SULPRIX

What it is

SULPRIX contains amisulpride in tablet form, available in strengths of 100 mg, 200 mg and 400 mg. Amisulpride is a neuroleptic of the benzamide class that binds selectively to human dopaminergic D2 and D3 receptor subtypes.

Approved indications

— Acute schizophrenic disorders in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent. — Chronic schizophrenic disorders in which positive symptoms and/or negative symptoms are prominent, including patients characterised by predominant negative symptoms.

Dosing overview

For acute psychotic episodes, oral doses between 400 mg per day and 800 mg per day are recommended, and in individual cases the daily dose may be increased up to 1200 mg per day. For patients characterised by predominant negative symptoms, oral doses between 50 mg per day and 300 mg per day are recommended. Maintenance treatment should be established individually with the minimally effective dose.

Key safety warnings

Neuroleptic malignant syndrome is a potentially fatal syndrome that has been reported in association with antipsychotic medicines, including amisulpride, and is characterised by hyperthermia, muscle rigidity, rhabdomyolysis, autonomic instability and elevated CPK. Amisulpride can lower the seizure threshold, therefore patients with a history of seizures should be closely monitored during amisulpride therapy. Amisulpride produces a dose-dependent prolongation of the QT interval, which is known to potentiate the risk of occurrence of serious ventricular arrhythmias such as torsades de pointes. Before administration, it is recommended to monitor factors which could favour the onset of QT interval prolongation, including bradycardia less than 55 beats per minute, electrolyte imbalance (particularly hypokalaemia), congenital prolongation of the QT interval, and ongoing treatment with medications likely to produce pronounced bradycardia, hypokalaemia, slowing of intracardiac conduction or prolongation of the QTc interval. Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics, including amisulpride, and unexplained infections or fever may be evidence of blood dyscrasia requiring immediate haematological investigation. Amisulpride causes an increase in plasma prolactin levels which is reversible after discontinuation, and this may result in galactorrhoea, amenorrhoea, gynaecoomastia, breast pain, orgasmic dysfunction and impotence. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death, with most deaths appearing to be either cardiovascular (such as heart failure or sudden death) or infectious (such as pneumonia) in nature.

Contraindications

Hypersensitivity to amisulpride or to other ingredients of the product. Concomitant prolactin-dependent tumours such as pituitary gland prolactinomas and breast cancer. Phaeochromocytoma. Children up to puberty. Lactation. Concomitant use with medications which could induce torsades de pointes, including Class Ia antiarrhythmic agents (such as quinidine and disopyramide), Class III antiarrhythmic agents (such as amiodarone and sotalol) and other medications such as bepridil, cisapride, sultopride, thioridazine, methadone, intravenous erythromycin, intravenous vincamine, halofantrine, pentamidine and sparfloxacin. Levodopa, due to reciprocal antagonism between levodopa and neuroleptics.

Regulatory history

SULPRIX amisulpride 400 mg tablets was first listed on the ARTG on 10 June 2009, followed by the 100 mg and 200 mg tablet strengths on 26 November 2009.