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Otovel Generic Name & Formulations
Legal Class
Rx
General Description
Ciprofloxacin 0.3%, fluocinolone acetonide 0.025%; otic soln; preservative-free.
Pharmacological Class
Antibiotic (quinolone) + steroid.
How Supplied
Single-dose vials (0.25mL)—14
Manufacturer
Generic Availability
NO
Otovel Indications
Indications
Acute otitis media in pediatric patients with tympanostomy tubes due to S. aureus, S. pneumoniae, H. influenzae, M. catarrhalis, P. aeruginosa.
Otovel Dosage and Administration
Adults and Children
<6 months: not studied. ≥6 months: 1 vial (0.25mL) into affected ear(s) twice daily for 7 days.
Otovel Contraindications
Contraindications
Viral otic infections (eg, varicella, herpes simplex, fungal).
Otovel Boxed Warnings
Not Applicable
Otovel Warnings/Precautions
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.
Otovel Pharmacokinetics
See Literature
Otovel Interactions
Not Applicable
Otovel Adverse Reactions
Adverse Reactions
Otorrhea, excessive granulation tissue, ear infection, ear pruritus, tympanic membrane disorder, auricular swelling, balance disorder.
Otovel Clinical Trials
See Literature
Otovel Note
Not Applicable
Otovel Patient Counseling
See Literature
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