|As with other neuroleptics, Neuroleptic Malignant Syndrome, characterized by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated CPK, may occur. In the event of hyperthermia, particularly with high daily doses, all antipsychotic drugs including Amisulpride Tablets should be discontinued.Amisulpride is eliminated by the renal route. In cases of mild-to-moderate renal insufficiency (creatine clearance >10ml/min), the daily dose should be decreased or intermittent treatment could be considered (see section 4.2).Amisulpride Tablets may lower the seizure threshold. Therefore patients with a history of epilepsy should be closely monitored during therapy.Amisulpride is not recommended for use in patients over 65 years of age, owing to a lack of experience. It may lead to sedation and hypotension in this patient population (see section 5.2).As with other antidopaminergic agents, caution should also be exercised when prescribing Amisulpride Tablets to patients with Parkinson's disease since it may cause worsening of the disease. Amisulpride Tablets should be used only if neuroleptic treatment cannot be avoided.Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Amisulpride Tablets and preventative measures undertaken.Acute withdrawal symptoms including nausea, vomiting and insomnia have very rarely been described after abrupt cessation of high doses of antipsychotic drugs. Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisa, dystonia and dyskinesia) has been reported. Therefore, gradual withdrawal is advisable.|
Prolongation of the QT intervalAmisulpride induces a dose-dependent prolongation of the QT interval. This effect is known to potentiate the risk of serious ventricular arrhythmias such as torsades de pointes.Before any administration, and if possible according to the patient's clinical status, it is recommended to exclude the following factors which could favour the occurrence of this rhythm disorder:- cardiac disorders or family history of sudden death,- bradycardia less than 55 bpm,- electrolyte imbalance, in particular,hypokalaemia, hypomagnesaemia,- congenital prolongation of the QT interval.- on-going treatment with a medication likely to produce pronounced bradycardia (< 55 bpm), hypokalaemia, decreased intracardiac conduction, or prolongation of the QT interval (see section 4.5).
Cerebrovascular accident (CVA)In randomised, placebo-controlled clinical trials in elderly patients with dementia treated with atypical antipsychotics, a three-fold increase was observed in the risk of cerebrovascular adverse events. The mechanism leading to this increase in risk is unknown. It cannot be excluded that this effect might occur with other antipsychotics or in other patient populations. Amisulpride should therefore be used with caution in patients at risk for CVA.
Elderly patients with dementiaElderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death in clinical trials with atypical antipsychotics were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality.The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug, as opposed to some characteristic(s) of the patients is not clear.
HyperglycaemiaHyperglycaemia has been reported during treatment with some atypical antipsychotics including amisulpride. Patients on amisulpride with or at risk of diabetes should monitor their glucose levels regularly. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.