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OTOVEL
Ear infections (topicals)
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Drug Name:

OTOVEL Rx

Generic Name and Formulations:
Ciprofloxacin 0.3%, fluocinolone acetonide 0.025%; otic soln; preservative-free.

Company:
Arbor Pharmaceuticals, LLC

Therapeutic Use:

Indications for OTOVEL:

Acute otitis media in pediatric patients with tympanostomy tubes due to S. aureus, S. pneumoniae, H. influenzae, M. catarrhalis, P. aeruginosa.

Adults and Children:

<6 months: not studied. ≥6 months: 1 vial (0.25mL) into affected ear(s) twice daily for 7 days.

Contraindications:

Viral otic infections (eg, varicella, herpes simplex, fungal).

Warnings/Precautions:

Discontinue if superinfection or hypersensitivity occurs. Reevaluate if no improvement after 1 week or if ≥2 episodes occur within 6 months. Pregnancy. Nursing mothers.

Pharmacological Class:

Antibiotic (quinolone) + steroid.

Adverse Reactions:

Otorrhea, excessive granulation tissue, ear infection, ear pruritus, tympanic membrane disorder, auricular swelling, balance disorder.

Generic Availability:

NO

How Supplied:

Single-dose vials (0.25mL)—14

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