The sugar-free solution is caramel-flavoured, contains methyl parahydroxybenzoate and is supplied with an oral syringe.
• The other oral solution contains methyl and propyl parahydroxybenzoate, sodium and trace ethanol from flavouring, and is supplied with an oral syringe.
• After-opening shelf life and excipients differ, so check the exact product rather than assuming oral solutions are identical.

Oral solution

Route: Oral

Strengths: 100 mg/mL

Tablet

Route: Oral

Strengths: 50 mg, 100 mg, 200 mg, 400 mg