AMISULPRIDE

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:

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 dosage may also be required because of renal insufficiency.

Children:

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 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

Adverse effects have been ranked under headings of frequency using the following convention: very common (≥ 1/10); common (≥ 1/100; < 1/10); uncommon (≥ 1/1,000; < 1/100); rare (≥ 1/10,000; < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).

4) Immune system disorders: Uncommon: allergic reaction Endocrine disorders: Common: amisulpride causes an increase in plasma prolactin levels which is reversible after drug discontinuation. This may result in galactorrhoea, amenorrhoea, gynaecomastia, breast pain, and erectile dysfunction.

4), hypertriglyceridemia and hypercholesterolaemia Rare: hyponatraemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH) Psychiatric disorders: Common: insomnia, anxiety, agitation, orgasmic dysfunction Uncommon: confusion 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 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.

Common: somnolence, acute dystonia (spasm torticollis, oculogyric crisis, trismus) may appear. This is reversible without discontinuation of amisulpride upon treatment with an antiparkinsonian agent. Uncommon: seizures, tardive dyskinesia characterized 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. 4 Warnings). 4 Warnings).

Respiratory, thoracic and mediastinal disorders:

). 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 medicinal product. g. 8). • Phaeochromocytoma.

• Children before the onset of puberty. 5). 4 Special warnings and precautions for use As with other neuroleptics, 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 drugs 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, amisulpride, like other neuroleptics, should be used with particular caution because of a possible risk of hypotension or sedation.

Reduction in dosage 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 neuroleptic treatment cannot be avoided. Withdrawal symptoms including nausea, vomiting and insomnia have been described after abrupt cessation of high therapeutic doses of antipsychotic drugs. Recurrence of psychotic symptoms may also occur and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported with amisulpride.

• Hypersensitivity to the active ingredient or to other ingredients of the medicinal product. g. 8). • Phaeochromocytoma. • Children before the onset of puberty. 5).