P&T Portfolio--Avelox

March 18, 2002

Bayer's Avelox IV

 

HEALTH-SYSTEM EDITION

P&T PORTFOLIO

Generic name

Moxifloxacin IV

Proprietary name/manufacturer

AVELOX IV/Bayer

FDA-approved indications

Treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia (CAP), and uncomplicated skin and skin structure infections caused by susceptible strains of the infecting microorganisms in adults

Pharmacology

Moxifloxacin, a third-generation fluoroquinolone antibiotic, has a broad spectrum of antimicrobial activity, including gram-positive and gram-negative organisms. Moxifloxacin's bactericidal action results from inhibition of DNA topoisomerases required for bacterial DNA replication, transcription, repair, and recombination. Since this mechanism of action is different from that of macrolides, beta-lactams, aminoglycosides, or tetracyclines, microorganisms resistant to these classes of drugs may be susceptible to moxifloxacin and other quinolones.

Efficacy

The approval of moxifloxacin IV was based upon data from two large clinical trials comparing the efficacy of sequential (IV to oral) moxifloxacin therapy with that of other antibiotics given sequentially for the treatment of hospitalized patients with CAP. In the first study, clinical success rates were 88% for moxifloxacin-treated patients and 89% for the fluoroquinolone comparators, trovafloxacin or levofloxacin. In the second study, clinical success rates were 93% for moxifloxacin-treated patients compared with 85% for patients receiving amoxicillin/clavulanate with or without high-dose IV/p.o. clarithromycin. Comparative studies with other parenteral antibiotics are not available.

Pharmacokinetics

Protein binding50%
Volume of distribution1.7 to 2.7 L/kg
MetabolismGlucuronide and sulfate conjugation in liver
ExcretionUrine Feces
Half-life10-15 hours (multiple dose IV)

 

Contraindications

Hypersensitivity to moxifloxacin or any member of the quinolone class of antimicrobial agents

Warnings

• Moxifloxacin IV may prolong QTc interval.

• Safety and effectiveness in pediatric patients, adolescents under 18 years of age, and pregnant and lactating women have not been established.

• Quinolones may cause CNS events and should be used with caution in patients with CNS disorders (e.g., severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold.

• Pseudomembranous colitis has been reported with nearly all antibacterial agents.

• Achilles and other tendon ruptures have been reported with quinolones.

• Quinolones may produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species.

• Serious anaphylactic reactions can occur.

Adverse effects

  • Nausea (7%)

  • Diarrhea (6%)

  • Dizziness (3%)

Drug interactions

  • Antacids

  • Didanosine

  • Sucralfate

Dose

Acute bacterial sinusitis: 400 mg IV daily x 10 days

Acute bacterial exacerbation of chronic bronchitis: 400 mg IV daily x 5 days

Community-acquired pneumonia: 400 mg IV daily x 7-14 days

Uncomplicated skin and skin structure infections: 400 mg IV daily x 7 days

Conclusion/comments

Moxifloxacin injection is a broad-spectrum fluoroquinolone antimicrobial agent that has demonstrated efficacy for the treatment of a variety of infections. It is administered once daily with equivalent IV and oral dosages, which allows for convenient IV-to-oral sequential dosing. Sequential moxifloxacin (IV/p.o.) has similar efficacy to sequential trovafloxacin or levofloxacin (IV/p.o.) for the treatment of CAP, but comparisons with other antimicrobial agents, including additional fluoroquinolones, are not available. Moxifloxacin is also being studied for use in intra-abdominal and complicated skin infections.

 

Published February 2002. Content based on medical literature and product information available at that time.

 

 



P&T Portfolio--Avelox.

Drug Topics

2002;6:hse17.