Usual Adult Dose for Acute Otitis Externa

Usual dose: Instill 10 drops into the affected ear(s) once 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 5 minutes.
• If both ears are affected, this procedure should be repeated for the opposite ear.

Usual Adult Dose for Otitis Media

Usual dose: Instill 10 drops into the affected ear(s) 2 times a day
Duration of therapy: 14 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 5 minutes.
• If both ears are affected, this procedure should be repeated for the opposite ear.

Usual Pediatric Dose for Acute Otitis Externa

6 months to 13 years:

• Usual dose: Instill 5 drops into the affected ear(s) once a day
• Duration of therapy: 7 days

• Usual dose: Instill 10 drops into the affected ear(s) once a day
• Duration of therapy: 7 days

• Patients should lie with the affected ear upward before administration. Once instilled, the patient should remain in this position for at least 5 minutes.
• If both ears are affected, this procedure should be repeated for the opposite ear.

Usual Pediatric Dose for Otitis Media

1 to 12 years old:

• Usual dose: Instill 5 drops into the affected ear(s) 2 times a day
• Duration of therapy: 10 days

• Usual dose: Instill 10 drops into the affected ear(s) 2 times a day
• Duration of therapy: 14 days

• 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 5 minutes.
• If both ears are affected, this procedure should be repeated for the opposite ear.

• Treatment of acute otitis media in patients 1 to 12 years old with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus, and Streptococcus pneumoniae
• Treatment of chronic suppurative otitis media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, P aeruginosa, and S aureus

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 (otitis externa), 1 year (tympanostomy tubes and acute otitis media), and 12 years (chronic suppurative otitis media and perforated tympanic membranes).

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.

• This drug should be protected from light when not in use

• Each drop of solution delivers 0.05 mL, which is equivalent to 0.15 mg of this drug.
• Limitations of use: This drug is indicated for otic use only. It is not indicated for ophthalmic use or injection.

• Tell patients that this drug is for otic use only.
• Patients should be instructed to wash their hands before and after applying this drug.
• 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.
• Patients should be advised to immediately report any signs/symptoms of hypersensitivity reactions.