Augmentin for Otitis Media
High-dose amoxicillin-clavulanate (Augmentin) is highly effective for treating otitis media, particularly in cases where beta-lactamase-producing organisms are suspected or when initial amoxicillin treatment has failed. 1
First-Line Treatment Options
- High-dose amoxicillin (80-90 mg/kg/day in 2 divided doses) is recommended as the first-line treatment for most uncomplicated cases of acute otitis media (AOM) due to its effectiveness against common pathogens, safety profile, low cost, and narrow antimicrobial spectrum 1
- For patients who have taken amoxicillin in the previous 30 days, those with concurrent conjunctivitis, or when coverage for Moraxella catarrhalis is specifically desired, high-dose amoxicillin-clavulanate should be used as initial therapy 1
- 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
Efficacy Against Common Pathogens
Amoxicillin-clavulanate shows excellent activity against the main pathogens associated with AOM, including: 3
- Streptococcus pneumoniae (including penicillin-intermediate strains)
- Beta-lactamase producing strains of Haemophilus influenzae
- Moraxella catarrhalis
The high-dose formulation was specifically developed to eradicate penicillin-resistant S. pneumoniae and has demonstrated high bacteriological efficacy 4, 5
Clinical studies show that high-dose amoxicillin-clavulanate eradicated 96% of S. pneumoniae (including 92% of fully penicillin-resistant strains) and 89.7% of H. influenzae 5
Treatment Duration and Response
- Standard treatment duration is typically 10 days 1, 5
- Clinical improvement should be evident within 48-72 hours of initiating appropriate therapy 6
- If no improvement is seen after 48-72 hours, consider treatment failure and switch to an alternative antibiotic regimen 1, 6
Second-Line Options for Treatment Failures
- If initial treatment with amoxicillin fails after 48-72 hours, switching to high-dose amoxicillin-clavulanate is recommended 1
- For patients with penicillin allergies, alternative options include: 1, 6
- Cefdinir (14 mg/kg/day in 1 or 2 doses)
- Cefuroxime (30 mg/kg/day in 2 divided doses)
- Cefpodoxime (10 mg/kg/day in 2 divided doses)
- For type I penicillin allergies: clindamycin with or without a third-generation cephalosporin
Clinical Evidence Supporting Efficacy
- Randomized controlled 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 1, 5
- A systematic review showed that antibiotics reduce pain at 2-3 days compared to placebo (RR: 0.7), though the number needed to treat to benefit is 20 1
- Amoxicillin-clavulanate has been shown to significantly reduce the time to middle ear effusion disappearance (18.9 days vs 32.6 days) compared to placebo 1
Common Pitfalls and Considerations
- Inadequate dosing of the amoxicillin component when treating potentially resistant organisms is a common pitfall 2
- The 14:1 ratio formulation of amoxicillin-clavulanate is less likely to cause diarrhea than other preparations 1, 2
- While adverse effects are generally mild, they occur more frequently than with placebo (RR: 1.3), with gastrointestinal disturbances being most common 1, 3
- 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 1