Sulpistad 100 is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms.
- Acute psychotic episodes: 400 – 800 mg/day, may be increased up to 1200 mg/day. Doses above 1200 mg/day should not be used. Doses should be adjusted according to individual response.
- 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.
- Predominant negative symptoms: 50 – 300 mg/day. 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: 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 use of amisulpride from puberty to the age of 18 years is not recommended; in children up to puberty amisulpride is contraindicated.
- Renal insufficiency:
+ CrCl 30 – 60 ml/min: The dose should be reduced to half.
+ CrCl 10 – 30 ml/min: The dose should be reduced to a third.
+ CrCl < 10 ml/min: Particular care is recommended.
- Hepatic insufficiency: A dosage reduction should not be necessary.
- Duration of treatment: The duration of treatment should be determined by the treating physician. To avoid withdrawal symptoms treatment should be discontinued gradually.
Sulpistad 100 is administered orally. Tablets should be swallowed whole or halved, with a sufficient amount of liquid. Sulpistad 100 can be administered independently from meals.