Aspidon/Aspidon OS Use In Pregnancy & Lactation

Aspidon: 2 mg: Pregnancy: Adequate and well controlled studies with risperidone have not been conducted in pregnant women.
Neonates exposed to antipsychotic drugs (including risperidone) during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There was no increase in the incidence of malformations in embryo-fetal studies in rats and rabbits at 0.4-6 times MHRD. Increased pup mortality was noted at all doses in peripostnatal studies in rats. Risperidone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Clinical Considerations: Fetal/Neonatal Adverse Reactions: Monitor neonates exhibiting extrapyramidal or withdrawal symptoms. Some neonates recover within hours or days without specific treatment; others may require prolonged hospitalization.
There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder in neonates following in utero exposure to antipsychotics in the third trimester. 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.
Lactation: Risperidone and 9-hydroxyrisperidone are present in human breast milk. Because of the potential for serious adverse reactions in nursing infants from risperidone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Aspidon OS: Before taking the medicine, tell the doctor if the patient is pregnant, trying to become pregnant or breastfeeding. The doctor will decide if the patient can take it. The following symptoms may occur in newborn babies, of mothers that have used Risperidone (Aspidon OS) in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If the baby develops any of these symptoms the patient may need to contact the doctor.