Included as part of the PRECAUTIONS section.
Topical Ophthalmic Use Only
NOT FOR INJECTION. VIGAMOX® solution is for topical
ophthalmic use only and should not be injected subconjunctivally or introduced
directly into the anterior chamber of the eye.
In patients receiving systemically administered
quinolones, including moxifloxacin, serious and occasionally fatal
hypersensitivity (anaphylactic) reactions have been reported, some following
the first dose. Some reactions were accompanied by cardiovascular collapse,
loss of consciousness, angioedema (including laryngeal, pharyngeal or facial
edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic
reaction to moxifloxacin occurs, discontinue use of the drug. Serious acute hypersensitivity
reactions may require immediate emergency treatment. Oxygen and airway
management should be administered as clinically indicated.
Growth Of Resistant Organisms With Prolonged Use
As with other anti-infectives, prolonged use may result
in overgrowth of non-susceptible organisms, including fungi. If superinfection
occurs, discontinue use and institute alternative therapy. Whenever clinical
judgment dictates, the patient should be examined with the aid of
magnification, such as slit-lamp biomicroscopy, and, where appropriate,
Avoidance Of Contact Lens Wear
Patients should be advised not to wear contact lenses if
they have signs or symptoms of bacterial conjunctivitis.
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).
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.
Use In Specific Populations
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.
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.
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.
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
No overall differences in safety and effectiveness have
been observed between elderly and younger patients.