What is the recommended dose of amoxicillin (amoxicillin) for acute otitis media in pediatrics, including the maximum dose per day?

From the Guidelines

For acute otitis media in pediatric patients, amoxicillin is recommended at a dose of 80-90 mg/kg/day divided into two doses (given every 12 hours) 1. The maximum daily dose is 3 grams per day regardless of weight. Key considerations for the treatment include:

• The dosage is based on extrapolation from microbiologic studies and expert opinion, with a preponderance of benefit over risk 1.
• Amoxicillin is recommended as first-line therapy for AOM because it is generally effective when used in sufficient doses against susceptible and intermediate resistant pneumococci 1.
• The choice of a first-line treatment should be based on the anticipated clinical response and the microbiologic flora likely to be present 1.
• In areas with high prevalence of penicillin-resistant Streptococcus pneumoniae, the higher dose (90 mg/kg/day) is preferred. Some important points to consider:
• If the child has taken antibiotics in the past 30 days, has concurrent purulent conjunctivitis, or has recurrent otitis media, amoxicillin-clavulanate may be a better first-line choice due to concerns about beta-lactamase producing organisms.
• Amoxicillin is effective against the most common bacterial pathogens in acute otitis media, particularly Streptococcus pneumoniae, and achieves good concentrations in middle ear fluid.
• The medication should be taken with food to minimize gastrointestinal side effects, and caregivers should complete the full course even if symptoms improve before completion. It's also worth noting that:
• For most uncomplicated cases, a 10-day course is standard for children under 2 years of age, while a 5-7 day course may be sufficient for children 2 years and older with mild to moderate disease.
• The optimal duration of therapy for patients with AOM is uncertain 1.

From the FDA Drug Label

Table 1 (12 weeks) n 40 kg Recommended Dosage for Pediatric Patients Aged 3 Months and Older and Weight Less than 40 kg Ear/Nose/Throat Mild/ Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours

The recommended dose of amoxicillin for acute otitis media in pediatrics is:

• Mild/Moderate: 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours
• Severe: 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours The maximum dose per day is 45 mg/kg/day for severe infections, or 875 mg every 12 hours or 500 mg every 8 hours for patients over 40 kg 2.

From the Research

Amoxicillin Dosage for Pediatrics

• The recommended dose of amoxicillin for acute otitis media in pediatrics is 40 mg/kg/day, divided into three equal doses every 8 hours 3.
• However, some studies suggest that a higher dose of 75 to 90 mg/kg/day may be more effective in eradicating resistant Streptococcus pneumoniae, particularly during viral coinfection 3.
• A study comparing high-dose (80-90 mg/kg/d) versus standard-dose (40-45 mg/kg/d) amoxicillin found no significant difference in treatment success or adverse effects between the two groups 4.

Maximum Dose per Day

• The maximum dose per day of amoxicillin for acute otitis media in pediatrics is not explicitly stated in the provided studies.
• However, the studies suggest that doses up to 90 mg/kg/day are considered safe and effective 3, 4.

Treatment Regimens

• A pilot study found that once-a-day amoxicillin (40 mg/kg/day) was feasible and effective in treating acute otitis media, with no significant differences in treatment outcomes or side effects compared to a thrice-daily regimen 5.
• Another study found that a twice-daily regimen (60 mg/kg per day) was comparable to a thrice-daily regimen in terms of efficacy and adverse effects 6.