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 antibiotics: 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 e pidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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. Call your healthcare professional right away at the first sign of tendon pain, swelling, or inflammation. You should stop taking LEVAQUIN^® until tendinitis or tendon rupture has been ruled out, and avoid exercise, and using the affected area.

LEVAQUIN^® is contraindicated in persons with known hypersensitivity to LEVAQUIN^® or other quinolone antibiotics. Serious and occasionally fatal allergic reactions, as well as some of unknown origin, have been reported in patients receiving therapy with quinolones, including LEVAQUIN^®. These reactions may occur following the first dose or multiple doses. The drug should be discontinued at the first appearance of a skin rash, hives, or other symptoms of an allergic reaction. Hepatotoxicity (liver damage) has been reported in patients receiving LEVAQUIN^®. Call your doctor right away if you have unexplained symptoms such as: nausea or vomiting, stomach pain, fever, weakness, abdominal pain or tenderness, itching, unusual or unexplained tiredness, loss of appetite, light colored bowel movements, dark colored urine or yellowing of your skin or the whites of your eyes.

Convulsions have been reported in patients receiving quinolone antibiotics including LEVAQUIN^®. Tell your physician if you have a history of convulsions. Central nervous system disorders including convulsions, confusion, insomnia, depression, and anxiety may occur after the first dose. Changes in sensation and possible nerve damage (peripheral neuropathy) including pain, burning, tingling, numbness, and/or weakness have been reported. Diarrhea that usually ends after treatment is a common problem caused by antibiotics. Sometimes after starting treatment with antibiotics, you can develop watery and bloody stools (with or without stomach cramps and fever). This can occur during or up to 2 months after the use of antibiotics.

In a few people, LEVAQUIN^®, like some other antibiotics has been linked to abnormal heart rhythms that can be dangerous. Tell your doctor if you have a history of or currently have low potassium levels, abnormal heart rhythms, or are taking any medications for abnormal heart rhythms. LEVAQUIN^® can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get severe sunburn, blisters, or swelling of your skin. Blood glucose disturbances have been reported with use of quinolones, usually in diabetic patients taking oral anti-diabetes medicines or insulin.

If you develop any of these symptoms or side effects discussed above, contact your healthcare professional as soon as possible.

Safety and efficacy in pregnant women and nursing mothers have not been established. The risk-benefit assessment indicates that LEVAQUIN^® is only appropriate in pediatric patients for treatment of inhalational anthrax (post-exposure). The safety in pediatric patients treated for more than 14 days has not been studied.

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.

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

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

This product is available by prescription only. For information on Warnings, Precautions, Adverse Reactions Drug Interactions, and Use in Specific Populations, please see Medication Guide and full Product Information, including Boxed Warning.

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