Drug Class: Otic steroids with anti-infectives
Usual Adult Dose for Acute Otitis Externa
Ciprofloxacin 2 mg-hydrocortisone 10 mg otic suspension: Instill 3 drops into the affected ear(s) 2 times a day
- Duration of therapy: 7 days
Comments:
- Patients should lie with the affected ear upward before administration. Once instilled, the patient should remain in this position for at least 30 to 60 seconds.
- If both ears are affected, this procedure should be repeated for the opposite ear.
Use: Treatment of acute otitis externa due to susceptible strains of Pseudomonas aeruginosa, Staphylococcus aureus, and Proteus mirabilis
Usual Pediatric Dose for Acute Otitis Externa
1 year and older:
Ciprofloxacin 2 mg-hydrocortisone 10 mg otic suspension: Instill 3 drops into the affected ear(s) 2 times a day
- Duration of therapy: 7 days
Comments:
- The safety and efficacy of this drug was established in patients 2 years and older; efficacy was extrapolated for use in patients 1 year and older based on this data.
- Patients should lie with the affected ear upward before administration. Once instilled, the patient should remain in this position for at least 30 to 60 seconds.
- If both ears are affected, this procedure should be repeated for the opposite ear.
Use: Treatment of acute otitis externa due to susceptible strains of P aeruginosa, S aureus, and P mirabilis
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Precautions
CONTRAINDICATIONS:
- Hypersensitivity to either of the active components, any member of the quinolone class of antimicrobial agents, or any of the ingredients.
- Patients with known/suspected perforated tympanic membranes
- Viral infections of the external canal (including varicella and herpes simplex)
Safety and efficacy have not been established in patients younger than 1 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Patients should shake the bottle well immediately before use.
- The vial should be warmed in their hands for 1 to 2 minutes prior to administration to avoid dizziness associated with instillation of a cold solution into the ear canal.
Storage requirements:
- Avoid freezing; protect from light and heat when not in use.
- Unused portions should be discarded after completing treatment.
General:
- Safety and efficacy have not been studied in patients with perforated tympanic membranes.
- Limitations of use: This drug is indicated for otic use only. It is not indicated for ophthalmic use or injection.
Patient advice:
- Tell patients that this drug is for otic use only.
- Patients should be instructed to wash their hands before and after applying this drug. Patients should be told to avoid touching the dropper tip to the ear, fingers, or other sources.
- Advise patients to warm the vial in the hands for 1 to 2 minutes to prevent dizziness during administration.
- Patients should be encouraged to avoid missing doses and complete the entire course of therapy. Once treatment is complete, patients should discard any remaining drug.
- Patients should be advised to immediately report any signs/symptoms of hypersensitivity reactions.
