What is the treatment for otitis (inflammation of the middle ear) media?

From the Guidelines

The treatment for otitis media typically involves antibiotics, pain management, and supportive care, with amoxicillin being the first-line antibiotic for acute otitis media, prescribed at 80-90 mg/kg/day divided twice daily for 5-10 days 1. The choice of antibiotic and duration of treatment depend on the severity of the infection, the patient's age, and the presence of any underlying medical conditions.

• For acute otitis media, amoxicillin is usually the first-line treatment, with a dosage of 80-90 mg/kg/day divided twice daily for 5-10 days 1.
• If the patient has a penicillin allergy, alternative antibiotics such as azithromycin or clarithromycin may be used 1.
• Pain relief is also an important aspect of treatment, with options including acetaminophen or ibuprofen 1.
• For otitis media with effusion, a watchful waiting approach is often recommended, as most cases resolve spontaneously within 3 months 1. The goal of treatment is to eliminate the bacterial infection, reduce symptoms, and prevent complications, while also considering the potential risks and benefits of antibiotic use 1.
• The most recent and highest quality study on this topic is from 2022, which provides evidence-based recommendations for the management of otitis media in children 1.
• However, the 2004 study by the AAP and AAFP provides more specific guidance on the diagnosis and management of acute otitis media, including the use of amoxicillin as first-line therapy 1.
• The 2016 study on otitis media with effusion provides additional information on the definition, diagnosis, and management of this condition, including the use of a watchful waiting approach 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. 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. 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.

The treatment for otitis media (inflammation of the middle ear) includes:

• Amoxicillin-clavulanate (45/6.4 mg/kg/day every 12 hours or 40/10 mg/kg/day every 8 hours for 10 days) 2
• Azithromycin (10 mg/kg on Day 1 followed by 5 mg/kg on Days 2 to 5) 3 Key points:
• The clinical efficacy rates of amoxicillin-clavulanate and azithromycin are comparable.
• The incidence of diarrhea is lower in patients who received amoxicillin-clavulanate every 12 hours compared to every 8 hours.
• Azithromycin has a lower incidence of treatment-related adverse events, primarily gastrointestinal, compared to amoxicillin/clavulanate potassium.

From the Research

Treatment of Otitis Media

The treatment of otitis media has several aims, including relieving pain, controlling fever, and overcoming bacterial infection in cases of suppurative otitis media 4. The main treatment options are:

• Relieving pain and controlling fever with salicylates or paracetamol 4
• Using antibiotic therapy, with amoxicillin as the first-line treatment for suppurative otitis media 4, 5, 6
• Using alternative antibiotics, such as amoxicillin/clavulanic acid or second-generation cephalosporins, in cases of treatment failure or in children who have been treated for suppurative otitis media in the previous months 4, 5, 7

Antibiotic Therapy

Antibiotic therapy is only indicated in cases of suppurative otitis media, and the choice of antibiotic depends on the suspected causative organism 4. The most common organisms causing otitis media are Haemophilus influenzae and Streptococcus pneumoniae, and amoxicillin is effective against these organisms 4, 5. However, in cases of treatment failure, alternative antibiotics such as amoxicillin/clavulanic acid or second-generation cephalosporins may be used 4, 5, 7.

Duration of Treatment

The duration of antibiotic treatment for otitis media is typically 8-10 days, depending on the presence of spontaneous perforation 4. In cases of treatment failure, a bacteriological study of the effusion may be necessary to determine the appropriate antibiotic to use as a second-line treatment 4.

Watchful Waiting

In some cases, a delayed prescribing strategy may be used, where antibiotic therapy is delayed for 48-72 hours after diagnosis, and only initiated if symptoms persist or worsen 8, 6. This approach may be suitable for children with mild symptoms, and can help reduce the use of antibiotics and the development of antibiotic resistance 8.