QUIXIN SUMMARY
QUIXIN® (levofloxacin ophthalmic solution) 0.5% is a sterile topical ophthalmic solution. Levofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of Gram-positive and Gram-negative ocular pathogens. Levofloxacin is the pure (-)-( S)-enantiomer of the racemic drug substance, ofloxacin. It is more soluble in water at neutral pH than ofloxacin.
QUIXIN® solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
AEROBIC GRAM-POSITIVE MICROORGANISMS
Corynebacterium species *
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
Streptococcus
(Groups C/F)
Streptococcus
(Group G)
Viridans group streptococci
AEROBIC GRAM-NEGATIVE MICROORGANISMS
Acinetobacter Iwoffii *
Haemophilus influenzae
Serratia marcescens *
*Efficacy for this organism was studied in fewer than 10 infections.
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NEWS HIGHLIGHTS
Published Studies Related to Quixin (Levofloxacin Ophthalmic)
Ceftolozane-tazobactam compared with levofloxacin in the treatment of complicated
urinary-tract infections, including pyelonephritis: a randomised, double-blind,
phase 3 trial (ASPECT-cUTI). [2015] pyelonephritis... INTERPRETATION: Treatment with ceftolozane-tazobactam led to better responses
Effect of levofloxacin on neutrophilic airway inflammation in stable COPD: a
randomized, double-blind, placebo-controlled trial. [2014] study of the effect of levofloxacin in patients with stable COPD... CONCLUSION: In stable COPD, levofloxacin treatment causes a short-term reduction
Efficacy of levofloxacin in the treatment of BK viremia: a multicenter,
double-blinded, randomized, placebo-controlled trial. [2014] determine the efficacy of levofloxacin in the treatment of BK viremia... CONCLUSIONS: A 30-day course of levofloxacin does not significantly improve BK
Randomized, double-blind, multicenter phase 2 study comparing the efficacy and
safety of oral solithromycin (CEM-101) to those of oral levofloxacin in the
treatment of patients with community-acquired bacterial pneumonia. [2013] Solithromycin, a new macrolide, and the first fluoroketolide in clinical
development, with activity against macrolide-resistant bacteria, was tested in
132 patients with moderate to moderately severe community-acquired bacterial
pneumonia (CABP) in a multicenter, double-blind, randomized phase 2 study...
Prulifloxacin versus levofloxacin in the treatment of respiratory and urinary
tract infections: a multicentre, double-blind, randomized controlled clinical
trial. [2012] respiratory and urinary infections of Chinese patients... CONCLUSION: Prulifloxacin is as effective and well tolerated as levofloxacin in
Clinical Trials Related to Quixin (Levofloxacin Ophthalmic)
Intravenous Azithromycin Plus Intravenous Ceftriaxone Followed by Oral Azithromycin With Intravenous Levofloxacin Followed by Oral Levofloxacin for the Treatment of Moderate to Severely Ill Hospitalized Patients With Community Acquired Pneumonia [Completed]
A trial in which patients over 18 years of age who are hospitalized with community acquired
pneumonia and are otherwise eligible for entry into the study are randomly selected to
receive one of two treatment regimens. After written informed consent is obtained, patients
will receive one of the following two treatment regimens: 1) intravenous administration of
azithromycin and ceftriaxone followed by azithromycin tablets, or 2) intravenous
administration of levofloxacin followed by levofloxacin tablets. At least four study visits
are normally conducted up to approximately one month after starting therapy. The objective
of this study is to compare the safety and efficacy of the two treatment regimens.
Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation [Recruiting]
This randomized phase III trial studies how well levofloxacin works in preventing infection
in young patients with acute leukemia receiving chemotherapy or undergoing stem cell
transplant. Giving antibiotics may be effective in preventing or controlling early infection
in patients receiving chemotherapy or undergoing stem cell transplant for acute leukemia. It
is not yet known whether levofloxacin is effective in preventing infection.
Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori [Terminated]
This prospective controlled randomized open-label clinical trial is designed to determine
the eradication rate of 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole regimen
compared with 7-day standard triple therapy for adults infected with Helicobacter pylori in
Eastern Taiwan.
Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment [Completed]
To examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and
without Bismuth for H. pylori treatment.
"Efficacy and Safety of Levofloxacin vs Isoniazid in Latent Tuberculosis Infection in Liver Transplant Patients". [Terminated]
A multicenter, prospective, non-inferiority, randomized and open clinical trial comparing
levofloxacin with isoniazid in the treatment of latent tuberculosis infection in patients
eligible for liver transplantation.
Patients over 18 years of age on the waiting list for liver transplantation.
Sample size: n=870 patients.
HYPOTHESIS
Levofloxacin treatment of latent tuberculosis infection, begun while on the waiting list for
liver transplantation, is safer and not less effective than isoniazid treatment begun after
transplantation when liver function is stable.
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Page last updated: 2015-08-10
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