Avelox I.V. (moxifloxacin hydrochloride)
Company: Bayer
Approval Status: Approved November 2001
Treatment for: Susceptible strains of sinusitis, bronchitis, pneumonia, skin structure infections
Areas: Immunology/Infectious Diseases; Pulmonary/Respiratory Diseases
| General Information | Clinical Results | Side Effects | Mechanism of Action | Additional Information |
General Information
Avelox is an antibacterial agent indicated for the treatment of adults with infections caused by susceptible strains of the designated microorganisms in the following conditions: acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community acquired pneumonia, and uncomplicated skin/skin structure infections.
The active ingredient is moxifloxacin hydrochloride. In its I.V. form, Avelox is administered as an introvenous 0.8% sodium chloride solution containing 400 mg moxifloxacin.
Avelox is also available in tablet form.
Clinical Results
A large, randomized, double-blind, contriolled clinical trial was conducted in the United States and Canada to compare the efficacy of Avelox I.V. versus an IV/PO fluroquinolone control (trovafloxacin or levofloxacin), in the treatment of community acquired pneumonia. Each of the 516 patients who were enrolled in the study were given one of the I.V. treatments over a period of 7-14 days. During the 7-30 day post-therapy visit, 362 were evaluated in the primary efficacy analysis. The Avelox therapy had a clinical success rate of 86%, while the fluroquinolone comparators had a 89% success rate.
Another study (open-label) enrolled 628 patients to compare Avelox to sequential IV/PO amoxicillin/clavulanate with or without high-dose IV/PO clarithromycin for the treatment of multiple bacteria. These comparitors are not FDA approved. At the primary efficacy timepoint (Day 5-7), the success rate of Avelox was 93%, while the comparators with or without clarithromycin had a lower success rate of 85%. During the 21-28 day post-therapy visit, the Avelox therapy showed a similar clinical superiority, with a 84% success rate, compared to 74% for the comparators.
Side Effects
Most adverse reactions to Avelox in clinical trials were mild to moderate. Treatment was discontinued due to drug-related adverse reactions in 5.7% of patients treated sequentially (intravenous followed by oral) in the trials in which the patient population had community acquired pneumonia. The trials in which patients were treated with the tablet form of Avelox alone, saw 3.6% discontinuation due to adverse effects.
In clinical trials, the most common adverse effects were the following:
- Nausea (7%)
- Diarrhea (6%)
- Dizziness (3%)
Mechanism of Action
Moxifloxacin has in vitro activity against a wide range
of Gram-positive and Gram-negative microorganisms. The bactericidal
action of moxifloxacin results from inhibition of the topoisomerase
II (DNA gyrase) and topoisomerase IV required for bacterial DNA
replication, transcription, repair, and recombination. It appears
that the C8-methoxy moiety contributes to enhanced activity and
lower selection of resistant mutants of Gram-positive bacteria
compared to the C8-H moiety. The presence of the bulky bicycloamine
substituent at the C-7 position prevents active efflux, associated
with the NorA or pmrA genes seen in certain Gram-positive
bacteria.
The mechanism of action for quinolones, including moxifloxacin, is
different from that of macrolides, beta-lactams, aminoglycosides,
or tetracyclines; therfore, microorganisms resistant to these
classes of drugs may be susceptible to moxifloxacin and other
quinolones. There is no known cross-resistance between mosifloxacin
and other classes of anitmicrobials. (From Avelox package
insert)
Additional Information
For more information about Avelox I.V. and Avelox Tablets, please visit the following web site, sponsored by Bayer: www.Avelox.com.
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
