Presentation and Status in Health Basket
30 X 100 mg
30 X 400 mg
Usually, if the daily dose is ≤ 400 mg, it is to be administered as a once-daily dose. If the daily dose exceeds 400 mg, it is to be administered as two divided doses.
Predominantly negative episodes: Doses between 50 mg/day and 300 mg/day are recommended. Doses should be adjusted individually. The optimum dosage is about 100 mg/day. For patients with mixed positive and negative symptoms, doses should be adjusted to obtain optimal control of positive symptoms.
Acute psychotic episodes: When initiating treatment: It is possible to start via the IM route for a few days, at a maximum dose of 400 mg/day, switching thereafter to oral treatment, Oral doses between 400 mg/day and 800 mg/day are recommended. The maximum dose should never exceed 1200 mg. Given that there has been no large-scale safety assessment of doses higher than 1200 mg/day, these doses should not be used.
To oral treatment: Oral doses between 400 mg/day and 800 mg/day are recommended. The maximum dose should never exceed 1200 mg. Given that there has been no large-scale safety assessment of doses higher than 1200 mg/day, these doses should not be used. there has been no large-scale safety assessment of doses higher than 1200 mg/day, these doses should not be used.
Thereafter: The dosage should then be maintained or adjusted according to the patient’s individual response. In all cases, the maintenance treatment should be established individually with the minimum effective dose.
Elderly: The safety of Amisulpride has been examined in a limited number of elderly patients. Amisulpiride should be used with particular caution in this patients population due to the risk of hypotension or sedation. Reduction in dosage may also be required because of renal insufficiency.
Children & adolescents: The efficacy and safety of amisulpride from puberty to the age of 18 years have not been established: there are limited data available on the use of amisulpride in adolescents in schizophrenia. Therefore, the use of amisulpride from puberty to the age of 18 years is not recommended. Amisulpiride is contra-indicated in children under 15 years of age.
Renal insufficiency: Amisulpride is eliminated via the renal route. In patients with renal insufficiency, the dose should be reduced by half when creatinine clearance (CrCl) is between 30-60 ml/min and to a third in patients with CrCl between 10-30 ml/min. Because of the lack of data on patients with serious renal insufficiency (CrCl <10 ml/min), careful monitoring is recommended in this population.
Hepatic insufficiency: Since amisulpride is weakly metabolized, a dosage reduction is not necessary in patients with hepatic insufficiency.
For full details see prescribing information.
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 withdrawal) are prominent, including patients characterised by predominant negative symptoms.
This medicine must not be used in the following cases: Known hypersensitivity to amisulpride or to any of the ingredients of the medicinal product, Serious hypertensive episodes have been reported in patients with pheochromocytoma using antidopaminergic drugs, including some benzamides. It is therefore advisable to abstain from prescribing this medicinal product in known or suspected pheochromocytoma carriers, • Children under 15 years of age, because no clinical data are available on this age group, Breast-feeding, Women of childbearing potential unless using adequate contraception. Known or suspected prolactin-dependent tumors, e.g. prolactin-secreting pituitary adenoma and breast cancer, In combination with: citalopram, escitalopram, non-antiparkinsonian dopamine agonists (cabergoline, quinagolide), levodopa.
Potentially fatal Neuroleptic malignant syndrome: As with other neuroleptics, Neuroleptic Malignant Syndrome, a potentially fatal 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 Solian should be discontinued.
Prolongation of the QT interval: Amisulpride induces a dose-dependent prolongation of the QT interval. This effect, known to potentiate the risk of serious ventricular arrhythmias, particularly of the torsades de pointes type, is enhanced in patients with bradycardia, hypokalemia, or congenital or acquired prolonged QT interval (combination with a medicinal product which prolongs the QTc interval). Consequently, when the clinical situation permits, it is recommended to ensure that there are no factors which could promote the occurrence of this rhythm disorder before administration: Bradycardia less than 55 bpm, Hypokalemia, Congenital prolongation of the QT interval, Ongoing treatment with a medicinal product likely to cause marked bradycardia (<55 bpm), hypokalemia, delayed intracardiac conduction, or prolongation of the QTc interval. An ECG should be performed as part of the initial assessment of patients requiring long-term treatment with a neuroleptic agent.
Stroke: In randomized, placebo-controlled clinical studies in elderly patients with dementia and treated with certain atypical antipsychotics agents, a threefold risk of stroke was observed versus placebo. The mechanism underlying this increased risk is unknown. Increased risk with other antipsychotics agents or in other patient populations cannot be ruled out. This medicinal product must be used with caution in patients who have risk factors for stroke.
Elderly patients with dementia: The risk of mortality increases in elderly patients suffering from dementia-related psychosis and treated with antipsychotic drugs. Analysis of 17 placebo-controlled studies (mean duration of 10 weeks), conducted in patients mainly taking atypical antipsychotic drugs, showed that the risk of mortality increased 1.6- to 1.7-fold in patients treated with these medicinal products versus placebo. After a mean treatment period of 10 weeks, the risk of mortality was 4.5% in the treated patient group versus 2.6% in the placebo group. Although the causes of death varied in the clinical trials with the atypical antipsychotic drugs, the majority of deaths appeared to be either cardiovascular (e.g. heart failure, sudden death) or infectious (e.g. pneumonia). Epidemiological studies suggest that treatment with conventional antipsychotic drugs may increase mortality, as is the case for atypical antipsychotic drugs. The respective contribution of the antipsychotic drug and patient characteristics to the increase in mortality found in the epidemiological studies is unclear.
Venous thromboembolism: Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotic drugs often present acquired risk factors for VTE, any potential risk factors for VTE must be identified before and during treatment with Solian and preventive measures should be taken.
Breast cancer: Amisulpride may increase prolactin levels. Therefore, caution should be exercised and patients with a history or a family history of breast cancer should be closely monitored during amisulpride therapy.
Benign pituitary tumour: Amisulpride may increase prolactin levels. Cases of benign pituitary tumours such as prolactinoma have been observed during amisulpride therapy. In case of very high levels of prolactin or clinical signs of pituitary tumour (such as visual field defect and headache), pituitary imaging should be performed. If the diagnosis of pituitary tumour is confirmed, the treatment with amisulpride must be stoppedץ
Hyperglycemia/metabolic syndrome: Cases of hyperglycemia or glucose intolerance and occurrence or exacerbation of diabetes have been reported in patients treated with some antipsychotic drugs, including amisulpride. Patients receiving Solian should undergo clinical and laboratory monitoring that complies with current recommendations. Particular caution is recommended in patients with diabetes or with risk factors for diabetes.
Seizure: Amisulpride can lower the seizure threshold. Therefore patients with a history of seizures should be closely monitored during treatment with Solian.
Special populations: As amisulpride is eliminated by the renal route, the dose should be decreased or an alternative treatment considered in patients with renal insufficiency. There are no data concerning patients with serious renal insufficiency Amisulpride, like all antipsychotics, should be used with particular caution in elderly patients due to the potential risk of sedation and hypotension. Dose reduction may also be required in elderly patients with kidney failure. Amisulpride, like all antidopaminergic drugs, should be used with caution in patients with Parkinson’s disease due to the risk of worsening disease. Amisulpride should be used only if neuroleptic treatment is absolutely necessary.
Withdrawal syndrome: Withdrawal symptoms, including nausea, vomiting and insomnia have been described following sudden discontinuation of high doses of antipsychotics. Psychotic symptoms may also recur and involuntary movements (e.g. akathisia, dystonia and dyskinesia) have been reported with amisulpride. It is therefore advisable to discontinue amisulpride treatment gradually.
Other: Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics, including Solian. Unexplained infections or fever may be evidence of blood dyscrasia, and requires immediate haematological investigation. It is inadvisable to use this medicinal product in combination with alcohol, levodopa, dopaminergic antiparkinsonian drugs, antiparasitics agents likely to induce torsades de pointes, methadone, other neuroleptics and drugs likely to induce torsades de pointes.
Related to excipients: This medicinal product contains lactose. It is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases).
Insomnia, anxiety, agitation, extrapyramidal symptoms, daytime drowsiness. Elevation of serum prolactin levels, reversible at treatment discontinuation, which may cause galactorrhea, amenorrhea, gynecomastia, swollen breasts, impotence, frigidity. Weight gain, constipation, nausea, vomiting, dry mouth.
For full details see prescribing information.
Sedative agents: It must be taken into account that many drugs or substances can have additive depressant effects on the central nervous system and contribute to a decrease in alertness. These drugs include morphine derivatives (analgesics, antitussives, and replacement treaments), neuroleptics, barbiturates, benzodiazepines, non-benzodiazepine anxiolytics (such as meprobamate), hypnotics, sedative antidepressants (amitriptyline, doxepin, mianserine, mirtazapine, trimipramine), sedative H1-antihistamines, centrally-acting antihypertensives, baclofen, and thalidomide.
Drugs likely to induce torsades de pointes: This serious cardiac rhythm disorder can be caused by a certain number of antiarrhythmic and non-antiarrhythmic drugs. Hypokalemia is a promoting factor, as is bradycardia and pre-existing congenital or acquired QT interval prolongation. This particularly concerns class IA and III antiarrhythmics as well as some neuroleptics. The effect is also induced by other molecules that do not belong to these classes. For dolasetron, erythromycin, spiramycin, and vincamine, only forms administered intravenously are concerned by this interaction. In general, using two torsadogenic drugs concomitantly is contraindicated. Nevertheless, methadone as well as certain sub-classes are exceptions to the rule: Antiparasitics (halofantrine, lumefantrine, pentamidine) are only inadvisable in combination with other torsadogenic drugs. Neuroleptics likely to induce torsades de pointes are also inadvisable but not contraindicated in combination with other torsadogenic drugs. Antiparasitics likely to induce torsades de pointes (halofantrine, lumefantrine, pentamidine) Increased risk of ventricular arrhythmias, particularly torsades de pointes. If possible, treatment with one of the two drugs should be discontinued. If the combination cannot be avoided, control QT before implementing treatment and ECG monitored. Dopaminergic antiparkinsonian drugs (amantadine, apomorphine, bromocriptine, entacapone, lisuride, pergolide, piribedil, pramipexole, rasagiline, ropinirole, rotigotine selegiline) Mutual antagonism of effects between dopamine agonists and neuroleptics. Dopamine agonists can induce or worsen psychotic disorders. When it is necessary to use a neuroleptic in a patient with Parkinson’s disease who is taking dopamine agonists, the dopamine agonists must be gradually reduced and finally discontinued (sudden withdrawal of dopamine agonists exposes the patient to a risk of neuroleptic malignant syndrome).
Other drugs likely to induce torsades de pointes: class IA antiarrhythmics (quinidine, hydroquinidine, disopyramide) and class III antiarrhythmics (amiodarone, dronedarone, sotalol, dofetilide, ibutilide), and other drugs such as arsenic compounds, bepridil, cisapride, diphemanil, IV dolasetron, domperidone, IV erythromycin, levofloxacin, mequitazine, mizolastine, prucalopride, IV vincamine, moxifloxacin, IV spiramycin, toremifene, vandetanib. Increased risk of ventricular arrhythmias, particularly torsades de pointes.
Other neuroleptics likely to induce torsades de pointes: (chlorpromazine, cyamemazine, droperidol, flupenthixol, fluphenazine, haloperidol, levomepromazine, pimozide, pipamperone, pipotiazine, sertindole, sulpiride, sultopride, tiapride, zuclopenthixol).
For full details see prescribing information.
Pregnancy and Lactation
Pregnancy: In animal studies, amisulpride did not show 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. Neonates exposed to antipsychotics (including Solian) 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.
Lactation: Due to a lack of data about whether amisulpride is excreted in breast milk, breast-feeding is contra-indicated.
To date, data concerning acute overdose with amisulpride are limited. The reported signs and symptoms generally result from increased pharmacological activity manifested clinically by drowsiness, sedation, coma, hypotension and extrapyramidal symptoms. Cases with a fatal outcome have been reported mainly in combination with other antipsychotic drugs. There is no known specific antidote to amisulpride. In the event of acute overdose, use of concomitant medication must be investigated and appropriate measures taken: Close monitoring of vital functions. Cardiac monitoring (risk of prolongation of the QT interval) until the patient recovers. If severe extrapyramidal symptoms occur, anticholinergic agents must be administered. Since amisulpride is poorly dialyzable, hemodialysis is of limited use to eliminate the drug.