Rizem 2 ODT Use In Pregnancy & Lactation

Pregnancy: There are no adequate data from the use of risperidone in pregnant women. According to postmarketing data reversible extrapyramidal symptoms in the neonate were observed following the use of risperidone during the last trimester of pregnancy. Consequently newborns should be monitored carefully. Risperidone was not teratogenic in animal studies but other types of reproductive toxicity were seen. The potential risk for humans is unknown. Therefore, Risperidone Orally Disintegrating Tablet should not be used during pregnancy unless clearly necessary. If discontinuation during pregnancy is necessary, it should not be done abruptly.
Lactation: 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 in small quantities. There are no data available on adverse reactions in breastfeeding infants. Therefore, the advantage of breastfeeding should be weighed against the potential risks for the child.