Amoxicillin/clavulanic acid was approved for medical use in the United States in 1984.[5] It is on the World Health Organization's List of Essential Medicines.[7][8] The World Health Organization classifies amoxicillin/clavulanic-acid as critically important for human medicine.[9] It is available as a generic medication.[5] In 2021, it was the 115th most commonly prescribed medication in the United States, with more than 5million prescriptions.[10][11]
It is also used for tuberculosis that is resistant to other treatments.[5] The World Health Organization recommends giving amoxicillin-clavulanate along with meropenem as one of the therapeutic options in drug resistant tuberculosis.[14] However, across the spectrum of dosage of amoxicillin-clavulanate combination, the dose of clavulanate is constant at 125 mg, whereas the dose of amoxicillin varies at 250 mg, 500 mg and 875 mg. Thus the use of low dose amoxicillin-clavulanate in combination with meropenem may be used in part of treatment regime for drug resistant TB and this has been demonstrated in a clinical setting also. Its efficacy is attributed not to the amoxicillin component, but to the protective action of clavulanic acid over meropenem against beta-lactamase produced by the mycobacteria. Therefore, the minimum dosage of amoxicillin (250 mg) is recommended.[15]
Rarely, cholestatic jaundice (also referred to as cholestatic hepatitis, a form of liver toxicity) has been associated with amoxicillin/clavulanic acid. The reaction may occur up to several weeks after treatment has stopped, and usually takes weeks to resolve. It is more frequent in men, older people, and those who have taken long courses of treatment; the estimated overall incidence is one in 100,000 exposures.[13] In the United Kingdom, co-amoxiclav carries a warning from the Committee on Safety of Medicines to this effect.[12]
British scientists working at Beecham (now part of GlaxoSmithKline), filed for patent protection for the drug combination in 1977, which was granted in 1982.[17]
It was sold under the brand name Augmentin.[12][18]
Many branded products indicate their strengths as the quantity of amoxicillin. Augmentin 250, for example, contains 250 mg of amoxicillin and 125 mg of clavulanic acid.[12][19]
Amoxicillin/clavulanic acid is used in numerous animals for a variety of conditions:
Dogs: Skin and soft tissue infections such as wounds, abscesses, cellulitis, superficial/juvenile and deep pyoderma due to susceptible strains of the following organisms: β-lactamase-producing Staphylococcus aureus, non-β-lactamase-producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., and E. coli; and periodontal infections due to susceptible strains of both aerobic and anaerobic bacteria.[21]
Cats: Skin and soft tissue infections such as wounds, abscesses, and cellulitis/dermatitis due to susceptible strains of the following organisms: β-lactamase-producing Staphylococcus aureus, non-β-lactamase-producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella spp; urinary tract infections (cystitis) due to susceptible strains of E. coli.[21]
^World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
^World Health Organization (2021). World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. hdl:10665/345533. WHO/MHP/HPS/EML/2021.02.
^ abcdGordon D (2010). "Amoxicillin–Clavulanic Acid (Co-Amoxiclav)". In Grayson ML, et al. (eds.). Kucers' the Use of Antibiotics: a Clinical Review of Antibacterial, Antifungal, Antiparasitic and Antiviral Drugs. London: Hodder Arnold/ASM Press. pp. 193–4. ISBN978-0-340-92767-0.
^World Health Organization (2016). WHO treatment guidelines for drug-resistant tuberculosis, 2016 update. World Health Organization. hdl:10665/250125. ISBN9789241549639.
^ ab"Recent Animal Drug Approvals". U.S. Food and Drug Administration. 15 March 2024. Archived from the original on 5 April 2024. Retrieved 5 April 2024. This article incorporates text from this source, which is in the public domain.
^Federation of Veterinarians in Europe Position Paper: "Antibiotic Resistance & Prudent Use of Antibiotics in Veterinary Medicine"