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Topical antibiotics used to treat common ear disorders
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Two ear disorders commonly affect children — acute otitis externa and otitis media with effusion requiring tympanostomy tube (TT) insertion. Although TT insertion is not managed by pediatricians, it is the most common ambulatory surgical procedure performed in children, and thus, pediatricians are best informed of recent advances in its associated drug therapies. By contrast, acute otitis externa (AOE) is commonly diagnosed and treated in the pediatrician’s office. This month’s column focuses on the pharmacotherapies used in the treatment of AOE and TT insertion. A more recently FDA-approved product, Otiprio (single-dose ciprofloxacin 6%; Otonomy), is also discussed.
Clinical practice guidelines for the management for otitis media with infusion requiring TT insertion and AOE have been published by American Academy of Otolaryngology-Head and Neck Surgery in 2013 and 2014, respectively. Otorrhea is the most common sequela of TT insertion. Several controlled trials have compared topical with oral antibiotics for the treatment of TT otorrhea, with these trials demonstrating improved outcomes with topical therapy as compared with oral therapy (77%-97% vs. 30%-67% clinical cure, respectively). Antimicrobial activity toward Pseudomonas aeruginosa is one reason topical antibiotics have demonstrated greater outcomes. Combined topical and oral antibiotic therapy provides no advantage, as demonstrated by clinical trial data. Only topical antibiotic drops that are approved by the FDA for use with TT should be prescribed, including ciprofloxacin and ofloxacin (Table). Note that some topical antibiotic otic drops should not be used in children with a nonintact tympanic membrane, such as following TT insertion, including Cortisporin (neomycin/polymyxin/hydrocortisone, Monarch Pharmaceuticals) or Cipro HC (ciprofloxacin/hydrocortisone, Bayer). Neomycin, an aminoglycoside antibiotic, is potentially ototoxic.
Topical antibiotics are highly effective for treatment of acute TT otorrhea. Efficacy is enhanced when the drops distribute to the middle ear space, by cleaning of the ear canals before drop administration or tragus pumping, after drop administration. These techniques and instructions are explained to caregivers in the otolaryngologist’s office. Oral antibiotics are indicated for TT otorrhea only in specific clinical scenarios, such as concurrent bacterial infections (eg, sinusitis), signs of severe infection or worsening otorrhea despite topical antibiotic use. Topical antibiotic drop application during TT insertion to prevent otorrhea may include one dose intraoperatively, as well as for use for up to several days postoperatively. Sterile ophthalmic topical antibiotic products (eg, ciprofloxacin, ofloxacin, sulfacetamide/prednisolone) or otic topical antibiotic products (ciprofloxacin, ofloxacin) are used. Evidence does not support the prolonged use (ie, 7-10 day) of topical antibiotics to prevent otorrhea, as described by a 2013 Cochrane Systematic Review.
Otiprio was approved by the FDA in 2015 for a one-time intratympanic use at the time of TT insertion in infants and children aged 6 months or older. Otiprio is stored refrigerated as a thermosensitive liquid suspension that thickens to a gel when warmed (ie., to 37°C; 98.6°F). As a gel, Otiprio can provide a prolonged concentration of ciprofloxacin to the middle ear for up to 2 weeks.
Topical antibiotic drops additionally serve an important role in the treatment of AOE and are commonly prescribed by pediatricians. Clinical practice guidelines published in 2014 recommend the use of topical antibiotics for the initial treatment of uncomplicated AOE because they are highly effective. There are no significant differences in clinical efficacy among topical antibiotic class (ie, quinolone vs. nonquinolone) or product (ie, with or without combined corticosteroid, or antibiotic vs. antiseptic). Use of the appropriate administration technique by the caregiver is important, including instilling product drops to fill the ear canal, maintaining position by the patient for several minutes and tragal pumping as necessary. As described earlier, only specific otic preparations should be used if the infant or child has a nonintact tympanic membrane. Neomycin-based products, nonsterile preparations, acidic products (antiseptics) and products containing alcohol should not be used. Only quinolone-based products are approved by the FDA for use for the treatment of AOE with a nonintact tympanic membrane. In February of this year, Otiprio was approved for use in the treatment of AOE in infants and children aged 6 months or older for infection by P. aeruginosa and S. aureus. Uniquely, this approved indication is specific for administration to the patient by a health care professional only (ie, not for administration by the caregiver).
Conclusions
Several products are available to treat infants and children for two common ear conditions, otitis media with effusion and TT placement, along with AOE. National evidence-based guidelines have been published to guide prescribers with appropriate product choice. As clinical efficacy differences among the products has not been demonstrated, product choice is guided by cost, prescriber experience and preference, and caregiver preference. Most of the otic topical antibiotic products listed here are relatively inexpensive. Additional important considerations include the integrity of the patient’s tympanic membrane, because some topical antibiotic products should not be used with a nonntact tympanic membrane, due to the potential of drug-induced ototoxicity. Otiprio, newly approved by the FDA for AOE, and additionally approved for acute otitis media with effusion and TT insertion, is a unique product given as a single dose by a health care professional. Its thermosensitive properties allow it to transform from a liquid to a gel once instilled into the middle ear space, prolonging its duration of action. However, limiting this potential benefit is its high cost, especially when professional health care administration charges and reimbursement costs are considered. Administration of Otiprio in the operating room may alter an ambulatory vs. inpatient designation, and resultant professional fees and reimbursements.
- References:
- Edmunds AL. PT. 2017;42:307-311.
- Rosenfeld RM, et al. Otolaryngol Head Neck Surg. 2013;doi:10.1177/0194599813490141.
- Rosenfeld RM, et al Otolaryngol Head Neck Surg. 2014;doi: 10.1177/0194599813517083.
- Syed MI, et al. Cochrane Database Syst Rev. 2013;doi:10.1002/14651858.CD008512.pub2.
- For more information:
- Edward A. Bell, PharmD, BCPS, is a professor of pharmacy practice at Drake University College of Pharmacy and Health Sciences and Blank Children’s Hospital and Clinics, Des Moines, Iowa. He also is a member of the Infectious Diseases in Children Editorial Board. Bell can be reached at ed.bell@drake.edu.
Disclosure: Bell reports no relevant financial disclosures.