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. |
| Molecular Weight | 437.9 |
| 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 | MOXAM (moxifloxacin) is contraindicated in the first trimester due to risk of arthropathy and cartilage damage in animal studies and potential fetal harm. |
| 2nd trimester | Use in second trimester is generally avoided; if essential, consider risk-benefit as fluoroquinolones may affect fetal cartilage development. |
| 3rd trimester | Avoid in third trimester; no well-controlled human studies, potential for fetal articular cartilage damage. |
Clinical note
Comprehensive clinical and safety monograph for MOXAM (MOXAM).
| Placental transfer | Moxifloxacin crosses the placenta. Animal studies show transfer; human data limited but presumed similar due to molecular weight and lipophilic nature. |
| Breastfeeding | Moxifloxacin is excreted in human breast milk. Use while breastfeeding is not recommended due to potential adverse effects on the nursing infant, including cartilage damage. American Academy of Pediatrics considers fluoroquinolones compatible with breastfeeding, but caution is advised. |
■ 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 fluoroquinoloneHistory of tendon disorders with fluoroquinolonesPregnancy (first trimester) – contraindicatedChildren under 18 years (systemic use) due to arthropathy riskConcomitant use with tyramine-rich foods or drugs (MAO interaction history, but not absolute)
| 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 |
| Food/Dietary | Avoid alcohol during treatment and for several days after completion to prevent disulfiram-like reaction (nausea, vomiting, headache, flushing). No other food restrictions, but maintain adequate vitamin K intake from dietary sources (e.g., green leafy vegetables) to support coagulation. |
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| Lactation Rating | L3 (Moderately Safe) or Avoid |
| 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. |
| 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. |
| Clinical Pearls | MOXAM (moxalactam) is a broad-spectrum oxacephem antibiotic with activity against Gram-negative bacilli including Pseudomonas aeruginosa and anaerobes. Due to its structural similarity to cephalosporins, it can cause hypoprothrombinemia and bleeding; monitor prothrombin time and administer vitamin K prophylactically. Use caution in patients with renal impairment; adjust dose accordingly. Cross-allergenicity with penicillins may occur. |
| Patient Advice | Take exactly as prescribed; complete the full course even if you feel better. · If you experience unusual bleeding or bruising, contact your healthcare provider immediately. · Avoid alcohol while on this medication to prevent disulfiram-like reaction. · Inform your doctor about all other medications, especially anticoagulants (e.g., warfarin). · Report any signs of allergic reaction: rash, itching, swelling, difficulty breathing. |