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Loxapine Pregnancy and Breastfeeding Warnings

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

Loxapine Pregnancy Warnings

In rats, embryofetal toxicity has been demonstrated with doses approximately one-half of the maximum recommended human doses on a mg/m2 basis. Teratogenicity has not been demonstrated in the rat, rabbit, or dog. 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. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is not recommended unless the benefit outweighs the risk to the fetus US FDA pregnancy category: C Comments: Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

Loxapine Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes

This drug is present in the milk of lactating dogs There is no information available on the use of this drug during breastfeeding, and therefore, an alternate drug may be preferred.

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