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. Presumed Bacteriologic Eradication Day 10Day 24–28 S. pneumoniae70/76 (92%)67/76 (88%) H. influenzae30/42 (71%)28/44 (64%) M catarrhalis10/10 (100%)10/10 (100%) Overall110/128 (86%)105/130 (81%)
Oral Antibiotics for Possible Perforated Eardrum:
- Azithromycin is an option for the treatment of acute otitis media, which may be associated with a possible perforated eardrum.
- The clinical success rate for azithromycin in the treatment of acute otitis media is around 83% at Day 12.
- Azithromycin has been shown to be effective against common pathogens associated with acute otitis media, including S. pneumoniae, H. influenzae, and M. catarrhalis 1.
From the Research
For a possible perforated eardrum, amoxicillin-clavulanate is recommended as the first-line oral antibiotic treatment, given its broad coverage against common ear pathogens, including Streptococcus pneumoniae, Haemophilus influenzae, and Staphylococcus aureus. The choice of antibiotic is crucial in managing a possible perforated eardrum to prevent secondary infection and promote healing.
- Amoxicillin-clavulanate (875/125mg twice daily for 7-10 days) is preferred due to its efficacy in eradicating bacterial pathogens from the middle ear fluid, as demonstrated in studies such as 2.
- Fluoroquinolones like ciprofloxacin or ofloxacin may also be considered, but their use should be based on individual clinical findings and underlying health status, as suggested by 3.
- It's essential to use oral antibiotics alongside appropriate pain management and keeping the ear dry during the healing process.
- Patients should avoid swimming and submerging the ear in water and should be advised to follow up with an ENT specialist, especially if symptoms don't improve within 48-72 hours.
- The perforated eardrum itself often heals spontaneously within 1-3 months, but antibiotic therapy helps prevent secondary infection while healing occurs, as noted in various studies including 4, 5, and 6.