Augmentin in Brief
- Active ingredients: Amoxicillin and Clavulanic Acid
- Brand names: Augmentin, Clavamox, Co-amoxiclav
- Therapeutic class: Antibiotic
- Pharmacologic class: Aminopenicillin, Beta-lactam
(Beta-Lactam and Beta-Lactamase Inhibitor Combination)
- Pregnancy Category: B
- Originally discovered: 1977, Beecham Research Laboratories,
Augmentin is an antibacterial combination consisting of the semisynthetic
antibiotic amoxicillin and the beta-lactamase inhibitor, clavulanate
potassium (the potassium salt of clavulanic acid).
The presence of clavulanic acid in Augmentin protects amoxicillin from
degradation by beta-lactamase enzymes and effectively extends the antibacterial
spectrum to include many bacteria normally resistant to amoxicillin.
Co-amoxiclav was invented around 1977/78 by British
scientists working at Beecham, which filed for US patent protection
for the drug combination in 1979. U.S. Patents 4,441,609 was granted
FDA approved uses
Co-amoxiclav is indicated for the treatment of the following infections
due to susceptible strains of sensitive organisms:
- Lower respiratory tract infections - tracheobronchitis, bronchitis,
- Otitis media (middle ear infection)
- Skin and skin structure infections - cellulitis (infection
of the dermis and subcutaneous tissue), erysipelas (superficial form
of cellulitis), folliculitis (inflammation of the hair follicles,
if the infection of the follicle is deeper and involves more follicles,
it moves into the furuncle and carbuncle), furuncles, carbuncles,
abscesses, impetigo (large vesicles or honey-crusted sores), infected
ulcers and infected burns and other.
- Urinary tract infections (UTI) - infections of the urinary
tract (kidneys, ureters, bladder and urethra)
Off-label & Investigational uses
- Antimicrobial prophylaxis in gynecologic surgery4
- Intra-abdominal and pelvic sepsis
- Pelvic inflammatory disease7
- Chlamydial infections - Co-amoxiclav may have
potential for the treatment of polymicrobial infections involving
- Exacerbations of mild-to-moderate chronic obstructive pulmonary disease (COPD) -- amoxicillin/clavulanate significantly prolongs the time to the next exacerbation9.
- Uncomplicated appendicitis8. A complicated appendicitis, where the appendix is perforated, requires surgery, and it is difficult to distinguish complicated disease from uncomplicated.
"Pros" and "Cons"
- The main advantage of Augmentin over Amoxicillin is a broader
antimicrobial spectrum. Augmentin provides an additional
coverage of beta-lactamase producing B. catarrhalis, H. influenzae,
N. gonorrhoeae, and S. aureus (not MRSA). The expanded coverage
makes it a useful alternative when amoxicillin
resistance is present and persons cannot tolerate alternative antibiotics.
- Can be given without regard to meals. The absorption is not affected by food.
- Excellent tissue penetration. Diffuses readily
into most body tissues and fluids, with the exception of brain and
- Long-established track record in scientific studies and in practice.
- Very effective for middle ear infection (otitis media).
Augmentin is among the preferred beta-lactam
antibiotics for the treatment of acute otitis media2.
- Animal and human bites. Because of its anaerobic coverage,
Co-amoxiclav is an excellent drug for treating infections
caused by human and animal bites.
- In situations when there is an increased development of beta-lactamase
producing organisms, it may be the first choice
for the treatment of otitis media, sinusitis, bronchitis, urinary
tract infections and skin and soft tissue infections.
- Higher rate of diarrhea and other gastrointestinal problems, than with
amoxicillin alone1. Diarrhea or loose stools occurs in approximately 20-30% people
- Liver injury. Can produce a wide range of liver injury
including intrahepatic cholestasis without hepatitis, acute hepatocellular
injury, and cholestatic hepatitis with hepatocellular necrosis. It
can produce cholecystitis-like symptoms. Normalization of liver enzymes
usually occurs between 11.5-18 weeks after discontinuation
of drug. Rarely the liver enzymes remain elevated with resulting
chronic liver disease and progression to cirrhosis.
The most important predisposing factor is age more than 65.
The reporting rate of hepatitis is on average 9-fold higher for Augmentin than for amoxicillin1.
- Superinfection. Prolonged use may result in fungal or bacterial
superinfection, including C. difficile-associated diarrhea and pseudomembranous
- Lacks activity against atypical microbes.
- Frequently causes hypersensitivity reactions and rash.
- Broad spectrum of antimicrobial activity increases the risk of evolving resistance.
Mode of action
Augmentin is bactericidal and works by inhibiting the synthesis of bacterial cell walls.
Amoxicillin inhibits bacterial cell wall mucopeptide synthesis. Clavulanic
acid inactivates a wide range of beta-lactam enzymes found in bacteria
resistant to beta-lactam antibiotics.
Time to clear out the system
The half-life of amoxicillin after the oral administration of Augmentin
is 1.3 hours and that of clavulanic acid is 1.0 hour.
- 1. Salvo F, Polimeni G, Moretti U, Conforti A, Leone R, Leoni O, Motola D, Dusi G, Caputi AP.
Adverse drug reactions related to amoxicillin alone and in association with clavulanic acid: data from
spontaneous reporting in Italy. Journal
of Antimicrob Chemother April 21, 2007
- 2. Beta-lactam Antibiotics Against S pneumoniae.
Pharmacotherapy 19(11):1308-1314, 1999.
- 3. Cormio G, Bettocchi S, Ceci O, Nappi L, Di
Fazio F, Cacciapuoti C, Selvaggi L. Antimicrobial prophylaxis in laparoscopic
gynecologic surgery. J Chemother. 2003 Dec;15(6):574-8.
- 4. Cormio G, Vicino M, Loizzi V, Tangari D, Selvaggi
L. Antimicrobial prophylaxis in vaginal gynecologic surgery.
J Chemother. 2007 Apr;19(2):193-7. PubMed
- 5. Grange JD, Amiot X, Grange V, Gutmann L, Biour
M, Bodin F, Poupon R. Amoxicillin-clavulanic acid therapy of spontaneous
bacterial peritonitis: a prospective study of twenty-seven cases in
cirrhotic patients. Hepatology. 1990 Mar;11(3):360-4. PubMed
- 6. Beale AS, Faulds E, Hurn SE, Tyler J, Slocombe
B. Comparative activities of amoxycillin, amoxycillin/clavulanic acid
and tetracycline against Chlamydia trachomatis in cell culture and
in an experimental mouse pneumonitis.
J Antimicrob Chemother.
- 7. Uri FI, Sartawi SA, Dajani YF, Masoud AA,
Barakat HF. Augmentin compared with
triple drug therapy for pelvic inflammatory disease. Int J Gynaecol
Obstet. 1992 May;38(1):41-3. PubMed
- 8. Vons C, Barry C, Maitre S, Pautrat K, Leconte M, Costaglioli B, Karoui M, Alves A, Dousset B, Valleur P, Falissard B, Franco D. Amoxicillin plus clavulanic acid versus appendicectomy for treatment of acute uncomplicated appendicitis: an open-label, non-inferiority, randomised controlled trial. Lancet. 2011 May 7;377(9777) PubMed
- 9. Llor C, Moragas A, Hernández S, Bayona C, Miravitlles M. Efficacy of antibiotic therapy for acute exacerbations of mild to moderate chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2012 Oct 15;186(8):716-23. PubMed
Published: July 01, 2008
Last updated: December 05, 2013
- Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It possesses the ability to inactivate a wide range
of beta-lactamase enzymes secreted by resistant microorganisms.
- When used alone, beta-lactamase inhibitors (clavulanate, sulbactam
and tazobactam) have weak intrinsic antibacterial activity, but
their effectiveness increases when they are combined with a beta-lactam antibiotic.
- Augmentin has a higher rate of diarrhea and liver damage than amoxicillin.