AMISULPRIDE

Posology 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. Doses above 1200 mg/day 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 in example between 400-800mg/day.

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. 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 and appropriate strength tablets should be used.

Special populations Elderly (over 65 years):

The safety of amisulpride has been examined in a limited number of elderly patients. Amisulpride should be used with particular caution because of a possible risk of hypotension and sedation. Reduction in dose may also be required because of renal insufficiency.

Paediatric population :

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. 3).

Renal impairment:

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. 4).

Hepatic impairment:

Since amisulpride is weakly metabolised a dose reduction should not be necessary. Duration of treatment Data from controlled clinical trials covering a period of 1 year is available. The duration of treatment should be determined by the treating physician.

The following frequency estimates are used in assessing adverse effects:

Very common: (≥1/10) Common: (≥1/100 to <1/10) Uncommon: (≥1/1,000 to <1/100) Rare: (≥1/10,000 to <1/1,000) Very rare: (<1/10,000) Not known: (cannot be estimated from the available data) The following adverse reactions have been observed in controlled clinical trials and through spontaneous reporting post marketing.

It should be noted that in some instances it can be difficult to differentiate adverse reactions from symptoms of the underlying disease. 4) Common Weight gainInvestigations Uncommon Elevations of hepatic enzymes, mainly transaminases 1 Reversible after discontinuation of amisulpride.

2 These symptoms are generally mild at optimal doses and partially reversible without discontinuation of amisulpride upon administration of antiparkinsonian medication. The incidence of extrapyramidal symptoms which is dose related, remains very low in the treatment of patients with predominantly negative symptoms with doses of 50- 300 mg/day.

3 This is reversible without discontinuation of amisulpride upon treatment with an antiparkinsonian agent. 4 Occurs usually after long term administration of amisulpride. Antiparkinsonian medication is ineffective or may induce aggravation of the symptoms.

5 After abrupt cessation of high doses of amisulpride. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

As with other antipsychotics, neuroleptic malignant syndrome, a potentially fatal complication, characterised 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 medicinal products including amisulpride should be discontinued.

Hyperglycaemia has been reported in patients treated with some atypical antipsychotic agents, including amisulpride, therefore patients with an established diagnosis of diabetes mellitus or with risk factors for diabetes who are started on amisulpride, should get appropriate glycaemic monitoring.

Amisulpride is eliminated by the renal route. 2). Amisulpride may lower the seizure threshold. Therefore patients with a history of epilepsy should be closely monitored during amisulpride therapy. In elderly patients (over 65 years), amisulpride, like other antipsychotics, should be used with particular caution because of a possible risk of hypotension or sedation.

Reduction in dose may also be required because of renal insufficiency. As with other antidopaminergic agents, caution should be also exercised when prescribing amisulpride to patients with Parkinson's disease since it may cause worsening of the disease.

Amisulpride should be used only if antipsychotic treatment cannot be avoided. Acute withdrawal symptoms including nausea, vomiting and insomnia have very rarely been described after abrupt cessation of high doses of antipsychotics. Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported.

Therefore, gradual withdrawal of amisulpride is advisable. Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics, including amisulpride. 8), and requires immediate haematological investigation. Prolongation of the QT interval Caution should be exercised when amisulpride is prescribed in patients with known cardiovascular disease or family history of QT prolongation and concomitant use with antipsychotics should be avoided.

g. 5)