Otovel Ear Drops

Generic name:ciprofloxacin and fluocinolone acetonide
Dosage form: otic solution
Drug class:Otic steroids with anti-infectives

Medically reviewed by Drugs.com. Last updated on Oct 1, 2021.

Indications and Usage for Otovel Ear Drops

OTOVEL is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.

Otovel Ear Drops Dosage and Administration

• OTOVEL is for otic use only. It is not for ophthalmic use, or for injection.

The recommended dosage regimen is as follows:

• Instill the contents of one single-dose vial 0.25 mL into the affected ear canal twice daily (approximately every 12 hours) for 7 days. Use this dosing for patients aged 6 months of age and older.
• Warm the solution by holding the vial in the hand for 1 to 2 minutes. This is to avoid dizziness, which may result from the instillation of a cold solution into the ear canal.
• The patient should lie with the affected ear upward, and then instill the medication.
• Pump the tragus 4 times by pushing inward to facilitate penetration of the medication into the middle ear.
• Maintain this position for 1 minute. Repeat, if necessary, for the opposite ear [see Instructions for Use] .

Dosage Forms and Strengths

Otic Solution: Each single-dose vial of OTOVEL (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) delivers 0.25 mL of solution equivalent to ciprofloxacin 0.75 mg and fluocinolone acetonide 0.0625 mg.

Contraindications

OTOVEL is contraindicated in:

• Patients with known hypersensitivity to fluocinolone acetonide or other corticosteroids, ciprofloxacin o...