Levofloxacin

Levofloxacin

Levofloxacin Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tabletsand other antibacterial drugs, levofloxacin tabletsshould 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 tablets 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 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 tablet is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible 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 anti-pseudomonal β-lactam is recommended [see Clinical Studies (14.1)].

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

Levofloxacin tablet is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-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 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 tablet 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 [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 tablet is indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.4)].

1.5 Acute Bacterial Exacerbation of Chronic Bronchitis

Levofloxacin tablet is indicated for the treatment of acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.

1.6 Complicated Skin and Skin Structure Infections

Levofloxacin tablet is 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 tablet 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 Staphylococcus aureus, or Streptococcus pyogenes.

1.8 Chronic Bacterial Prostatitis

Levofloxacin tablet is 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 tablet is indicated 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 tablet is indicated 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)].

1.11 Acute Pyelonephritis: 5 or 10 day Treatment Regimen

Levofloxacin tablet 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 tabletis 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 tabletis indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of levofloxacin tablet is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin tablethas not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin tabletsin 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 tabletstherapy 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 tablet 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 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)].

History

There is currently no drug history available for this drug.

Other Information

Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate.

Figure 1

The Chemical Structure of Levofloxacin

Structure product formula for Levofloxacin

Its molecular formula is C18H20FN3O4 • ½ H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish–white to yellow–white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine.

The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9.

Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order:

Al+3> Cu+2> Zn+2> Mg+2> Ca+2.

Excipients and Description of Dosage Forms

Each levofloxacin tablet intended for oral administration contains levofloxacin hemihydrate equivalent to 250 mg or 500 mg or 750 mg of levofloxacin. In addition, each tablet contains the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, talc and  titanium dioxide.

Levofloxacin Manufacturers


  • Proficient Rx Lp
    Levofloxacin Tablet, Film Coated [Proficient Rx Lp]
  • Remedyrepack Inc.
    Levofloxacin Tablet, Film Coated [Remedyrepack Inc. ]
  • Blenheim Pharmacal, Inc.
    Levofloxacin Tablet, Film Coated [Blenheim Pharmacal, Inc.]
  • Proficient Rx Lp
    Levofloxacin Tablet, Film Coated [Proficient Rx Lp]
  • Camber Pharmaceuticals, Inc.
    Levofloxacin Tablet, Film Coated [Camber Pharmaceuticals, Inc.]
  • Preferred Pharmaceuticals, Inc.
    Levofloxacin Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]
  • Akorn, Inc.
    Levofloxacin Injection [Akorn, Inc.]
  • Stat Rx Usa Llc
    Levofloxacin Tablet, Film Coated [Stat Rx Usa Llc]
  • H.j. Harkins Company, Inc.
    Levofloxacin Tablet, Film Coated [H.j. Harkins Company, Inc.]
  • Physicians Total Care, Inc.
    Levofloxacin Tablet, Film Coated [Physicians Total Care, Inc.]
  • Rebel Distributors Corp
    Levofloxacin Tablet, Film Coated [Rebel Distributors Corp]
  • Unit Dose Services
    Levofloxacin Tablet, Film Coated [Unit Dose Services]
  • Mylan Institutional Inc.
    Levofloxacin Tablet, Film Coated [Mylan Institutional Inc.]
  • Bryant Ranch Prepack
    Levofloxacin Tablet, Film Coated [Bryant Ranch Prepack]
  • Cadila Healthcare Limited
    Levofloxacin Tablet, Film Coated [Cadila Healthcare Limited]
  • Wockhardt Limited
    Levofloxacin Tablet [Wockhardt Limited]
  • Wockhardt Usa Llc.
    Levofloxacin Tablet [Wockhardt Usa Llc.]
  • Sandoz Inc
    Levofloxacin Injection, Solution [Sandoz Inc]
  • Bryant Ranch Prepack
    Levofloxacin Tablet, Film Coated [Bryant Ranch Prepack]
  • Lake Erie Medical Dba Quality Care Products Llc
    Levofloxacin Tablet, Film Coated [Lake Erie Medical Dba Quality Care Products Llc]
  • Remedyrepack Inc.
    Levofloxacin Tablet, Film Coated [Remedyrepack Inc. ]
  • Lake Erie Medical Dba Quality Care Products Llc
    Levofloxacin Tablet, Film Coated [Lake Erie Medical Dba Quality Care Products Llc]
  • Pd-rx Pharmaceuticals, Inc.
    Levofloxacin Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Levofloxacin (Levofloxacin) Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Levofloxacin (Levofloxacin) Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Levofloxacin (Levofloxacin) Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • Avkare, Inc.
    Levofloxacin (Levofloxacin) Tablet, Film Coated [Avkare, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Levofloxacin Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • West-ward Pharmaceutical Corp
    Levofloxacin Injection, Solution [West-ward Pharmaceutical Corp]
  • Lake Erie Medical Dba Quality Care Products Llc
    Levofloxacin Tablet, Film Coated [Lake Erie Medical Dba Quality Care Products Llc]
  • Major Pharmaceuticals
    Levofloxacin Tablet [Major Pharmaceuticals]
  • Dr. Reddy’s Laboratories Limited
    Levofloxacin Tablet, Film Coated [Dr. Reddy’s Laboratories Limited ]
  • Remedyrepack Inc.
    Levofloxacin Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Levofloxacin Tablet, Film Coated [Remedyrepack Inc. ]
  • American Health Packaging
    Levofloxacin Tablet, Film Coated [American Health Packaging]
  • Sandoz Inc
    Levofloxacin Tablet, Film Coated [Sandoz Inc]
  • Clinical Solutions Wholesale
    Levofloxacin Tablet, Film Coated [Clinical Solutions Wholesale]
  • Major Pharmaceuticals
    Levofloxacin Tablet, Film Coated [Major Pharmaceuticals]
  • Fresenius Kabi Usa, Llc
    Levofloxacin Injection [Fresenius Kabi Usa, Llc]
  • Remedyrepack Inc.
    Levofloxacin Tablet, Film Coated [Remedyrepack Inc. ]
  • New Horizon Rx Group, Llc
    Levofloxacin Tablet [New Horizon Rx Group, Llc]
  • Remedyrepack Inc.
    Levofloxacin Tablet, Film Coated [Remedyrepack Inc. ]
  • Aidarex Pharmaceuticals Llc
    Levofloxacin Tablet [Aidarex Pharmaceuticals Llc]
  • Preferred Pharmaceuticals, Inc.
    Levofloxacin Tablet [Preferred Pharmaceuticals, Inc.]
  • Preferred Pharmaceuticals, Inc
    Levofloxacin Tablet, Film Coated [Preferred Pharmaceuticals, Inc]
  • Preferred Pharmaceuticals, Inc.
    Levofloxacin Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]
  • Preferred Pharmaceuticals, Inc.
    Levofloxacin Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]
  • Preferred Pharmaceuticals, Inc.
    Levofloxacin Tablet [Preferred Pharmaceuticals, Inc.]
  • Preferred Pharmaceuticals, Inc
    Levofloxacin Tablet, Film Coated [Preferred Pharmaceuticals, Inc]
  • Blenheim Pharmacal, Inc.
    Levofloxacin Tablet, Film Coated [Blenheim Pharmacal, Inc.]
  • Greenstone Llc
    Levofloxacin Tablet, Film Coated [Greenstone Llc]
  • Direct Rx
    Levofloxacin Tablet, Film Coated [Direct Rx]
  • Direct Rx
    Levofloxacin Tablet, Film Coated [Direct Rx]
  • Readymeds
    Levofloxacin Tablet, Film Coated [Readymeds]
  • Proficient Rx
    Levofloxacin Tablet, Film Coated [Proficient Rx]
  • Proficient Rx Lp
    Levofloxacin Tablet, Film Coated [Proficient Rx Lp]
  • Northwind Pharmaceuticals
    Levofloxacin Tablet, Film Coated [Northwind Pharmaceuticals]
  • Bryant Ranch Prepack
    Levofloxacin Tablet [Bryant Ranch Prepack]
  • Aurobindo Pharma Limited
    Levofloxacin Tablet, Film Coated [Aurobindo Pharma Limited]
  • Heritage Pharmaceuticals Inc.
    Levofloxacin Injection [Heritage Pharmaceuticals Inc.]
  • Claris Lifesciences Inc.
    Levofloxacin Injection, Solution [Claris Lifesciences Inc.]
  • Cardinal Health
    Levofloxacin Tablet, Film Coated [Cardinal Health]
  • Citron Pharma Llc
    Levofloxacin Tablet, Film Coated [Citron Pharma Llc]
  • Teva Pharmaceuticals Usa Inc
    Levofloxacin Tablet, Film Coated [Teva Pharmaceuticals Usa Inc]
  • Macleods Pharmaceuticals Limited
    Levofloxacin Tablet, Film Coated [Macleods Pharmaceuticals Limited]
  • Lupin Pharmaceuticals, Inc.
    Levofloxacin Tablet, Film Coated [Lupin Pharmaceuticals, Inc.]
  • Auromedics Pharma Llc
    Levofloxacin Injection, Solution, Concentrate [Auromedics Pharma Llc]
  • Torrent Pharmaceuticals Limited
    Levofloxacin Tablet [Torrent Pharmaceuticals Limited]
  • Boca Pharmacal, Llc
    Levofloxacin Tablet, Film Coated [Boca Pharmacal, Llc]
  • Cardinal Health
    Levofloxacin Tablet [Cardinal Health]
  • Sagent Pharmaceuticals
    Levofloxacin Injection, Solution [Sagent Pharmaceuticals]
  • Sagent Pharmaceuticals
    Levofloxacin Injection, Solution [Sagent Pharmaceuticals]
  • Sagent Pharmaceuticals
    Levofloxacin Injection, Solution [Sagent Pharmaceuticals]
  • Zydus Pharmaceuticals (Usa) Inc.
    Levofloxacin Tablet, Film Coated [Zydus Pharmaceuticals (Usa) Inc.]
  • Sagent Pharmaceuticals
    Levofloxacin Injection, Solution [Sagent Pharmaceuticals]
  • Direct Rx
    Levofloxacin Tablet [Direct Rx]
  • Hospira, Inc.
    Levofloxacin Injection, Solution [Hospira, Inc.]
  • Medsource Pharmaceuticals
    Levofloxacin Tablet, Film Coated [Medsource Pharmaceuticals]
  • Directrx
    Levofloxacin Tablet, Film Coated [Directrx]