WHY OTOVEL?

SINGLE. STERILE. SIMPLE.

OTOVEL® (ciprofloxacin and fluocinolone acetonide) is a topical solution containing a combination of ciprofloxacin 0.3% and fluocinolone acetonide 0.025%, shown to reduce time to otorrhea cessation caused by acute otitis media with tympanostomy tubes (AOMT) in clinical studies. OTOVEL treats AOMT caused by bacterial infections due to S. aureus, S. pneumoniae, H. influenzae, M. catarrhalis, and P. aeruginosa. OTOVEL is approved for use in children 6 months of age and older.1

OTOVEL is dosed BID for 7 days. A total of 14 single-use vials contain 1 premeasured dose each. Each dose is individually sealed, so parents can rest assured that every dose is sterile, precise, and preservative free. Additionally, OTOVEL is a solution, so it requires no mixing or shaking before use.1

Setting parent expectations about tympanostomy tubes

Many parents of children with recurrent acute otitis media (AOM) believe that the insertion of tympanostomy tubes prevents future episodes of AOM. In fact, a study reported that 83% of children with ear tubes will have AOMT within 18 months.2 It is important to help parents understand that tympanostomy tubes decrease the frequency, severity, and duration of middle ear infections—not the child’s susceptibility to getting AOMT. When children with ear tubes do get AOMT, tympanostomy tubes provide many benefits2,3:

  • Children are far less symptomatic (fever is rare; ear pain is mild or nonexistent)

  • Middle ear ventilation facilitates draining of discharge (otorrhea)

  • Appetite and sleep are rarely disrupted

  • Significant conductive hearing loss does not occur

  • Avoids progression of AOM to acute coalescent mastoiditis, epidural abscess, sigmoid sinus thrombosis, and meningitis by direct temporal bone extension

  • Duration of ear infection is typically decreased

  • Multiple courses of antibiotics are not usually necessary

  • Exposure to systemic antibiotics is minimized, as topicals are able to effectively treat AOMT at the site of infection, bypassing systemic circulation

▼ 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. Dohar JE. Tympanostomy tubes: not the magic bullet for acute otitis media. http://www.medscape.org/viewarticle/730700. Published October 21, 2010. Accessed March 23, 2016. 3. Rosenfeld RM, Schwartz SR, Pynnonen MA, Tunkel DE, Hussey HM. Clinical practice guideline: tympanostomy tubes in children—executive summary. Otolaryngol Head Neck Surg. 2013;149(1):8-16.