What is the weight-based dosing for acute otitis (inflammation of the middle ear) media?

From the Guidelines

For otitis media, amoxicillin is the first-line antibiotic with a recommended weight-based dosing of 80-90 mg/kg/day divided into two doses for 5-7 days in children, as recommended by the American Academy of Pediatrics and the American Academy of Family Physicians 1.

Weight-Based Dosing

The dosage of 80 to 90 mg per kg per day is based on extrapolation from microbiologic studies and expert opinion, with a preponderance of benefit over risk 1. This weight-based dosing is particularly important in pediatric patients to ensure adequate drug concentrations at the infection site while minimizing side effects.

Alternative Treatments

For patients allergic to penicillin, alternatives include azithromycin or cefdinir, with dosing recommendations based on weight 1. However, the most recent and highest quality study recommends amoxicillin as the first-line treatment for AOM 1.

Pain Management

Pain management with acetaminophen or ibuprofen should also be provided based on weight, with recommended doses of 10-15 mg/kg/dose for acetaminophen and 5-10 mg/kg/dose for ibuprofen.

Key Considerations

• The higher doses of amoxicillin are needed because Streptococcus pneumoniae, a common causative organism, has developed increasing resistance to standard antibiotic doses 1.
• Weight-based dosing is crucial in pediatric patients to ensure effective treatment and minimize side effects.
• The choice of antibiotic should be based on the anticipated clinical response and the microbiologic flora likely to be present 1.

From the FDA Drug Label

The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5.

The weight-based dosing for otitis media is as follows:

• Single dose: 30 mg/kg
• 3-day regimen: 10 mg/kg once daily for 3 days
• 5-day regimen: 10 mg/kg on the first day, followed by 5 mg/kg on Days 2 through 5 The dosing is calculated based on the patient's weight, with the following guidelines:
• 5-10 kg (11-22 lbs): 3.75 mL (150 mg) for the single dose, or 2.5 mL (100 mg) on Day 1 and 1.25 mL (50 mg) on Days 2-5
• 11-20 kg (23-44 lbs): 7.5 mL (300 mg) for the single dose, or 5 mL (200 mg) on Day 1 and 2.5 mL (100 mg) on Days 2-5
• 21-30 kg (45-66 lbs): 11.25 mL (450 mg) for the single dose, or 7.5 mL (300 mg) on Day 1 and 3.75 mL (150 mg) on Days 2-5
• 31-40 kg (67-88 lbs): 15 mL (600 mg) for the single dose, or 10 mL (400 mg) on Day 1 and 5 mL (200 mg) on Days 2-5
• 41 kg and above (89 lbs and above): 22.5 mL (900 mg) for the single dose, or 12.5 mL (500 mg) on Day 1 and 6.25 mL (250 mg) on Days 2-5 2

From the Research

Weight-Based Dosing for Otitis Media

• The American Academy of Pediatrics recommends the use of high-dose amoxicillin for the treatment of acute uncomplicated otitis media, with a dose of 80 to 90 mg/kg per day 3.
• A study comparing amoxicillin and azithromycin in the prevention of recurrent acute otitis media used a dose of 20 mg/kg per day for amoxicillin and 10 mg/kg once a week for azithromycin 4.
• Another study evaluating the efficacy of clarithromycin in the treatment of acute otitis media caused by penicillin-susceptible, -intermediate, and -resistant Streptococcus pneumoniae used a dose of 15 mg/kg twice a day for clarithromycin and 20 mg/kg twice a day for amoxicillin 5.
• A prospective randomized double-blind trial comparing trimethoprim-sulfamethoxazole and amoxicillin-clavulanate in the treatment of acute otitis media used a twice-daily dosing regimen, but the exact dose was not specified in the provided text 6.
• A study comparing clarithromycin and amoxicillin suspensions in the treatment of pediatric patients with acute otitis media used a dose of 7.5 mg/kg twice daily for clarithromycin and 20 mg/kg twice daily for amoxicillin, with a maximum dose of 500 mg for clarithromycin and 750 mg for amoxicillin 7.

Dosing Considerations

• The dose of amoxicillin should be adjusted based on the patient's weight, with a recommended dose of 80 to 90 mg/kg per day for acute uncomplicated otitis media 3.
• The use of high-dose amoxicillin may be limited by the standard adult dose of 1500 mg/d, and primary care physicians may prescribe a lower-than-recommended dose in older children and those in the higher weight category 3.
• The efficacy of clarithromycin and amoxicillin in the treatment of acute otitis media has been demonstrated in several studies, with varying doses and dosing regimens used 7, 4, 5.