Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] • Potential for Microbial Overgrowth with Prolonged Use [see Warnings and Precautions ( 5.2)] Most common adverse reactions were ear discomfort (3%), ear pain (2.3%), and ear pruritus (1.5%).
(6) To report SUSPECTED ADVERSE REACTIONS, contact NorthStar RxLLC, at 1-800-206- 7821or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In Phases II and III clinical trials, a total of 937 patients were treated with ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension.
This included 400 patients with acute otitis media with tympanostomy tubes (AOMT) and 537 patients with AOE.
The reported adverse reactions are listed below: Acute Otitis Media in Pediatric Patients with Tympanostomy Tubes The following adverse reactions occurred in 0.5% or more of the patients with non-intact tympanic membranes.
Ad v erse Reactions In cidence (N=400) Ear discomfort 3.0% Ear pain 2.3% Ear precipitate (residue) 0.5% Irritability 0.5% Taste Perversion 0.5% The following adverse reactions were each reported in a single patient: tympanostomy tube blockage;
ear pruritus;
oral moniliasis;
and erythema.
5 WARNINGS AND PRECAUTIONS • Hypersensitivity and anaphylaxis have been reported with systemic use of quinolones.
Discontinue use if this occurs with use of ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension.
( 5.1) • Prolonged use may result in overgrowth of non-susceptible bacteria and fungi.
( 5.2) 5.1 Hypersensitivity Reactions Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones.
Like all medications, Ciprofloxacin And Dexamethasone can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: