What is the recommended management of acute otitis media in children, including indications for antibiotics, first‑line drug choice and dosage, observation period, and alternatives for penicillin‑allergic patients?

Treatment of Acute Otitis Media in Children

High-dose amoxicillin (80–90 mg/kg/day divided twice daily) is the first-line antibiotic for most children with acute otitis media when antibiotics are indicated, but observation without immediate antibiotics is appropriate for children ≥6 months with non-severe symptoms and reliable 48–72 hour follow-up. 1, 2

Immediate Pain Management (Mandatory for All Patients)

• Administer weight-based acetaminophen or ibuprofen immediately to every child with ear pain, regardless of whether antibiotics are prescribed. 1, 2
• Antibiotics provide no symptomatic relief in the first 24 hours, and approximately 30% of children younger than 2 years still have pain or fever after 3–7 days of antibiotic therapy. 1, 2
• Topical analgesic ear drops may provide relief within 10–30 minutes, though supporting evidence is limited. 1

Age-Based Treatment Algorithm

Infants < 6 Months

• Prescribe immediate antibiotics for all infants younger than 6 months; observation is not recommended due to higher complication risk. 2
• Use high-dose amoxicillin 80–90 mg/kg/day divided twice daily for a mandatory 10-day course. 1, 2

Children 6–23 Months

• Prescribe immediate antibiotics for bilateral AOM, severe symptoms (moderate-to-severe ear pain or fever ≥39°C), or otorrhea with middle-ear effusion. 1, 3, 2
• Observation is acceptable for unilateral non-severe AOM only when reliable 48–72 hour follow-up can be ensured. 1, 2
• Use a 10-day antibiotic course for all children in this age group, regardless of severity. 1, 2

Children 2–5 Years

• Prescribe immediate antibiotics for severe symptoms (moderate-to-severe ear pain or fever ≥39°C). 1, 3
• Observation with safety-net prescription is appropriate for non-severe AOM when reliable 48–72 hour follow-up is available. 1, 3
• Use a 7-day course for mild-moderate symptoms; extend to 10 days for severe symptoms. 1, 2

Children ≥6 Years

• Prescribe immediate antibiotics for severe symptoms. 1
• Observation is appropriate for non-severe AOM with reliable follow-up. 1
• Use a 5–7 day course for mild-moderate symptoms; extend to 10 days for severe symptoms. 1, 2

First-Line Antibiotic Selection

• High-dose amoxicillin (80–90 mg/kg/day divided twice daily, maximum 2 grams per dose) is first-line therapy for most children. 1, 3, 2
• This dosing achieves middle-ear fluid concentrations that overcome penicillin-resistant Streptococcus pneumoniae (approximately 35% of isolates) and covers beta-lactamase-negative Haemophilus influenzae and Moraxella catarrhalis. 1, 2

When to Use Amoxicillin-Clavulanate First-Line

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

• The child received amoxicillin within the past 30 days
• Concurrent purulent conjunctivitis is present (suggests H. influenzae)
• The child attends daycare or lives in an area with high beta-lactamase-producing pathogen prevalence
• Coverage for Moraxella catarrhalis is needed

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

Penicillin-Allergy Alternatives

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

• Cefdinir 14 mg/kg/day once daily is the preferred alternative due to convenience. 1, 2
• Cefuroxime 30 mg/kg/day divided twice daily or cefpodoxime 10 mg/kg/day divided twice daily are acceptable alternatives. 1, 2
• Cross-reactivity between penicillins and second/third-generation cephalosporins is lower than historically reported, making these agents generally safe. 1, 2

Severe (IgE-Mediated) Penicillin Allergy

• Azithromycin may be used, recognizing it is less effective than amoxicillin for AOM. 2
• Do not use trimethoprim-sulfamethoxazole or erythromycin-sulfisoxazole due to substantial pneumococcal resistance. 1, 2

Observation Strategy (When Appropriate)

• Provide a safety-net prescription to be filled only if symptoms worsen or fail to improve within 48–72 hours. 4
• Ensure a mechanism for reliable follow-up within 48–72 hours; this may include phone contact or a scheduled return visit. 4, 3
• Educate parents about the self-limited nature of most AOM episodes, the importance of early pain management, and potential antibiotic adverse effects. 4
• In studies, approximately 66% of children in watchful waiting groups completed treatment without antibiotics. 4

Management of Treatment Failure

If Symptoms Worsen or Fail to Improve at 48–72 Hours

• Re-evaluate the child to confirm the AOM diagnosis and exclude alternative causes. 1, 2
• If initially observed, start high-dose amoxicillin 80–90 mg/kg/day. 1, 3
• If amoxicillin was used initially, switch to amoxicillin-clavulanate (90 mg/kg/day amoxicillin component). 1, 2
• If amoxicillin-clavulanate fails, administer intramuscular ceftriaxone 50 mg/kg once daily for 3 consecutive days (maximum 1–2 grams). 1, 2
• A 3-day ceftriaxone course is superior to a single-dose regimen for AOM unresponsive to initial antibiotics. 1, 2

After Multiple Treatment Failures

• Consider tympanocentesis with culture and susceptibility testing to guide further antimicrobial selection. 1, 2
• If tympanocentesis is unavailable, use clindamycin with or without coverage for H. influenzae and M. catarrhalis (such as cefdinir, cefixime, or cefuroxime). 2
• For multidrug-resistant S. pneumoniae serotype 19A, levofloxacin or linezolid may be used only after infectious disease and otolaryngology specialist consultation. 2

Post-Treatment 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 therapy. 1, 2
• This post-AOM effusion (otitis media with effusion) requires monitoring but not antibiotics unless it persists >3 months with documented hearing loss. 1, 2
• Routine follow-up visits are not required for all children; consider reassessment for infants <6 months, children with severe initial presentations, those with recurrent AOM, or when parents express concern. 2

Recurrent AOM Management

Recurrent AOM is defined as ≥3 episodes in 6 months or ≥4 episodes in 12 months with at least one episode in the preceding 6 months. 2

Prevention Strategies

• Administer pneumococcal conjugate vaccine (PCV-13) and annual influenza vaccine. 1, 2
• Encourage exclusive breastfeeding for at least 6 months. 1, 2
• Limit pacifier use after 6 months of age. 1, 2
• Avoid supine bottle feeding. 1, 2
• Eliminate tobacco smoke exposure. 1, 2
• Reduce daycare attendance when feasible. 1, 2

Surgical Intervention

• Tympanostomy tubes are indicated for children meeting the recurrent-AOM criteria, with failure rates of approximately 21% for tubes alone and 16% for tubes combined with adenoidectomy. 1, 2
• Long-term prophylactic antibiotics are not recommended because modest benefit does not outweigh the risk of antimicrobial resistance. 1, 2

Critical Pitfalls to Avoid

• Do not prescribe antibiotics for isolated tympanic-membrane redness without bulging or middle-ear effusion. 2
• Do not use topical antibiotics for AOM; these are reserved for otitis externa or tympanostomy tube otorrhea. 1, 2
• Do not use systemic corticosteroids for AOM; evidence shows no benefit. 1
• Antibiotics do not eliminate the risk of mastoiditis; 33–81% of mastoiditis cases had received antibiotics previously. 1
• Do not extend the duration of a failing antibiotic; instead, switch to an agent with broader antimicrobial coverage. 2
• Immediate antibiotics resulted in faster symptom resolution (especially in children <2 years) but also increased multidrug-resistant S. pneumoniae carriage at day 12 compared to watchful waiting. 4