OTOVEL SAFETY PROFILE

CONFIDENCE

OTOVEL: Well-tolerated in clinical studies1

Incidence of adverse events was comparable between OTOVEL® (ciprofloxacin and fluocinolone acetonide) and active comparators (ciprofloxacin alone and fluocinolone acetonide alone).

Treatment-related adverse events occurring in ≥1 patient in clinical studies1

Adverse ReactionsNumber (%) of Patients
OTOVEL
(N=224)		Ciprofloxacin
(N=220)		Fluocinolone acetonide
(N=213)
Otorrhea 12 (5.4%)9 (4.1%)12 (5.6%)
Excessive granulation tissue 3 (1.3%)0 (0.0%)2 (0.9%)
Ear infection 2 (0.9%)3 (1.4%)1 (0.5%)
Ear pruritus 2 (0.9%)1 (0.5%)1 (0.5%)
Tympanic membrane disorder 2 (0.9%)0 (0.0%)0 (0.0%)
Auricular swelling 1 (0.4%)1 (0.5%)0 (0.0%)
Balance disorder 1 (0.4%)0 (0.0%)0 (0.0%)

Study design: Two phase III multicenter, randomized, double-blind, active-controlled, parallel-group studies of pediatric patients of either sex aged 6 months to 12 years with AOMT in at least one ear, who presented with otorrhea for 3 weeks or less, and with moderate or severe purulent otorrhea at inclusion. Exclusion criteria included: tympanostomy tubes (TT) placement 3 days or less before study entry; TT containing antiseptic or antibacterial activity; T-type tubes; otitis externa; suspected viral, fungal, or mycobacterial ear infection; use of topical or systemic antimicrobial, antifungal, or steroid agents within the previous 7 days of study entry; concurrent use of anti-inflammatory agents.2

▼ IMPORTANT SAFETY INFORMATION

Contraindications
OTOVEL is contraindicated in:

  • Patients with known hypersensitivity to fluocinolone acetonide or other corticosteroids, ciprofloxacin or other quinolones, or to any other components of OTOVEL.

  • Viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections.

INDICATIONS

OTOVEL® (ciprofloxacin and fluocinolone acetonide) is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to S. aureus, S. pneumoniae, H. influenzae, M. catarrhalis, and P. aeruginosa.

IMPORTANT SAFETY INFORMATION

Contraindications
OTOVEL is contraindicated in:

  • Patients with known hypersensitivity to fluocinolone acetonide or other corticosteroids, ciprofloxacin or other quinolones, or to any other components of OTOVEL.

  • Viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections.

Warnings and Precautions
Hypersensitivity Reactions - OTOVEL should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria and itching. Serious acute hypersensitivity reactions may require immediate emergency treatment.

Potential for Microbial Overgrowth with Prolonged Use - Prolonged use of OTOVEL may result in overgrowth of non-susceptible bacteria and fungi. If the infection is not improved after one week of treatment, cultures should be obtained to guide further treatment. If such infections occur, discontinue use and institute alternative therapy.

Continued or Recurrent Otorrhea - If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within 6 months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.

Adverse Reactions
The most common adverse reactions that occurred in 1 or more of the patients are otorrhea, excessive granulation tissue, ear infection, ear pruritus, tympanic membrane disorder, auricular swelling, and balance disorder.

For additional safety information, consult the Otovel full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

References: 1. OTOVEL [package insert]. Ridgeland, MS: WraSer Pharmaceuticals. 2. Spektor Z, Pumarola P, Ismail K, et al. Efficacy and safety of ciprofloxacin plus fluocinolone in otitis media with tympanostomy tubes in pediatric patients: a randomized clinical trial. JAMA Otolaryngol Head Neck Surg. 2017;143(4):341-349.