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HIGHLIGHTS OF PRESCRIBING INFORMATION |
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.
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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)].
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RECENT MAJOR CHANGES
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Warnings and Precautions |
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Tendinopathy and Tendon Rupture (5.1)
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9/2008 |
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INDICATIONS AND USAGE
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LEVAQUIN® is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4).
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Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3)
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Acute bacterial sinusitis (1.4)
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Acute bacterial exacerbation of chronic bronchitis (1.5)
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Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7)
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Chronic bacterial prostatitis (1.8)
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Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12)
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Acute pyelonephritis (1.11)
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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)
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DOSAGE AND ADMINISTRATION
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Dosage in patients with normal renal function (2.1)
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Type of Infection |
Dose Every 24 hours |
Duration
(days) |
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Nosocomial Pneumonia (1.1) |
750 mg |
7–14 |
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Community Acquired Pneumonia (1.2) |
500 mg |
7–14 |
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Community Acquired Pneumonia (1.3) |
750 mg |
5 |
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Acute Bacterial Sinusitis (1.4) |
750 mg |
5 |
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500 mg |
10–14 |
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Acute Bacterial Exacerbation of Chronic Bronchitis (1.5) |
500 mg |
7 |
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Complicated Skin and Skin Structure Infections (SSSI) (1.6) |
750 mg |
7–14 |
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Uncomplicated SSSI (1.7) |
500 mg |
7–10 |
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Chronic Bacterial Prostatitis (1.8) |
500 mg |
28 |
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Complicated Urinary Tract Infection (1.9) or Acute Pyelonephritis (1.11) |
750 mg |
5 |
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Complicated Urinary Tract Infection (1.10) or Acute Pyelonephritis (1.11) |
250 mg |
10 |
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Uncomplicated Urinary Tract Infection (1.12) |
250 mg |
3 |
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Inhalational Anthrax (Post-Exposure) (1.13) |
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Adults and Pediatric Patients > 50 kg and ≥ 6 months of age |
500 mg |
60 |
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Pediatric Patients < 50 kg and ≥ 6 months of age |
8 mg/kg BID (not to exceed 250 mg/dose) |
60 |
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Adjust dose for creatinine clearance < 50 mL/min (2.3, 8.6, 12.3)
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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)
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Dilute single-use vials to 5 mg/mL prior to IV infusion (2.6)
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Do not mix with other medications in vial or IV line (2.6)
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DOSAGE FORMS AND STRENGTHS
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Formulation (3) |
Strength |
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Tablets |
250 mg, 500 mg, and 750 mg |
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Oral Solution |
25 mg/mL |
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Injection: single-use vials for dilution |
500 mg in 20 mL
750 mg in 30 mL |
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Injection: premix single-use flexible containers |
250 mg in 50 mL
500 mg in 100 mL
750 mg in 150 mL |
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CONTRAINDICATIONS
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Known hypersensitivity to LEVAQUIN® or other quinolones (4, 5.2)
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WARNINGS AND PRECAUTIONS
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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 (
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