VIGAMOX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VIGAMOX (VIGAMOX).
Fluoroquinolone antibiotic that inhibits DNA gyrase and topoisomerase IV, preventing bacterial DNA replication.
| Metabolism | Not extensively metabolized; systemic absorption is minimal after ophthalmic administration. |
| Excretion | Renal: 70-80% unchanged; biliary/fecal: 15-20% |
| Half-life | Terminal elimination half-life: 12-14 hours; clinically relevant for once-daily dosing |
| Protein binding | 40-50% bound to serum proteins |
| Volume of Distribution | 1.5-2.0 L/kg; indicates extensive tissue distribution |
| Bioavailability | Ophthalmic: <1% systemic; oral: 80-90% (not clinically used orally) |
| Onset of Action | Ophthalmic: within 30 minutes for conjunctival infection; subconjunctival injection: immediate |
| Duration of Action | Ophthalmic: 12-24 hours after single dose; requires multiple daily dosing for sustained effect |
1 drop in affected eye(s) every 4 hours while awake for 7 days; may increase to 1 drop every 2 hours on day 1.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | No adjustment required; drug undergoes minimal systemic absorption. |
| Liver impairment | No adjustment required; drug undergoes minimal systemic absorption. |
| Pediatric use | Children 1 year and older: same as adult dosing; 1 drop every 4 hours while awake for 7 days. |
| Geriatric use | No specific adjustment; use with caution due to potential age-related corneal changes. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VIGAMOX (VIGAMOX).
| Breastfeeding | Unknown if moxifloxacin is excreted in human breast milk after ocular administration. However, fluoroquinolones are known to be excreted in breast milk after systemic administration. M/P ratio not available. Caution should be exercised. Consider risk versus benefit. |
| Teratogenic Risk | Pregnancy Category C. No adequate studies in pregnant women. In animal studies, moxifloxacin was not teratogenic in rats or rabbits at doses up to 5 and 20 times the maximum recommended human ophthalmic dose, respectively. However, moxifloxacin caused decreased fetal body weight and increased fetal loss in rats at maternally toxic doses. Use only if potential benefit justifies potential risk to the fetus. Avoid in first trimester if possible due to theoretical risk of arthropathy. |
■ FDA Black Box Warning
Not applicable (ophthalmic use only; systemic fluoroquinolones have boxed warning for tendinitis/tendon rupture, peripheral neuropathy, CNS effects, and myasthenia gravis exacerbation, but VIGAMOX ophthalmic solution does not carry a boxed warning due to minimal systemic absorption).
| Common Effects | Eye discomfort Dry eye Burning sensation in eye |
| Serious Effects |
["Hypersensitivity to moxifloxacin or any fluoroquinolone."]
| Precautions | ["Prolonged use may result in overgrowth of non-susceptible organisms including fungi.","Ophthalmic use only; not for injection.","Contact lens wearers should remove lenses during treatment."] |
Loading safety data…
| Fetal Monitoring | Standard prenatal monitoring. No specific fetal monitoring required. Monitor for maternal signs of hypersensitivity or local ocular adverse effects. |
| Fertility Effects | No human data on fertility effects. In animal studies, moxifloxacin did not impair fertility in rats at oral doses up to 300 mg/kg/day (approximately 6000 times the human ophthalmic dose). |