Levofloxacin tablets are indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of levofloxacin is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin tablets have not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin 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 levofloxacin tablet therapy should only be used when the benefit outweighs the risk [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.9)].
The usual dose of levofloxacin tablets is 250 mg, 500 mg or 750 mg administered orally 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)].
|Type of Infection *||Dosed Every 24 hours||Duration (days)†|
|Nosocomial Pneumonia||750 mg||7 to 14|
|Community Acquired Pneumonia ‡||500 mg||7 to 14|
|Community Acquired Pneumonia §||750 mg||5|
|Acute Bacterial Sinusitis||750 mg||5|
|500 mg||10 to 14|
|Acute Bacterial Exacerbation of Chronic Bronchitis||500 mg||7|
|Complicated Skin and Skin Structure Infections (SSSI)||750 mg||7 to 14|
|Uncomplicated SSSI||500 mg||7 to 10|
|Chronic Bacterial Prostatitis||500 mg||28|
|Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)¶||750 mg||5|
|Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)#||250 mg||10|
|Uncomplicated Urinary Tract Infection||250 mg||3|
|Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg and ≥ 6 months of age ÞßPediatric patients < 50 kg and ≥ 6 months of age Þß||500 mgsee Table 2 below (2.2)|| |
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