APO-AMISULPRIDE

What it is

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

Approved indications

— Treatment of 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. In individual cases, the daily dose may be increased up to 1200 mg/day. Doses above 1200 mg/day have not been extensively evaluated for safety and should not be used; doses above 800 mg/day have not been shown to be superior to lower doses and may increase the incidence of adverse events. APO-AMISULPRIDE should be administered twice daily for doses above 400 mg. Maintenance treatment should be established individually with the minimally effective dose; for patients characterised by predominant negative symptoms, oral doses between 50 mg/day and 300 mg/day are recommended.

Key safety warnings

Neuroleptic Malignant Syndrome (NMS) is a potentially fatal syndrome that may occur with APO-AMISULPRIDE, characterised by hyperthermia, muscle rigidity, rhabdomyolysis, autonomic instability, and elevated CPK; if symptoms suggesting NMS occur, particularly hyperthermia with high daily doses, all antipsychotic medicines including APO-AMISULPRIDE should be discontinued. APO-AMISULPRIDE can lower the seizure threshold; therefore patients with a history of seizures should be closely monitored during therapy. APO-AMISULPRIDE causes an increase in plasma prolactin levels which is reversible after discontinuation, which may result in galactorrhoea, amenorrhoea, gynaecomastia, breast pain, orgasmic dysfunction and impotence. APO-AMISULPRIDE produces a dose-dependent prolongation of the QT interval, which is known to potentiate the risk of serious ventricular arrhythmias such as torsades de pointes. Before administration, monitoring of factors that could favour onset of this rhythm disorder is recommended, including bradycardia less than 55 bpm, electrolyte imbalance particularly hypokalaemia, congenital prolongation of the QT interval, and concomitant treatment with medications likely to produce pronounced bradycardia, hypokalaemia, or QTc prolongation. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death; most deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g. pneumonia) in nature.

Contraindications

APO-AMISULPRIDE is contraindicated in hypersensitivity to the active ingredient or other product ingredients, concomitant prolactin-dependent tumours (e.g. pituitary prolactinomas and breast cancer), phaeochromocytoma, children up to puberty, lactation, and in combination with medications which could induce torsades de pointes including Class Ia antiarrhythmic agents (quinidine, disopyramide), Class III antiarrhythmic agents (amiodarone, sotalol), and other medications such as bepridil, cisapride, sultopride, thioridazine, methadone, intravenous erythromycin, intravenous vincamine, halofantrine, pentamidine, and sparfloxacin. APO-AMISULPRIDE is also contraindicated in combination with levodopa due to reciprocal antagonism between levodopa and neuroleptics.

Regulatory history

APO-AMISULPRIDE was first approved on 28 October 2011. The product was first listed on the ARTG on 3 November 2011, with registrations for 50 mg, 100 mg, 200 mg and 400 mg tablet strengths.