Floxin Otic (Ofloxacin Otic) - Summary

FLOXIN OTIC SUMMARY

FLOXIN^®Otic
(ofloxacin otic solution 0.3%)

FLOXIN^® Otic (ofloxacin otic solution) 0.3% is a sterile aqueous anti-infective (anti-bacterial) solution for otic use.

FLOXIN^® Otic (ofloxacin otic solution) 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:

Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus.

Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to, Proteus mirabilis, Pseudomonas aeruginosa, and Staphylococcus aureus.

Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus, and Streptococcus pneumoniae.

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NEWS HIGHLIGHTS

Published Studies Related to Floxin Otic (Ofloxacin Otic)

Ofloxacin otic drops vs neomycin-polymyxin B otic drops as prophylaxis against early postoperative tympanostomy tube otorrhea. [2006.12]
OBJECTIVES: To evaluate the incidence of tympanostomy tube (TT) sequelae, tube otorrhea, and tube obstruction immediately postoperatively in patients receiving TT for otitis media and to compare patients receiving postoperative otic drops with controls... CONCLUSIONS: Nonpatency and otorrhea are the most frequent sequelae immediately following TT placement. Few studies have compared different treatment regimens in a randomized controlled trial. These results demonstrate that otic drops clearly provide benefit postoperatively in preventing TT plugging and otorrhea but primarily in patients who have middle ear fluid at the time of TT placement. In addition, consideration of drop choice should be based on patient tolerance and medication safety profiles.

Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of granulation tissue in children with acute otitis media with otorrhea through tympanostomy tubes. [2004.06]
OBJECTIVE: Comparison of topical ciprofloxacin/dexamethasone otic suspension (CIP/DEX) to ofloxacin otic solution (OFL) for treatment of granulation tissue in children with AOMT... CONCLUSION: CIP/DEX was superior to OFL in the treatment of granulation tissue in children with AOMT.

Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of children with acute otitis media with otorrhea through tympanostomy tubes. [2004.01]
OBJECTIVE: To determine the efficacy and safety of topical ciprofloxacin/dexamethasone otic suspension compared with ofloxacin otic solution in the treatment of acute otitis media with otorrhea through tympanostomy tubes (AOMT) in pediatric patients... CONCLUSION: Topical ciprofloxacin/dexamethasone treatment is superior to topical ofloxacin in the treatment of AOMT.

Efficacy of ofloxacin and other otic preparations for acute otitis media in patients with tympanostomy tubes. [2001.01]
Otorrhea occurs in 21 to 50% of all children with tympanostomy tubes in the United States.

Comparison of ofloxacin otic solution with oral amoxycillin plus chloramphenicol ear drop in treatment of chronic suppurative otitis media with acute exacerbation. [2000.01]
The efficacy and safety of 0.3 per cent Ofloxacin otic solution (OFLX) 6 drops twice daily was compared with those of oral Amoxycillin 500 mg three times daily plus 1 per cent Chloramphenicol ear drop at 3 drops three times daily (AMOX + CRP) in a two-week treatment of chronic suppurative otitis media (CSOM) with acute exacerbation...

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Clinical Trials Related to Floxin Otic (Ofloxacin Otic)

An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis [Active, not recruiting]
The purpose of this study is to compare the safety and effectiveness of levofloxacin 750 mg for 2 weeks or 750 mg for 3 weeks, compared to levofloxacin 500 mg for 4 weeks in the treatment of chronic prostatitis.

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.

A Study to Evaluate the Bioequivalence of an Oral Suspension Formulation, an Oral Solution Formulation, and the Marketed Tablet Formulation of Levofloxacin in Healthy Subjects [Completed]
The primary objective of the study was to assess the bioequivalence of the oral suspension formulation, the oral solution formulation, and the marketed tablet formulation of levofloxacin, with the marketed tablet as the reference.

Study of Efficacy of Levofloxacin 0.5% Ophthalmic Solution Administered Three Times a Day for Bacterial Conjunctivitis [Completed]
The aim of the study is to evaluate the clinical and microbiological efficacies of three times daily administration of levofloxacin 0,5% eye drops as compared to the more frequent dosing (up to 8 times a day during the first 2 days and up to 4 times a day during the next 3 days) in patients with bacterial conjunctivitis.

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