AMISULPRIDE-WGR

What it is

AMISULPRIDE-WGR contains amisulpride as the active ingredient, available in tablet strengths of 50 mg, 100 mg, 200 mg and 400 mg. The tablets contain lactose as an excipient with known effect. AMISULPRIDE-WGR tablets are gluten free.

Approved indications

— Acute and chronic 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, including patients characterised by predominant negative symptoms.

Dosing overview

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

Key safety warnings

Neuroleptic Malignant Syndrome (NMS) is a potentially fatal syndrome that may be characterised by hyperthermia, muscle rigidity, rhabdomyolysis, autonomic instability, and elevated CPK. In the event of any symptoms which could suggest NMS, all antipsychotic medicines including AMISULPRIDE-WGR should be discontinued. AMISULPRIDE-WGR 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 any administration, it is recommended to monitor factors which could favour the onset of this rhythm disorder, including bradycardia less than 55 bpm, electrolyte imbalance (particularly hypokalaemia), congenital prolongation of the QT interval, and on-going treatment with medications likely to produce pronounced bradycardia, hypokalaemia, slowing of intracardiac conduction, or prolongation of the QT interval. AMISULPRIDE-WGR causes an increase in plasma prolactin levels which is reversible after discontinuation of the medicine, and may result in galactorrhoea, amenorrhoea, gynaecomastia, breast pain, orgasmic dysfunction and impotence. AMISULPRIDE-WGR can lower the seizure threshold, and patients with a history of seizures should be closely monitored during therapy. The emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported with AMISULPRIDE-WGR, and gradual withdrawal is advisable. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death, with most deaths appearing to be either cardiovascular (e.g. heart failure, sudden death) or infectious (e.g. pneumonia) in nature.

Contraindications

AMISULPRIDE-WGR is contraindicated in patients with hypersensitivity to the active ingredient or other ingredients, concomitant prolactin-dependent tumours (e.g. pituitary gland prolactinomas and breast cancer), phaeochromocytoma, in children up to puberty, during lactation, and in combination with medications that could induce torsades de pointes (Class Ia and Class III antiarrhythmic agents, and other medications such as bepridil, cisapride, sultopride, thioridazine, methadone, intravenous erythromycin, intravenous vincamine, halofantrine, pentamidine, sparfloxacin) and levodopa.

PBS listing

No information regarding PBS listing has been provided in the source documents.

Regulatory history

AMISULPRIDE-WGR was first registered on the ARTG on 3 November 2011, with four strengths listed: 50 mg, 100 mg, 200 mg and 400 mg tablet blister packs (ARTG entries 178893, 178907, 178905 and 178897 respectively), all under licence category RE.