MedPath

Levofloxacin

Generic Name
Levofloxacin
Brand Names
Levaquin, Quinsair
Drug Type
Small Molecule
Chemical Formula
C18H20FN3O4
CAS Number
100986-85-4
Unique Ingredient Identifier
RIX4E89Y14
Background

Levofloxacin is a fluoroquinolone antibiotic and the optical S-(-) isomer of racemic ofloxacin. It reportedly carries 8 to 128-fold more activity against both gram-negative and gram-positive bacteria compared to R-(+)-ofloxacin and remains stereochemically stable following administration (i.e. it does not invert to the inactive isomer). Levofloxacin, along with other quinolones such as gatifloxacin and moxifloxacin, is a member of the third generation of fluoroquinolones, colloquially referred to as the "respiratory quinolones" due to improved activity against gram-positive bacteria commonly implicated in respiratory infections.

Levofloxacin was first approved by the FDA in 1996, and was approved in Canada and several South American countries soon after.

Indication

In oral and intravenous formulations, levofloxacin is indicated in adults for the treatment of various infections caused by susceptible bacteria, including infections of the upper respiratory tract, lower respiratory tract, skin, skin structures, urinary tract, and prostate. The oral formulation is also indicated in both adults and children 6 months of age and older for the post-exposure management of inhalational anthrax caused by Bacillus anthracis and for the treatment and/or prophylaxis of plague caused by Yersinia pestis.

In its ophthalmic formulation, levofloxacin is indicated for the treatment of bacterial conjunctivitis caused by susceptible organisms. An inhalational solution available in Canada is indicated for the management of cystic fibrosis patients aged 18 years or older with chronic pulmonary Pseudomonas aeruginosa infections.

Associated Conditions
Abscesses caused by susceptible bacteria, Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) caused by susceptible bacteria, Acute Pyelonephritis caused by Infection Due to Escherichia Coli, Bacterial Conjunctivitis caused by susceptible bacteria, Cellulitis caused by susceptible bacteria, Community Acquired Pneumonia (CAP) caused by susceptible bacteria, Furuncle caused by susceptible bacteria, Impetigo caused by susceptible bacteria, Inhalational Anthrax, Nosocomial Pneumonia caused by Pseudomonas Infections, Nosocomial Pneumonia caused by susceptible bacteria, Plague caused by Yersinia pestis, Pyoderma caused by susceptible bacteria, Wound Infections caused by susceptible bacteria, Acute bacterial sinusitis caused by susceptible bacteria, Chronic Bacterial prostatitis caused by susceptible bacteria, Chronic Pseudomonas Infections, Complicated Urinary Tract Infection caused by susceptible bacteria, Complicated skin and skin-structure infections caused by susceptible bacteria, Uncomplicated Urinary Tract Infection caused by susceptible bacteria, Uncomplicated skin and skin-structure infections caused by susceptible bacteria

A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults

Phase 3
Completed
Conditions
Maxillary Sinusitis
Interventions
Other: placebo
First Posted Date
2008-03-26
Last Posted Date
2011-05-11
Lead Sponsor
Pfizer
Target Recruit Count
541
Registration Number
NCT00643409
Locations

Pfizer Investigational Site

A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Mild to Moderate Pneumonia in Adult Patients

Phase 3
Completed
Conditions
Pneumonia
Interventions
First Posted Date
2008-03-26
Last Posted Date
2008-03-26
Lead Sponsor
Pfizer
Target Recruit Count
468
Registration Number
NCT00643734
Locations
🇷🇺

Pfizer Investigational Site, Smolensk, Russian Federation

A Study to Evaluate the Effect of Food on Levofloxacin Pharmacokinetics From an Oral Solution Formulation

Phase 1
Completed
Conditions
Healthy
First Posted Date
2008-01-28
Last Posted Date
2016-12-22
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
24
Registration Number
NCT00601432

Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With a Mild Infection of a Foot Ulcer

Phase 2
Completed
Conditions
Diabetic Foot Ulcer
Interventions
Drug: gentamicin-collagen sponge
First Posted Date
2008-01-15
Last Posted Date
2022-05-31
Lead Sponsor
Innocoll
Target Recruit Count
70
Registration Number
NCT00593567
Locations
🇺🇸

Chesapeake Research Group LLC, Pasadena, Maryland, United States

Study of Efficacy of Levofloxacin 0.5% Ophthalmic Solution Administered Three Times a Day for Bacterial Conjunctivitis

Phase 2
Completed
Conditions
Bacterial Conjunctivitis
Interventions
First Posted Date
2007-11-29
Last Posted Date
2007-11-29
Lead Sponsor
Laser Microsurgery Centre, Poland
Target Recruit Count
119
Registration Number
NCT00565123
Locations
🇵🇱

Centrum Mikrochirurgii Oka Laser, Warszawa, Mazowieckie, Poland

MDR TB, Levofloxacin, Multi-Drug-Resistant Pulmonary Tuberculosis

Phase 4
Completed
Conditions
Tuberculosis, Pulmonary
Interventions
First Posted Date
2007-07-03
Last Posted Date
2009-03-04
Lead Sponsor
Sanofi
Target Recruit Count
100
Registration Number
NCT00495339
Locations
🇷🇺

Sanofi-Aventis, Moscow, Russian Federation

Effectiveness of Topical 0.5% Levofloxacin to Reduce the Conjunctival Bacterial Flora Before Intraocular Surgery

Phase 4
Completed
Conditions
Conjunctival Bacterial Flora
First Posted Date
2007-06-25
Last Posted Date
2007-06-25
Lead Sponsor
Ludwig-Maximilians - University of Munich
Target Recruit Count
140
Registration Number
NCT00491049
Locations
🇩🇪

Augenklinik der LMU, Munich, Bavaria, Germany

A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease

Phase 3
Completed
Conditions
Pelvic Inflammatory Disease
Interventions
First Posted Date
2007-03-28
Last Posted Date
2014-09-08
Lead Sponsor
Bayer
Target Recruit Count
460
Registration Number
NCT00453349
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