USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. Teratogenic Effects: 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.


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 has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when VIGAMOX® solution is administered to a nursing mother.


Pediatric Use The safety and effectiveness of VIGAMOX® solution in infants below 1 year of age have not been established.


There is no evidence that the ophthalmic administration of VIGAMOX® solution has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals.


Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger patients.


NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to determine the carcinogenic potential of moxifloxacin have not been performed. However, in an accelerated study with initiators and promoters, moxifloxacin was not carcinogenic in rats following up to 38 weeks of oral dosing at 500 mg/kg/day (approximately 21,700 times the highest recommended total daily human ophthalmic dose for a 50 kg person, on a mg/kg basis).


Rx Only Licensed to Alcon by Bayer Intellectual Property GmbH. U.S. Patent Nos. 5,607,942; 6,716,830; 7,671,070


Moxifloxacin was not mutagenic in four bacterial strains used in the Ames Salmonella reversion assay. As with other quinolones, the positive response observed with moxifloxacin in strain TA 102 using the same assay may be due to the inhibition of DNA gyrase. Moxifloxacin was not mutagenic in the CHO/HGPRT mammalian cell gene mutation assay. An equivocal result was obtained in the same assay when v79 cells were used. Moxifloxacin was clastogenic in the v79 chromosome aberration assay, but it did not induce unscheduled DNA synthesis in cultured rat hepatocytes. There was no evidence of genotoxicity in vivo in a micronucleus test or a dominant lethal test in mice.


Moxifloxacin had no effect on fertility in male and female rats at oral doses as high as 500 mg/kg/day, approximately 21,700 times the highest recommended total daily human ophthalmic dose. At 500 mg/kg orally there were slight effects on sperm morphology (head-tail separation) in male rats and on the estrous cycle in female rats.


PATIENT COUNSELING INFORMATION Patients should be advised not to touch the dropper tip to any surface to avoid contaminating the contents.


Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.


Systemically administered quinolones including moxifloxacin have been associated with hypersensitivity reactions, even following a single dose. Patients should be told to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction.


© 2015 Novartis | 10/15 | US-VIG-15-E-0386


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