Levofloxacin

LEVOFLOXACIN- levofloxacin tablet, film coated
PD-Rx Pharmaceuticals, Inc.

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS

• Fluoroquinolones, including levofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [ see Warnings and Precautions ( 5.1)] , including:
o Tendinitis and tendon rupture [ see Warnings and Precautions ( 5.2) ]
o Peripheral neuropathy [ see Warnings and Precautions ( 5.3) ]
o Central nervous system effects [ see Warnings and Precautions ( 5.4) ]

Discontinue levofloxacin immediately and avoid the use of fluoroquinolones, including levofloxacin, in patients who experience any of these serious adverse reactions [ see Warnings and Precautions ( 5.1) ]

• Fluoroquinolones, including levofloxacin, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid levofloxacin in patients with a known history of myasthenia gravis [ see Warnings and Precautions ( 5.5) ].

• Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [ see Warnings and Precautions (5.1-5.15) ], reserve levofloxacin for use in patients who have no alternative treatment options for the following indications:
o Uncomplicated urinary tract infection [ see Indications and Usage ( 1.12) ]
o Acute bacterial exacerbation of chronic bronchitis [ see Indications and Usage ( 1.13) ]
o Acute bacterial sinusitis [ see Indications and Usage ( 1.14)] .

1 INDICATIONS & USAGE

1.1 Nosocomial Pneumonia

Levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillinsusceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an antipseudomonal β-lactam is recommended [see Clinical Studies ( 14.1) ].

1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen

Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus , Streptococcus pneumoniae (including multidrug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila , or Mycoplasma pneumoniae [see Dosage and Administration ( 2.1) and Clinical Studies ( 14.2)].

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

1.3 Community-Acquired Pneumonia: 5-day Treatment Regimen


Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant strains [MDRSP]), Haemophilus influenzae , Haemophilus parainfluenzae , Mycoplasma pneumoniae , or Chlamydophila pneumoniae [see Dosage and Administration ( 2.1) and Clinical Studies ( 14.3) ] .

1.4 Complicated Skin and Skin Structure Infections

Levofloxacin tablets are indicated in adult patients 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)].

1.5 Uncomplicated Skin and Skin Structure Infections

Levofloxacin tablets are indicated in adult patients 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.

1.6 Chronic Bacterial Prostatitis


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

1.7 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 in adults and pediatric patients, 6 months of age and older [see Dosage and Administartion ( 2.2)]. . The effectiveness of levofloxacin tablets are based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin tablets has 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 tablets therapy should only be used when the benefit outweighs the risk [see Clinical Studies ( 14.9)].

1.8 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 [see Dosage and Administration ( 2.2) ]. 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 Clinical Studies ( 14.10) ].

1.9 Complicated Urinary Tract Infections: 5-day Treatment Regimen


Levofloxacin tablets are indicated in adult patients for the treatment of complicated urinary tract infections due to Escherichia coli , Klebsiella pneumoniae , or Proteus mirabilis [see Clinical Studies ( 14.7)] .

1.10 Complicated Urinary Tract Infections: 10-day Treatment Regimen

Levofloxacin tablets are indicated in adult patients for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis , Enterobacter cloacae , Escherichia coli , Klebsiella pneumoniae , Proteus mirabilis , or Pseudomonas aeruginosa [see Clinical Studies ( 14.8)] .

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