From the FDA Drug Label
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%. Presumed Bacteriologic Eradication Day 10 Day 24–28 S. pneumoniae 70/76 (92%) 67/76 (88%) H. influenzae 30/42 (71%) 28/44 (64%) M catarrhalis 10/10 (100%) 10/10 (100%) Overall 110/128 (86%) 105/130 (81%) Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older INFECTION DOSING REGIMEN Every 12 hours Every 8 hours Otitis media b, 45 mg/kg/day 40 mg/kg/day sinusitis, lower respiratory tract infections, and more severe infections Less severe infections 25 mg/kg/day 20 mg/kg/day
Otitis Media Antibiotic Indication:
- Amoxicillin-Clavulanate: The recommended dose for otitis media is 45 mg/kg/day every 12 hours or 40 mg/kg/day every 8 hours for patients aged 12 weeks and older 1.
- Azithromycin: Azithromycin is effective in the treatment of acute otitis media, with a clinical success rate of 89% at Day 10 and 85% at Day 24 to 28 2. Key Points:
- Amoxicillin-clavulanate and azithromycin are both effective antibiotics for the treatment of otitis media.
- The dosage and duration of treatment may vary depending on the patient's age, weight, and severity of the infection.
From the Research
Antibiotics are indicated for acute otitis media (AOM) in specific clinical scenarios according to the Australian Therapeutic Guidelines (eTG), with immediate antibiotic therapy recommended for severe AOM, bilateral AOM in children under 2 years, AOM with perforation, or AOM in patients who are systemically unwell or immunocompromised. For non-severe cases in otherwise healthy individuals, watchful waiting for 24-48 hours is appropriate, with antibiotics only if symptoms persist or worsen. The first-line antibiotic treatment is amoxicillin, with a recommended duration of 7 days, as a 7-day regimen is noninferior to a 10-day regimen in clinical responses, according to a recent systematic review and network meta-analysis 3. For patients with penicillin hypersensitivity, alternatives include trimethoprim-sulfamethoxazole or cefuroxime. In cases of treatment failure or recurrent infections, amoxicillin-clavulanate may be used.
Some key points to consider when choosing an antibiotic for AOM include:
- The bacteriologic and clinical efficacy of the antibiotic, with amoxicillin/clavulanate showing superior efficacy compared to azithromycin in eradicating bacterial pathogens from middle ear fluid 4
- The potential for antibiotic resistance, with the increasing prevalence of drug-resistant Streptococcus pneumoniae emphasizing the importance of judicious antibiotic use 5
- The age of the child, with children under 2 years requiring immediate antibiotic therapy for bilateral AOM 6
- The presence of underlying medical conditions, with patients who are systemically unwell or immunocompromised requiring immediate antibiotic therapy 7
Overall, the goal of antibiotic treatment for AOM is to prevent complications such as mastoiditis or hearing loss, particularly in high-risk groups, while also minimizing the risk of antibiotic resistance and promoting judicious use of antibiotics.