What is the recommended dosing of Augmentin (amoxicillin/clavulanate) for acute otitis media in children?

Augmentin Dosing for Acute Otitis Media in Children

For acute otitis media in children, high-dose amoxicillin-clavulanate (Augmentin) should be dosed at 90 mg/kg/day of amoxicillin with 6.4 mg/kg/day of clavulanate, divided in two doses daily. 1, 2

First-Line Treatment Options

• High-dose amoxicillin (80-90 mg/kg/day in 2 divided doses) is the first-line treatment for uncomplicated acute otitis media in most children due to its effectiveness against common pathogens, safety profile, low cost, and narrow antimicrobial spectrum 1, 3

• For children who have taken amoxicillin in the previous 30 days, those with concurrent conjunctivitis (otitis-conjunctivitis syndrome), or when coverage for β-lactamase–producing organisms is specifically desired, high-dose amoxicillin-clavulanate should be used as initial therapy 1, 2

• The recommended dosage for high-dose amoxicillin-clavulanate is 90 mg/kg/day of amoxicillin with 6.4 mg/kg/day of clavulanate (14:1 ratio) given in 2 divided doses 1, 2

Rationale for Dosing

• High-dose amoxicillin-clavulanate achieves middle ear fluid levels that exceed the minimum inhibitory concentration (MIC) of intermediately resistant and many highly resistant pneumococcal serotypes 1, 4

• The 14:1 ratio formulation of amoxicillin-clavulanate is less likely to cause diarrhea than other preparations with higher clavulanate concentrations 2, 5

• Clinical trials have demonstrated superior efficacy of high-dose amoxicillin-clavulanate compared to azithromycin in eradicating S. pneumoniae (96% vs 80.4%) from the middle ear 6

Treatment Duration and Response

• Standard treatment duration is typically 10 days 2, 4

• Clinical improvement should be evident within 48-72 hours of initiating appropriate therapy 1

• If no improvement is seen after 48-72 hours, consider treatment failure and reassess the patient 1

Alternative Options for Penicillin Allergic Patients

• For patients with non-severe penicillin allergy, alternative options include:

  • Cefdinir (14 mg/kg/day in 1 or 2 doses) 1
  • Cefuroxime (30 mg/kg/day in 2 divided doses) 1, 2
  • Cefpodoxime (10 mg/kg/day in 2 divided doses) 1

• The cross-reactivity between penicillins and second/third-generation cephalosporins is lower than historically reported, making these reasonable alternatives for patients with non-severe penicillin allergy 1

Common Pitfalls and Considerations

• Inadequate dosing of the amoxicillin component when treating potentially resistant organisms is a common pitfall 2

• While twice-daily dosing has been shown to be as effective as three-times-daily dosing, it is associated with significantly less diarrhea and may improve compliance 1, 7

• Adverse effects are generally mild, with gastrointestinal disturbances being most common; using the 14:1 ratio formulation can help minimize diarrhea 2, 5

• For treatment failures, switching to a different antibiotic class or considering tympanocentesis may be necessary 1

• Widespread use of pneumococcal conjugate vaccines (PCV13) may reduce the prevalence of multidrug-resistant pneumococcal serotypes, potentially decreasing the need for high-dose amoxicillin or amoxicillin-clavulanate in the future 1, 2