The Food and Drug Administration has expanded the indications for Levaquin to include complicated skin and skin structure infections, such as major abscesses; ulcers; and infections of deep.wounds due to surgical incisions, bites, or lacerations.
Since 1996, Levaquin (levofloxacin) has been approved for treating uncomplicated skin and skin structure infections, as well as for respiratory and urinary tract infections.
In trials, Levaquin improved or cleared complicated skin infections in 84% of patients, compared with 80% of patients receiving a comparator drug. This difference was not statistically significant.
A once-daily dose of 750 mg for 7-14 days is recommended. The higher dose provides safety and tolerability comparable to the lower doses recommended for previous indications, said Dr. Leon Smith, director of medicine at Saint Michael's Medical Center, Newark, N.J., and a researcher in the trials.
Its rapid absorption rate also allows for a shorter inpatient stay, Dr. Smith said.
In clinical trials, the incidence of drug-related adverse reactions associated with Levaquin was 6.3%. The most common adverse effects were nausea and diarrhea.
Levaquin is indicated to treat complicated skin and skin structure infections due to methicillin-sensitive Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis but has been shown to be clinically effective against a wide range of microorganisms.
Unlike other antimicrobials for this indication, Levaquin provides good broad-spectrum coverage for gram-positive and gramnegative bacteria, said Dr. Marketa Limova, director of the wound and ulcer clinic at the University of California, San Francisco.
"It's a good idea to start a patient on Levaquin while you're waiting for the culture come back," she added.
COPYRIGHT 2001 International Medical News Group
COPYRIGHT 2001 Gale Group