FDA Approves New Indication For Levaquin (Levofloxacin) For
Skin Infections
RARITAN, NJ -- September 15, 2000 -- The United States Food and Drug
Administration (FDA) has approved a new indication for Levaquin®
Tablets/Injection (levofloxacin tablets/injection) to treat complicated skin and skin
structure infections at a dose of 750 mg once daily.
This is the ninth indication for Levaquin, which is already widely used in 500 mg
and 250 mg doses to treat respiratory, urinary and other types of skin infections.
Doctors worldwide have prescribed more than 150 million courses of levofloxacin
since 1993.
"Levaquin is an important option in the treatment of complicated skin infections,"
said Leon Smith, MD, Director of Medicine, St. Michael's Medical Center, Newark,
NJ, and an investigator in the complicated skin trials. "A higher dose is needed
because these infections often occur in patients with underlying conditions, such
as poor circulation and compromised immune systems. The 750 mg dose of
Levaquin provides comparable safety and tolerability to lower doses."
Complicated skin and skin structure infections include deep wounds -- surgical
incisions, bites and lacerations that have become infected, major abscesses and
infected ulcers. There are more than 1 million cases of complicated skin
infections resulting from surgery each year in the United States.
Complicated skin infections are also common in patients with other health
concerns that may adversely affect their immune response to infection, their
body's delivery of medicine to the infected area or their ability to heal, such as the
elderly and individuals with HIV/AIDS.
Levaquin is indicated to treat complicated skin and skin structure infections due
to: methicillin-sensitive Staphylococcus aureus, Enterococcus faecalis,
Streptococcus pyogenes or Proteus mirabilis. The recommended course of
therapy for treatment of complicated skin and skin structure infections is a single
dose of Levaquin 750 mg given once daily for seven to 14 days. Levaquin 750
mg is available in oral and intravenous formulations, which are bioequivalent.
The results of the recently completed Phase III trial demonstrate the safety and
efficacy of levofloxacin 750 mg once daily for the treatment of complicated skin
infections. Among 270 clinically evaluable subjects, clinical success rates (cure +
improved) were 84.1 percent in the levofloxacin treatment group compared with
80.3 in the comparator treatment group. The comparators in the clinical trials
were injectable ticarcillin/clavulanate either alone or followed by oral
amoxicillin/clavulanate.
The safety profile of levofloxacin has been studied extensively. Adverse events
reported with the 750 mg dose of Levaquin were consistent with the 500 mg
profile. The incidence of drug-related adverse events in subjects during all Phase
III clinical trials conducted in the U.S. and Canada (in which levofloxacin 250 mg
to 750 mg, depending on indication, was administered) was 6.3 percent. The
most common adverse events related to levofloxacin use were nausea (1.3
percent) and diarrhea (1.0 percent).
Levaquin is also indicated for the treatment of mild to moderate uncomplicated
skin and skin structure infections, at a dose of 500 mg once daily. Levaquin is the
only antimicrobial indicated to treat community-acquired pneumonia (CAP) due to
penicillin-resistant S. pneumoniae (MIC value for penicillin larger than or equal to
2 ug/mL). In addition, Levaquin is indicated to treat mild, moderate and severe
cases of CAP caused by other pathogens, acute maxillary sinusitis and bacterial
exacerbation of chronic bronchitis. Levaquin is administered at 500 mg once
daily for these respiratory infections. Additionally, Levaquin is indicated to treat
mild to moderate complicated urinary tract infections, mild to moderate acute
pyelonephritis and mild to moderate uncomplicated urinary tract infections, at a
dose of 250 mg once daily.
Resistance to Levaquin is rare, according to an ongoing study of respiratory
pathogens from the U.S. and around the world. Responsible and appropriate use
of all antibiotics is recommended so that emergence of antibiotic-resistant strains
of bacteria is minimized.
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.