MOXAM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MOXAM (MOXAM).
Moxifloxacin is a fluoroquinolone antibiotic that inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, thereby interfering with DNA replication, transcription, repair, and recombination.
| Metabolism | Moxifloxacin is primarily metabolized via glucuronide conjugation (sulfation and N-methylation are minor pathways); CYP450 enzymes are not significantly involved. |
| Excretion | Renal: ~70% unchanged; biliary/fecal: ~20% as unchanged drug and metabolites; minor metabolism via glucuronidation. |
| Half-life | Terminal elimination half-life: 6-8 hours; prolonged in renal impairment (up to 20 hours with CrCl <30 mL/min). |
| Protein binding | ~30% bound to albumin. |
| Volume of Distribution | 0.25-0.4 L/kg, indicating distribution primarily in extracellular fluid. |
| Bioavailability | Oral: 80-90% (tablet) and 70-80% (suspension) due to moderate first-pass metabolism. |
| Onset of Action | Intravenous: Within 30 minutes; Oral: 1-2 hours. |
| Duration of Action | 12-24 hours; clinical effect correlates with serum levels above MIC for 40-50% of dosing interval. |
| Action Class | Quinolones/ Fluroquinolones |
400 mg orally every 24 hours for 7-14 days.
| Dosage form | INJECTABLE |
| Renal impairment | For CrCl 30-49 mL/min: 400 mg every 24 hours. For CrCl 15-29 mL/min: 400 mg every 48 hours. For CrCl <15 mL/min or hemodialysis: 400 mg every 96 hours (after dialysis). |
| Liver impairment | No dose adjustment required for mild to moderate hepatic impairment (Child-Pugh A and B). Not recommended in severe hepatic impairment (Child-Pugh C). |
| Pediatric use | Not recommended for use in patients under 18 years of age due to lack of safety and efficacy data. |
| Geriatric use | No specific dose adjustment; use caution due to age-related renal impairment. Monitor renal function and adjust dose based on creatinine clearance. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MOXAM (MOXAM).
| Breastfeeding | MOXAM is excreted in human milk in low concentrations. M/P ratio not reported. Generally considered compatible with breastfeeding due to poor oral bioavailability and minimal exposure, but caution advised in infants with gastrointestinal disturbances or allergic history. |
| Teratogenic Risk | MOXAM (moxalactam) is a beta-lactam antibiotic classified as FDA Pregnancy Category B. Animal studies do not indicate fetal harm, but no adequate human studies exist. First trimester: no reported teratogenicity; second and third trimesters: considered safe when clinically indicated. |
■ FDA Black Box Warning
Fluoroquinolones, including moxifloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in patients over 60 years of age, those taking corticosteroids, and patients with kidney, heart, or lung transplants.
| Serious Effects |
["Hypersensitivity to moxifloxacin or any fluoroquinolone","Previous tendon disorder related to fluoroquinolone use","Patients with known QT prolongation or ventricular arrhythmias including torsades de pointes","Patients with uncorrected hypokalemia or hypomagnesemia","Concurrent use with Class IA or Class III antiarrhythmic agents"]
| Precautions | ["Tendon damage","Peripheral neuropathy","CNS effects (e.g., dizziness, confusion, seizures)","QT prolongation","Hypersensitivity reactions","Blood glucose disturbances","Photosensitivity","Clostridium difficile-associated diarrhea","Myasthenia gravis exacerbation"] |
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| Fetal Monitoring |
| Monitor for hypersensitivity reactions, diarrhea (Clostridioides difficile infection), and superinfection. Periodic renal and hepatic function tests recommended due to potential nephrotoxicity and hepatotoxicity. No specific fetal monitoring required. |
| Fertility Effects | No known adverse effects on fertility. Animal studies showed no impairment of fertility at therapeutic doses. |