Augmentin(R) (amoxicillin/clavulanate) in the treatment of community-acquired respiratory tract infection: a review of the continuing development of an innovative antimicrobial agent
Abstract
Amoxicillin/clavulanate (Augmentin) is a broad-spectrum antibacterial that has been available for clinical use in a wide range of indications for over 20 years and is now used primarily in the treatment of community-acquired respiratory tract infections. Amoxicillin/clavulanate was developed to provide a potent broad spectrum of antibacterial activity, coverage of beta-lactamase-producing pathogens and a favourable pharmacokinetic/pharmacodynamic (PK/PD) profile. These factors have contributed to the high bacteriological and clinical efficacy of amoxicillin/clavulanate in respiratory tract infection over more than 20 years. This is against a background of increasing prevalence of antimicrobial resistance, notably the continued spread of beta-lactamase-mediated resistance in Haemophilus influenzae and Moraxella catarrhalis, and penicillin, macrolide and quinolone resistance in Streptococcus pneumoniae. The low propensity of amoxicillin/clavulanate to select resistance mutations as well as a favourable PK/PD profile predictive of high bacteriological efficacy may account for the longevity of this combination in clinical use. However, in certain defined geographical areas, the emergence of S. pneumoniae strains with elevated penicillin MICs has been observed. In order to meet the need to treat drug-resistant S. pneumoniae, two new high-dose amoxicillin/clavulanate formulations have been developed. A pharmacokinetically enhanced tablet dosage form of amoxicillin/clavulanate 2000/125 mg twice daily (available as Augmentin XR in the USA), has been developed for use in adult respiratory tract infection due to drug-resistant pathogens, such as S. pneumoniae with reduced susceptibility to penicillin, as well as beta-lactamase-producing H. influenzae and M. catarrhalis. Amoxicillin/clavulanate 90/6.4 mg/kg/day in two divided doses (Augmentin ES-600) is for paediatric use in persistent or recurrent acute otitis media where there are risk factors for the involvement of beta-lactamase-producing strains or S. pneumoniae with reduced penicillin susceptibility. In addition to high efficacy, amoxicillin/clavulanate has a well known safety and tolerance profile of the two new high-dose formulations are not significantly different from those of conventional formulations. Amoxicillin/clavulanate is included in guidelines and recommendations for the treatment of bacterial sinusitis, acute otitis media, community-acquired pneumonia and acute exacerbations of chronic bronchitis. Amoxicillin/clavulanate continues to be an important agent in the treatment of community-acquired respiratory tract infections, both now and in the future.
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Irrational and indiscriminate use of amoxicillin and clavulanic acid has become a global concern and has contributed to antimicrobial resistance.
“The irrational and indiscriminate use of amoxicillin and clavulanic acid has become a global concern. Excessive duration, suboptimal dosing, and inappropriate indication selection have all contributed to the growing challenge of antimicrobial resistance to amoxicillin and clavulanic acid [4,5].”
From Clinical Outcomes and Real-World Effectiveness of Amoxicillin-Clavulanic Acid Across Indian Healthcare Settings: A Retrospective Multicenter Study (2026) · cites this paper as [4]
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- Authors
- White, A. R.
- Affiliations
- GlaxoSmithKline (United Kingdom) (GB)
- Corresponding author
- White, A. R.
- Venue
- Journal of Antimicrobial Chemotherapy
- Publisher
- Oxford University Press (OUP)
- Published
- 2004-02-01
- Volume
- 53
- Issue
- 90001
- Pages
- 3i-20
- ISSN
- 0305-7453 (ISSN-L)
- 1460-2091
- OpenAlex
- W2160637002
- Cited by
- 198
- References
- 99
- Citations by year
- 2026: 8 · 2025: 14 · 2024: 12 · 2023: 17 · 2022: 9 · 2021: 8 · 2020: 13 · 2019: 9 · 2018: 7 · 2017: 8 · 2016: 5 · 2015: 12 · 2014: 7 · 2013: 5 · 2012: 6
- FWCI
- 8.14
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Antimicrobial Chemotherapy (publishedVersion)
- PubMed (publishedVersion)
- Funders
- GlaxoSmithKline
- Topics
- Health Sciences › Medicine › Pharmacology › Antibiotics Pharmacokinetics and Efficacy
- Health Sciences › Medicine › Epidemiology › Pneumonia and Respiratory Infections
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Medicine › Antibiotic Resistance in Bacteria
- Keywords
- amoxicillin-clavulanic acid, community-acquired respiratory tract infections, beta-lactamase resistance, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, penicillin resistance, pharmacokinetics/pharmacodynamics, acute otitis media, bacterial sinusitis, drug-resistant pathogens, antimicrobial resistance, macrolide resistance, quinolone resistance, drug safety
- MeSH terms
- Drug Administration Schedule, Drug Therapy, Combination, Humans, Respiratory Tract Infections, Community-Acquired Infections, Amoxicillin-Potassium Clavulanate Combination, Drug Resistance, Bacterial
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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