Acute Otitis Media with Tympanostomy Tubes (AOM TT)
FLOXIN
Otic (ofloxacin otic) solution
0.3% and FLOXIN Otic SINGLES (ofloxacin
otic) solution 0.3% . . . the first FDA-approved therapy . . .
acute
otitis media
In
pediatric patients ³1
year of age with
tympanostomy tubes due to pathogens
listed on the following page.
Nonsystemic
therapy proven as effective as Augmentin®
in AOM TT 2,3,*
 |
|
*
Note: All subjects with
Pseudomonas aeruginosa as their sole
pathogen were excluded from this
analysis since Augmentin is not
indicated for this organism. |
A
multicenter, randomized, parallel-group,
evaluator-blinded study comparing the safety and
efficacy of ofloxacin otic solution and Augmentin
oral suspension in pediatric patients ages 1 to 12.
Augmentin is a registered trademark
of SmithKline Beecham, Inc.
†
The primary efficacy analysis was a comparison of
overall clinical response. The overall clinical
assessment of the subjects was determined as cure or
failure based on the clinical response of the
subjects 17 to 20 days after start of study.
Clinical cure=complete resolution of otorrhea (dry
ear). Clinical failure=all other outcomes.
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