Posology : מינונים

4.2. Posology and method of administration
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.
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 (see section 4.4). Reduction in dosage may also be required because of renal insufficiency.

Children and 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; in children up to puberty amisulpride is contraindicated, as its safety has not yet been established (see section 4.3).

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 severe renal insufficiency (CRCL <10 ml/min), careful monitoring is recommended in this population (see Section 4.4).

Hepatic insufficiency
Since amisulpride is weakly metabolized, a dosage reduction is not necessary in patients with hepatic insufficiency.