From the Guidelines
For pediatric patients with otitis media, the maximum amoxicillin dose is 90 mg/kg/day divided into two doses (given every 12 hours), not to exceed 3 grams per day total. This high-dose regimen is recommended for children with acute otitis media, particularly in areas with high prevalence of penicillin-resistant Streptococcus pneumoniae 1. The standard duration of therapy is 10 days for children under 2 years of age or those with severe symptoms, while a 5-7 day course may be sufficient for older children with mild to moderate disease.
Key Considerations
- Amoxicillin remains the first-line antibiotic for otitis media due to its effectiveness against common pathogens, good middle ear penetration, safety profile, palatability, and relatively low cost 1.
- For patients with penicillin allergy, alternatives include cefdinir, cefuroxime, or cefpodoxime, as they are highly unlikely to be associated with cross-reactivity with penicillin allergy 1.
- If a patient fails to improve within 48-72 hours on high-dose amoxicillin, consider switching to amoxicillin-clavulanate to cover beta-lactamase producing organisms 1.
- Analgesics like acetaminophen or ibuprofen should also be provided for pain management.
Dosing and Administration
- The recommended dose of amoxicillin is 80-90 mg/kg per day, which is supported by both the 2013 1 and 2004 1 guidelines.
- However, the most recent and highest quality study 1 recommends a dose of 90 mg/kg per day, which is the recommended maximum dose.
From the FDA Drug Label
Based on the amoxicillin component, amoxicillin and clavulanate potassium should be dosed as follows: Patients Aged 12 weeks (3 months) and Older: Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older INFECTIONDOSING REGIMEN Every 12 hours 200 mg/5 mL or 400 mg/5 mL oral suspension a Otitis media b, sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day every 12 hours
The maximum amoxicillin dose for pediatrics for otitis media is 45 mg/kg/day every 12 hours, based on the amoxicillin component, for patients aged 12 weeks (3 months) and older, as per the dosing regimen provided in Table 1 2.
From the Research
Amoxicillin Dosing for Acute Otitis Media in Children
- The American Academy of Pediatrics recommends high-dose amoxicillin for the treatment of acute uncomplicated otitis media (OM) 3.
- The recommended dose is 80 to 90 mg/kg per day, which can exceed the standard adult dose of 1500 mg/d in older or heavier children 3.
- A study found that primary care physicians often prescribe lower-than-recommended doses of amoxicillin for older or heavier children 3.
- Another study compared the effectiveness of high-dose amoxicillin/clavulanic acid with cefdinir in the treatment of acute otitis media, and found that high-dose amoxicillin/clavulanic acid was more effective 4.
- The maximum dose of amoxicillin for children is not explicitly stated in the studies, but it is implied that the recommended dose of 80 to 90 mg/kg per day should not exceed the standard adult dose of 1500 mg/d 3.
Comparison of Amoxicillin Dosing Regimens
- A study compared once or twice daily doses of amoxicillin with three or four times daily doses, and found that the results were comparable 5.
- Another study compared amoxicillin/clavulanic acid with cefdinir, and found that amoxicillin/clavulanic acid was more effective in eradicating penicillin-resistant S. pneumoniae 6.
- A study found that high-dose amoxicillin/clavulanic acid was more effective than cefdinir in the treatment of acute otitis media, especially in younger children 4.
Considerations for Amoxicillin Dosing
- The dose of amoxicillin should be based on the child's weight, with a maximum dose of 1500 mg/d 3.
- The American Academy of Pediatrics recommends using high-dose amoxicillin for the treatment of acute uncomplicated otitis media 3.
- The choice of amoxicillin dosing regimen should be based on the severity of the infection, the susceptibility of the pathogen, and the child's age and weight 5, 6, 4.