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Indications

LEVAQUIN^® Tablets/Injection and Oral Solution 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 (eg, patient cannot tolerate an oral dosage form). Please see Dosage and Administration in full Prescribing Information for specific recommendations.

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.

Acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.

Acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible 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 antipseudomonal ß-lactam is recommended.

Community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multidrug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae. MDRSP isolates are strains resistant to two or more of the following antibacterials: penicillin (MIC >2 µg/mL), 2nd generation cephalosporins, eg cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

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 methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes.

Chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible 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 caused by Escherichia coli, including cases with concurrent bacteremia.

Uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.

Inhalational anthrax (post-exposure): To reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of LEVAQUIN^® is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. LEVAQUIN^® has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of LEVAQUIN^® in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged LEVAQUIN^® therapy should only be used when the benefit outweighs the risk [see Dosage and Administration and Clinical Studies in full Prescribing Information].

To reduce the development of drug-resistant bacteria and maintain the effectiveness of LEVAQUIN^® and other antibacterial drugs, LEVAQUIN^® should be used only to treat 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.

Important Safety Information for LEVAQUIN^®

Fluoroquinolones, including LEVAQUIN^®, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart, or lung transplants. Tendon ruptures that required surgical repair have been reported in patients receiving fluoroquinolones, including LEVAQUIN^® during and after therapy; cases occurring up to several months after completion of therapy have been reported. If patient is determined to have tendinitis or tendon rupture, discontinue therapy.

LEVAQUIN^® is contraindicated in persons with known hypersensitivity to LEVAQUIN^® or other quinolone antibacterials. Serious and occasionally fatal events, such as hypersensitivity and/or anaphylactic reactions and some of unknown etiology, have been reported in patients receiving therapy with quinolones, including LEVAQUIN^®. These reactions may include serious, sometimes fatal skin reactions such as toxic epidermal necrolysis or Stevens-Johnson Syndrome; effects on the liver, including hepatitis, jaundice, and acute hepatic necrosis or failure; renal toxicities including interstitial nephritis and/or acute renal insufficiency or failure; and hematologic effects, including agranulocytosis, thrombocytopenia, and other hematologic abnormalities. These reactions may occur following the first dose or multiple doses. Discontinue LEVAQUIN^® at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity.

Severe hepatotoxicity (including acute hepatitis and fatal events) not associated with hypersensitivity has also been reported. Discontinue immediately if signs and symptoms of hepatitis develop.

Central nervous system effects, including convulsions, toxic psychoses, confusion, anxiety, depression, and insomnia, may occur after the first dose. As with other quinolones, LEVAQUIN^® should be used with caution in patients with known or suspected disorders that may predispose them to seizures or lower the seizure threshold.

Clostridium difficile-associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including LEVAQUIN^®, and may range in severity from mild diarrhea to fatal colitis. If diarrhea occurs, evaluate for CDAD and treat appropriately.

Rare cases of peripheral neuropathy have been reported in patients receiving quinolones, including LEVAQUIN^®. Discontinue if symptoms of neuropathy occur to prevent the development of an irreversible condition.

Some quinolones, including LEVAQUIN^® have been associated with prolongation of the QT interval, infrequent cases of arrhythmia, and rare cases of torsades de pointes. LEVAQUIN^® should be avoided in patients with known risk factors such as prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving class IA (quinidine, procainamide), or class III (amiodarone, sotalol) antiarrhythmic agents.

Moderate to severe photosensitivity/phototoxicity reactions can be associated with the use of quinolones after sun or UV light exposure. Excessive exposure to the sun or UV light should be avoided.

Blood glucose disturbances have been reported with use of quinolones, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent or with insulin. Careful monitoring of blood glucose is recommended when LEVAQUIN^® is administered concomitantly with an antidiabetic agent.

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 not be taken within 2 hours before or after LEVAQUIN^® administration. Elevations of the prothrombin time in the setting of concurrent warfarin and LEVAQUIN^® use have been associated with episodes of bleeding. Monitoring for prothrombin time, INR, and evidence of bleeding is recommended.

LEVAQUIN^® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions from LEVAQUIN^® in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

The risk-benefit assessment indicates that LEVAQUIN^® is only appropriate in pediatric patients >6 months of age for treatment of inhalational anthrax (post-exposure). An increased incidence of musculoskeletal disorders (arthralgia, arthritis, tendonopathy, and gait abnormality) compared to controls has been observed in pediatric patients receiving LEVAQUIN^® and the safety in pediatric patients treated for more than 14 days has not been studied.

The most common adverse drug reactions (>3%) in US clinical trials were nausea, headache, diarrhea, insomnia, constipation, and dizziness.

For additional information on Warnings, Precautions, Adverse Reactions, Drug Interactions, and Use in Specific Populations, please see full Prescribing Information, including Boxed Warning.

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