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SOLIAN (AMISULPRIDE): USE IN SPECIFIC POPULATIONS
Pregnancy Category C in Australia; in The USA Amisulpride pregnancy category is not appropriated
Neonates exposed to antipsychotic drugs (including amisulpride) during the third trimester of pregnancy are at risk of experiencing extrapyramidial neurological disturbances and/or withdrawal symptoms following delivery. There have been post-market reports of hypertonia, agitation, hypotonia, somnolence, tremor, respiratory distress, and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required additional medical treatment or monitoring. All newborns should be carefully monitored to assess the severity of adverse effects.
There was no evidence of teratogenicity in embryofoetal development studies in mice and rabbits following oral doses of up to 2 (mice) and 4 (rabbits) times the maximum recommended human dose based on body surface area, administered daily during the period of organogenesis. Oral treatment of female rats from prior to mating to late gestation or weaning, achieving systemic drug exposure (plasma AUC) similar to that in humans at the maximum dose, was associated with increased preimplantation loss, slight impairment of ossification and reduced pup weight gain to weaning. Teratogenicity of Solian (Amisulpride) was not observed.
The safety of amisulpride during human pregnancy has not been established, and therefore use of this medicine is not recommended during pregnancy unless the benefits justify the potential risks and the administered dose and duration of treatment should be as low and as short as possible.
It is not known whether Amisulpride (Solian) tablets and oral solution or its metabolites are excreted in animal or human breast milk. Breast-feeding is therefore contraindicated during amisulpride treatment.
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, the use of Amisulpride (Solian) oral solution and tablets is contraindicated.
Effects on ability to drive and use machines
Even used as recommended, amisulpride may affect reaction time and/or cause somnolence so that the ability to drive vehicles or operate machinery can be impaired.
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Solian prescribing information
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