Included as part of the PRECAUTIONS section.
Topical Ophthalmic Use Only
NOT FOR INJECTION. MOXEZA™
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.
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 25,000 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 25,000 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 5,000 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, MOXEZA™ 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 MOXEZA™ solution is administered to a nursing mother.
The safety and effectiveness of MOXEZA™ solution in infants
below 4 months of age have not been established.
There is no evidence that the ophthalmic administration of
moxifloxacin 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.