Ophthalmic (Mast Cell Stabilizer)
PREGNANCY RECOMMENDATION: No Human Data—Probably Compatible
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
PREGNANCY SUMMARY
No reports describing the use of lodoxamide in human pregnancy have been located. The animal data suggest low risk. Moreover, the drug is available as an ophthalmic solution and such use has not resulted in detectable levels in the plasma. The drug appears to be compatible in pregnancy.
FETAL RISK SUMMARY
Lodoxamide is a mast cell stabilizer that is available as an ophthalmic 0.1% solution. It is indicated in the treatment of ocular disorders referred to by the terms vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis. In healthy adult volunteers, administration of one drop in each eye four times daily for 10 days did not result in measurable lodoxamide plasma concentrations (detection limit 2.5 ng/mL) (1).
Reproduction studies have been conducted in rats and rabbits. Oral doses in these species that were more than 5000 times the proposed human clinical dose produced no evidence of developmental toxicity (1)
No evidence of carcinogenicity was observed in long-term studies with oral doses in rats. There also was no evidence of mutagenicity or genetic damage in multiple assays or evidence of impaired reproductive function in laboratory animal studies (1).
It is not known if lodoxamide crosses the human placenta. The molecular weight (about 554) is low enough, but the absence of detectable plasma levels suggests that embryo–fetal exposure will be very low or nil.
BREASTFEEDING SUMMARY
No reports describing the use of lodoxamide during lactation have been located. The molecular weight (about 554) is low enough for excretion into breast milk, but the absence of detectable plasma levels suggests that the effects on a nursing infant are probably nil.
Reference
1.Product information. Alomide. Alcon Laboratories, 2003.