Drug Class: Otic steroids with anti-infectives
Usual Adult Dose for Otitis Externa
Recommended dose: 4 drops in 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 tragus should be pumped inward 4 times, and the patient should remain in this position for at least 1 minute.
- If both ears are affected, this procedure should be repeated for the opposite ear.
Use:
- Treatment of acute otitis externa in patients due to Staphylococcus aureus and/or Pseudomonas aeruginosa
Usual Pediatric Dose for Otitis Media
6 months and older:
- Recommended dose: 4 drops in 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 tragus should be pumped inward 4 times, and the patient should remain in this position for at least 1 minute.
- If both ears are affected, this procedure should be repeated for the opposite ear.
Uses:
- Treatment of acute otitis media in patients with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Moraxella catarrhalis, and/or Pseudomonas aeruginosa
- Treatment of acute otitis externa in patients due to S aureus and/or P aeruginosa
Usual Pediatric Dose for Otitis Externa
6 months and older:
- Recommended dose: 4 drops in 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 tragus should be pumped inward 4 times, and the patient should remain in this position for at least 1 minute.
- If both ears are affected, this procedure should be repeated for the opposite ear.
Uses:
- Treatment of acute otitis media in patients with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Moraxella catarrhalis, and/or Pseudomonas aeruginosa
- Treatment of acute otitis externa in patients due to S aureus and/or P aeruginosa
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Precautions
Safety and efficacy have not been established in patients younger than 6 months
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Patients should shake the bottle well 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:
- This drug should be protected from light when not in use. Unused suspension should be discarded at the end of treatment.
General:
- Each dose of 4 drops delivers 0.14 mL, which is equivalent to 0.42 mg of ciprofloxacin and 0.14 mg dexamethasone.
- Limitations of use: This drug is indicated for otic use only. It is not indicated for ophthalmic use or injection.
Monitoring:
- Tendon inflammation/pain/rupture
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. During instillation, patients should be told to avoid contamination caused by touching the tip to the surface of the eye, fingers, etc.
- Caution 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. Remaining suspension should be discarded at the end of treatment.