What are the treatment options for otitis media?

From the Guidelines

For otitis media, the most effective treatment approach is to use antibiotics, such as amoxicillin, in combination with pain relievers and decongestants, as this has been shown to reduce symptoms and duration of middle ear effusion 1. The recommended treatment typically includes antibiotics, pain relievers, and decongestants. Amoxicillin is the first-line antibiotic, usually prescribed at 80-90 mg/kg/day divided into two doses for 5-10 days, depending on severity. For penicillin-allergic patients, alternatives include azithromycin (10 mg/kg on day 1, then 5 mg/kg for 4 days) or clarithromycin (15 mg/kg/day divided twice daily for 10 days). Some key points to consider in the treatment of otitis media include:

• Accurate diagnosis of acute otitis media and optimal management of ear pain are crucial 1
• Watchful waiting is optional in mild to moderate acute otitis media, but antibiotics can shorten symptoms and duration of middle ear effusion 1
• Topical antibiotic therapy is the treatment of choice in acute tube otorrhea, with options including ofloxacin or ciprofloxacin-dexamethasone 1
• Symptomatic hearing loss due to persistent otitis media with effusion is best treated with tympanostomy tubes 1 For pain management, acetaminophen (10-15 mg/kg every 4-6 hours) or ibuprofen (10 mg/kg every 6-8 hours) can be used. Decongestants like pseudoephedrine may help relieve ear pressure. It's essential to complete the full course of antibiotics even if symptoms improve quickly, and watchful waiting for 48-72 hours may be appropriate for mild cases in children over 2 years without severe symptoms, as many cases resolve spontaneously 1. Antibiotics work by eliminating the bacterial infection, while pain relievers reduce inflammation and discomfort, and decongestants help open the eustachian tubes to drain fluid from the middle ear. In cases of acute TTO, topical antibiotic therapy is recommended, and systemic antibiotic therapy is reserved for complicated cases or when topical therapy fails 1.

From the FDA Drug Label

14.2 Acute Bacterial Otitis Media and Diarrhea in Pediatric Patients One U.S./Canadian clinical trial was conducted which compared 45/6. 4 mg/kg/day (divided every 12 hours) of amoxicillin and clavulanate potassium for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of amoxicillin and clavulanate potassium for 10 days in the treatment of acute otitis media.

Safety and efficacy using azithromycin 30 mg/kg given over 3 days Protocol 4 In a double-blind, controlled, randomized clinical study of acute otitis media in pediatric patients from 6 months to 12 years of age, azithromycin (10 mg/kg per day for 3 days) was compared to amoxicillin/clavulanate potassium (7:1) in divided doses q12h for 10 days

Protocol 5 A double blind, controlled, randomized trial was performed at nine clinical centers Pediatric patients from 6 months to 12 years of age were randomized 1:1 to treatment with either azithromycin (given at 30 mg/kg as a single dose on Day 1) or amoxicillin/clavulanate potassium (7:1), divided q12h for 10 days.

Protocol 6 In a non-comparative clinical and microbiological trial, 248 patients from 6 months to 12 years of age with documented acute otitis media were dosed with a single oral dose of azithromycin (30 mg/kg on Day 1).

Otitis Media Medicines are amoxicillin-clavulanate and azithromycin.

• Amoxicillin-clavulanate is used to treat acute otitis media in pediatric patients, with a dosage of 45/6.4 mg/kg/day divided every 12 hours for 10 days.
• Azithromycin is also used to treat acute otitis media in pediatric patients, with different dosing regimens:
  • 10 mg/kg per day for 3 days
  • 30 mg/kg as a single dose on Day 1
  • 30 mg/kg on Day 1 in a non-comparative clinical trial 2 and 3

From the Research

Otitis Media Medicine

• The first-line treatment for acute otitis media (AOM) is high-dose amoxicillin (80-90 mg/kg/day) 4, 5, 6.
• For patients who are allergic to penicillin, a macrolide can be used as an alternative 6.
• Amoxicillin/clavulanate is also an effective treatment option, particularly for patients with beta-lactamase-producing pathogens 4, 5, 7.
• Cefdinir, cefprozil, cefpodoxime, cefuroxime, and ceftriaxone are other antibiotic options that can be used for the treatment of AOM 4, 5.

Antibiotic Resistance

• The increasing prevalence of drug-resistant Streptococcus pneumoniae and beta-lactamase-producing organisms presents a clinical challenge for practitioners in the selection of empiric antimicrobial therapy 4, 5, 8.
• High-dose amoxicillin may not be necessary if the local prevalence of nonsusceptible S. pneumoniae is low 8.
• The use of pharmacokinetic/pharmacodynamic principles can help guide the selection of antibiotics for AOM 5.

Treatment Outcomes

• Amoxicillin/clavulanate has been shown to have superior bacteriologic and clinical efficacy compared to azithromycin in children with AOM 7.
• Clinical outcomes, such as the resolution of signs and symptoms, are similar between different antibiotic treatment options 7.
• The choice of antibiotic should be based on factors such as the patient's age, medical history, and local resistance patterns 4, 5, 6.