Monitoring Safety and Efficiency of the Preparation Amisulpride (Solian®) in Common Clinical Practice

Authors: E. Češková ;  J. Suchopár 1
Authors‘ workplace: Psychiatrická klinika LF MU a FN, Brno přednostka prof. MUDr. E. Češková, CSc. ;  Infopharm a. s., Praha 1
Published in: Čes. a slov. Psychiat., 105, 2009, No. 2, pp. 53-60.
Category: Original Article


The tolerability and safety of amisulpride (f.o. Solian®) has been followed for 3 months in 2 135 out-patients with schizophrenia. Totally 2 963 of side- effects in 1 243 treated (e.g. 58.22% of all treated) were observed. 2 437 side effects (82.24%) were evaluated as mildly severe, 499 (16.84 %) as moderately severe and 27 (0.91 %) as severe. According to expectation, the most frequently observed side-effects were fatigue and drowsiness (23.39), further insomnia (14.75 %) and anxiety (14.65% of all side-effects). On the other side few prolactin-dependent side-effects have been observed (6.40 % of all side-effects in 8.38 % of treated). The occurrence of menstrual abnormalities has been very rare, only in 3 cases (0.26% of all women into the study), which might be explained by the age of women included. There was a high dependence of side effects occurrence on concomitant medication. Whatever co-medication has increased significantly the occurrence of 4 out of 8 most frequently observed side effects, e.g. insomnia, fatigue and drowsiness, anxiety and extrapyramidal symptoms. Both positive and negative symptoms were improved during the 3-months therapy. With a mean daily dose of 476.6 ±176.49 mg a very good and good effect on negative symptoms was seen in 88.43% of treated, on positive symptoms in 88.24% of treated.

Key words:
amisulpride, adverse events, positive and negative symptoms in schizophrenia.


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