Floxin (Ofloxacin) - Summary

FLOXIN SUMMARY

FLOXIN® (ofloxacin tablets) Tablets is a synthetic broad-spectrum antimicrobial agent for oral administration.

FLOXIN (ofloxacin tablets) Tablets are indicated for the treatment of adults with mild to moderate infections (unless otherwise indicated) caused by susceptible strains of the designated microorganisms in the infections listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations.

Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae or Streptococcus pneumoniae.

Community-acquired Pneumonia due to Haemophilus influenzae or Streptococcus pneumoniae.

Uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Proteus mirabilis.

Acute, uncomplicated urethral and cervical gonorrhea due to Neisseria gonorrhoeae. (See WARNINGS.)

Nongonococcal urethritis and cervicitis due to Chlamydia trachomatis. (See WARNINGS.)

Mixed infections of the urethra and cervix due to Chlamydia trachomatis and Neisseria gonorrhoeae. (See WARNINGS.)

Acute pelvic inflammatory disease (including severe infection) due to Chlamydia trachomatis and/or Neisseria gonorrhoeae. (See WARNINGS.)

NOTE: If anaerobic microorganisms are suspected of contributing to the infection, appropriate therapy for anaerobic pathogens should be administered.

Uncomplicated cystitis due to Citrobacter diversus, Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa.

Complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter diversus *, or Pseudomonas aeruginosa *.

Prostatitis due to Escherichia coli.

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* = Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients.

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 ofloxacin. Therapy with ofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.

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NEWS HIGHLIGHTS

Published Studies Related to Floxin (Ofloxacin)

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

Double-blind, randomized, placebo-controlled study of three-month treatment with the combination of ofloxacin and roxithromycin in recent-onset reactive arthritis. [2013]
In a randomized, double-blind, placebo-controlled trial, 56 patients with recent-onset ReA [enteroarthritis, n = 47 (84%); uroarthritis, n = 9 (16%)] were randomly assigned to receive 200 mg ofloxacin and 150 mg roxithromycin twice daily (Combi, n = 26) or placebo (n = 30) for 3 months... Three-month treatment with the combination of ofloxacin and roxithromycin had no advantage over placebo in patients with recent-onset ReA.

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...

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Clinical Trials Related to Floxin (Ofloxacin)

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.

MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers [Completed]
224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic.

MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers [Completed]
224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic.

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.

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