Register for FDA approves Levaquin for multi-drug resistant form of S. pneumoniae in CAP
PneumoniaAugust 2, 2004
The U.S. Food and Drug Administration (FDA) has approved the fluoroquinolone antibiotic Levaquin (levofloxacin) Tablets/Injection and Levaquin (levofloxacin in 5% dextrose) Injection to treat multi-drug resistant strains of Streptococcus pneumoniae in community acquired pneumonia (CAP).
"This approval is significant as it increases the flexibility that physicians have to treat patients with drug-resistant bacterial infections with a medication that has demonstrated proven safety and efficacy over time," said Thomas G. Slama, MD, Clinical Professor of Medicine, Indiana School of Medicine, Indianapolis.
Levaquin is indicated to treat mild-to-severe community acquired pneumonia (CAP) due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae.
Levaquin may be used to treat CAP in a 5-day, 750 mg once-daily dosing regimen called the Leva-pak. Levaquin is also approved to treat CAP at a dose of 500 mg daily for 7 to 14 days.
Levaquin is dosed once-daily and indicated for a wide variety of infections in addition to CAP including, acute bacterial exacerbation of chronic bronchitis, acute maxillary sinusitis, nosocomial pneumonia, mild to moderate cases of complicated and uncomplicated urinary tract infections, acute pyelonephritis, and chronic bacterial prostatitis.
Ortho-McNeil Pharmaceutical, Inc., is a Johnson & Johnson company. Ortho-McNeil Pharmaceutical, Inc. markets prescription drugs in the areas of women's health, infectious disease, central nervous system, pain treatment, urology, and migraine headaches. This article was prepared by Anti-Infectives Week editors from staff and other reports.
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