LEVAQUIN Receives FDA Approval for Treatment of Chronic Bacterial Prostatitis

RARITAN, N.J. -- The Food and Drug Administration (FDA) has approved LEVAQUIN(R) (levofloxacin) tablets/injection and LEVAQUIN (levofloxacin in 5 percent dextrose) injection for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis or Staphylococcus epidermidis. Chronic bacterial prostatitis is a recurrent or persistent infection of the prostate gland and the number one reason men under the age of 50 visit a urologist. With this indication, LEVAQUIN becomes the only once-daily fluoroquinolone indicated to treat chronic bacterial prostatitis.

LEVAQUIN is marketed by Ortho-McNeil Pharmaceutical, Inc. Chronic bacterial prostatitis is the 10th indication for LEVAQUIN since it was first approved by the FDA in 1997.

"LEVAQUIN with its broad range of coverage, including both gram positive and gram negative pathogens, coupled with its once daily dosing, make it an exceptionally effective antibiotic for the treatment for chronic bacterial prostatitis," said Randall B. Meacham, MD, associate professor and head, Division of Urology, University of Colorado Health Sciences Center, Denver, Colorado.

Chronic bacterial prostatitis accounts for an estimated 2 million outpatient visits yearly. It is estimated as many as 35 percent of men aged 50 and older may have chronic prostatitis and that 50 percent of men will experience symptoms of prostatitis at some point in their lives. Men with chronic bacterial prostatitis can experience a variety of symptoms including an increase in the frequency and urge to urinate, difficulty urinating, painful urination, chills and fever and pain in the lower back area. Gram- negative organisms historically have been the most common cause of chronic bacterial prostatitis, but gram-positive organisms have been increasing in importance.

LEVAQUIN is dosed once daily and indicated for a wide variety of infections including community acquired pneumonia, nosocomial pneumonia, mild to moderate cases of complicated urinary tract infections, acute pyelonephritis, uncomplicated urinary tract infections, acute maxillary sinusitis and acute bacterial exacerbation of chronic bronchitis. 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.

More than 250 million patients have been treated with levofloxacin worldwide since 1993.

Ortho-McNeil Pharmaceutical, Inc., a Johnson & Johnson company, offers a range of solutions for some of the most common urological health conditions facing men and women today, including overactive bladder, interstitial cystitis, and urinary tract infections. In addition to infectious diseases and urology, the company markets pharmaceutical products in therapeutic categories including central nervous system and women's health.

*Videx is a registered trademark of Bristol-Myers Squibb Company

Source: Ortho-McNeil Pharmaceutical, Inc.