What is the recommended first‑line therapy for acute otitis media in otherwise healthy children and adults, including oral amoxicillin dosing, indications for high‑dose amoxicillin‑clavulanate, alternative regimens for penicillin allergy, criteria for watchful waiting, and management of chronic suppurative otitis media?

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 both children and adults, with treatment duration of 10 days for children under 2 years, 7 days for children 2–5 years with mild-moderate disease, and 5–7 days for older children and adults with uncomplicated cases. 1

Diagnostic Criteria Before Treatment

Acute otitis media requires all three of the following elements before initiating antibiotics 1:

• Acute onset of symptoms (ear pain, irritability, fever)
• Objective evidence of middle ear effusion on pneumatic otoscopy (impaired tympanic membrane mobility, bulging, or air-fluid level)
• Signs of middle ear inflammation (moderate-to-severe bulging, new otorrhea not from otitis externa, or mild bulging with recent-onset pain < 48 hours)

Common pitfall: Isolated tympanic membrane redness without effusion does not constitute acute otitis media and should not be treated with antibiotics. 1, 2

Immediate Pain Management (All Patients)

• Initiate weight-based acetaminophen or ibuprofen immediately for all patients with otalgia, regardless of whether antibiotics are prescribed 1
• Analgesics provide symptomatic relief within 24 hours, whereas antibiotics provide no pain relief in the first 24 hours 1
• Continue analgesics throughout the acute phase; 30% of children under 2 years still have pain after 3–7 days of antibiotic therapy 1

Decision Algorithm: Immediate Antibiotics vs. Observation

Immediate Antibiotics Required For:

• All infants < 6 months regardless of severity 1
• Children 6–23 months with severe AOM (moderate-to-severe otalgia, otalgia ≥ 48 hours, or fever ≥ 39°C) or bilateral AOM 1
• Children 6–23 months with unilateral non-severe AOM when reliable follow-up cannot be ensured 1
• Children ≥ 24 months with severe AOM 1
• All adults with confirmed AOM (observation not established for adults) 2

Observation Without Immediate Antibiotics Appropriate For:

• Children 6–23 months with unilateral non-severe AOM and reliable follow-up 1
• Children ≥ 24 months with non-severe AOM and reliable follow-up 1

Observation requirements: Provide a safety-net prescription to be filled only if symptoms worsen or fail to improve within 48–72 hours, and arrange reliable follow-up mechanism (scheduled visit or telephone contact) 1

First-Line Antibiotic Therapy

Standard Amoxicillin (First Choice)

Pediatric dosing: 80–90 mg/kg/day divided twice daily (maximum 2 grams per dose) 1

Adult dosing: 875 mg every 12 hours or 500 mg every 8 hours for severe disease or recent antibiotic exposure 2

Duration:

• 10 days for children < 2 years (all severity levels) 1
• 10 days for children 2–5 years with severe symptoms 1
• 7 days for children 2–5 years with mild-moderate symptoms 1
• 5–7 days for children ≥ 6 years with mild-moderate symptoms 1
• 5–7 days for adults with uncomplicated cases 2

Rationale: High-dose amoxicillin achieves 92% eradication of Streptococcus pneumoniae (including penicillin-resistant strains), 84% eradication of beta-lactamase-negative Haemophilus influenzae, and 62% eradication of beta-lactamase-positive H. influenzae 1

When to Use Amoxicillin-Clavulanate Instead of Plain Amoxicillin

Switch to amoxicillin-clavulanate (amoxicillin component 90 mg/kg/day + clavulanate 6.4 mg/kg/day, divided twice daily) as first-line therapy when any of the following are present 1:

• Amoxicillin use within the preceding 30 days
• Concurrent purulent conjunctivitis (suggests H. influenzae)
• Recurrent AOM unresponsive to amoxicillin
• Attendance at daycare or high local prevalence of beta-lactamase-producing organisms

Adult high-dose regimen: Amoxicillin-clavulanate 2000 mg/125 mg twice daily for moderate disease with recent antibiotic exposure or age > 65 years 2

Important: Twice-daily dosing of amoxicillin-clavulanate causes significantly less diarrhea than three-times-daily dosing while maintaining equivalent efficacy 1, 3

Penicillin Allergy Alternatives

Non-Severe (Non-IgE-Mediated) Penicillin Allergy

Cross-reactivity between penicillins and second/third-generation cephalosporins is negligible (approximately 0.1%), making these agents safe 1:

Preferred oral cephalosporins (in order):

• Cefdinir 14 mg/kg/day once daily (preferred for convenience) 1
• Cefuroxime 30 mg/kg/day divided twice daily (children); 500 mg twice daily (adults) 1
• Cefpodoxime 10 mg/kg/day divided twice daily 1

Parenteral option:

• Ceftriaxone 50 mg/kg IM/IV once daily for 1–3 days (reserved for vomiting, inability to take oral medication, or treatment failure) 1

Severe Type I (IgE-Mediated) Penicillin Allergy

All cephalosporins are contraindicated in documented Type I hypersensitivity 1

Macrolide alternatives (lower efficacy):

• Azithromycin or clarithromycin are the only safe oral options 1
• Major limitation: Bacterial failure rates of 20–25% due to pneumococcal macrolide resistance exceeding 40% in the United States 1

Do NOT use: Trimethoprim-sulfamethoxazole or erythromycin-sulfisoxazole have substantial resistance and should be avoided 1

Management of Treatment Failure

Reassess at 48–72 hours if symptoms worsen or fail to improve 1

Treatment Failure Algorithm:

1. If initially observed without antibiotics: Start high-dose amoxicillin 1

2. If amoxicillin fails: Switch to amoxicillin-clavulanate 90 mg/kg/day 1

3. If amoxicillin-clavulanate fails: Administer intramuscular ceftriaxone 50 mg/kg once daily for 3 consecutive days (a 3-day course is superior to a single-dose regimen) 1

4. After multiple failures: Consider tympanocentesis with culture and susceptibility testing 1

5. If tympanocentesis unavailable: Use clindamycin with or without coverage for H. influenzae and M. catarrhalis 1

6. For multidrug-resistant S. pneumoniae serotype 19A: Consider levofloxacin or linezolid only after consulting infectious disease and otolaryngology specialists 1

Critical pitfall: Do NOT simply extend the duration of a failing antibiotic; switch to an agent with broader coverage 1

Chronic Suppurative Otitis Media

• Do NOT use topical antibiotics for suppurative otitis media; these are contraindicated and only indicated for otitis externa or tube otorrhea 1
• Avoid ototoxic topical preparations when tympanic membrane integrity is uncertain 1
• For tympanostomy tube otorrhea: Topical antibiotics such as ciprofloxacin-dexamethasone are the treatment of choice, rather than oral antibiotics 1

Post-Treatment Middle Ear Effusion (Otitis Media with Effusion)

• 60–70% of children have middle ear effusion at 2 weeks after successful AOM treatment, declining to 40% at 1 month and 10–25% at 3 months 1
• This post-AOM effusion (otitis media with effusion) requires monitoring but NOT antibiotics unless it persists > 3 months with hearing loss 1
• Do NOT prescribe antibiotics, decongestants, antihistamines, or nasal steroids for otitis media with effusion; they are ineffective 1
• Watchful waiting for 3 months with re-examination every 3–6 months until effusion resolves 1
• Obtain audiometry if effusion persists ≥ 3 months 1

Recurrent Acute Otitis Media

Definition: ≥ 3 episodes in 6 months or ≥ 4 episodes in 12 months with at least one episode in the preceding 6 months 1

Prevention Strategies:

• Pneumococcal conjugate vaccine (PCV-13) 1
• Annual influenza vaccination 1
• Encourage breastfeeding for at least 6 months 1
• Reduce or eliminate pacifier use after 6 months of age 1
• Avoid supine bottle feeding 1
• Minimize daycare attendance when possible 1
• Eliminate tobacco smoke exposure 1

Surgical Intervention:

• Consider tympanostomy tube placement for children meeting recurrent AOM definition 1
• Failure rates: 21% for tubes alone vs. 16% for tubes with adenoidectomy 1
• Adenoidectomy benefit is age-dependent and controversial; consider at age ≥ 4 years 1

Do NOT use long-term prophylactic antibiotics for recurrent AOM; the modest benefit does not justify antibiotic resistance risks 1

Critical Pitfalls to Avoid

• Antibiotics do NOT prevent complications: 33–81% of children who develop acute mastoiditis had received prior antibiotics 1
• Do NOT confuse otitis externa for otitis media: Persistent ear drainage with external ear erythema and swelling is otitis externa, not treatment-failure AOM; escalation to ceftriaxone is inappropriate 1
• Do NOT use corticosteroids (including prednisone) for acute otitis media; current evidence does not support their effectiveness 1
• Do NOT use intranasal or systemic steroids for acute otitis media; they are not effective 1
• Avoid fluoroquinolones as first-line therapy in adults due to antimicrobial resistance concerns and side effects 2
• Do NOT use macrolides (azithromycin) or trimethoprim-sulfamethoxazole as first-line therapy due to high resistance rates (> 40% for macrolides, 50% for TMP-SMX against S. pneumoniae) 2