Fertility: Studies have not been performed to evaluate the effect of ocular administration of VIGAMOX* Solution on fertility.
Pregnancy: Teratogenic Effects.
Pregnancy Category C: Moxifloxacin was not teratogenic when administered to pregnant rats during organogenesis at oral doses as high as 500 mg/kg/day (approximately 21,700 times the highest recommended total daily human ophthalmic dose); however, decreased fetal body weights and slightly delayed fetal skeletal development were observed. There was no evidence of teratogenicity when pregnant Cynomolgus monkeys were given oral doses as high as 100 mg/kg/day (approximately 4,300 times the highest recommended total daily human ophthalmic dose). An increased incidence of smaller fetuses was observed at 100 mg/kg/day. There are no or limited amount of data from the use of VIGAMOX Solution in pregnant women. However, no effects on pregnancy are anticipated since the systemic exposure to moxifloxacin from topical ocular application is negligible.
Since there are no adequate and well-controlled studies in pregnant women VIGAMOX Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: Moxifloxacin/metabolites have not been measured in human milk, although it can be presumed to be excreted in human milk. Animal studies have shown excretion of low levels in breast milk after oral administration of moxifloxacin. However, at therapeutic doses of VIGAMOX Solution no effects on the suckling child are anticipated. Caution should be exercised when VIGAMOX Solution is administered to a nursing mother.