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Not All Quinolones Are Alike:
LEVAQUIN® and Ciprofloxacin

There is no generic equivalent to LEVAQUIN

LEVAQUIN® and ciprofloxacin in respiratory tract infections

In community-acquired pneumonia:

  • LEVAQUIN® is indicated first line against S pneumoniae in certain patient types; ciprofloxacin is not2-4
  • LEVAQUIN® is indicated first line for atypical pathogens; ciprofloxacin is not 2-4
  • LEVAQUIN® 750 mg reaches lung concentrations (epithelial lining fluid) of 22.1 µg/mL at 4 hr postdose vs 1.9 µg/mL for ciprofloxacin 500 mg*5
  • 99% of S pneumoniae isolates are susceptible to LEVAQUIN® vs 82% to ciprofloxacin1
  • LEVAQUIN® has been shown to eradicate MDRSP at 12 hr, while ciprofloxacin allowed regrowth6
  • LEVAQUIN® is indicated for once-daily dosing; ciprofloxacin is dosed twice daily4

* Pharmacokinetic data do not necessarily correlate with clinical results.

LEVAQUIN® has demonstrated clinical success† in >90% of patients with common respiratory infections including7-15:

  • Acute bacterial sinusitis (ABS)7,8
  • Acute bacterial exacerbation of chronic bronchitis9-12
  • Community-acquired pneumonia (CAP)13-15

† Clinical success=cured+improved.

See the Expert Recommendations for a comprehensive list of guideline publications that recommend LEVAQUIN® in common respiratory infections.

LEVAQUIN® and ciprofloxacin in genitourinary infections

In complicated urinary tract infections and acute pyelonephritis:

  • In a pharmacokinetic study 87% of each LEVAQUIN® dose is excreted as active drug in the urine vs 40% to 50% of each ciprofloxacin dose‡4
  • Ciprofloxacin is recognized by E coli efflux pumps, one mechanism of quinolone resistance; LEVAQUIN® is not recognized by identified efflux pumps16
    • May leave subtherapeutic levels of ciprofloxacin, increasing the potential for resistance16
  • LEVAQUIN® is indicated for once-daily dosing; ciprofloxacin is dosed twice daily4

In chronic bacterial prostatitis:

  • LEVAQUIN® and ciprofloxacin are both indicated for gram-negative E coli; ciprofloxacin is also indicated for P mirabilis4
  • LEVAQUIN® is indicated for the gram-positive pathogens E faecalis and S epidermidis; ciprofloxacin is not indicated for gram-positive pathogens4
  • LEVAQUIN® is indicated for once-daily dosing; ciprofloxacin is dosed twice daily4
  • 87% of each LEVAQUIN® dose is excreted as active drug in the urine vs 40% to 50% of each ciprofloxacin dose‡4
  • LEVAQUIN® reaches a prostate-tissue-to-plasma ratio of 2.96 vs 1.86 for ciprofloxacin17,18
  • LEVAQUIN® demonstrated clinical success§ of 75% (102/136) in a clinical study|| vs 73% (91/125) for ciprofloxacin (P=NS)19
    • In this study, pathogen susceptibility was 94.7% for LEVAQUIN® vs 90.6% for ciprofloxacin19
    • Posttherapy pathogen eradication rates for E coli were 93.3% (n=15) for LEVAQUIN® vs 81.8% (n=11) for ciprofloxacin (P=NS)19

‡ Pharmacokinetic data do not necessarily correlate with clinical success.
§ Clinical success=cured+improved.
|| Included E coli, coagulase-negative staphylococci, S epidermidis, S haemolyticus, S agalactiae, E faecalis, or S mitis in intent-to-treat patients.
¶ In a double-blind, multicenter, active-controlled trial, 377 men with chronic bacterial prostatitis were randomized to levofloxacin 500 mg/once daily (n=197) or ciprofloxacin 500 mg twice daily (n=180) for 28 days.19

Not All Quinolones Are Alike:
LEVAQUIN® and Moxifloxacin

Key properties: coverage, pharmacokinetics,* and dosing

  • In CAP, LEVAQUIN® is indicated for the atypical pathogens M pneumoniae, C pneumoniae, and L pneumophila; moxifloxacin is indicated for M pneumoniae and C pneumoniae but does not cover L pneumophila20
  • LEVAQUIN® 750 mg reaches peak plasma levels of 9.2 µg/mL; moxifloxacin peak plasma levels reach 3.1 µg/mL†1
  • LEVAQUIN® 750 mg and 500 mg reach peak lung concentrations (epithelial lining fluid) of 22.1 µg/mL and 15.23 µg/mL, respectively; moxifloxacin peak ELF levels reach 11.66 µg/mL‡5,21
  • 87% of each LEVAQUIN® dose is excreted as active drug in the urine; 20% of each moxifloxacin dose20
  • <4% of each LEVAQUIN® dose is excreted as active drug in the feces; 25% of each moxifloxacin dose20
  • Moxifloxacin is indicated to eradicate B fragilis, a protective gut anaerobe20; LEVAQUIN® is not
  • LEVAQUIN® 750 mg is indicated for 5-day dosing in CAP and acute bacterial sinusitis; moxifloxacin only offers 10-day dosing in these indications20
  • LEVAQUIN® 750 mg is indicated for 5-day dosing in complicated urinary tract infections and acute pyelonephritis; moxifloxacin is not indicated for these infections20

* Pharmacokinetic data do not necessarily correlate with clinical results.
† Single dose in healthy volunteers.
‡ Measured after 5 daily doses.

LEVAQUIN® and moxifloxacin in CAP

Similar success was shown in a clinical study with LEVAQUIN® 500 mg and moxifloxacin 400 mg.§22

  • LEVAQUIN® 750 mg has never been tested against moxifloxacin

§ Clinical success=cured+improved.

LEVAQUIN® achieves high concentrations for fast pathogen killing23

  • LEVAQUIN® 500 mg kills 99% of S pneumoniae in vitro in as little as 54 minutes24

LEVAQUIN® is the only quinolone with 5-day therapy in
4 respiratory and genitourinary indications

See full indications for complete list of pathogens.

LEVAQUIN® brings the option of 5-day therapy to more patients than any other quinolone.4,20

  • Data show that brief therapeutic regimens offer the prospect of better patient compliance and a reduced potential for resistance25,26

Download a LEVAQUIN® Dosing Card.

References:
  1. Data on file. Ortho-McNeil-Janssen Pharmaceuticals, Inc.
  2. Gilbert DN, Moellering RC, Eliopoulos GM, Sande MA. The Sanford Guide to Antimicrobial Therapy, 38th ed. Sperryville, VA; Antimicrobial Therapy, Inc. 2008.
  3. Mandell LA, Wunderink RG, Anzueto A, et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007;44(suppl 2):S27-S72.
  4. Cipro (ciprofloxacin) [Prescribing Information]. West Haven, CT: Bayer Pharmaceuticals Corporation.
  5. Gotfried MH, Danziger LH, Rodvold KA. Steady-state plasma and intrapulmonary concentrations of levofloxacin and ciprofloxacin in healthy adult subjects. Chest. 2001;119:1114-1122.
  6. Zhanel GG, Walters M, Laing N, Hoban DJ. In vitro pharmacodynamic modelling simulating free serum concentrations of fluoroquinolones against multidrug-resistant Streptococcus pneumoniae. J Antimicrob Chemother. 2001;47:435-440.
  7. Adelglass J, Jones TM, Ruoff G, et al. A multicenter, investigator-blinded, randomized comparison of oral levofloxacin and oral clarithromycin in the treatment of acute bacterial sinusitis. Pharmacotherapy. 1998;18:1255-1263.
  8. Lasko B, Lau CY, Saint-Pierre C, et al, and The Canadian Sinusitis Study Group. Efficacy and safety of oral levofloxacin compared with clarithromycin in the treatment of acute sinusitis in adults: a multicentre, double-blind, randomized study. J Int Med Res. 1998;26:281-291.
  9. DeAbate CA, Russell M, McElvaine P, et al. Safety and efficacy of oral levofloxacin versus cefuroxime axetil in acute bacterial exacerbation of chronic bronchitis. Respir Care. 1997;42:206-213.
  10. Habib MP, Gentry LO, Rodriguez-Gomez G, et al. Multicenter, randomized study comparing efficacy and safety of oral levofloxacin and cefaclor in treatment of acute bacterial exacerbations of chronic bronchitis. Infect Dis Clin Pract. 1998;7:101-109.
  11. Hautamaki D, Bruya T, Kureishi A, Warner J, Church D. Short-course (5-day) moxifloxacin versus 7-day levofloxacin therapy for treatment of acute exacerbations of chronic bronchitis. Today’s Ther Trends. 2001;19:117-136.
  12. Urueta-Robledo J, Ariza H, Jardim JR, et al. Moxifloxacin versus levofloxacin against acute exacerbations of chronic bronchitis: The Latin American Cohort. Respir Med. 2006;100:1504-1511.
  13. Dunbar LM, Wunderink RG, Habib MP, et al. High-dose, short-course levofloxacin for community-acquired pneumonia: a new treatment paradigm. Clin Infect Dis. 2003;37:752-760.
  14. Carbon C, Ariza H, Rabie WJ, et al. Comparative study of levofloxacin and amoxycillin/clavulanic acid in adults with mild-to-moderate community-acquired pneumonia. Clin Microbiol Infect. 1999;5:724-732.
  15. File TM Jr, Segreti J, Dunbar L, et al. A multicenter, randomized study comparing the efficacy and safety of intravenous and/or oral levofloxacin versus ceftriaxone and/or cefuroxime axetil in treatment of adults with community-acquired pneumonia. Antimicrob Agents Chemother. 1997;41:1965-1972.
  16. Yang S, Clayton SR, Zechiedrich EL. Relative contributions of the AcrAB, MdfA and NorE efflux pumps to quinolone resistance in Escherichia coli. J Antimicrob Chemother. 2003;51:545-556.
  17. Drusano GL, Preston SL, Van Guilder M, et al. A population pharmacokinetic analysis of the penetration of the prostate by levofloxacin. Antimicrob Agents Chemother. 2000;44:2046-2051.
  18. Zhanel GG, Ennis K, Vercaigne L, et al. A critical review of the fluoroquinolones. Drugs. 2002;62:13-59.
  19. Bundrick W, Heron SP, Ray P, et al. Levofloxacin versus ciprofloxacin in the treatment of chronic bacterial prostatitis: a randomized double-blinded multicenter study. Urology. 2003;62:537-541.
  20. Avelox (moxifloxacin) [Prescribing Information]. West Haven, CT: Bayer Pharmaceuticals Corporation.
  21. Capitano B, Mattoes HM, Shore E, et al. Steady-state intrapulmonary concentrations of moxifloxacin, levofloxacin, and azithromycin in older adults. Chest. 2004;125:965-973.
  22. Center for Drug Evaluation and Research. Avelox® new drug application. www.fda.gov/cder/foi/nda/2001/21277_Avelox_statr.pdf. Accessed November 5, 2007.
  23. Lister PD, Sanders CC. Pharmacodynamics of levofloxacin and ciprofloxacin against Streptococcus pneumoniae. J Antimicrob Chemother. 1999;43:79-86.
  24. Shah PM, Schwärzel R. Bactericidal activity of levofloxacin against Streptococcus pneumoniae in an in-vitro model simulating serum pharmacokinetic parameters. J Antimicrob Chemother. 1999;43(suppl C):71-75.
  25. Kardas P. Comparison of patient compliance with once-daily and twice-daily antibiotic regimens in respiratory tract infections: results of a randomized trial. J Antimicrob Chemother. 2007;59:531-536.
  26. World Health Organization. WHO Global Strategy for Containment of Antimicrobial Resistance. WHO/CDS/CSR/DRS/2001.2.

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 S pneumoniae [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.

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