Prescription Drug Information: Levofloxacin

LEVOFLOXACIN- levofloxacin tablet, film coated
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WARNING:

Fluoroquinolones, including levofloxacin, 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)].

Fluoroquinolones, including levofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid levofloxacin in patients with a known history of myasthenia gravis [see WARNINGS AND PRECAUTIONS (5.2)].

1 INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tabletsand other antibacterial drugs, levofloxacin tablets 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.

Levofloxacin tablets are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section.

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 MICROBIOLOGY(12.4)]. Therapy with levofloxacin tabletsmay 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 isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin tablets. 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

Levofloxacin tablets are indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus , Pseudomonas aeruginosa , Serratiamarcescens , Escherichia coli, Klebsiellapneumoniae, Haemophilusinfluenzae, 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 to 14-Day Treatment Regimen

Levofloxacin tablets are indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus , Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilusinfluenzae , Haemophilusparainfluenzae , Klebsiellapneumoniae , Moraxella catarrhalis , Chlamydophilapneumoniae , Legionella pneumophila , or Mycoplasma pneumoniae [see DOSAGE AND ADMINISTRATION (2.1) and CLINICAL STUDIES(14.2)].

MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC ≥2 mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

1.3 Community-Acquired Pneumonia: 5-Day Treatment Regimen

Levofloxacin tablets are indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae ( excluding multi-drug-resistant isolates [MDRSP]), Haemophilusinfluenzae, Haemophilusparainfluenzae, Mycoplasma pneumoniae, or Chlamydophilapneumoniae [see DOSAGE AND ADMINISTRATION (2.1) and CLINICAL STUDIES(14.3)].

1.4 Acute Bacterial Sinusitis: 5-Day and 10 to 14-Day Treatment Regimens

Levofloxacin tablets are indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae , Haemophilusinfluenzae , or Moraxella catarrhalis [see CLINICAL STUDIES(14.4)].

1.5 Acute Bacterial Exacerbation of Chronic Bronchitis

Levofloxacin tablets are indicated for the treatment of acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus , Streptococcus pneumoniae , Haemophilusinfluenzae , Haemophilusparainfluenzae , or Moraxella catarrhalis.

1.6 Complicated Skin and Skin Structure Infections

Levofloxacin tablets are 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

Levofloxacin tablets are 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

Levofloxacin tablets are indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli , Enterococcus faecalis , or methicillin-susceptible Staphylococcus epidermidis [see CLINICAL STUDIES(14.6)].

1.9 Complicated Urinary Tract Infections: 5-Day Treatment Regimen

Levofloxacin tablets are indicated for the treatment of complicated urinary tract infections due to Escherichia coli , Klebsiellapneumoniae , or Proteus mirabilis [see CLINICAL STUDIES(14.7)].

1.10 Complicated Urinary Tract Infections: 10-Day Treatment Regimen

Levofloxacin tablets are indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis , Enterobacter cloacae , Escherichia coli , Klebsiellapneumoniae , Proteus mirabilis , or Pseudomonas aeruginosa [see CLINICAL STUDIES(14.8)].

1.11 Acute Pyelonephritis: 5 or 10-Day Treatment Regimen

Levofloxacin tablets are 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

Levofloxacin tablets are indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiellapneumoniae, or Staphylococcus saprophyticus.

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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