Leponex Use In Pregnancy & Lactation

Women of child-bearing potential and contraceptive measures: Some female patients treated with antipsychotics other than clozapine may become amenorrheic. A return to normal menstruation may occur as a result of switching from other antipsychotics to clozapine. Adequate contraceptive measures must therefore be ensured in women of childbearing potential.
Use in Pregnancy: Reproduction studies in animals have revealed no evidence of impaired fertility or harm to the fetus due to clozapine. However, the safe use of clozapine in pregnant women has not been established. Therefore, clozapine (Leponex) should be used in pregnancy only if the expected benefit clearly outweighs any potential risk.
Non-teratogenic effects: Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following 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.
Antipsychotic drugs, including clozapine, should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in Lactation: Animal studies suggest that clozapine is excreted in breast milk and has an effect in the suckling offspring. Therefore, mothers receiving clozapine (Leponex) should not breast-feed.