No information provided.
None.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to MOXEZA™ solution in 1263 patients, between 4 months and 92 years of age, with signs and symptoms of bacterial conjunctivitis. The most frequently reported adverse reactions were eye irritation, pyrexia and conjunctivitis, reported in 1-2% of patients.
MOXEZA™ solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Aerococcus viridans*
Corynebacterium macginleyi*
Enterococcus faecalis*
Micrococcus luteus*
Staphylococcus arlettae*
Staphylococcus aureus
Staphylococcus capitis
Staphylococcus epidermidis
Staphylococcus haemolyticus
Staphylococcus hominis
Staphylococcus saprophyticus*
Staphylococcus warneri*
Streptococcus mitis*
Streptococcus pneumoniae
Streptococcus parasanguinis*
Escherichia coli*
Haemophilus influenzae
Klebsiella pneumoniae*
Propionibacterium acnes
Chlamydia trachomatis*
*Efficacy for this organism was studied in fewer than 10 infections.
Moxifloxacin steady-state plasma pharmacokinetics were evaluated in healthy adult male and female subjects who were administered multiple, bilateral, topical ocular doses of MOXEZA™ solution two times daily for four days with a final dose on day 5. The average steady-state AUC0-12 was 8.17 ± 5.31 ng•h/mL. Moxifloxacin Cmax following twice-daily bilateral ophthalmic administration of moxifloxacin AF 0.5% for 5 days is approximately 0.02% of that achieved with the oral formulation of moxifloxacin hydrochloride (Cmax following oral dosing of 400 mg AVELOX*, 4.5 ± 0.5 mcg/mL).
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.
4 mL bottle filled with 3 mL of sterile ophthalmic solution of moxifloxacin hydrochloride, 0.5% as base.
Storage And HandlingMOXEZA™ solution is supplied as a sterile ophthalmic solution in the Alcon DROP-TAINER® dispensing system consisting of a natural low density polyethylene bottle and dispensing plug and tan polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package.
3 mL in a 4 mL bottle - NDC 0065-0006-03
StorageStore at 2°C- 25°C (36°F - 77°F).
Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 USA
Included as part of the PRECAUTIONS section.
PRECAUTIONS Topical Ophthalmic Use OnlyNOT 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.
Hypersensitivity ReactionsIn 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 UseAs 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.
Avoidance of Contact Lens WearPatients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.
Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of FertilityLong-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 Pregnancy Category CMoxifloxacin 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.
Nursing MothersMoxifloxacin 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.
Pediatric UseThe 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 immature animals.
Geriatric UseNo overall differences in safety and effectiveness have been observed between elderly and younger patients.
Instill 1 drop in the affected eye(s) 2 times daily for 7 days.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to MOXEZA™ solution in 1263 patients, between 4 months and 92 years of age, with signs and symptoms of bacterial conjunctivitis. The most frequently reported adverse reactions were eye irritation, pyrexia and conjunctivitis, reported in 1-2% of patients.
DRUG INTERACTIONSNo information provided.
