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)

*
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 isolates [MDRSP]), Haemophilusinfluenzae, Haemophilusparainfluenzae, Klebsiellapneumoniae, Moraxella catarrhalis, Chlamydophilapneumoniae, Legionella pneumophila , or Mycoplasma pneumoniae [see INDICATIONS AND USAGE (1.2)].
§
Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilusinfluenzae, Haemophilusparainfluenzae, Mycoplasma pneumoniae, or Chlamydophilapneumoniae [ see INDICATIONS AND USAGE(1.3)].
This regimen is indicated for cUTI due to Escherichia coli, Klebsiellapneumoniae, 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, Klebsiellapneumoniae, Proteus mirabilis, Pseudomonasaeruginosa; 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 levofloxacin tabletsin 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 (5.10), USE IN SPECIFIC POPULATIONS (8.4), and CLINICAL STUDIES (14.9)]. Prolonged levofloxacin tablettherapy should only be used when the benefit outweighs the risk.
à
Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.

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

Pediatric patients < 50 kg and ≥ 6 months of age Þ, ß

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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