Risperidex Use In Pregnancy & Lactation



Dexcel Pharma/AmediusTec


Apex Pharma Marketing
Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: The safety of Risperidex Tablets for use during human pregnancy has not been established. Although, in experimental animals, risperidone did not show direct reproductive toxicity, some indirect, prolactin- and CNS-mediated effects were observed. No teratogenic effect of risperidone was noted in any study.
Neonates exposed to antipsychotic drugs (including Risperidex Tablets) during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms that may vary in severity following delivery. These symptoms in the neonates may include agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Risperidex Tablets should only be used during pregnancy if the benefits outweigh the risks.
Breast-feeding: In animal studies, risperidone and 9-hydroxy-risperidone are excreted in the milk. It has been demonstrated that risperidone and 9-hydroxy-risperidone are also excreted in human breast milk. Therefore, women receiving Risperidone Tablets should not breast-feed.
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