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The objective of this paper is to provide consensus recommendations for the management of acute otitis media (AOM) that pediatricians can incorporate into their daily practices. These recommendations were developed during a roundtable meeting that convened clinicians versed in the management of AOM. This meeting was sponsored by an educational grant from SmithKline Beecham Pharmaceuticals. In addition, clinical studies on AOM identified via MEDLINE search were considered in the development of these recommendations. The Drug-Resistant Streptococcus pneumoniae Therapeutic Working Group guidelines for the management of AOM are reviewed in detail. All of the articles identified from the data sources were evaluated and all information deemed relevant was included in this review. AOM is one of the most common infectious diseases affecting infants and children and one of the leading causes of office visits and antibiotic prescriptions for this population. The incidence of AOM has increased during the past 25 years, probably the result of an increased utilization of day care facilities in the United States. The predominant pathogens in AOM include S. pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. The high prevalence of drug-resistant S. pneumoniae and beta-lactamase-producing organisms presents a clinical challenge for practitioners in the selection of empiric antimicrobial therapy. Pharmacokinetic/pharmacodynamic principles should be considered in addition to minimum inhibitory concentrations in selecting antibiotics for AOM. Amoxicillin at conventional or high doses (80-90 mg/kg/day) remains an appropriate choice for first-line therapy for AOM. For patients in whom amoxicillin is unsuccessful, second-line therapy should have demonstrated activity against penicillin-resistant S. pneumoniae as well as beta-lactamase-producing pathogens. Appropriate options for second-line therapy include high-dose amoxicillin/clavulanate (90 mg/kg/day based on the amoxicillin component) and ceftriaxone. Cefuroxime has been suggested as a second-line agent in the past, but recent surveillance data suggest it may no longer be active against penicillin-resistant strains of S. pneumoniae. Tympanocentesis is useful for identifying the causative pathogen, and it may be beneficial for patients who have failed multiple courses of antibiotics. The pneumococcal conjugate vaccine recently was approved for use in children and should be administered to all children less than 2 years old and those at risk for recurrent AOM (e.g., day care attendance, siblings with a history of recurrent AOM). Consensus recommendations are provided for the management of AOM, with a focus on antimicrobial therapy. The current challenges in the management of AOM include the need for an increased understanding of epidemiology, increasing resistance among common middle ear pathogens, use of pharmacokinetic/pharmacodynamic principles in designing treatment strategies, and understanding the potential impact of the pneumococcal conjugate vaccine.