Loxapine Pregnancy and Breastfeeding Warnings

Loxapine is also known as: Adasuve, Loxitane, Loxitane C, Loxitane IM

Loxapine Pregnancy Warnings

Loxapine has not been formally assigned to a pregnancy category by the FDA. Loxapine has been assigned to pregnancy Risk Factor C by Briggs et al. Animal studies have failed to reveal evidence of embryotoxicity or teratogenicity. There are no controlled data in human pregnancy. 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. Loxapine is only recommended for use during pregnancy when benefit outweighs risk.

Loxapine Breastfeeding Warnings

There are no data on the excretion of loxapine into human milk. However, the presence of loxapine and its metabolites have been found in the milk of lactating dogs. The manufacturer recommends that caution be used when administering loxapine to nursing women.

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