EVAQUIN- levofloxacin tablet, film coated
LEVAQUIN- levofloxacin solution
LEVAQUIN- levofloxacin injection, solution
Janssen Pharmaceuticals, Inc.
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS
? Fluoroquinolones, including LEVAQUIN� , have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions (5.1)] , including:
Tendinitis and tendon rupture [see Warnings and Precautions (5.2)]
Peripheral neuropathy [see Warnings and Precautions (5.3)]
Central nervous system effects [see Warnings and Precautions (5.4)]
Discontinue LEVAQUIN immediately and avoid the use of fluoroquinolones, including LEVAQUIN, in patients who experience any of these serious adverse reactions [see Warnings and Precautions (5.1)]
? Fluoroquinolones, including LEVAQUIN� , may exacerbate muscle weakness in patients with myasthenia gravis. Avoid LEVAQUIN� in patients with a known history of myasthenia gravis [see Warnings and Precautions (5.5)] .
? Because fluoroquinolones, including LEVAQUIN, have been associated with serious adverse reactions [see Warnings and Precautions (5.1�5.14)], reserve LEVAQUIN for use in patients who have no alternative treatment options for the following indications:
Uncomplicated urinary tract infection [see Indications and Usage (1.12)]
Acute bacterial exacerbation of chronic bronchitis [see Indications and Usage (1.13)]
Acute bacterial sinusitis [see Indications and Usage (1.14)].
1 INDICATIONS AND USAGE
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 isolates of the designated microorganisms in the conditions listed in this section. 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).
1.1 Nosocomial Pneumonia
LEVAQUIN� is indicated for the treatment of 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 ?-lactam is recommended [see Clinical Studies (14.1)].
1.2 Community-Acquired Pneumonia: 7�14 day Treatment Regimen
LEVAQUIN� is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus , Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae , Haemophilus parainfluenzae , Klebsiella pneumoniae , Moraxella catarrhalis , Chlamydophila pneumoniae , Legionella pneumophila , or Mycoplasma pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.2)].
MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC ?2 mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.
1.3 Community-Acquired Pneumonia: 5-day Treatment Regimen
LEVAQUIN� is indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae , Haemophilus parainfluenzae , Mycoplasma pneumoniae , or Chlamydophila pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.3)].
1.4 Complicated Skin and Skin Structure Infections
LEVAQUIN� is indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus , Enterococcus faecalis , Streptococcus pyogenes , or Proteus mirabilis [see Clinical Studies (14.5)].
1.5 Uncomplicated Skin and Skin Structure Infections
LEVAQUIN� is indicated for the treatment of 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.
1.6 Chronic Bacterial Prostatitis
LEVAQUIN� is indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli , Enterococcus faecalis , or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies (14.6)].
1.7 Inhalational Anthrax (Post-Exposure)
LEVAQUIN� is indicated for 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 (2.1 , 2.2) and Clinical Studies (14.9)].
1.8 Plague
LEVAQUIN� is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older. Efficacy studies of LEVAQUIN� could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.10)].
1.9 Complicated Urinary Tract Infections: 5-day Treatment Regimen
LEVAQUIN� is indicated for the treatment of complicated urinary tract infections due to Escherichia coli , Klebsiella pneumoniae , or Proteus mirabilis [see Clinical Studies (14.7)].
1.10 Complicated Urinary Tract Infections: 10-day Treatment Regimen
LEVAQUIN� is indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis , Enterobacter cloacae , Escherichia coli , Klebsiella pneumoniae , Proteus mirabilis , or Pseudomonas aeruginosa [see Clinical Studies (14.8)].
1.11 Acute Pyelonephritis: 5 or 10-day Treatment Regimen
LEVAQUIN� is indicated for the treatment of acute pyelonephritis caused by Escherichia coli , including cases with concurrent bacteremia [see Clinical Studies (14.7 , 14.8)].
1.12 Uncomplicated Urinary Tract Infections
LEVAQUIN� is indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli , Klebsiella pneumoniae , or Staphylococcus saprophyticus.
? Because fluoroquinolones, including LEVAQUIN, have been associated with serious adverse reactions [see Warnings and Precautions (5.1�5.14)] and for some patients uncomplicated urinary tract infection is self-limiting, reserve LEVAQUIN for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options.
1.13 Acute Bacterial Exacerbation of Chronic Bronchitis
LEVAQUIN� is indicated for the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB) due to methicillin-susceptible Staphylococcus aureus , Streptococcus pneumoniae , Haemophilus influenzae , Haemophilus parainfluenzae , or Moraxella catarrhalis.
? Because fluoroquinolones, including LEVAQUIN, have been associated with serious adverse reactions [see Warnings and Precautions (5.1�5.14)] and for some patients ABECB is self-limiting, reserve LEVAQUIN for treatment of ABECB in patients who have no alternative treatment options.
1.14 Acute Bacterial Sinusitis: 5-day and 10�14 day Treatment Regimens
LEVAQUIN� is indicated for the treatment of acute bacterial sinusitis (ABS) due to Streptococcus pneumoniae , Haemophilus influenzae , or Moraxella catarrhalis [see Clinical Studies (14.4)].
? Because fluoroquinolones, including LEVAQUIN, have been associated with serious adverse reactions [see Warnings and Precautions (5.1�5.14)] and for some patients ABS is self-limiting, reserve LEVAQUIN for treatment of ABS in patients who have no alternative treatment options.
1.15 Usage
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 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.