What antibiotic should be given for acute otitis media?

From the Guidelines

Amoxicillin is the recommended first-line antibiotic treatment for acute otitis media, as evidenced by the most recent and highest quality study 1. The dosage of amoxicillin should be 80 to 90 mg per kg per day, as suggested by the American Academy of Pediatrics and the American Academy of Family Physicians 1.

• The choice of amoxicillin is based on its effectiveness against susceptible and intermediate resistant pneumococci, as well as its safety, affordability, and acceptable taste.
• The optimal duration of therapy for patients with AOM is uncertain, but a standard course of 5-10 days is commonly recommended.
• In cases of penicillin allergy, alternatives such as amoxicillin-clavulanic acid may be considered, as recommended by the Expert Committee 1.
• It is essential to note that antibiotics are usually not needed in most cases of otitis media, and a strategy of watchful waiting could reduce unnecessary antibiotic use, unless the child is younger than 2 years with bilateral otitis media.
• Analgesics like acetaminophen or ibuprofen should also be provided for pain management, and closer follow-up is warranted in children under 2 years, those with recurrent infections, or patients with underlying conditions. Key considerations for treatment include:
• The anticipated clinical response and the microbiologic flora likely to be present
• The potential for antibiotic resistance and the need for alternative treatments
• The importance of pain management and follow-up care to ensure optimal outcomes.

From the FDA Drug Label

From the perspective of evaluating pediatric clinical trials, Days 11 to 14 were considered on-therapy evaluations because of the extended half-life of azithromycin. In a double-blind, controlled clinical study of acute otitis media performed in the United States, azithromycin (10 mg/kg on Day 1 followed by 5 mg/kg on Days 2 to 5) was compared to amoxicillin/clavulanate potassium (4:1). The clinical success rate (i. e., cure plus improvement) at the Day 11 visit was 88% for azithromycin and 88% for the control agent. 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. The clinical efficacy rates at the end of therapy visit (defined as 2 to 4 days after the completion of therapy) and at the follow-up visit (defined as 22 to 28 days post-completion of therapy) were comparable for the 2 treatment groups, with the following cure rates obtained for the evaluable patients: At end of therapy, 87% (n = 265) and 82% (n = 260) for 45 mg/kg/day every 12 hours and 40 mg/kg/day every 8 hours, respectively.

Antibiotic Options for Otitis Media:

• Amoxicillin-clavulanate: The clinical efficacy rates for amoxicillin-clavulanate were comparable for the 2 treatment groups, with cure rates of 87% and 82% for 45 mg/kg/day every 12 hours and 40 mg/kg/day every 8 hours, respectively 2.
• Azithromycin: The clinical success rate for azithromycin was 88% at the Day 11 visit and 73% at the Day 30 visit 3. The choice of antibiotic should be based on the specific needs of the patient and the severity of the infection. Both amoxicillin-clavulanate and azithromycin are effective options for the treatment of otitis media.

From the Research

Antibiotic Treatment for Otitis Media

The following antibiotics are recommended for the treatment of otitis media:

• Amoxicillin is the first-line antibiotic recommended for uncomplicated acute otitis media (AOM) in children and adults 4, 5, 6, 7, 8
• High-dose amoxicillin/clavulanate is recommended as a second-line therapy for patients who have failed first-line therapy 4, 5, 8
• Ceftriaxone is recommended as a second-line or third-line therapy for patients who have failed first-line therapy or have severe cases of AOM 4, 5, 8
• Cefuroxime axetil is recommended as a second-line therapy, but its effectiveness against penicillin-resistant S. pneumoniae is questionable 4, 5, 6, 8
• Trimethoprim-sulfamethoxazole is recommended as a second-line or third-line therapy for patients who have failed first-line therapy 6, 8

Considerations for Antibiotic Selection

When selecting an antibiotic, the following factors should be considered:

• In vitro activity against drug-resistant S. pneumoniae 4, 5, 8
• Pharmacokinetics and pharmacodynamic principles 4
• Adverse events and side effect profile 5, 8
• Palatability of the suspension and cost 5
• Patient's age, medical history, and compliance with therapy 6, 8
• Presence of comorbid infections or risk factors for recurrent AOM 8