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The FDA approved a new indication for a dosing regimen of levofloxacin (Levaquin) of 750 mg per day for 5 days for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis in adults. Levofloxacin is a product of Ortho-Mc-Neil Pharmaceuticals.


The short-course therapy is available in Levapak format and was previously approved for the treatment of community-acquired pneumonia due to penicillin-susceptible S. pneumoniae (excluding multidrug-resistant strains), H. influenzae, H. parainfluenzae, or Mycoplasma pneumoniae. The regimen is the first and only short-course fluoroquinolones regimen approved for the treatment of acute bacterial sinusitis.


The approval was based on results of a clinical trial in 780 patients showing that the regimen was as effective as a 500 mg per 10-day course of levofloxacin in achieving complete or partial resolution of acute bacterial sinusitis symptoms.


The most common drug-related adverse events in clinical trials were nausea and diarrhea.


Consult product labeling for warnings and precautions.