What is the first-line treatment for acute otitis media (AOM)?

From the Guidelines

The first-line treatment for acute otitis media (AOM) is high-dose amoxicillin, at a dose of 80-90 mg/kg/day divided into two doses. This recommendation is based on the most recent and highest quality study available, which suggests that amoxicillin is effective against the most common bacterial pathogens in AOM, including Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis 1.

• The duration of treatment depends on the patient's age and severity of symptoms, with children under 2 years or those with severe symptoms typically requiring a 10-day course, while older children with mild to moderate disease may be treated for 5-7 days.
• For patients with a penicillin allergy, alternative treatments include cefdinir, cefuroxime, or cefpodoxime, as these medications have a low risk of cross-reactivity with penicillin 1.
• In cases where the patient has received amoxicillin in the previous 30 days or has a history of recurrent infections, amoxicillin-clavulanate may be preferred due to concerns about resistant organisms 1.
• Analgesics such as acetaminophen or ibuprofen should be provided for pain management, as they can help alleviate symptoms and improve the patient's quality of life.
• The choice of antibiotic should be based on the anticipated clinical response and the microbiologic flora likely to be present, with amoxicillin being the first-line treatment due to its effectiveness, safety, and narrow microbiologic spectrum 1.

From the FDA Drug Label

For the 366 patients who were evaluated for clinical efficacy at the Day 12 visit, the clinical success rate (i.e., cure plus improvement) was 83% for azithromycin and 88% for the control agent. 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 The combined clinical success rate (i.e., cure and improvement) at the Day 11 visit was 84% for azithromycin. The clinical success rate (i.e., cure plus improvement) at the Day 11 visit was 88% for azithromycin and 88% for the control agent.

The first-line treatment for acute otitis media (AOM) is amoxicillin/clavulanate potassium.

• Azithromycin is an alternative for patients who are allergic to amoxicillin/clavulanate potassium or have other contraindications.
• The clinical success rate of azithromycin is around 83-88%. 2 2

From the Research

First-Line Treatment for Acute Otitis Media (AOM)

The first-line treatment for acute otitis media (AOM) is amoxicillin, as recommended by several studies 3, 4, 5, 6, 7.

• Amoxicillin at conventional or high doses (80-90 mg/kg/day) is considered an appropriate choice for first-line therapy for AOM 3.
• High-dose amoxicillin (at least 80 mg/kg/day) should be the first-line therapy in uncomplicated infections 6.
• The cumulative fraction of response (CFR) with amoxicillin varied from 83% to 96% against S. pneumoniae and from 78% to 86% against H. influenzae 6.

Alternative Treatments

For patients in whom amoxicillin is unsuccessful, second-line therapy should have demonstrated activity against penicillin-resistant S. pneumoniae as well as beta-lactamase-producing pathogens 3.

• Appropriate options for second-line therapy include high-dose amoxicillin/clavulanate (90 mg/kg/day based on the amoxicillin component) and ceftriaxone 3.
• Amoxicillin/clavulanate (40 mg/kg/day) should be the choice when additional coverage for H. influenzae is desired 6.
• Administration of 3 daily doses of ceftriaxone increases bacteriological eradication probability when compared with one-day regimen 6.

Considerations for Treatment

Several issues should be considered when alternative antibiotics are selected to treat amoxicillin failures, such as the most likely pathogens with their susceptibility patterns, and antibiotic issues including clinical efficacy for specific pathogens, adverse reactions, palatability, dosing schedules, and cost 7.

• Enhanced beta-lactamase stability, activity against penicillin-resistant S pneumoniae, and once- or twice-daily dosing regimens must be considered when antibiotics are chosen for patients in whom amoxicillin therapy has failed 7.