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AMISULPRIDE is a brand name for Amisulpride. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Amisulpride is indicated for the 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…
Verbatim from this product's MHRA label. Tap a section to expand.
For acute psychotic episodes, oral doses between 400 mg/d and 800 mg/d are recommended. In individual cases, the daily dose may be increased up to 1200 mg/d. Doses above 1200 mg/d have not been extensively evaluated for safety and therefore should not be used.
No specific titration is required when initiating the treatment with Amisulpride. Doses should be adjusted according to individual response. For patients with mixed positive and negative symptoms, doses should be adjusted to obtain optimal control of positive symptoms.
Maintenance treatment should be established individually with the minimally effective dose. For patients characterised by predominant negative symptoms, oral doses between 50 mg/d and 300 mg/d are recommended. Doses should be adjusted individually.
Amisulpride can be administered once daily at oral doses up to 300 mg, higher doses should be administered bid. The minimum effective dose should be used.
Elderly:
Amisulpride should be used with particular caution because of a possible risk of hypotension or sedation.
Children:
Amisulpride is contra-indicated in children under 15 years of age as its safety has not yet been established.
Renal insufficiency:
Amisulpride is eliminated by the renal route. In renal insufficiency, the dose should be reduced to half in patients with creatinine clearance (CRCL) between 30-60 ml/min and to a third in patients with CRCL between 10-30 ml/min. As there is no experience in patients with severe renal impairment (CRCL < 10 ml/min) particular care is recommended in these patients (see
). 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.
). Hepatic insufficiency: since the drug is weakly metabolised a dosage reduction should not be necessary. 3 Contraindications Hypersensitivity to the active ingredient or to other ingredients of the drug. g. pituitary gland prolactinomas and breast cancer.
Phaeochromocytoma. Children under 15 years of age. Lactation. Combination with the following 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. Combination with levodopa (see
Hypersensitivity to the active ingredient or to other ingredients of the drug. g. pituitary gland prolactinomas and breast cancer. Phaeochromocytoma. Children under 15 years of age. Lactation. Combination with the following 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.
Combination with levodopa (see
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 […]