These highlights do not include all the information needed to use LEVAQUIN safely and effectively. See full prescribing information for LEVAQUIN.
LEVAQUIN (levofloxacin) Tablet, Film Coated for Oral use
LEVAQUIN (levofloxacin) Solution for Oral use
LEVAQUIN (levofloxacin) Injection, Solution, Concentrate for Intravenous use
LEVAQUIN (levofloxacin) Injection, Solution for Intravenous use
Initial U.S. Approval: 1996
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 bacteria.
Warning:
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 [See Warnings and Precautions (5.1)].
RECENT MAJOR CHANGES
Warnings and Precautions
Tendinopathy and Tendon Rupture (5.1)
9/2008
INDICATIONS AND USAGE
LEVAQUIN® is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4).
Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3)
Acute bacterial sinusitis (1.4)
Acute bacterial exacerbation of chronic bronchitis (1.5)
Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7)
Chronic bacterial prostatitis (1.8)
Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12)
Acute pyelonephritis (1.11)
Inhalational anthrax, post-exposure (1.13). Not tested in humans for post-exposure prevention of inhalational anthrax; plasma concentrations are likely to predict efficacy (14.9)
DOSAGE AND ADMINISTRATION
Dosage in patients with normal renal function (2.1)
Type of Infection
Dose Every 24 hours
Duration
(days)
Nosocomial Pneumonia (1.1)
750 mg
7–14
Community Acquired Pneumonia (1.2)
500 mg
7–14
Community Acquired Pneumonia (1.3)
750 mg
5
Acute Bacterial Sinusitis (1.4)
750 mg
5
500 mg
10–14
Acute Bacterial Exacerbation of Chronic Bronchitis (1.5)
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI) (1.6)
750 mg
7–14
Uncomplicated SSSI (1.7)
500 mg
7–10
Chronic Bacterial Prostatitis (1.8)
500 mg
28
Complicated Urinary Tract Infection (1.9) or Acute Pyelonephritis (1.11)
750 mg
5
Complicated Urinary Tract Infection (1.10) or Acute Pyelonephritis (1.11)
250 mg
10
Uncomplicated Urinary Tract Infection (1.12)
250 mg
3
Inhalational Anthrax (Post-Exposure) (1.13)
Adults and Pediatric Patients > 50 kg and ≥ 6 months of age
IV Injection, Single-Use or Premix: Slow IV infusion only, over 60 or 90 minutes depending on dose. Avoid rapid or bolus IV (2.5)
Dilute single-use vials to 5 mg/mL prior to IV infusion (2.6)
Do not mix with other medications in vial or IV line (2.6)
DOSAGE FORMS AND STRENGTHS
Formulation (3)
Strength
Tablets
250 mg, 500 mg, and 750 mg
Oral Solution
25 mg/mL
Injection: single-use vials for dilution
500 mg in 20 mL
750 mg in 30 mL
Injection: premix single-use flexible containers
250 mg in 50 mL
500 mg in 100 mL
750 mg in 150 mL
CONTRAINDICATIONS
Known hypersensitivity to LEVAQUIN® or other quinolones (4, 5.2)
WARNINGS AND PRECAUTIONS
Risk of tendinitis and tendon rupture is increased. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroids, and in patients with kidney, heart or lung transplants. Discontinue if pain or inflammation in a tendon occurs (5.1, 8.5)
Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dose (4, 5.2)
Hematologic (including agranulocytosis, thrombocytopenia), and renal toxicities may occur after multiple doses (5.3)
Hepatotoxicity: Severe, and sometimes fatal, hepatoxicity has been reported. Discontinue immediately if signs and symptoms of hepatitis occur (5.4)
Central nervous system effects, including convulsions, anxiety, confusion, depression, and insomnia may occur after the first dose. Use with caution in patients with known or suspected disorders that may predispose them to seizures or lower the seizure threshold (5.5)
Clostridium difficile-associated colitis: eva luate if diarrhea occurs (5.6)
Peripheral neuropathy: discontinue if symptoms occur in order to prevent irreversibility (5.7)
Prolongation of the QT interval and isolated cases of torsade de pointes have been reported. Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval (5.8, 8.5)
ADVERSE REACTIONS
The most common reactions (≥3%) were nausea, headache, diarrhea, insomnia, constipation and dizziness (6.2).
To report SUSPECTED ADVERSE REACTIONS, contact Ortho-McNeil-Janssen Scientific Affairs Customer Communications Center at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Interacting Drug
Interaction
Multivalent cation-containing products including antacids, metal cations or didanosine
Absorption of levofloxacin is decreased when the tablet or oral solution formulation is taken within 2 hours of these products. Do not co-administer the intravenous formulation in the same IV line with a multivalent cation, e.g., magnesium (2.4, 7.1)
Warfarin
Effect may be enhanced. Monitor prothrombin time, INR, watch for bleeding (7.2)
Antidiabetic agents
Carefully monitor blood glucose (5.10, 7.3)
USE IN SPECIFIC POPULATIONS
Geriatrics: Severe hepatotoxicity has been reported. The majority of reports describe patients 65 years of age or older (5.4, 8.5, 17). May have increased risk of tendinopathy (including rupture), especially with concomitant corticosteroid use (5.1, 8.5, 17). May be more susceptible to prolongation of the QT interval. (5.8, 8.5, 17).
Pediatrics: Musculoskeletal disorders (arthralgia, arthritis, tendonopathy, and gait abnormality) seen in more LEVAQUIN®-treated patients than in comparator. Shown to cause arthropathy and osteochondrosis in juvenile animals (5.9, 8.4, 13.2). Safety in pediatric patients treated for more than 14 days has not been studied. Risk-benefit appropriate only for the treatment of inhalational anthrax (post-exposure) (1.13, 2.2, 8.4, 14.9)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide
Revised: 12/2010
Back to Highlights and Tabs
FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
1.1 Nosocomial Pneumonia
1.2 Community-Acquired Pneumonia: 7–14 day Treatment Regimen
17.2 Administration with Food, Fluids, and Concomitant Medications
17.3 Serious and Potentially Serious Adverse Reactions
17.4 Drug Interactions with Insulin, Oral Hypoglycemic Agents, and Warfarin
17.5 FDA-Approved Medication Guide
Principal Display Panel
Principal Display Panel
FULL PRESCRIBING INFORMATION
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 [See Warnings and Precautions (5.1)].
1 INDICATIONS AND 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.
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 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).
Culture and susceptibility testing
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 [see Clinical Pharmacology (12.4)]. Therapy with LEVAQUIN® 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 LEVAQUIN®. 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.
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 β-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 strains resistant to two or more of the following antibacterials: penicillin (MIC ≥2mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.
LEVAQUIN® is indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.3)].
1.4 Acute Bacterial Sinusitis: 5-day and 10–14 day Treatment Regimens
LEVAQUIN® is indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.4)].
1.5 Acute Bacterial Exacerbation of Chronic Bronchitis
LEVAQUIN® is indicated for the treatment of acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.
1.6 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)].
1.7 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.
1.8 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)].
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)].
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.
1.13 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)].
2 DOSAGE AND ADMINISTRATION
2.1 Dosage in Adult Patients with Normal Renal Function
The usual dose of LEVAQUIN® Tablets or Oral Solution is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1. The usual dose of LEVAQUIN® Injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50mL/min)
Type of Infection*
Dosed Every 24 hours
Duration (days)†
*
Due to the designated pathogens [see Indications and Usage (1)].
†
Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡
Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§
Due to Streptococcus pneumoniae (excluding multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶
This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
#
This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
Þ
Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ß
The safety of LEVAQUIN® in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.9), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged LEVAQUIN® therapy should only be used when the benefit outweighs the risk.
Nosocomial Pneumonia
750 mg
7–14
Community Acquired Pneumonia‡
500 mg
7–14
Community Acquired Pneumonia§
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10–14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
