Moxeza (soln)
| Moxeza (soln) | ||
|---|---|---|
| DOSAGE | Conjunctivitis: BID x 7 days | |
| Bacterial Keratitis (Off-Label Use) | ||
| Low risk of vision loss: 1 gtts q1-2hr + Optional add on tobramycin or ciprofloxacin ung qHS | ||
| Moderate risk of vision loss: Loading dosage q5min for 5 doses, then q30min until midnight, then q1hr | ||
| Vision-threatening: Consider fortified tobraymycin or gentamicin (15 mg/ml) q1hr, alternating with fortified cefazolin (50mg/ML) or vancomycin (25mg/mL) q1hr. | ||
| GENERIC | moxifloxacin 0.5% | |
| SIZE | 3mL | |
| INDICATIONS | MOXEZA® solution is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Off label for corneal ulcer. | |
| MECHANISM OF ACTION | fluoroquinolone (4th) Binds bacterial DNA gyrase topoisomerase II and topoisomerase IV | |
| MICROBIOLOGY | Moxifloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section: Active against a broad range of gram negative and positive 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 influenza Klebsiella pneumoniae* Propionibacterium acnes Chlamydia trachomatis* The following in vitro data are available, but their clinical significance in ophthalmic infections is unknown. The safety and effectiveness of MOXEZA® solution in treating ophthalmic infections due to these organisms have not been established in adequate and well-controlled trials. Moxifloxacin has been shown to be active in vitro against most strains of the microorganisms listed below. These organisms are considered susceptible when evaluated using systemic breakpoints; however, a correlation between the in vitro systemic breakpoint and ophthalmologic efficacy has not been established. The list of organisms is provided as guidance only in assessing the potential treatment of conjunctival infections. Moxifloxacin exhibits in vitro minimal inhibitory concentrations (MICs) of 2 mcg/mL or less (systemic susceptible breakpoint) against most (≥ 90%) strains of the following ocular pathogens. Aerobic Gram-positive microorganisms: Staphylococcus caprae Staphylococcus cohnii Staphylococcus lugdunensis Staphylococcus pasteuri Streptococcus agalactiae Streptococcus milleri group Streptococcus oralis Streptococcus pyogenes Streptococcus salivarius Streptococcus sanguis Aerobic Gram-negative microorganisms: Acinetobacter baumannii Acinetobacter calcoaceticus Acinetobacter junii Enterobacter aerogenes Enterobacter cloacae Haemophilus parainfluenzae Klebsiella oxytoca Moraxella catarrhalis Moraxella osloensis Morganella morganii Neisseria gonorrhoeae Neisseria meningitides Pantoea agglomerans Proteus vulgaris Pseudomonas stutzeri Serratia liquefaciens Serratia marcescens Stenotrophomonas maltophilia Anaerobic microorganisms: Clostridium perfringens Peptostreptococcus anaerobius Peptostreptococcus magnus Peptostreptococcus micros Peptostreptococcus prevotii Other microorganisms: Mycobacterium tuberculosis Mycobacterium avium Mycobacterium kansasii Mycobacterium marinum | |
| CONTRAINDICATIONS & WARNINGS | Hypersensitivity to Moxifloxacin, other quinolones or any components. | |
| PEDIATRIC USE | The safety and effectiveness of MOXEZA® solution in infants below 4 months of age have not been established. | |
| PREGNANCY | 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. | |
| NOTE | ||