From the Guidelines
For a patient diagnosed with acute otitis media and a ruptured eardrum, high-dose amoxicillin is the recommended first-line antibiotic treatment, with a dosage of 80-90 mg/kg per day in 2 divided doses for children, as stated in the 2013 Pediatrics study 1. The choice of amoxicillin is based on its effectiveness against common AOM bacterial pathogens, as well as its safety, low cost, acceptable taste, and narrow microbiologic spectrum. In cases where the patient has taken amoxicillin in the previous 30 days, has concurrent conjunctivitis, or requires coverage for M catarrhalis, therapy should be initiated with high-dose amoxicillin-clavulanate, as recommended in the same study 1. For patients with a penicillin allergy, alternative treatments such as cefdinir, cefuroxime, or cefpodoxime can be considered, as they are highly unlikely to be associated with cross-reactivity with penicillin, according to the 2013 Pediatrics study 1. It's essential to keep the ear dry and avoid getting water in the ear, and eardrops should only be used if specifically prescribed. The ruptured eardrum typically heals on its own within weeks, but antibiotics are necessary to treat the underlying infection and prevent complications. Key points to consider when treating a patient with acute otitis media and a ruptured eardrum include:
- Using high-dose amoxicillin as the first-line treatment
- Considering alternative treatments for patients with a penicillin allergy
- Keeping the ear dry and avoiding water in the ear
- Using eardrops only if specifically prescribed
- Monitoring for treatment failure and adjusting the antibiotic regimen as needed, as recommended in the 2004 American Family Physician study 1.
From the FDA Drug Label
From the perspective of evaluating pediatric clinical trials, Days 11 to 14 were considered on-therapy evaluations because of the extended half-life of azithromycin. In a double-blind, controlled clinical study of acute otitis media performed in the United States, azithromycin (10 mg/kg on Day 1 followed by 5 mg/kg on Days 2 to 5) was compared to amoxicillin/clavulanate potassium (4:1). The combined clinical success rate (i.e., cure and improvement) at the Day 11 visit was 88% for azithromycin and 88% for the control agent. For the 521 patients who were evaluated at the Day 30 visit, the clinical success rate was 73% for azithromycin and 71% for the control agent In the safety analysis of the above study, the incidence of treatment-related adverse events, primarily gastrointestinal, in all patients treated was 9% with azithromycin and 31% with the control agent.
The antibiotic that needs to be administered for a patient diagnosed with acute otitis media and a ruptured eardrum is amoxicillin-clavulanate or azithromycin.
- Amoxicillin-clavulanate is effective in treating acute otitis media, with a cure rate of 87% at the end of therapy and 67% at follow-up 2.
- Azithromycin is also effective, with a clinical success rate of 88% at the Day 11 visit and 73% at the Day 30 visit 3. Key considerations for choosing an antibiotic include the severity of the infection, the patient's age and weight, and any potential allergies or sensitivities. It is essential to consult a healthcare professional to determine the best course of treatment for the patient.
From the Research
Antibiotic Treatment for Acute Otitis Media with Ruptured Eardrum
- The treatment of acute otitis media (AOM) with a ruptured eardrum typically involves the use of antibiotics to manage the infection and prevent further complications.
- According to the study by 4, 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, with options including high-dose amoxicillin/clavulanate (90 mg/kg/day based on the amoxicillin component) and ceftriaxone.
- A systematic review by 5 found that amoxicillin-clavulanate should be the treatment of choice for children between 6 months and 12 years of age with AOM.
- Another study by 6 recommends amoxicillin and the amoxicillin-clavulanate combination for AOM caused by Streptococcus pneumoniae, while oral cephalosporin is preferred in AOM due to Moraxella catarrhalis and Haemophilus influenzae.
- A recent study by 7 found that treatment failure with amoxicillin was uncommon and did not differ by pathogen or beta-lactamase production, supporting the use of amoxicillin as a first-line treatment for AOM.
Recommended Antibiotics
- Amoxicillin
- Amoxicillin-clavulanate
- Ceftriaxone (as a second-line option)
- Oral cephalosporin (for AOM due to Moraxella catarrhalis and Haemophilus influenzae)