Category C—Although the human pregnancy experience with loxapine is very limited, structural anomalies have not been associated with other agents in this subclass. Because of the very limited human pregnancy experience with atypical antipsychotics, ACOG does not recommend the routine use of these agents in pregnancy, but a risk-benefit assessment may indicate that such use is appropriate. A 1996 review on the management of psychiatric illness concluded that patients with histories of chronic psychosis represent a high-risk group (for both the mother and the fetus) and should be maintained on pharmacologic therapy before and during pregnancy.
No reports describing the use during human lactation have been located. The relatively low molecular weight of loxapine (about 328) suggests that the drug are excreted into breast milk. The effect of this exposure on a nursing infant is unknown. In 2001, the American Academy of Pediatrics classified antipsychotics as drugs whose effect on the nursing infant is unknown but may be of concern. Because of the very limited human experience with antipsychotics, the ACOG does not recommend the routine use of these agents during lactation, but a risk-benefit assessment may indicate that such use is appropriate.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Elderly and debilitated patients should be started on lower dosage.
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
Although specific dosage guidelines are not available for oral loxapine, adjustments may be needed depending upon clinical response and the degree of hepatic impairment due to extensive metabolism of loxapine in the liver.