LEVAQUIN SUMMARY
LEVAQUIN® is a synthetic broad spectrum antibacterial agent for oral and intravenous administration.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of LEVAQUIN® (levofloxacin) and other antibacterial drugs, LEVAQUIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
LEVAQUIN Tablets/Injection are indicated for the treatment of adults (>/=18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed below. LEVAQUIN Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form). Please see DOSAGE AND ADMINISTRATION for specific recommendations.
Acute maxillary sinusitis due to
Streptococcus pneumoniae, Haemophilus influenzae, or
Moraxella catarrhalis.
Acute bacterial exacerbation of chronic bronchitis due to
Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae,
or
Moraxella catarrhalis.
Nosocomial pneumonia due to methicillin-susceptible
Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or
Streptococcus pneumoniae.
Adjunctive therapy should be used as clinically indicated. Where
Pseudomonas aeruginosa
is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal (beta)-lactam is recommended. (See CLINICAL STUDIES.)
Community-acquired pneumonia due to
Staphylococcus aureus, Streptococcus pneumoniae
(including penicillin-resistant strains, MIC value for penicillin >/=2 µg/mL), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila,
or
Mycoplasma pneumoniae.
(See CLINICAL STUDIES.)
Complicated skin and skin structure infections due to methicillin-susceptible
Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes,
or
Proteus mirabilis.
Uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to
Staphylococcus aureus
or
Streptococcus pyogenes.
Chronic bacterial prostatitis due to
Escherichia coli, Enterococcus faecalis,
or
Staphylococcus epidermidis.
Complicated urinary tract infections (mild to moderate) due to
Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis,
or
Pseudomonas aeruginosa.
Acute pyelonephritis (mild to moderate) caused by
Escherichia coli.
Uncomplicated urinary tract infections (mild to moderate) due to
Escherichia coli, Klebsiella pneumoniae,
or
Staphylococcus saprophyticus.
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin. Therapy with levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected.
As with other drugs in this class, some strains of
Pseudomonas aeruginosa
may develop resistance fairly rapidly during treatment with levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.
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