Is Augmentin (amoxicillin-clavulanate) effective for treating sinusitis?

From the Guidelines

Augmentin (amoxicillin-clavulanate) is effective for treating sinusitis, particularly in cases where there is a high risk of bacterial resistance or in patients with severe or worsening symptoms.

Key Points

• Amoxicillin with or without clavulanate is the first-line treatment for acute bacterial sinusitis in children 1.
• The use of high-dose amoxicillin with clavulanate (2 g orally twice daily or 90 mg/kg/d orally twice daily) is recommended for adults with ABRS who are at a high risk of being infected with an amoxicillin-resistant organism 1.
• Factors that would prompt clinicians to consider prescribing amoxicillin-clavulanate instead of amoxicillin alone include situations in which bacterial resistance is likely, presence of moderate to severe infection, and presence of comorbidity or extremes of life 1.
• The predicted clinical efficacy of amoxicillin/clavulanate for adult patients is around 90-92% 1.
• Some studies suggest that the benefits of antibiotic therapy appear to be greatest for patients with S pneumoniae infection, compared with other bacterial causes of URI, including H influenzae and Moraxella species 1.

Treatment Considerations

• Clinicians should reassess initial management if there is either a caregiver report of worsening or failure to improve within 72 hours of initial management 1.
• Observation therapy may be considered as an alternative strategy to immediate therapy for AOM and sinusitis for older patients without severe symptoms 1.
• The role of observation instead of immediate antibiotic therapy is an important consideration for children with AOM and acute bacterial sinusitis 1.

From the FDA Drug Label

1.3 Sinusitis – caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis.

Augmentin (amoxicillin-clavulanate) is effective for treating sinusitis caused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis 2.

• The drug is indicated for the treatment of sinusitis due to these susceptible bacteria.
• Key points to consider when using Augmentin for sinusitis include:
  • The presence of beta-lactamase-producing bacteria
  • The severity of the infection
  • The patient's renal function, as dose adjustments may be necessary in cases of severe renal impairment.

From the Research

Efficacy of Augmentin for Sinusitis

• The efficacy of Augmentin (amoxicillin-clavulanate) for treating sinusitis has been studied in several clinical trials 3, 4, 5, 6, 7.
• A randomized clinical trial published in 2021 found that high-dose amoxicillin plus clavulanate did not appear to benefit adults with clinically diagnosed acute sinusitis compared to standard-dose amoxicillin plus clavulanate 3.
• Another study published in 2018 found that adults with clinically diagnosed acute bacterial sinusitis were more likely to improve rapidly when treated with immediate-release high-dose amoxicillin/clavulanate than with standard-dose, but not when treated with extended-release high-dose amoxicillin/clavulanate 4.
• A review of the continuing development of amoxicillin/clavulanate published in 2004 noted that the combination has been used for over 20 years to treat community-acquired respiratory tract infections, including sinusitis, and has a high bacteriological and clinical efficacy 5.
• Clinical trials have shown that amoxicillin/clavulanate extended release tablets have excellent bacteriological and clinical success rates in the treatment of acute bacterial sinusitis and community-acquired pneumonia, even in patients infected with antimicrobial-resistant pathogens 6.

Dosage and Administration

• Studies have compared different dosing regimens of amoxicillin/clavulanate, including every 12 hours vs every 8 hours 7.
• A multicenter double-blind randomized double-dummy controlled trial published in 1998 found that amoxicillin and clavulanate given every 12 hours was as effective and safe as administration every 8 hours for the treatment of acute bacterial maxillary sinusitis 7.
• High-dose formulations of amoxicillin/clavulanate have been developed to treat drug-resistant pathogens, such as Streptococcus pneumoniae with reduced susceptibility to penicillin 5, 6.

Safety and Tolerance

• The safety and tolerance profile of amoxicillin/clavulanate is well known, with common adverse effects including diarrhea 3, 4, 7.
• Severe diarrhea was reported in a higher percentage of patients treated with high-dose amoxicillin/clavulanate compared to standard-dose in some studies 4.
• The safety and tolerance profile of the new high-dose formulations of amoxicillin/clavulanate is not significantly different from that of conventional formulations 5.