). This effect is known to potentiate the risk of serious ventricular arrhythmias such as torsades de pointes. 5 Interaction with other medicinal products and other forms of interaction). Baseline ECG is recommended prior to treatment in all patients especially in the elderly and patients with a positive personal or family history of cardiac disease or abnormal findings on cardiac clinical examination.
g. at dose escalation) should be assessed on an individual patient basis. The dose of Amisulpride should be reduced if QT is prolonged and discontinued if QTc is >500ms. Periodic electrolyte monitoring is recommended particularly if the patient is taking diuretics or during inter-current illness.
Concomitant antipsychotics should be avoided. Stroke In randomized clinical trials versus placebo performed in a population of elderly patients with dementia and treated with certain atypical antipsychotic drugs, a 3-fold increase of the risk of cerebrovascular events has been observed.
The mechanism of such risk increase is not known. An increase in the risk with other antipsychotic drugs, or other populations of patients cannot be excluded. Amisulpride should be used with caution in patients with stroke risk factors.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 5 Interaction with other medicinal products and other forms of interaction Combinations which are contraindicated Medications which could induce torsades de pointes: - class Ia antiarrhythmic agents such as quinidine, disopyramide, procainamide.
- class III antiarrhythmic agents such as amiodarone, sotalol. - other medications such as bepridil, cisapride, sultopride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin. This list is not exhaustive.
Levodopa: reciprocal antagonism of effects between levodopa and neuroleptics. Combinations which are not recommended Amisulpride may enhance the central effects of alcohol. Combinations which require precautions for use Medications which enhance the risk of torsades de pointes or could prolong the QT interval: - bradycardia-inducing medications such as beta-blockers, bradycardia- inducing calcium channel blockers such as diltiazem and verapamil, clonidine, guanfacine; digitalis.
- medications which induce hypokalaemia or electrolyte imbalance: hypokalemic diuretics, stimulant laxatives, IV amphotericin B, glucocorticoids, tetracosactides. - neuroleptics such as pimozide, haloperidol; imipramine, antidepressants; lithium.
Combinations to be taken into account CNS depressants including narcotics, anaesthetics, analgesics, sedative H1 antihistamines, barbiturates, benzodiazepines and other anxiolytic drugs, clonidine and derivatives. Antihypertensive drugs and other hypotensive medications.
: levodopa) since it may attenuate their action. 6 Pregnancy and lactation Pregnancy In animals, amisulpride did not show direct reproductive toxicity. A decrease in fertility linked to the pharmacological effects of the drug (prolactin mediated effect) was observed.
No teratogenic effects of amisulpride were noted. Very limited clinical data on exposed pregnancies are available. Therefore, the safety of amisulpride during human pregnancy has not been established. Use of the drug is not recommended during pregnancy unless the benefits justify the potential risks.
If amisulpride is used during pregnancy, neonates may show adverse effects of amisulpride and thus appropriate monitoring should be considered. For women of childbearing potential, effective contraception should be fully discussed with the physician prior to treatment.
Neonates exposed to antipsychotics (including Amisulpride during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully. 8 Undesirable effects Adverse effects have been ranked under headings of frequency using the following convention: Very common (≥ 1/10) Common (≥1/100, <1/10) Uncommon (≥1/1000, <1/100) Rare (≥ 1/10,000, <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data).
Clinical trials data The following adverse effects have been observed in controlled clinical trials. It should be noted that in some instances it can be difficult to differentiate adverse events from symptoms of the underlying disease.
• Nervous system disorders: Very common: Extrapyramidal symptoms may occur: tremor, rigidity, hypokinesia, hypersalivation, akathisia, dyskinesia. These symptoms are generally mild at optimal dosages and partially reversible without discontinuation of amisulpride upon administration of antiparkinsonian medication.
The incidence of […]