From the Guidelines
For otitis media treatment in children, Augmentin (amoxicillin/clavulanate) is typically dosed at 40 mg/kg/day of the amoxicillin component, divided into two doses, for 5 days, as recommended by the World Health Organization 1. The medication works by combining amoxicillin, which disrupts bacterial cell wall synthesis, with clavulanate, which inhibits beta-lactamase enzymes that would otherwise inactivate amoxicillin. This combination is effective against many common otitis media pathogens including beta-lactamase producing strains of Haemophilus influenzae and Moraxella catarrhalis, as well as Streptococcus pneumoniae. Some studies suggest alternative dosing regimens, such as 90 mg/kg/day of the amoxicillin component, divided into two doses, for 5-7 days in uncomplicated cases and 10 days for severe cases or in children under 2 years old 1. However, the World Health Organization's recommendation of 40 mg/kg/day for 5 days is a more conservative and widely accepted approach, prioritizing simplicity and reducing the risk of antibiotic resistance. Patients should complete the full course of antibiotics even if symptoms improve before completion to prevent recurrence and antibiotic resistance. It is essential to note that the dosage may vary depending on the severity of the infection, the patient's age, and other factors, and clinicians should consult local guidelines and resistance patterns to inform their treatment decisions.
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 INFECTION | DOSING REGIMEN Otitis media | 45 mg/kg/day every 12 hours or 40 mg/kg/day every 8 hours
The 250 mg/125 mg amoxicillin and clavulanate potassium tablets should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250 mg/125 mg amoxicillin and clavulanate potassium tablets (250/125) versus the 250 mg/62.5 mg amoxicillin and clavulanate potassium tablets (Chewable).
The recommended dosing for Augmentin (amoxicillin/clavulanate) PO for the treatment of otitis media is:
- 45 mg/kg/day every 12 hours or
- 40 mg/kg/day every 8 hours for patients aged 12 weeks (3 months) and older 2. For patients weighing 40 kg or more, the adult dosing regimen should be followed 2.
From the Research
Recommended Dosing for Augmentin PO in Otitis Media
The recommended dosing for Augmentin (amoxicillin/clavulanate) PO for the treatment of otitis media varies depending on the formulation and patient population.
- For children with acute otitis media, a dose of 45/6.4 mg/kg/day twice daily or 40/10 mg/kg/day three times daily is commonly used 3, 4.
- A high-dose formulation of 90/6.4 mg/kg/day in two divided doses has also been developed to provide better coverage for penicillin-resistant strains of Streptococcus pneumoniae 5.
- The choice of dosing regimen may depend on factors such as the severity of the infection, the presence of penicillin-resistant pathogens, and the patient's ability to tolerate the medication.
Efficacy and Safety of Different Dosing Regimens
Studies have compared the efficacy and safety of different dosing regimens for Augmentin in the treatment of otitis media.
- One study found that a twice-daily regimen of 45/6.4 mg/kg/day was as effective as a three-times-daily regimen of 40/10 mg/kg/day, with a lower incidence of diarrhea 3.
- Another study found that a high-dose regimen of 90/6.4 mg/kg/day was effective in eradicating penicillin-resistant S. pneumoniae, with a similar safety profile to a conventional twice-daily regimen 5.
- A comparison of Augmentin with cefaclor found that Augmentin was superior in the acute phase of treatment, but produced more adverse effects such as diarrhea and diaper rash 6.
Considerations for Clinical Practice
When selecting a dosing regimen for Augmentin in the treatment of otitis media, clinicians should consider factors such as the patient's age, weight, and medical history, as well as the severity of the infection and the presence of penicillin-resistant pathogens.
- The choice of dosing regimen should be based on the available evidence and clinical guidelines, with consideration of the potential benefits and risks of each option 7, 4.
- Clinicians should also be aware of the potential for adverse effects such as diarrhea and diaper rash, and monitor patients closely for these and other side effects 3, 6.