Levofloxacin (Page 2 of 17)
1.13 Inhalational Anthrax (Post-Exposure)
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 tablets 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 tablets 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))].
1.14 Plague
Levofloxacin tablets are 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 levofloxacin tablets 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)].
2 DOSAGE AND ADMINISTRATION
2.1 Dosage in Adult Patients with Normal Renal Function
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)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)
| ||
| 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 Þ, ß | 500 mg | 60ß |
| see Table 2 below (2.2) | 60ß | |
| Plague, adult and pediatric patients > 50 kg à | 500 mg | 10 to 14 |
| Pediatric patients < 50 kg and ≥ 6 months of age | see Table 2 below (2.2) | 10 to 14 |
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