What is the recommended treatment—including antibiotic selection, dosage, and duration—and criteria for observation in acute otitis media for children aged 6 months and older and adults, taking into account moderate to severe otalgia, otorrhea, bulging tympanic membrane, recent amoxicillin use, risk factors for resistant Streptococcus pneumoniae, and penicillin allergy?

Treatment of Acute Otitis Media

High-dose amoxicillin (80-90 mg/kg/day divided twice daily) is the first-line antibiotic for acute otitis media in children ≥6 months and adults when antibiotics are indicated, but observation with close follow-up is appropriate for children ≥6 months with non-severe disease when reliable follow-up can be ensured within 48-72 hours. 1, 2

Diagnostic Criteria Required Before Treatment

Acute otitis media requires all three of the following elements to justify antibiotic therapy 1, 2:

• Acute onset of symptoms (ear pain, irritability, fever) within 48 hours 1
• Middle ear effusion documented by impaired tympanic membrane mobility on pneumatic otoscopy, bulging, or air-fluid level 1, 2
• Signs of middle ear inflammation: moderate-to-severe bulging of the tympanic membrane OR new otorrhea not due to otitis externa OR mild bulging with recent-onset pain (<48 hours) or intense erythema 1, 2

Critical pitfall: Isolated tympanic membrane redness without effusion does not constitute AOM and should not be treated with antibiotics. 2, 3

Immediate Pain Management (Mandatory for All Patients)

Initiate acetaminophen or ibuprofen immediately in every patient with otalgia, regardless of whether antibiotics are prescribed. 1, 2 Pain relief typically occurs within 24 hours from analgesics, whereas antibiotics provide no symptomatic benefit in the first 24 hours. 2 Continue analgesics throughout the acute phase; approximately 30% of children <2 years still have pain after 3-7 days of antibiotic therapy. 2

Decision Algorithm: Immediate Antibiotics vs. Observation

Always Treat Immediately With Antibiotics 1, 2:

• All children <6 months with AOM 2
• Children 6-23 months with bilateral AOM (even if non-severe) 1
• Any age with severe AOM: moderate-to-severe otalgia OR otalgia ≥48 hours OR fever ≥39°C (102.2°F) 1, 2
• Any age with otorrhea (new onset, not due to otitis externa) 1
• Any age when reliable follow-up cannot be ensured 2

Observation Without Immediate Antibiotics is Appropriate 1, 2:

• Children 6-23 months with unilateral, non-severe AOM AND reliable follow-up 1
• Children ≥24 months with non-severe AOM (unilateral or bilateral) AND reliable follow-up 1

Non-severe criteria: Mild otalgia <48 hours AND temperature <39°C (102.2°F) 1

Observation Strategy Requirements 1, 2:

• Provide a safety-net prescription to be filled only if symptoms worsen or fail to improve within 48-72 hours 1, 2
• Arrange reliable follow-up mechanism (scheduled return visit or telephone contact) within 48-72 hours 1, 2
• Educate caregivers that most AOM episodes are self-limited, emphasize early pain control, and discuss antibiotic adverse effects 1
• Approximately 66% of children complete observation without needing antibiotics 1

First-Line Antibiotic Selection

Standard First-Line: High-Dose Amoxicillin 1, 2

Dosing:

• Children: 80-90 mg/kg/day divided twice daily (maximum 2 grams per dose) 1, 2
• Adults: 1.5-4 g/day 2

Use amoxicillin when 1:

• No amoxicillin use in past 30 days
• No concurrent purulent conjunctivitis
• No penicillin allergy

High-dose amoxicillin achieves middle ear fluid concentrations adequate to overcome penicillin-resistant Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis (responsible for ~70% of AOM cases). 2

First-Line Alternative: Amoxicillin-Clavulanate 1, 2

Use amoxicillin-clavulanate (90 mg/kg/day amoxicillin + 6.4 mg/kg/day clavulanate, divided twice daily) when 1, 2:

• Amoxicillin received in past 30 days 1
• Concurrent purulent conjunctivitis (suggests H. influenzae with β-lactamase production) 1, 4
• History of recurrent AOM unresponsive to amoxicillin 1
• Children <2 years attending daycare or areas with high β-lactamase-producing organism prevalence 2

Twice-daily dosing of amoxicillin-clavulanate causes significantly less diarrhea than three-times-daily dosing with equivalent efficacy. 2

Penicillin Allergy Alternatives 1, 2

For non-severe (non-IgE-mediated) penicillin allergy, cross-reactivity with second/third-generation cephalosporins is negligible (~0.1%, far lower than the historically cited 10%) 2:

• Cefdinir 14 mg/kg/day once daily (preferred for convenience) 1, 2
• Cefuroxime 30 mg/kg/day divided twice daily 1, 2
• Cefpodoxime 10 mg/kg/day divided twice daily 1, 2

For severe IgE-mediated reactions, consider azithromycin, though it has lower efficacy (bacterial failure rates 20-25% due to macrolide resistance >40% in the U.S.). 2, 3

Critical pitfall: Do not use trimethoprim-sulfamethoxazole or erythromycin-sulfisoxazole due to substantial pneumococcal resistance. 2

Treatment Duration

Age-based duration 2:

• Children <2 years: 10 days (regardless of severity) 2
• Children 2-5 years: 7 days for mild-moderate AOM; 10 days for severe AOM 2
• Children ≥6 years: 5-7 days for mild-moderate AOM; 10 days for severe AOM 2

Treatment Failure Management

Reassess at 48-72 hours if symptoms worsen or fail to improve. 1, 2

Escalation Algorithm 1, 2:

1. If initially observed → Start high-dose amoxicillin 2
2. If amoxicillin fails → Switch to amoxicillin-clavulanate (90 mg/kg/day amoxicillin component) 1, 2
3. If amoxicillin-clavulanate fails → Intramuscular ceftriaxone 50 mg/kg once daily for 3 consecutive days (superior to 1-day regimen) 2, 3
4. After multiple failures → Consider tympanocentesis with culture and susceptibility testing 2
5. If tympanocentesis unavailable → Clindamycin with or without coverage for H. influenzae and M. catarrhalis 2
6. For multidrug-resistant S. pneumoniae serotype 19A → Levofloxacin or linezolid after infectious disease and otolaryngology consultation 2

Critical pitfall: Do not continue the same failing antibiotic beyond 48-72 hours; this represents treatment failure requiring a change in therapy. 3

Post-Treatment Expectations and Follow-Up

Middle ear effusion persists in 60-70% of children at 2 weeks, 40% at 1 month, and 10-25% at 3 months after successful treatment. 2 This post-AOM effusion (otitis media with effusion) requires monitoring but NOT antibiotics unless it persists >3 months with hearing loss, bilateral disease with documented hearing difficulty, or structural abnormalities develop. 2

Routine follow-up visits are not necessary for all children but consider reassessment for 2:

• Young children with severe symptoms
• Children with recurrent AOM
• When specifically requested by parents

Special Considerations

Concurrent Purulent Conjunctivitis 4

For children with both AOM and purulent conjunctivitis, use amoxicillin-clavulanate as first-line (suggests H. influenzae with β-lactamase production). 4 Consider adding topical fluoroquinolones (ciprofloxacin, ofloxacin, or besifloxacin) for conjunctivitis. 4

Risk Factors for Resistant S. pneumoniae 1, 2

• Recent antibiotic use (within 30 days)
• Daycare attendance
• Age <2 years
• Geographic areas with high resistance prevalence

Recurrent AOM 2

Defined as ≥3 episodes in 6 months OR ≥4 episodes in 12 months (with ≥1 in preceding 6 months). 2

Prevention strategies 2:

• Pneumococcal conjugate vaccine (PCV-13)
• Annual influenza vaccination
• Encourage breastfeeding ≥6 months
• Reduce/eliminate pacifier use after 6 months
• Avoid supine bottle feeding
• Minimize daycare attendance when possible
• Eliminate tobacco smoke exposure

Do NOT use long-term prophylactic antibiotics for recurrent AOM; modest benefit does not justify antibiotic resistance risks. 2

Consider tympanostomy tubes for recurrent AOM; failure rates are 21% for tubes alone and 16% for tubes with adenoidectomy (age-dependent benefit). 2

Complications 1

Antibiotics halve the risk of mastoiditis at the population level, but the number needed to treat is ~4,800 to prevent 1 case, precluding universal antibiotic therapy as a mastoiditis prevention strategy. 1 Notably, 33-81% of children who develop acute mastoiditis had received prior antibiotics. 2

Common Pitfalls to Avoid

• Do NOT treat isolated tympanic membrane redness without middle ear effusion 2, 3
• Do NOT use antibiotics for otitis media with effusion (fluid without acute symptoms) 2
• Do NOT use topical antibiotics for AOM; these are contraindicated and only indicated for otitis externa or tube otorrhea 2
• Do NOT use ototoxic topical preparations when tympanic membrane integrity is uncertain 2
• Do NOT use corticosteroids (including prednisone) routinely in AOM treatment; current evidence does not support their effectiveness 2
• Do NOT escalate to ceftriaxone for otitis externa; persistent ear drainage with external ear erythema and swelling indicates otitis externa, not AOM treatment failure 2