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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 Comparison of the Safety and Efficacy of Two Different Regimens of Levofloxacin in the Treatment of Acute Bacterial Sinusitis(Sinus Infection) in Adults.

Phase 3
Completed
Conditions
Sinusitis
First Posted Date
2005-10-12
Last Posted Date
2011-06-10
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
784
Registration Number
NCT00236522

A Study to Compare the Safety and Effectiveness of 2 Doses of Levofloxacin Given for Different Time Periods in Patients With Pneumonia

Phase 3
Completed
Conditions
Pneumonia
First Posted Date
2005-10-12
Last Posted Date
2011-06-10
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
530
Registration Number
NCT00236821

A Study to Evaluate the Safety and Effectiveness of Levofloxacin Compared With Ciprofloxacin in Patients With Chronic Bacterial Prostatitis

Phase 3
Completed
Conditions
Prostatitis
First Posted Date
2005-10-12
Last Posted Date
2011-06-10
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
383
Registration Number
NCT00236808

A Study Evaluating the Safety and Efficacy of Treating Sinus Infection With Levofloxacin 750 mg for 5 Days.

Phase 3
Completed
Conditions
Maxillary Sinusitis
First Posted Date
2005-10-12
Last Posted Date
2011-06-10
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
18
Registration Number
NCT00236652

Trial of Levofloxacin as Prophylaxis After Allogeneic Stem Cell Transplantation (SCT)

Phase 2
Conditions
Malignancy
Allogeneic Stem Cell Transplantation
First Posted Date
2005-09-22
Last Posted Date
2007-11-30
Lead Sponsor
Charite University, Berlin, Germany
Registration Number
NCT00215007
Locations
🇩🇪

Charite, CBF, Berlin, Germany

A Comparison of the Effectiveness and Safety of Levofloxacin to That of Ciprofloxacin in Treating Complicated Urinary Tract Infection and Acute Pyelonephritis.

Phase 3
Completed
Conditions
Urinary Tract Infections
Pyelonephritis
First Posted Date
2005-09-21
Last Posted Date
2011-06-10
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
1109
Registration Number
NCT00210886

Levofloxacin Pharmacokinetics (PK) in the Severely Obese

Phase 4
Completed
Conditions
Obesity
Critical Illness
Interventions
First Posted Date
2005-09-15
Last Posted Date
2018-06-06
Lead Sponsor
Joel Thompson, PhD
Target Recruit Count
15
Registration Number
NCT00176306
Locations
🇺🇸

University of Kentucky, Lexington, Kentucky, United States

Levofloxacin For The Management Of Patients With Abnormal Prostate Specific Antigen (PSA)

Phase 3
Completed
Conditions
Prostatic Hyperplasia
Prostatitis
First Posted Date
2005-09-15
Last Posted Date
2017-05-30
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
240
Registration Number
NCT00169585
Locations
🇮🇹

GSK Investigational Site, Bagno a Ripoli (FI), Toscana, Italy

Comparative Effects of Azithromycin, Telithromycin and Levofloxacin on Drug Metabolizing Enzymes

Phase 4
Completed
Conditions
Healthy
First Posted Date
2005-09-14
Last Posted Date
2005-09-14
Lead Sponsor
Bassett Healthcare
Target Recruit Count
16
Registration Number
NCT00164112

Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery

Not Applicable
Completed
Conditions
Endophthalmitis
First Posted Date
2005-08-29
Last Posted Date
2016-02-12
Lead Sponsor
City, University of London
Target Recruit Count
35000
Registration Number
NCT00136344
Locations
🇧🇪

University Hospital Antwerp, UZA Ophthalmology, Antwerp, Belgium

🇮🇹

Ospedale Borgo Trento, Verona, Italy

🇧🇪

Jan Yperman Ziekenhuis, Ieper, Belgium

and more 21 locations
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