A double-blind, randomized, clinical study compared Augmentin ES-600 Powder for Oral Suspension (90/ mg/kg/day, divided every 12 hours) to AUGMENTIN (45/ mg/kg/day, divided every 12 hours) for 10 days in 450 pediatric patients (3 months to 12 years) with acute otitis media. The primary objective of the study was to compare the safety of Augmentin ES-600 Powder for Oral Suspension to AUGMENTIN. There was no statistically significant difference between treatments in the proportion of patients with 1 or more adverse events. The most frequently reported adverse events for Augmentin ES-600 Powder for Oral Suspension and the comparator of AUGMENTIN were coughing (% versus %), vomiting (% versus %), contact dermatitis (., diaper rash, % versus %), fever (% versus %), and upper respiratory infection (% versus %), respectively. The frequencies of protocol-defined diarrhea with Augmentin ES-600 Powder for Oral Suspension(%) and AUGMENTIN (%) were similar (95% confidence interval on difference: –% to %). Only 2 patients in the group treated with Augmentin ES-600 Powder for Oral Suspension and 1 patient in the group treated with AUGMENTIN were withdrawn due to diarrhea.
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