MOXEZA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MOXEZA (MOXEZA).
Moxifloxacin is a fluoroquinolone antibiotic that inhibits DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, repair, and recombination.
| Metabolism | Moxifloxacin undergoes hepatic metabolism via glucuronide and sulfate conjugation; negligible metabolism via CYP450 enzymes. Approximately 45% excreted unchanged in urine and 20% in feces. |
| Excretion | Renal: 70% unchanged; biliary/fecal: 20%; metabolized: 10% |
| Half-life | Terminal half-life: 12 hours; allows once-daily dosing |
| Protein binding | 40% bound to serum albumin |
| Volume of Distribution | 2.5 L/kg; indicates extensive tissue distribution |
| Bioavailability | Oral: 80% |
| Onset of Action | Oral: 1-2 hours; intravenous: within 30 minutes |
| Duration of Action | 24 hours; clinical effect persists due to prolonged half-life |
400 mg orally once daily with or without food.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | CrCl ≥30 mL/min: no adjustment; CrCl 15-29 mL/min: 400 mg every 48 hours; CrCl <15 mL/min or hemodialysis: 400 mg every 96 hours. |
| Liver impairment | Child-Pugh Class A and B: no adjustment; Child-Pugh Class C: not recommended due to lack of data. |
| Pediatric use | Safety and efficacy not established in pediatric patients <18 years. |
| Geriatric use | No specific dose adjustment required; monitor renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MOXEZA (MOXEZA).
| Breastfeeding | It is unknown if moxifloxacin is excreted in human milk after ophthalmic administration. Systemic absorption is minimal; however, fluoroquinolones have been detected in breast milk after systemic doses. The M/P ratio for moxifloxacin is not established for ophthalmic use. Caution should be exercised when administered to a nursing woman due to potential for adverse effects in the infant (e.g., arthropathy). |
| Teratogenic Risk | Moxeza (moxifloxacin ophthalmic) is classified as FDA Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Systemic exposure after ophthalmic administration is minimal; however, systemic fluoroquinolones have been associated with arthropathy in juvenile animals. Based on animal data, moxifloxacin is not teratogenic at doses up to 500 mg/kg/day in rats and rabbits, but fetal toxicity (minor skeletal variations) occurred at maternally toxic doses. Risk to the fetus cannot be ruled out; use only if potential benefit justifies potential risk. |
■ FDA Black Box Warning
Fluoroquinolones, including moxifloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid use in patients with known history of myasthenia gravis.
| Serious Effects |
Hypersensitivity to moxifloxacin or any fluoroquinolone, history of tendinopathy with fluoroquinolones, patients with known QT prolongation or uncorrected hypokalemia, and concurrent use with Class IA or III antiarrhythmic agents.
| Precautions | Tendonitis and tendon rupture, peripheral neuropathy, CNS effects (including seizures and increased intracranial pressure), QT prolongation, hypersensitivity reactions, blood glucose disturbances, Clostridium difficile-associated diarrhea, photosensitivity, and exacerbation of myasthenia gravis. |
Loading safety data…
| Fetal Monitoring | No specific monitoring required for ophthalmic use due to low systemic absorption. However, if used systemically, monitor for signs of tendinitis or tendon rupture, QT prolongation (ECG if risk factors), and central nervous system effects. For ophthalmic use, monitor for ocular adverse effects (e.g., conjunctival irritation, keratitis). |
| Fertility Effects | Fluoroquinolones, including moxifloxacin, have not been associated with impaired fertility in animal studies. No specific human data are available for ophthalmic use regarding fertility effects. Systemic fluoroquinolones may reduce fertility by affecting spermatogenesis, but this has not been reported for moxifloxacin. |