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SOLIAN (AMISULPRIDE): PRECAUTIONS

Neuroleptic Malignant Syndrome (NMS) is a potentially fatal syndrome that has been reported in association with anti-psychotic medicines, including amisulpride. Neuroleptic malignant syndrome is characterised by hyperthermia, muscle rigidity, autonomic instability, and elevated CPK, may occur. In the event of any symptoms which could suggest NMS, in particular hyperthermia, particularly with high daily doses, all antipsychotic medicines including amisulpride should be discontinued.

Amisulpride (Solian) in solution and tablets is eliminated by the renal route. In cases of renal insufficiency, the dose should be decreased and intermittent treatment should be considered.

There are limited data on the potential for renally-cleared medicines to interfere with the clearance of amisulpride. Therefore, amisulpride should be used with caution with other renally-excreted medicines, including lithium.

The impact of hepatic impairment on hepatic metabolism and hepato-biliary excretion of amisulpride has not been studied. Amisulpride should be used with caution in patients with moderate or severe hepatic impairment.

Solian (Amisulpride) can lower the seizure threshold. Therefore patients with a history of seizures should be closely monitored during amisulpride therapy.

In elderly patients, amisulpride therapy, like other neuroleptics, should be used with particular caution because of a possible risk of hypotension or sedation.

Withdrawal symptoms have been described after abrupt cessation of high therapeutic doses of antipsychotic drugs. The emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported with amisulpride. Therefore, gradual withdrawal of amisulpride is advisable.

Leucopenia, neutropenia and agranulocytosis have been reported with antipsychotics, including Solian (Amisulpride) tablets and solution. Unexplained infections or fever may be evidence of blood dyscrasia and requires immediate haematological investigation.

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 neuroleptic treatment cannot be avoided.

Amisulpride causes an increase in plasma prolactin levels which is reversible after discontinuation of the medicine. This may result in amenorrhoea, galactorrhoea, gynaecomastia, orgasmic dysfunction, breast pain, impotence.

Acute dystonia (spasm oculogyric crisis, torticollis, trismus) may appear. This is reversible without discontinuation of Solian (Amisulpride) solution and tablets upon treatment with an antiparkinsonian agent.

Extrapyramidal symptoms may occur: rigidity, tremor, hypokinesia, akathisia, hypersalivation. These symptoms are generally mild at optimal dosages 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 50-300mg/day.

The presentation of akathisia may be variable and comprises subjective complaints of restlessness and an overwhelming urge to move and either distress or motor phenomena such as pacing, swinging of the legs while seated, rocking from foot to foot, or both. Particular attention should be paid to the monitoring for such symptoms and signs as, left untreated, akathisia is associated with poor compliance and an increased risk of relapse.

Tardive dyskinesia characterised by rhythmic, involuntary movements primarily of the tongue and/or face have been reported, usually after long-term administration. Antiparkinsonian medication is ineffective or may induce aggravation of the symptoms.



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