Zeldox Use In Pregnancy & Lactation

Use in Pregnancy: No studies have been conducted in pregnant women. Women of childbearing potential receiving ziprasidone should therefore, be advised to use an appropriate method of contraception. 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.
Ziprasidone should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus (See Pharmacology: Toxicology: Preclinical Safety Data under Actions).
Use in Lactation: There are no adequate and well-controlled studies in lactating women. Limited data indicate that ziprasidone is excreted into breast milk at very low levels. Patients should be advised not to breastfeed if they are receiving ziprasidone.
Fertility: There are no adequate and well-controlled studies in women and men exposed to ziprasidone.
Contraception - Women of childbearing potential receiving ziprasidone should be advised to use an appropriate method of contraception.