General Information

Avelox (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent.

Avelox is specifically indicated for the treatment of adults with infections caused by susceptible organisms in the conditions: acute bacterial sinusitis, community acquired pneumonia and acute exacerbations of chronic bronchitis.

Avelox is supplied as tablets for oral administration. The usual dose of Avelox is 400 mg orally every 24 hours. The recommended dose should not be exceeded. The duration of therapy depends on the type of infection as described below.

• acute bacterial sinusitis: 10 days
• community acquired pneumonia: 10 days 
• acute exacerbations of chronic bronchitis: 5 days

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; therefore, 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.

Side Effects

Adverse effects associated with the use of Avelox may include, but are not limited to, the following:

• nausea
• diarrhea

Clinical Trial Results

FDA approval was based on the following:

Acute bacterial exacerbation of chronic bronchitis

Avelox tablets (400 mg once daily for 5 days) were evaluated for acute bacterial exacerbation of chronic bronchitis in two large randomized, double-blind, controlled clinical studies. Clarithromycin (500 mg twice daily) was used as the active control in both studies and the treatment duration was 7 days in one study (0124), and 10 days in the other (0127). The overall clinical response as follows:

Study 0124

• Avelox: 82% (271/331)
• Clarithromycin: 80% (270/338)

Study 0127

• Avelox: 89% (222/250)
• Clarithromycin: 89% (224/251)

Community acquired pneumonia

Three large randomized, double-blind controlled clinical studies were conducted to evaluate the efficacy of Avelox tablets (400 mg once daily for 10 days) in patients with clinically and radiologically documented community acquired pneumonia. Clarithromycin (500 mg twice daily for 10 days) was used as the active control in two studies (0119 and 0130) and high dose amoxycillin (1000 mg three times daily for 10 days) in the remaining one (0140). The overall response was as follows:

Study 0119

• Avelox: 93% (141/152)
• Clarithromycin: 92% (141/153)

Study 0130

• Avelox: 95% (184/194)
• Clarithromycin: 95% (178/188)

Study 0140

• Avelox: 89% (143/160)
• Amoxycillin: 89% (159/178)

Acute bacterial sinusitis

In a large randomized, double-blind controlled study, Avelox tablets (400 mg once daily for 10 days) were compared with cefuroxime axetil (250 mg twice daily for 10 days) in the treatment of acute bacterial sinusitis. The Overall clinical response results obtained from this study are as follows:

• Avelox: 86%
• cefuroxime axetil  89%