"Every year as many as 10 million U.S. children risk side effects from antibiotic prescriptions that are unlikely to help their upper respiratory conditions. Many of these infections are caused by viruses, which are not helped by antibiotics."...
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.
Last reviewed on RxList: 8/17/2007
This monograph has been modified to include the generic and brand name in many instances.
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