What is the appropriate dose of Augmentin (amoxicillin-clavulanate) for a 32-pound male with otitis media?

From the Guidelines

For a 32-pound male child with otitis media, the recommended Augmentin dosage is 90 mg/kg/day of the amoxicillin component, with 6.4 mg/kg/day of clavulanate, divided into two doses, as per the most recent guidelines 1. This translates to approximately 651 mg of Augmentin (amoxicillin 585 mg and clavulanate 66 mg) twice daily for 10 days, considering the child's weight is 14.5 kg. The most appropriate formulation would be Augmentin oral suspension 600mg/5mL, giving 5.4 mL twice daily, or the 400mg/5mL formulation, giving 8.1 mL twice daily. This dosage provides adequate coverage against common otitis media pathogens including Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis, including beta-lactamase producing strains, as supported by the guidelines 1. The clavulanic acid component inhibits bacterial beta-lactamase enzymes that would otherwise inactivate amoxicillin. Key points to consider:

• Ensure the child completes the full 10-day course even if symptoms improve earlier to prevent recurrence and antibiotic resistance.
• The medication should be given with food to minimize gastrointestinal side effects.
• Parents should be advised that common side effects include diarrhea, diaper rash, and vomiting.
• If severe diarrhea develops, they should contact their healthcare provider as this could indicate C. difficile infection. It's also important to note that the choice of antibiotic should be based on the anticipated clinical response and the microbiologic flora likely to be present, as stated in the guidelines 1.

From the FDA Drug Label

One U.S./Canadian clinical trial was conducted which compared 45/6. 4 mg/kg/day (divided every 12 hours) of amoxicillin and clavulanate potassium for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of amoxicillin and clavulanate potassium for 10 days in the treatment of acute otitis media. The clinical efficacy rates at the end of therapy visit (defined as 2 to 4 days after the completion of therapy) and at the follow-up visit (defined as 22 to 28 days post-completion of therapy) were comparable for the 2 treatment groups, with the following cure rates obtained for the evaluable patients: At end of therapy, 87% (n = 265) and 82% (n = 260) for 45 mg/kg/day every 12 hours and 40 mg/kg/day every 8 hours, respectively.

For a 32-pound male with otitis media, the dose of Augmentin can be calculated as follows:

• 45 mg/kg/day divided every 12 hours: 45 mg/kg/day x (32 pounds / 2.2 pounds/kg) = 652 mg/day, or approximately 326 mg every 12 hours.
• 40 mg/kg/day divided every 8 hours: 40 mg/kg/day x (32 pounds / 2.2 pounds/kg) = 581 mg/day, or approximately 194 mg every 8 hours. Given the information from the clinical trial, 45 mg/kg/day every 12 hours and 40 mg/kg/day every 8 hours are both effective dosing regimens for the treatment of acute otitis media in pediatric patients 2.

From the Research

Augmentin Dose for a 32 Pound Male with Otitis Media

• The recommended dose of Augmentin (amoxicillin-clavulanate) for the treatment of otitis media is based on the patient's weight 3, 4, 5, 6, 7.
• According to the studies, the dose of amoxicillin-clavulanate for children with otitis media is typically 45/6.4 mg/kg/day in two divided doses for 10 days 3 or 90/6.4 mg/kg/d in 2 divided doses for 10 days 7.
• For a 32 pound (approximately 14.5 kg) male, the calculated dose would be:
  • 45/6.4 mg/kg/day: 45 mg/kg/day x 14.5 kg = 652.5 mg/day, divided into two doses of approximately 326.25 mg every 12 hours.
  • 90/6.4 mg/kg/d: 90 mg/kg/day x 14.5 kg = 1305 mg/day, divided into two doses of approximately 652.5 mg every 12 hours.
• It is essential to note that these calculations are based on the studies provided and may not reflect the current recommended dosage or the specific clinical guidelines for the treatment of otitis media 4, 7.
• The efficacy of amoxicillin-clavulanate in treating otitis media has been demonstrated in several studies, with success rates ranging from 80.9% to 94.9% 3, 5, 7.
• Amoxicillin-clavulanate has been shown to be effective against various bacterial pathogens, including Streptococcus pneumoniae and Haemophilus influenzae 3, 7.