RARITAN, N.J., Feb. 3 -- The United States Food and Drug Administration (FDA) approved a supplemental new drug application for LEVAQUIN®(levofloxacin tablets/injection) for the treatment of penicillin-resistant S. pneumoniae in community acquired pneumonia (CAP).
This new indication makes LEVAQUIN the first prescription antimicrobial agent specifically indicated for CAP caused by this resistant bacterium. LEVAQUIN now gives physicians an important option to consider when penicillin-resistant pneumococcal pneumonia is present or suspected.
LEVAQUIN has been marketed in the United States by Ortho-McNeil Pharmaceutical, Inc. since January 1997. It is also indicated for the treatment of mild, moderate and severe CAP caused by other pathogens, acute maxillary sinusitis and acute bacterial exacerbation of chronic bronchitis, in addition to mild to moderate uncomplicated skin and skin structure infections, complicated urinary tract infections, acute pyelonephritis and uncomplicated urinary tract infections.
"I recommend that physicians consider a fluoroquinolone with enhanced activity against penicillin-resistant S. pneumoniae if this organism is suspected," said John G. Bartlett, M.D., Division of Infectious Diseases, Johns Hopkins University. Data provided to the FDA demonstrated that LEVAQUIN was effective in each of 15 cases of pneumonia caused by penicillin-resistant S. pneumoniae (pooled data), including six with bacteremia.
"The resistance of S. pneumoniae to penicillin is increasing globally," Dr. Bartlett continued. "It is the result of misuse, and calls attention to the need for the proper use of LEVAQUIN and all other antimicrobials."
LEVAQUIN is well tolerated. More than 100 million courses of LEVAQUIN have been prescribed worldwide since 1993.
The most common drug-related adverse events for LEVAQUIN in U.S. clinical trials were nausea (1.3 percent) and diarrhea (1.1 percent). There was a low incidence of dizziness (0.4 percent) and insomnia (0.3 percent).
The safety and efficacy of levofloxacin in pediatric patients, adolescents (under 18), pregnant women, and nursing mothers have not been established. Levofloxacin is contraindicated in persons with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product. Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones, including levofloxacin. These reactions often occur following the first dose. The drug should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.
Antacids containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc, or Videx* (didanosine) chewable/buffered tablets or the pediatric powder for oral solution should be taken at least two hours before or two hours after levofloxacin administration.
For more information on Warnings, Precautions, and additional Adverse Reactions that may occur, regardless of drug relationship, please see the full prescribing information.
Ortho-McNeil Pharmaceutical, Inc., a Johnson & Johnson Company, is based in Raritan, N.J. The Company markets LEVAQUIN and pharmaceutical products in several therapeutic categories including infectious diseases, central nervous system, wound healing and women's health.
Note: full Prescribing Information is available upon request.
*Videx is a registered trademark of Bristol-Myers Squibb Company.
SOURCE Ortho-McNeil Pharmaceutical, Inc.
CONTACT: William Foster of Ortho-McNeil Pharmaceutical, 908-218-6637, firstname.lastname@example.org