id of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining. 5.3 avoidance of contact lens wear patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.

ect-level (noael) for developmental toxicity was 100 mg/kg/day (30 times the human auc at the recommended human ophthalmic dose). embryo-fetal studies were conducted in pregnant rabbits administered with 2, 6.5, or 20 mg/kg/day moxifloxacin by intravenous administration on gestation days 6 to 20, to target the period of organogenesis. abortions, increased incidence of fetal malformations, delayed fetal skeletal ossification, and reduced placental and fetal body weights were observed at 20 mg/kg/day (1,086 times the human auc at the recommended human ophthalmic dose), a dose that produced maternal body weight loss and death. the noael for developmental toxicity was 6.5 mg/kg/day (246 times the human auc at the recommended human ophthalmic dose). pregnant cynomolgus monkeys were administered moxifloxacin at doses of 10, 30, or 100 mg/kg/day by intragastric intubation between gestation days 20 and 50, targeting the period of organogenesis. at the maternal toxic doses of ≥30 mg/kg/day, increased abortion, vomiting, and diarrhea were observed. smaller fetuses/reduced fetal body weights were observed at 100 mg/kg/day (2,864 times the human auc at the recommended human ophthalmic dose). the noael for fetal toxicity was 10 mg/kg/day (174 times the human auc at the recommended human ophthalmic dose). in a pre- and postnatal study, rats were administered moxifloxacin by oral gavage at doses of 20, 100, and 500 mg/kg/day from gestation day 6 until the end of lactation. maternal death occurred during gestation at 500 mg/kg/day. slight increases in the duration of pregnancy, reduced pup birth weight, and decreased prenatal and neonatal survival were observed at 500 mg/kg/day (estimated 277 times the human auc at the recommended human ophthalmic dose). the noael for pre- and postnatal development was 100 mg/kg/day (estimated 30 times the human auc at the recommended human ophthalmic dose). 8.2 lactation risk summary there is no data regarding the presence of moxifloxacin ophthalmic solution in human milk, the effects on the breastfed infants, or the effects on milk production/excretion to inform risk of moxifloxacin ophthalmic solution to an infant during lactation. a study in lactating rats has shown transfer of moxifloxacin into milk following oral administration. systemic levels of moxifloxacin following topical ocular administration are low [see clinical pharmacology (12.3)], and it is not known whether measurable levels of moxifloxacin would be present in maternal milk following topical ocular administration. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for moxifloxacin ophthalmic solution and any potential adverse effects on the breastfed child from moxifloxacin ophthalmic solution. 8.4 pediatric use the safety and effectiveness of moxifloxacin ophthalmic solution have been established in all ages. use of moxifloxacin ophthalmic solution is supported by evidence from adequate and well controlled studies of moxifloxacin ophthalmic solution in adults, children, and neonates [see clinical studies (14)]. there is no evidence that the ophthalmic administration of moxifloxacin ophthalmic solution has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals. 8.5 geriatric use no overall differences in safety and effectiveness have been observed between elderly and younger patients.