Treatment of Otitis Media
High-dose amoxicillin (80-90 mg/kg/day divided twice daily) is the first-line antibiotic treatment for acute otitis media in children without penicillin allergy, based on its proven efficacy against common bacterial pathogens, excellent safety profile, low cost, and narrow microbiologic spectrum. 1, 2
Diagnostic Requirements Before Treatment
Acute otitis media requires three components for diagnosis: 1, 2
- Acute onset of symptoms
- Presence of middle ear effusion (confirmed by pneumatic otoscopy or tympanometry)
- Signs of middle ear inflammation with symptoms such as otalgia, irritability, or fever ≥39°C
Critical pitfall: Otitis media with effusion (OME) does not warrant antibiotic therapy and must be distinguished from AOM, as 40-80% of otitis media cases are over-diagnosed. 2
Initial Treatment Algorithm
When to Start Immediate Antibiotics 2
- All children under 6 months with AOM
- Children 6-23 months with bilateral AOM or severe symptoms
- Any child with severe AOM (moderate-to-severe otalgia or fever ≥39°C)
When Watchful Waiting is Appropriate 2
- Children over 2 years with nonsevere unilateral AOM
- Must have reliable follow-up mechanism in place
- Initiate antibiotics if no improvement within 48-72 hours
First-Line Antibiotic Selection
High-dose amoxicillin: 80-90 mg/kg/day divided twice daily for 10 days 1, 2, 3
This dosing achieves middle ear fluid levels exceeding the minimum inhibitory concentration for 83-87% of Streptococcus pneumoniae isolates, including intermediately resistant strains (penicillin MICs 0.12-1.0 μg/mL). 1
When to Use Amoxicillin-Clavulanate Instead 1, 4
High-dose amoxicillin-clavulanate (90 mg/kg/day of amoxicillin with 6.4 mg/kg/day of clavulanate, 14:1 ratio, divided twice daily) should be used when: 1, 4
- Amoxicillin taken within the previous 30 days
- Concurrent purulent conjunctivitis present
- Recurrent AOM unresponsive to amoxicillin
- Treatment failure after 48-72 hours of amoxicillin
The clavulanate component provides coverage against β-lactamase-producing organisms: currently 58-82% of H. influenzae and most M. catarrhalis produce β-lactamase. 1, 4 The 14:1 formulation causes significantly less diarrhea than other ratios (14% vs 34% in pediatric trials). 5
Penicillin Allergy Management 2, 6
For patients with true penicillin allergy who cannot tolerate cephalosporins:
- Cefdinir (14 mg/kg/day in 1-2 doses) is preferred, as cross-reactivity between penicillins and second/third-generation cephalosporins is lower than historically reported 4
- Azithromycin should be reserved only for patients who cannot tolerate cephalosporins 2, 6
Critical pitfall: Never switch from amoxicillin to azithromycin for treatment failure—use amoxicillin-clavulanate instead, as azithromycin has poor efficacy against H. influenzae and increasing S. pneumoniae resistance. 6
Treatment Failure Protocol
Reassess if no improvement within 48-72 hours: 2, 6
- Confirm AOM diagnosis (not OME)
- Switch to high-dose amoxicillin-clavulanate if initially on amoxicillin 1, 4
- Consider tympanocentesis for culture if second-line therapy fails 7
Effective antibiotics sterilize middle ear fluid of bacterial pathogens in >80% of cases within 72 hours. 4
Recurrent Otitis Media (≥3 episodes in 6 months or ≥4 in 12 months) 1, 4
First-line treatment: High-dose amoxicillin-clavulanate (90 mg/kg/day of amoxicillin with 6.4 mg/kg/day of clavulanate) for 10 days, as resistant organisms are more prevalent in recurrent cases. 4
Prophylaxis considerations: 4
- Chemoprophylaxis demonstrates 60-90% protective efficacy in truly recurrent AOM
- Low-dose penicillin, sulfonamide, or erythromycin can be considered after otolaryngology consultation
- Long-term prophylactic antibiotics are generally discouraged per current guidelines 2
Pain Management
Adequate analgesia should be provided regardless of antibiotic decision, using acetaminophen or ibuprofen for symptom relief. 3
Otitis Media with Effusion (OME)
Do not treat OME with antibiotics—antibiotics, decongestants, and nasal steroids do not hasten middle ear fluid clearance. 2, 3 Refer to otolaryngology only if evidence of anatomic damage, hearing loss, or language delay develops. 3