A Powerful once-a-day bacterial killer.

Welcome to LEVAQUIN.com. LEVAQUIN is a quinolone antibiotic used in adults as a lung, sinus, skin, and urinary tract infection treatment when such infections are caused by certain bacteria. LEVAQUIN kills many of the types of bacteria that can infect the lungs, sinuses, skin, and urinary tract and has been shown in a large number of clinical trials to be safe and effective for the treatment of many bacterial infections.

Explore this site to find out more about LEVAQUIN, why it is prescribed and what you can expect if you are taking LEVAQUIN.

If you have a prescription, click here to find out how and when to take LEVAQUIN.

Dosing information for prescribers can be found here.

 

LEVAQUIN INDICATIONS


LEVAQUIN is indicated for adults with:

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 anti-pseudomonal 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 due to Escherichia coli, including cases with concurrent bacteremia.

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

Efficacy of the LEVAQUIN 750 mg/once-daily/5-day regimen has been demonstrated for community-acquired pneumonia caused by Streptococcus pneumoniae (excluding MDRSP), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydia pneumoniae; and for complicated urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.

IMPORTANT SAFETY INFORMATION FOR LEVAQUIN

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

Safety and efficacy in pregnant women and nursing mothers have not been established. Levofloxacin is not indicated for pediatric patients (<18 years of age). Levofloxacin is contraindicated in persons with known hypersensitivity to levofloxacin 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 levofloxacin. These reactions may include effects on the liver, including hepatitis, jaundice, and acute hepatic necrosis or failure, and hematologic effects, including agranulocytosis, thrombocytopenia, and other hematologic abnormalities. These reactions may occur following the first dose or multiple doses. Discontinue levofloxacin 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.

Tendon ruptures that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin, during and after therapy. This risk is increased in patients over 65 years old, and is further increased with concomitant corticosteroid therapy. Discontinue in patients experiencing pain, inflammation, or tendon rupture.

Central nervous system effects, including convulsions, confusion, anxiety, depression, and insomnia, may occur after the first dose. As with other quinolones, levofloxacin should be used with caution in patients with known or suspected central nervous system 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 levofloxacin. If diarrhea occurs, evaluate for CDAD and treat appropriately.

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

Some quinolones, including levofloxacin, have been associated with prolongation of the QT interval, infrequent cases of arrhythmia, and rare cases of torsades de pointes. Levofloxacin 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.

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 levofloxacin administration.

For information on Warnings, Precautions, and additional Adverse Reactions that may occur, regardless of drug relationship, please see full US Prescribing Information.

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