What is the maximum dose of amoxicillin (amox) for pediatric otitis media?

Maximum Dose of Amoxicillin for Pediatric Otitis Media

The maximum recommended dose of amoxicillin for pediatric otitis media is 90 mg/kg/day divided in two doses, with a maximum of 2 grams per dose. 1, 2

First-Line Treatment Recommendations

• High-dose amoxicillin (80-90 mg/kg/day divided in 2 doses) is the recommended first-line treatment for most pediatric patients with acute otitis media (AOM) 1, 2
• This high-dose regimen is effective against common AOM bacterial pathogens, particularly Streptococcus pneumoniae, due to its safety, low cost, acceptable taste, and narrow microbiologic spectrum 1
• High-dose amoxicillin achieves middle ear fluid concentrations that exceed the minimum inhibitory concentration of intermediately resistant S. pneumoniae and many highly resistant serotypes for a longer period of the dosing interval 2

Special Populations Requiring Amoxicillin-Clavulanate

For certain patient populations, high-dose amoxicillin-clavulanate is preferred over amoxicillin alone:

• Children who have taken amoxicillin in the previous 30 days 1, 2
• Children with concurrent conjunctivitis (otitis-conjunctivitis syndrome) 1
• Children for whom coverage for Moraxella catarrhalis or β-lactamase–producing Haemophilus influenzae is desired 1, 2
• Children attending daycare 1
• Children under 2 years of age 1

Dosing of Amoxicillin-Clavulanate

• The recommended dose for amoxicillin-clavulanate is 90 mg/kg/day of amoxicillin with 6.4 mg/kg/day of clavulanate (amoxicillin to clavulanate ratio of 14:1) in 2 divided doses 1, 2
• This high-dose formulation is less likely to cause diarrhea than other amoxicillin-clavulanate preparations 1
• Clinical studies have shown that the twice-daily regimen (every 12 hours) is associated with significantly less diarrhea than the three-times-daily regimen (every 8 hours) 3

Alternative Treatments for Penicillin-Allergic Children

For children with penicillin allergy, alternative treatments include:

• Cefdinir (14 mg/kg/day in 1 or 2 doses) 1, 2
• Cefuroxime (30 mg/kg/day in 2 divided doses) 1, 2
• Cefpodoxime (10 mg/kg/day in 2 divided doses) 1, 2
• For children with immediate Type I hypersensitivity reactions to β-lactams: trimethoprim-sulfamethoxazole, azithromycin, clarithromycin, or erythromycin, though these have limited effectiveness against the major pathogens of AOM 1

Management of Treatment Failure

• If initial treatment with amoxicillin fails after 48-72 hours, switch to amoxicillin-clavulanate (90 mg/kg/day of amoxicillin with 6.4 mg/kg/day of clavulanate in 2 divided doses) 1, 2
• Alternatively, ceftriaxone (50 mg IM or IV for 3 days) may be used for treatment failures 1
• Bacteriologic studies have shown that the predominant pathogens isolated from children with AOM failing high-dose amoxicillin therapy were β-lactamase-producing organisms 4

Clinical Evidence Supporting High-Dose Amoxicillin

• Studies have demonstrated that high-dose amoxicillin (80-90 mg/kg/day) achieves eradication rates of 92% for S. pneumoniae, including penicillin-nonsusceptible strains 4
• High-dose amoxicillin/clavulanate (90/6.4 mg/kg/day) has shown bacteriologic eradication rates of 98% for S. pneumoniae, including 91% of penicillin-resistant S. pneumoniae with MICs of 2-4 μg/ml 5

Important Considerations and Caveats

• The maximum single dose should not exceed 2 grams, regardless of weight 1
• For children weighing 40 kg or more, adult dosing recommendations should be followed 3
• In communities with low prevalence of nonsusceptible S. pneumoniae (<10%), standard-dose amoxicillin (40-45 mg/kg/day) may be appropriate for uncomplicated cases in children who do not attend daycare and have not received antibiotics in the previous 4 weeks 1, 6
• Duration of therapy studied and recommended for acute otitis media is 10 days 3
• Renal impairment may require dose adjustment in severe cases 3