1 INDICATIONS AND USAGE
Levofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age) with infections caused by designated, susceptible bacteria (1,
12.4).
Pneumonia:
nosocomial (1.1 ) and community acquired (1.2 ,1.3 )
Acute
bacterial sinusitis (1.
4 )
Acute
bacterial exacerbation of chronic bronchitis (1.5 )
Skin
and skin structure infections: complicated (1.6 )
and uncomplicated (1.7 )
Chronic
bacterial prostatitis (1.8 )
Urinary
tract infections: complicated (1.9 ,1.10 )
and uncomplicated (1.12 )
Acute
pyelonephritis (1.11 )
Inhalational anthrax, post-exposure (1.13 ).
Plague (1.14)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets, USP and other antibacterial drugs, levofloxacin tablets, USP 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, USP is 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.
Cultureandsusceptibilitytesting
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 tablets, USP [seeMicrobiology (12.4)]. Therapy with levofloxacin tablets, USP may 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 Pseudomonasaeruginosa may develop resistance fairly rapidly during treatment with levofloxacin tablets, USP. 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, USP is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcusaureus, Pseudomonasaeruginosa, Serratiamarcescens, Escherichiacoli, Klebsiellapneumoniae, Haemophilusinfluenzae, or Streptococcuspneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonasaeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal -lactam is recommended [see
ClinicalStudies(
14.1
)].
1.2 Community-Acquired Pneumonia: 714 day Treatment Regimen
Levofloxacin tablets, USP is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcusaureus, Streptococcuspneumoniae (including multi-drug-resistant Streptococcuspneumoniae [MDRSP]), Haemophilusinfluenzae, Haemophilusparainfluenzae, Klebsiellapneumoniae, Moraxellacatarrhalis, Chlamydophilapneumoniae, Legionellapneumophila, or Mycoplasmapneumoniae[see
DosageandAdministration(
2.1
)
and
ClinicalStudies(
14.2
)].
MDRSP isolates are strains 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, USP is indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [seeDosage and Administration (2.1) and Clinical Studies (14.3)]
1.4 Acute Bacterial Sinusitis: 5-day and 1014 day Treatment Regimens
Levofloxacin tablets, USP is indicated for the treatment of acute bacterial sinusitis due to Streptococcuspneumoniae, Haemophilusinfluenzae, or Moraxellacatarrhalis[see
ClinicalStudies(
14.4
)].
1.5 Acute Bacterial Exacerbation of Chronic Bronchitis
Levofloxacin tablets, USP is indicated for the treatment of acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible Staphylococcusaureus, Streptococcuspneumoniae, Haemophilusinfluenzae, Haemophilusparainfluenzae, or Moraxellacatarrhalis.
1.6 Complicated Skin and Skin Structure Infections
Levofloxacin tablets, USP is indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcusaureus, Enterococcusfaecalis, Streptococcuspyogenes, or Proteusmirabilis[see
ClinicalStudies(
14.5
)].
1.7 Uncomplicated Skin and Skin Structure Infections
Levofloxacin tablets, USP is 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 Staphylococcusaureus, or Streptococcuspyogenes.
1.8 Chronic Bacterial Prostatitis
Levofloxacin tablets, USP is indicated for the treatment of chronic bacterial prostatitis due to Escherichiacoli, Enterococcusfaecalis, or methicillin-susceptible Staphylococcusepidermidis[see
ClinicalStudies(
14.6
)].
1.9 Complicated Urinary Tract Infections: 5-day Treatment Regimen
Levofloxacin tablets, USP is indicated for the treatment of complicated urinary tract infections due to Escherichiacoli, Klebsiellapneumoniae, or Proteusmirabilis[seeClinicalStudies(14.7)].
1.10 Complicated Urinary Tract Infections: 10-day Treatment Regimen
Levofloxacin tablets, USP is indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcusfaecalis, Enterobactercloacae, Escherichiacoli, Klebsiellapneumoniae, Proteusmirabilis, or Pseudomonasaeruginosa[seeClinicalStudies(14.8)].
1.11 Acute Pyelonephritis: 5 or 10-day Treatment Regimen
Levofloxacin tablets, USP is 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, USP is indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.
1.13 Inhalational Anthrax (Post-Exposure)
Levofloxacin tablets, USP is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillusanthracis. The effectiveness of levofloxacin tablets, USP is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin has 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 therapy should only be used when the benefit outweighs the risk [see
DosageandAdministration(
2.1
,
2.2
)
and
ClinicalStudies(
14.9
)].
1.14 Plague
Levofloxacin tablets, USP is 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 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)].