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In Phases II and III clinical trials, a total of 937 patients were treated with CIPRODEX® (ciprofloxacin and dexamethasone ) Otic. This included 400 patients with acute otitis media with tympanostomy tubes and 537 patients with acute otitis externa. The reported treatment-related adverse events are listed below:
Acute Otitis Media in pediatric patients with tympanostomy tubes
The following treatment-related adverse events occurred in 0.5% or more of the patients with non-intact tympanic membranes.
|Adverse Event||Incidence (N=400)|
|Ear precipitate (residue)||0.5%|
The following treatment-related adverse events were each reported in a single patient: tympanostomy tube blockage; ear pruritus; tinnitus; oral moniliasis; crying; dizziness; and erythema.
Acute Otitis Externa
The following treatment-related adverse events occurred in 0.4% or more of the patients with intact tympanic membranes.
|Adverse Event||Incidence (N=537)|
|Superimposed ear infection||0.6%|
The following treatment-related adverse events were each reported in a single patient: ear discomfort; decreased hearing; and ear disorder (tingling).
Read the Ciprodex (ciprofloxacin and dexamethasone) Side Effects Center for a complete guide to possible side effects
Specific drug interaction studies have not been conducted with CIPRODEX® (ciprofloxacin and dexamethasone ) Otic.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/17/2007
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