From the Guidelines
The treatment for acute non-recurrent suppurative otitis media should primarily involve oral antibiotics, with amoxicillin being the first-line choice at a dose of 80 to 90 mg per kg per day. This recommendation is based on the guideline released by the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP) 1. The choice of amoxicillin is due to its effectiveness against susceptible and intermediate resistant pneumococci, as well as its safety, affordability, and acceptable taste.
When considering treatment options, the following points are essential:
- Amoxicillin is recommended as the first-line therapy for acute otitis media (AOM) due to its efficacy and narrow microbiologic spectrum 1.
- The dosage of amoxicillin should be 80 to 90 mg per kg per day, as this option is based on extrapolation from microbiologic studies and expert opinion, with a preponderance of benefit over risk 1.
- For patients allergic to amoxicillin, alternative antibiotics such as cefdinir, cefpodoxime, or cefuroxime can be prescribed, provided the allergic reaction is not a type I hypersensitivity reaction 1.
- The optimal duration of therapy for patients with AOM is uncertain, but the general recommendation is to treat for 10 days in children and 7-10 days in adults.
It is crucial to note that the treatment of acute non-recurrent suppurative otitis media should prioritize the use of antibiotics to cover the most common bacterial pathogens, including Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Pain management and supportive care are also essential components of the treatment plan. By following these guidelines and recommendations, clinicians can provide effective treatment for acute non-recurrent suppurative otitis media and improve patient outcomes.
From the FDA Drug Label
For the 321 subjects who were evaluated at End of Treatment, the clinical success rate (cure plus improvement) was 87% for azithromycin, and 88% for the comparator For the 305 subjects who were evaluated at Test of Cure, the clinical success rate was 75% for both azithromycin and the comparator. In a non-comparative clinical and microbiological trial, 248 patients from 6 months to 12 years of age with documented acute otitis media were dosed with a single oral dose of azithromycin (30 mg/kg on Day 1). For the 240 patients who were evaluable for clinical modified Intent-to-Treat (MITT) analysis, the clinical success rate (i.e., cure plus improvement) at Day 10 was 89% and for the 242 patients evaluable at Day 24 to 28, the clinical success rate (cure) was 85%. 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. Otitis media-specific criteria were required for eligibility and a strong correlation was found at the end of therapy and follow-up between these criteria and physician assessment of clinical response 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. At follow-up, 67% (n = 249) and 69% (n = 243) for 45 mg/kg/day every 12 hours and 40 mg/kg/day every 8 hours, respectively.
Treatment Options for Acute Non-Recurrent Suppurative Otitis Media:
- Amoxicillin-Clavulanate: The clinical efficacy rates at the end of therapy visit were 87% and 82% for 45 mg/kg/day every 12 hours and 40 mg/kg/day every 8 hours, respectively.
- Azithromycin: The clinical success rate was 87% for azithromycin, and 88% for the comparator at the end of treatment. The choice of treatment should be based on the severity of the infection, patient age, and other factors, and should be made in consultation with a healthcare professional 2 3.
From the Research
Treatment Options for Acute Non-Recurrent Suppurative Otitis Media
- Amoxicillin at conventional or high doses (80-90 mg/kg/day) is an appropriate choice for first-line therapy for acute otitis media (AOM) 4.
- 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, with options including high-dose amoxicillin/clavulanate and ceftriaxone 4.
- Amoxicillin-sulbactam and amoxicillin-clavulanic acid have been shown to be effective in treating non-recurrent acute otitis media (nr-AOM) in children, with high clinical efficacy rates 5.
- Azithromycin has been compared to amoxicillin/clavulanate in several studies, with some showing equivalent clinical efficacy and others showing superior efficacy of amoxicillin/clavulanate 6, 7.
- A systematic review and meta-analysis found that azithromycin is comparable to amoxicillin/clavulanate in treating otitis media in children, with fewer clinical adverse events 7.
Considerations for Treatment
- The prevalence of drug-resistant S. pneumoniae and beta-lactamase-producing organisms should be considered when selecting empiric antimicrobial therapy 4.
- Pharmacokinetic/pharmacodynamic principles should be considered in addition to minimum inhibitory concentrations when selecting antibiotics for AOM 4.
- Tympanocentesis may be useful for identifying the causative pathogen and guiding treatment in patients who have failed multiple courses of antibiotics 4.
- The pneumococcal conjugate vaccine should be administered to all children less than 2 years old and those at risk for recurrent AOM 4.