What are the dosing guidelines for Augmentin ES 600 (amoxicillin/clavulanate) for pediatric patients to treat acute otitis media?

From the Guidelines

Augmentin ES 600 (amoxicillin/clavulanate) for pediatric patients with acute otitis media should be dosed at 90 mg/kg/day of the amoxicillin component, with 6.4 mg/kg per day of clavulanate, divided into two doses given every 12 hours. This recommendation is based on the guidelines for the diagnosis and management of acute otitis media, as outlined in the study published in Pediatrics in 2013 1. The study suggests that high-dose amoxicillin-clavulanate is recommended for children who have taken amoxicillin in the previous 30 days, those with concurrent conjunctivitis, or those for whom coverage for M catarrhalis is desired.

Key Considerations

• The amoxicillin to clavulanate ratio in Augmentin ES 600 is 14:1, which is consistent with the recommended ratio in the guidelines 1.
• The suspension contains 600 mg amoxicillin and 42.9 mg clavulanate per 5 mL, which should be shaken well before administering and refrigerated after reconstitution.
• Parents should complete the full course of treatment, even if symptoms improve earlier, to ensure complete eradication of bacteria.
• Common side effects include diarrhea, diaper rash, and vomiting.

Treatment Duration

• The treatment duration for acute otitis media with Augmentin ES 600 is typically 10 days, although this may vary depending on the severity of the infection and the patient's response to treatment.

Special Considerations

• For patients with a history of penicillin allergy, alternative treatments such as cefdinir, cefuroxime, or ceftriaxone may be considered, as the risk of cross-reactivity with cephalosporins is lower than historically reported 1.
• In cases of severe or recent penicillin allergy reaction history, a skin test may be recommended before administering a cephalosporin.

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: See dosing regimens provided in Table 1. Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older INFECTION DOSING REGIMEN Every 12 hours 200 mg/5 mL or 400 mg/5 mL oral suspension a 125 mg/5 mL or 250 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 40 mg/kg/day every 8 hours Less severe infections 25 mg/kg/day every 12 hours 20 mg/kg/day every 8 hours a Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children. b Duration of therapy studied and recommended for acute otitis media is 10 days.

The dosing guidelines for Augmentin ES 600 (amoxicillin/clavulanate) for pediatric patients to treat acute otitis media are as follows:

• For patients aged 12 weeks (3 months) and older, the recommended dose is 45 mg/kg/day every 12 hours for more severe infections, including otitis media.
• The duration of therapy for acute otitis media is 10 days 2.

From the Research

Dosing Guidelines for Augmentin ES 600

The dosing guidelines for Augmentin ES 600 (amoxicillin/clavulanate) for pediatric patients to treat acute otitis media are as follows:

• The high-dose formulation of amoxicillin/clavulanate is 90/6.4 mg/kg/day in two divided doses 3, 4, 5
• For children with acute otitis media, amoxicillin/clavulanate at a dose of 90 mg/kg/day (based on the amoxicillin component) is recommended as a second-line therapy 4
• The American Academy of Pediatrics recommends amoxicillin/clavulanate as a first-line treatment for acute otitis media, with a dose of 80-90 mg/kg/day 4

Efficacy of Augmentin ES 600

The efficacy of Augmentin ES 600 in treating acute otitis media in pediatric patients is supported by several studies:

• A randomized, investigator-blinded, multicenter trial found that amoxicillin/clavulanate (90/6.4 mg/kg/d in 2 divided doses for 10 days) was clinically and bacteriologically more effective than azithromycin in children with bacterial acute otitis media 5
• A single-blind study found that amoxicillin/clavulanate (45/6.4 mg/kg/day in two divided doses for 10 days) was significantly more likely to eradicate all bacterial pathogens and Haemophilus influenzae from middle ear fluid than azithromycin 6
• A systematic review found that amoxicillin/clavulanate was superior to azithromycin, cefdinir, placebo, cefaclor, and penicillin V in treating acute otitis media in children 7

Safety and Tolerability

The safety and tolerability of Augmentin ES 600 in pediatric patients are well established:

• Amoxicillin/clavulanate is generally well tolerated, with a low total incidence of adverse events (3.6%) and no serious events reported in a large pediatric postmarketing study 3
• The most frequently reported adverse events in children are mild gastrointestinal disturbances, with diarrhea being less frequent with twice-daily than with three-times-daily treatment 3