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Use in Pregnancy: Pregnancy Category B3: The safety of amisulpride during human pregnancy has not been established. Therefore, use of this drug is not recommended during pregnancy unless the benefits justify the potential risk to the fetus.
Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms after delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, 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 intensive care unit support and prolonged hospitalization.
Use in Lactation: It is not known whether amisulpride or its metabolites are excreted in animal or human breast milk. Therefore, breastfeeding during amisulpride treatment is not recommended.
