AMISULPRIDE

Posology For acute psychotic episodes, oral doses between 400 mg per day and 800 mg per day are recommended. In individual cases, the daily dose may be increased up to 1200 mg per day. Doses above 1200 mg per 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.

Maintenance treatment should be established individually with the minimally effective dose. For patients characterised by predominant negative symptoms, oral doses between 50 mg per day and 300 mg per 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 twice daily. Elderly Amisulpride should be used with particular caution because of a possible risk of hypotension or sedation.

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. 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 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 reactions 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); frequency not known (cannot be estimated from the available data).

4) 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:

Acute dystonia (spasm torticollis, oculogyric crisis, trismus) may appear. This is reversible without discontinuation of amisulpride upon treatment with an antiparkinsonian agent. Somnolence.

Uncommon:

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.

Seizures. 4), which is a potentially fatal complication.

Psychiatric disorders:

Common: Insomnia, anxiety, agitation, orgasmic dysfunction. Uncommon: confusion.

Gastrointestinal disorders:

Common: Constipation, nausea, vomiting, dry mouth.

Endocrine disorders:

) Hepatic insufficiency Since Amisulpride is weakly metabolised a dosage reduction should not be necessary. Method of administration For oral administration. 1. g. pituitary gland prolactinomas and breast cancer • Phaeochromocytoma • Children till puberty • Lactation • Combination with levodopa (see

1. g. pituitary gland prolactinomas and breast cancer • Phaeochromocytoma • Children till puberty • Lactation • Combination with levodopa (see