How should acute otitis media be treated in children aged 6 months to 2 years, children older than 2 years, and adults, including first‑line antibiotics, dosing, duration, analgesia, observation criteria, second‑line options, and referral indications?

Treatment of Acute Otitis Media by Age Group

High-dose amoxicillin (80–90 mg/kg/day divided twice daily) is the first-line antibiotic for acute otitis media across all age groups, with treatment duration and observation criteria varying by age and severity. 1

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Children 6 Months to 2 Years

Immediate Antibiotic Indications

• All children under 6 months require immediate antibiotics regardless of severity due to higher complication risk and difficulty monitoring clinical progress. 1
• Children 6–23 months with severe AOM (moderate-to-severe otalgia, otalgia ≥48 hours, or fever ≥39°C) require immediate antibiotics. 1
• Children 6–23 months with bilateral AOM require immediate antibiotics, even if non-severe. 1

Observation Criteria (6–23 Months Only)

• Observation without immediate antibiotics is appropriate only for children 6–23 months with non-severe unilateral AOM when reliable follow-up within 48–72 hours can be ensured. 1
• Provide a safety-net prescription to be filled if symptoms worsen or fail to improve within 48–72 hours. 1
• Joint decision-making with parents is essential, and they must understand the need to start antibiotics if the child worsens. 1

First-Line Treatment

• Amoxicillin 80–90 mg/kg/day divided into 2–3 doses (maximum 2 g per dose) for 10 days. 1
• High-dose amoxicillin achieves 92% eradication of Streptococcus pneumoniae (including penicillin-resistant strains) and 84% eradication of beta-lactamase-negative Haemophilus influenzae. 1

When to Use Amoxicillin-Clavulanate Instead

• Switch to amoxicillin-clavulanate (90 mg/kg/day amoxicillin + 6.4 mg/kg/day clavulanate, divided twice daily) if:
  • Amoxicillin was received within the prior 30 days 1
  • Concurrent purulent conjunctivitis is present (suggests H. influenzae) 1
  • History of recurrent AOM unresponsive to amoxicillin 1
• Twice-daily dosing of amoxicillin-clavulanate causes significantly less diarrhea than three-times-daily dosing while maintaining equivalent efficacy. 1

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Children Older Than 2 Years

Immediate Antibiotic Indications

• Children ≥2 years with severe AOM (moderate-to-severe otalgia, otalgia ≥48 hours, or fever ≥39°C) require immediate antibiotics. 1

Observation Criteria

• Children ≥2 years with non-severe AOM (unilateral or bilateral) are candidates for observation with reliable follow-up within 48–72 hours. 1
• Provide a safety-net prescription and ensure parents understand when to initiate antibiotics. 1
• In watchful-waiting cohorts, approximately 66% of children complete the illness without receiving antibiotics. 1

First-Line Treatment

• Amoxicillin 80–90 mg/kg/day divided twice daily (maximum 2 g per dose). 1
• Duration:
  • 7 days for children 2–5 years with mild-to-moderate AOM 1
  • 10 days for children 2–5 years with severe AOM 1
  • 5–7 days for children ≥6 years with mild-to-moderate AOM 1
  • 10 days for children ≥6 years with severe AOM 1

When to Use Amoxicillin-Clavulanate

• Same criteria as younger children: recent amoxicillin use, concurrent purulent conjunctivitis, or recurrent AOM unresponsive to amoxicillin. 1

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Adults

Immediate Antibiotic Indications

• Adults with severe symptoms (moderate-to-severe otalgia, otalgia ≥48 hours, or fever ≥39°C) require immediate antibiotics. 1

Observation Criteria

• Adults with non-severe AOM may be observed with reliable follow-up within 48–72 hours. 1

First-Line Treatment

• Amoxicillin 1.5–4 g/day divided into 2–3 doses. 1
• Duration typically 5–7 days for mild-to-moderate disease, 10 days for severe disease. 1

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Pain Management (All Ages)

Pain control must be addressed immediately in every patient, regardless of antibiotic decision. 1

• Acetaminophen or ibuprofen (weight-based dosing) should be initiated within the first 24 hours and continued throughout the acute phase. 1
• Analgesics typically provide relief within 24 hours, whereas antibiotics provide no symptomatic benefit in the first 24 hours. 1
• Even after 3–7 days of antibiotic therapy, approximately 30% of children under 2 years still have persistent pain or fever. 1

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Penicillin-Allergic Patients

Non-Severe (Non-IgE-Mediated) Allergy

• Cefdinir 14 mg/kg/day once daily (preferred for convenience) 1
• Cefuroxime 30 mg/kg/day divided twice daily 1
• Cefpodoxime 10 mg/kg/day divided twice daily 1
• Cross-reactivity between penicillins and second/third-generation cephalosporins is approximately 0.1%, far lower than historically reported. 1

Severe (IgE-Mediated) Allergy

• Ceftriaxone 50 mg/kg IM or IV once daily for 1–3 days (a 3-day course is superior to a single dose). 1
• For true Type I hypersensitivity, consider clindamycin plus an agent covering H. influenzae and M. catarrhalis (e.g., cefixime or cefdinir). 1

Agents to Avoid

• Do not use trimethoprim-sulfamethoxazole or erythromycin-sulfisoxazole due to substantial pneumococcal resistance (20–25% failure rates). 1
• Avoid macrolides (azithromycin, clarithromycin) as pneumococcal macrolide resistance exceeds 40% in the United States, with bacterial failure rates of 20–25%. 1

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Treatment Failure Management

Reassessment Protocol

• Re-evaluate at 48–72 hours if symptoms worsen or fail to improve. 1
• Confirm the diagnosis with pneumatic otoscopy to verify middle-ear effusion and inflammation. 1

Escalation Algorithm

1. If initially observed → start high-dose amoxicillin 1
2. If amoxicillin fails → switch to amoxicillin-clavulanate (90 mg/kg/day) 1
3. If amoxicillin-clavulanate fails → administer IM ceftriaxone 50 mg/kg once daily for 3 days (superior to a single-dose regimen) 1
4. After multiple failures → perform tympanocentesis with culture and susceptibility testing 1
5. If tympanocentesis is unavailable, consider 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

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Post-Treatment Expectations

• 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. 1
• This post-AOM effusion (otitis media with effusion) requires monitoring but not antibiotics unless it persists >3 months with hearing loss. 1
• Routine follow-up visits are not necessary unless the child has severe symptoms, recurrent AOM, or parental concerns. 1

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Referral Indications

Otolaryngology Referral

• Recurrent AOM (≥3 episodes in 6 months or ≥4 episodes in 12 months) for consideration of tympanostomy tubes 1
• Multiple treatment failures requiring tympanocentesis 1
• Persistent middle-ear effusion >3 months with hearing loss 1
• Structural abnormalities or complications (e.g., mastoiditis, facial nerve paralysis) 1

Infectious Disease Referral

• Multidrug-resistant pathogens requiring unconventional antibiotics (e.g., levofloxacin, linezolid) 1
• Immunocompromised patients with recurrent or complicated AOM 1

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Prevention Strategies

• Pneumococcal conjugate vaccine (PCV-13) and annual influenza vaccination reduce AOM incidence. 1
• Breastfeeding for at least 6 months provides protective benefit. 1
• Reduce or eliminate pacifier use after 6 months of age. 1
• Avoid supine bottle feeding and eliminate tobacco smoke exposure. 1
• Long-term prophylactic antibiotics are NOT recommended due to modest benefit and risk of antibiotic resistance. 1

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Critical Pitfalls to Avoid

• Antibiotics do not prevent complications: 33–81% of children who develop acute mastoiditis had received antibiotics previously. 1
• Isolated tympanic-membrane redness without effusion should not be treated with antibiotics. 1
• Do not prescribe antibiotics for otitis media with effusion (fluid without acute symptoms). 1
• Do not use topical antibiotics for AOM—they are contraindicated and only indicated for otitis externa or tube otorrhea. 1
• Do not use corticosteroids for routine AOM treatment, as current evidence does not support their effectiveness. 1