Stabel-10 Use In Pregnancy & Lactation

Pregnancy: There are no adequate and well-controlled trials of aripiprazole in pregnant women. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with aripiprazole.
Due to insufficient safety information in humans and concerns raised by animal reproductive studies, this medicinal product should not be used in pregnancy unless the expected benefit clearly justifies the potential risk to the fetus.
Newborn infants exposed to antipsychotics (including aripiprazole) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborn infants should be monitored carefully.
Breastfeeding: Aripiprazole/metabolites are excreted in human milk. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from aripiprazole therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility: Aripiprazole did not impair fertility based on data from reproductive toxicity studies.