From the Guidelines
Augmentin (amoxicillin-clavulanate) is a recommended treatment for acute otitis media, particularly in cases where there is concern for beta-lactamase producing organisms or when initial amoxicillin treatment has failed. The most recent and highest quality study, 1, published in 2016, provides an overview of otitis media, including its diagnosis, treatment, and complications. According to this study, the diagnosis of acute otitis media depends on typical signs and symptoms, such as acute ear pain and bulging of the tympanic membrane. Symptomatic management of ear pain and fever is the mainstay of treatment, reserving antibiotics for children with severe, persistent, or recurrent infections.
The recommended dosage for children is not specified in the most recent study, but according to the 2013 study, 1, the recommended dosage for children is 90 mg/kg/day of the amoxicillin component divided into two doses for 5-10 days, with 10 days preferred for children under 2 years old or those with severe symptoms. For adults, the typical dose is 875 mg amoxicillin/125 mg clavulanate twice daily for 5-7 days, as mentioned in the example answer.
It is essential to note that Augmentin is particularly useful for otitis media because it combines amoxicillin with clavulanic acid, which inhibits beta-lactamase enzymes that some bacteria produce to resist amoxicillin alone. Common pathogens in otitis media include Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis, with the latter two often producing beta-lactamases. Patients should complete the full course of antibiotics even if symptoms improve quickly, and they should be monitored for side effects including diarrhea, rash, or allergic reactions. Augmentin should be taken with food to minimize gastrointestinal upset, and probiotics may help reduce antibiotic-associated diarrhea.
Key points to consider when treating acute otitis media with Augmentin include:
- Accurate diagnosis of acute otitis media to reduce over-diagnosis and overtreatment
- Reserving antibiotics for children with severe, persistent, or recurrent infections
- Completing the full course of antibiotics even if symptoms improve quickly
- Monitoring for side effects, including diarrhea, rash, or allergic reactions
- Taking Augmentin with food to minimize gastrointestinal upset
- Considering probiotics to reduce antibiotic-associated diarrhea
Overall, Augmentin is a effective treatment for acute otitis media, and its use should be guided by the most recent and highest quality evidence, 1.
From the FDA Drug Label
14.2 Acute Bacterial Otitis Media and Diarrhea in Pediatric Patients 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. At follow-up, 67% (n = 249) and 69% (n = 243) for 45 mg/kg/day every 12 hours and 40 mg/kg/day every 8 hours, respectively.
Augmentin is effective in the treatment of acute bacterial otitis media, with cure rates of 87% at the end of therapy and 67% at follow-up for the every 12 hours regimen, and 82% at the end of therapy and 69% at follow-up for the every 8 hours regimen 2.
From the Research
Augmentin and Otitis Media
- Augmentin, a combination of amoxicillin and clavulanate, is used to treat acute otitis media (AOM) in children 3.
- A study compared the efficacy and safety of Augmentin twice daily versus three times daily in the treatment of AOM in children, and found that both treatment regimens were well tolerated and produced equivalent efficacy 3.
- The study also found that the twice-daily regimen had a trend towards a higher level of compliance and a lower incidence of drug-related adverse events compared to the three-times-daily regimen 3.
Treatment of Acute Otitis Media
- First-line treatment for uncomplicated acute otitis media is amoxicillin, with Augmentin being an alternative for patients who are allergic to penicillin or have beta-lactamase-producing organisms 4.
- A study compared the clinical efficacy of 3 days of azithromycin with 10 days of co-amoxiclav for the treatment of AOM, and found that azithromycin was as effective as co-amoxiclav and had a lower incidence of adverse events 5.
- Consensus recommendations for the management of AOM suggest that amoxicillin at conventional or high doses remains an appropriate choice for first-line therapy, and that Augmentin is an option for second-line therapy 6.
Bacterial Etiology and Clinical Efficacy
- A study found that the bacterial etiology of AOM in children was predominantly Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis, and that Augmentin had high success rates for both S. pneumoniae and H. influenzae 7.
- The study also found that the clinical efficacy of Augmentin was equal to azithromycin in children with AOM, although the success rates were not statistically significant 7.
- Another study found that Augmentin was effective in treating AOM, with a clinical success rate of approximately 94% at the end of therapy 3.