LOXAPINE

Fetal Risk Summary

No reports on the use of loxapine in human pregnancy have been located. In reproductive studies with mice, rats, rabbits, and dogs, a low incidence of exencephaly was observed in mouse fetuses, but no embryotoxicity or teratogenicity was found in the other species (1,2). The highest dose in rats and dogs was 2 times the maximum recommended human dose (2). Renal papillary abnormalities were found in offspring of rats treated from midgestation with doses approximately equivalent to the usual human dose (2).

Breast Feeding Summary

No reports describing the use of loxapine during human lactation have been located. The drug is excreted into the milk of lactating dogs (2). The relatively low molecular weight of loxapine (about 328) indicates that the drug would also be excreted into human milk. The potential effects of this exposure on a nursing infant are unknown.

References

1. Mineshita T, Hasewaga Y, Inoue Y, Kozen T, Yamamoto A. Teratological studies on fetuses and suckling young mice and rats of S-805. Oyo Yakuri 1970;4:305–16. As cited in Shepard TH. Catalog of Teratogenic Agents. 6th ed. Baltimore, MD:Johns Hopkins University Press, 1989:378.
2. Product information. Loxitane. Watson Laboratories, 2000.