When to treat otitis media (ear infections)?

From the Guidelines

Ear infections should be treated when symptoms are severe, persistent, or occur in high-risk individuals, with a "wait-and-see" approach for 48-72 hours often recommended for mild cases in adults and children over 2 years. For mild ear infections, watchful waiting is optional, and antibiotics do shorten symptoms and duration of middle ear effusion 1. The decision to treat ear infections should be based on the best available evidence, taking into account the risk of complications, such as hearing loss, and the potential for antibiotic resistance.

Key Considerations

• Treatment is indicated immediately for severe pain, high fever (over 102.2°F), infection in both ears in children under 2, or if symptoms worsen or don't improve after the observation period 1.
• When antibiotics are needed, amoxicillin is typically the first choice, with alternatives including azithromycin or clarithromycin for penicillin-allergic patients 1.
• Pain management with acetaminophen or ibuprofen is important, regardless of whether antibiotics are prescribed, and warm compresses to the ear and keeping the head elevated can provide additional comfort.
• Antibiotics are more commonly needed for children under 2 years because their immune systems are less developed and complications are more likely 1.
• Delaying antibiotics when appropriate helps prevent antibiotic resistance while still treating infections that truly require medication.

Management of Specific Conditions

• Acute otitis media (AOM) is characterized by the presence of fluid in the middle ear, together with signs and symptoms of an acute infection, and may require immediate antibiotics for severe cases 1.
• Otitis media with effusion (OME) is characterized by the presence of middle ear effusion behind an intact tympanic membrane, and management largely consists of watchful waiting, with ventilation tubes primarily for children with chronic effusions and hearing loss, developmental delays, or learning difficulties 1.
• Chronic suppurative otitis media (CSOM) is a leading cause of hearing loss in developing countries, and management may involve topical antibiotics and surgical intervention 1.

From the FDA Drug Label

In a double-blind, controlled, randomized clinical study of acute otitis media in pediatric patients from 6 months to 12 years of age, azithromycin (10 mg/kg per day for 3 days) was compared to amoxicillin/clavulanate potassium (7:1) in divided doses q12h for 10 days For the 366 patients who were evaluated for clinical efficacy at the Day 12 visit, the clinical success rate (i.e., cure plus improvement) was 83% for azithromycin and 88% for the control agent. Protocol 6 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%.

The decision of when to treat ear infections should be based on the presence of documented acute otitis media.

• Treatment with azithromycin can be considered for pediatric patients from 6 months to 12 years of age with acute otitis media.
• The clinical success rate of azithromycin in treating acute otitis media is 83-89%.
• Treatment should be initiated as soon as possible after diagnosis, with azithromycin dosing options including 10 mg/kg per day for 3 days or a single oral dose of 30 mg/kg 2.

From the Research

Treatment of Ear Infections

• Ear infections, also known as acute otitis media (AOM), are commonly diagnosed in children with moderate to severe bulging of the tympanic membrane or new-onset otorrhea not caused by acute otitis externa 3.
• Treatment includes pain management plus observation or antibiotics, depending on the patient's age, severity of symptoms, and whether the AOM is unilateral or bilateral 3.
• High-dose amoxicillin (80 to 90 mg per kg per day in two divided doses) is first-line therapy unless the patient has taken amoxicillin for AOM in the previous 30 days or has concomitant purulent conjunctivitis 3, 4.

Antibiotic Treatment

• Amoxicillin/clavulanate is typically used when the patient has taken amoxicillin for AOM in the previous 30 days or has concomitant purulent conjunctivitis 3.
• Cefdinir or azithromycin should be the first-line antibiotic in those with penicillin allergy based on risk of cephalosporin allergy 3.
• A single 60-mg/kg dose of azithromycin extended-release provides near equivalent effectiveness to a 10-day regimen of amoxicillin/clavulanate 90/6.4 mg/kg per day in the treatment of children with acute otitis media 5.

Prevention and Management

• Pneumococcal and influenza vaccines and exclusive breastfeeding until at least six months of age can reduce the risk of AOM 3, 6.
• Tympanostomy tubes should be considered in children with three or more episodes of AOM within six months or four episodes within one year with one episode in the preceding six months 3.
• Watchful waiting is an option in many cases of AOM, and most countries have issued guidelines that include this option 6.