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12/22/1999

Oral Moxifloxacin Approved for U.S. Market

Jane L. Miller

Bayer has received approval from FDA to market oral moxifloxacin hydrochloride (Avelox) for use in adults. The product is labeled for treatment of the following respiratory infections:
  • Acute bacterial sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis 
  • Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Staphylococcus aureus, or M. catarrhalis 
  • Mild or moderate community-acquired pneumonia caused by S. pneumoniae, H. influenzae, Mycoplasma pneumoniae, Chlamydia pneumoniae, or M. catarrhalis

Moxifloxacin is well absorbed from the gastrointestinal tract, is widely distributed throughout the body, and is eliminated primary as unchanged drug in the urine (about 20% of a dose) or feces (25%), a sulfate conjugate in feces (40%), and a glucuronide conjugate in urine (15%). The elimination half-life is about 12 hours. 

Moxifloxacin can prolong the QT interval in some patients. Caution is advised if moxifloxacin is given concurrently with other drugs that can prolong the QT interval. The manufacturer recommends that moxifloxacin not be prescribed for patients taking Class IA or Class III antiarrhythmics, patients with hypokalemia, or patients with known prolongation of the QT interval. 

Adverse effects include nausea, diarrhea, and dizziness. 

The recommended dosage of moxifloxacin is 400 mg orally once daily for 5 days (bacterial exacerbation of chronic bronchitis) or 10 days (pneumonia or sinusitis). Avelox is supplied as 400-mg tablets in bottles of 30 and packages of 5.