Vigamox Special Precautions

Warnings: For ocular use only. Not for injection. VIGAMOX Solution should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye. In patients receiving systemically administered quinolones, 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.
Precautions: General: 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, fluorescein staining. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis. Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including moxifloxacin, particularly in elderly patients and in those treated concurrently with corticosteroids. Therefore, treatment with VIGAMOX Solution should be discontinued at the first sign of tendon inflammation.
Information for Patients: Avoid contaminating the applicator tip with material from the eye, fingers or other source. Systemically administered quinolones have been associated with hypersensitivity reactions, even following a single dose. Discontinue use immediately and contact a physician at the first sign of a rash or allergic reaction.
Effects on ability to drive and use machines: Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at application, the patient must wait until the vision clears before driving or using machinery.
Carcinogenesis, Mutagenesis, Impairment of Fertility: 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.
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 following up to 38 weeks of oral dosing at 500 mg/kg/day.
Fertility: Studies have not been performed to evaluate the effect of ocular administration of VIGAMOX* Solution on fertility.
Use in 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.
Use in Lactation: 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.
Use in Children: Safety and effectiveness in pediatric patients below the age of 1 year 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.
Use in the Elderly: No overall differences in safety and effectiveness have been observed between elderly and other adult patients.