From the Guidelines
Azithromycin is not recommended as a first-line treatment for otitis media due to its limited effectiveness against common pathogens and increasing resistance to macrolides. The preferred first-line antibiotics for otitis media are amoxicillin (40-50 mg/kg/day divided twice daily for 5-10 days) or amoxicillin-clavulanate. Azithromycin should only be considered in patients with a true penicillin allergy, and even then, other alternatives like cefdinir or cefuroxime are often preferred. When azithromycin is used, the typical dosing is 10 mg/kg on day 1 (maximum 500 mg) followed by 5 mg/kg (maximum 250 mg) daily for days 2-5.
The reason azithromycin is not preferred is its limited effectiveness against common otitis media pathogens, particularly Streptococcus pneumoniae, which has shown increasing resistance to macrolides 1. Additionally, azithromycin has less optimal coverage against Haemophilus influenzae compared to amoxicillin-based regimens. Treatment success depends on selecting antibiotics with appropriate coverage against the most common causative bacteria, and azithromycin's spectrum of activity is not ideal for this infection.
Some key points to consider when prescribing antibiotics for otitis media include:
- The increasing resistance of common pathogens to macrolides and other antibiotics 1
- The importance of selecting antibiotics with appropriate coverage against the most common causative bacteria
- The need to discuss the risks associated with increasing antimicrobial resistance with patients prior to starting antibiotic therapy 1
- The potential for azithromycin to be used in other indications, such as sexually transmitted diseases and GI infections, but with consideration of rising resistance rates 1.
Overall, the use of azithromycin in otitis media should be approached with caution and considered only in specific circumstances, such as a true penicillin allergy, and with careful consideration of the potential risks and benefits.
From the FDA Drug Label
Protocol 2 In a non-comparative clinical and microbiologic trial performed in the United States, where significant rates of beta-lactamase producing organisms (35%) were found, 131 patients were evaluable for clinical efficacy.
Protocol 3 In another controlled comparative clinical and microbiologic study of otitis media performed in the United States, azithromycin was compared to amoxicillin/clavulanate potassium (4:1).
Protocol 4 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
Protocol 5 A double blind, controlled, randomized trial was performed at nine clinical centers Pediatric patients from 6 months to 12 years of age were randomized 1:1 to treatment with either azithromycin (given at 30 mg/kg as a single dose on Day 1) or amoxicillin/clavulanate potassium (7:1), divided q12h for 10 days.
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).
Azithromycin is effective in treating otitis media. The clinical success rates for azithromycin in the treatment of otitis media were:
- 84% at the Day 11 visit in Protocol 2 2
- 88% at the Day 11 visit in Protocol 3 2
- 83% at the Day 12 visit in Protocol 4 2
- 87% at End of Therapy in Protocol 5 2
- 89% at Day 10 in Protocol 6 2 The most common pathogens eradicated by azithromycin were:
- S. pneumoniae
- H. influenzae
- M. catarrhalis The clinical success rates for these pathogens were:
- S. pneumoniae: 82% to 92%
- H. influenzae: 64% to 82%
- M. catarrhalis: 73% to 80%
From the Research
Effectiveness of Azithromycin in Treating Otitis Media
- Azithromycin is an azalide with in vitro activity against otitis media pathogens, good middle ear penetration, and a prolonged half-life 3.
- Clinical trials have evaluated the clinical success rate, safety, and compliance of single-dose azithromycin (30 mg/kg) in the treatment of children with otitis media, showing end-of-treatment clinical success rates of 88% and maintained clinical success at the end-of-study of 82% 3.
- Per pathogen end-of-treatment clinical success rates observed were 91% among patients with Streptococcus pneumoniae, 77% among patients with Haemophilus influenzae, and 100% among patients with Moraxella catarrhalis 3.
Comparison with Other Antibiotics
- A meta-analysis suggests that patients treated with macrolides, including azithromycin, for acute otitis media may be more likely to have clinical failures compared to those treated with amoxicillin or amoxicillin/clavulanate 4.
- However, single-dose azithromycin (30 mg/kg) has been shown to be safe and effective for the treatment of uncomplicated acute otitis media in children, with comparable clinical success rates to 10-day standard amoxicillin/clavulanate 5.
Treatment Recommendations
- Amoxicillin is recommended as the first-line agent to treat uncomplicated acute otitis media, with azithromycin and other macrolides reserved for patients who cannot receive amoxicillin or amoxicillin/clavulanate 6, 7.
- For clinical treatment failures after 3 days of amoxicillin, recommended antimicrobial agents include oral amoxicillin/clavulanate, cefuroxime axetil, and ceftriaxone 6.