Amoxicillin and clavulanate potassium for oral suspension is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the "ß-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid.
Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a ß-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of ß-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated ß-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins.
Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors:
- antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following:
- –daycare attendance
[See CLINICAL PHARMACOLOGY, Microbiology.]
NOTE: Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Amoxicillin and Clavulanate Potassium for oral suspension, 600 mg/42.9 mg per 5 mL is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC ≥4 mcg/mL.
Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae (penicillin MIC ≤2 mcg/mL) and the β-lactamase–producing organisms listed above.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
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Reuters Health Information
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Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 5/4/2015 12:00:00 AM
Published Studies Related to Amoclan (Amoxicillin / Clavulanic Acid)
Amoxicillin/clavulanic acid-warfarin drug interaction: a randomized controlled trial. [2011.02]
AIMS: To investigate whether an interaction exists between amoxicillin/clavulanic acid (amoxiclav) and warfarin in patients treated with stable oral anticoagulant therapy... CONCLUSION: Amoxiclav did not modify anticoagulation in patients treated with stable warfarin therapy and without infection. (c) 2011 The Authors. British Journal of Clinical Pharmacology (c) 2011 The British Pharmacological Society.
Clinical and microbiological efficacy of moxifloxacin versus amoxicillin/clavulanic acid in severe odontogenic abscesses: a pilot study. [2009.01]
The aim of this study targeted the evaluation of the in vivo effect of moxifloxacin in the treatment of patients with severe odontogenic abscesses. This was a prospective, two-armed, randomised, unblinded, monocentric pilot study, which enrolled 21 hospitalized patients with severe odontogenic abscesses.
Prophylaxis versus pre-emptive treatment for infective and inflammatory complications of surgical third molar removal: a randomized, double-blind, placebo-controlled, clinical trial with sustained release amoxicillin/clavulanic acid (1000/62.5 mg). [2007.04]
The most common complications after surgical extraction of the third mandibular molar are trismus, oedema or swelling, local pain, dysphagia and infection. The aim of this comparative, double-blind, randomized clinical trial was to evaluate the efficacy of two sustained release amoxicillin/clavulanate regimens in the reduction of infection after third molar extractive surgery...
Efficacy and safety of IV/PO moxifloxacin and IV piperacillin/tazobactam followed
by PO amoxicillin/clavulanic acid in the treatment of diabetic foot infections:
results of the RELIEF study. 
regimens in patients with diabetic foot infections (DFIs)... CONCLUSION: Moxifloxacin has shown favorable safety and efficacy profiles in DFI
Moxifloxacin vs amoxicillin/clavulanic acid in outpatient AECOPD: maestral results. [2011.12.01]
Bacterial infections causing acute COPD exacerbations (AECOPD) frequently require antibacterial treatment. More evidence is needed to guide antibiotic choice.MAESTRAL was a multiregional, randomised, double-blind non-inferiority outpatient study... Both therapies were well tolerated.
Clinical Trials Related to Amoclan (Amoxicillin / Clavulanic Acid)
Efficacy of Short-Course Antimicrobial Treatment for Children With Acute Otitis Media and Impact on Resistance [Recruiting]
The investigators will study whether, in young children with acute otitis media (AOM),
shortening length of antibiotic treatment as a strategy for reducing antimicrobial
resistance provides satisfactory clinical outcome. This is a Phase 2b multicenter,
randomized, double-blind, placebo-controlled clinical trial in 600 children aged 6 through
23 months comparing the efficacy of consistent reduced-duration antimicrobial treatment (5
days) with that of consistent standard-duration treatment (10 days) for each episode of AOM
developing during a single respiratory season (October 1 through May 31).
Assessing the Necessity of Prescribing Antibiotics (Clavulin or Clindamycin Versus Placebo) Post-peritonsillar Abscess Drainage [Recruiting]
This study aims to look at the necessity for prescribing antibiotics post-drainage of
peritonsillar abscesses (PTA). This will be a single-blinded randomized-control trial with
two arms - patients receiving placebo versus those receiving a seven day course of oral
Amoxicillin-Clavulanic acid. The main objective measure will be to assess if there is
resolution of the peri-tonsillar abscess and there has been no reaccumulation. Patients will
be blinded to whether they receive placebo or amoxicillin-clavulanic acid. Patients will be
phoned after 7 days to assess if their symptoms have resolved via an over the phone
questionnaire. Anaerobic and aerobic cultures will be obtained.
The SCOUT Study: Short Course Therapy for Urinary Tract Infections in Children [Recruiting]
To determine if halting antimicrobial therapy in subjects who have exhibited clinical
improvement 5 days after starting antibiotic therapy (short course therapy) have the same
failure rate, defined as symptomatic Urinary Tract Infection (UTI) through Test of Cure
(TOC) on Day 11-14, as subjects who continue to take antibiotics for an additional 5 days
(standard course therapy). To determine if short-course therapy compared to standard course
therapy results in similar numbers of children with gastrointestinal colonization of
antimicrobial resistant Escherichia coli (E. coli) and Klebsiella pneumonia (K. pneumoniae).
Antibiotic Prophylaxis for PEG in Children [Recruiting]
The aim of this study is to evaluate if a single i. v. dose of co-amoxiclav before PEG can
reduce the incidence of peristomal wound infection in the paediatric population.
The Amputation Surgical Site Infection Trial (ASSIT) [Recruiting]
- Lower limb amputations are performed usually as a last resort in patients with acute
and chronic limb ischaemia (CLI) caused by vascular disease, poorly controlled diabetes
- In the period 2003-2008 there were approximately 5,000 amputations per year in the UK.
- The Centre for Disease Control defines a Surgical Site Infection (SSI) as an infection
within 30 days of an operation or up to one year if an implant is left in place and the
infection is related to an operative procedure.
- Figures from the Surgical Site Infection Surveillance reported that the highest rate of
surgical site infection was reported in association with lower limb amputation at
- There is a clear under-representation and the infection rate within our institution is
approximately 25% which reflects the infection rate reported in a recent trial by Sadat
et al (22. 5%)
- Prevention of surgical site infections is of paramount importance to patients,
healthcare providers and policy-makers, as they impact on morbidity and mortality and
have significant time and cost implications.
- Currently there is NO CONSENSUS as to what the best practice is towards antibiotic
administration in such patients. From a questionnaire-based audit we performed
including vascular departments across the entire country, practice varies in both
course duration (single dose â†’ 5 days antibiotic course) as well as choice of
- The guideline at our institution suggests the 5-day course of antibiotic prophylaxis.
The course duration varies depending on the clinical picture as well as microbiology
results and recommendations.
- There are no randomised control trials that have investigated this aspect of patient
care. We have set up one such trial and through it, we are looking to establish a
standard practice which will hopefully be as beneficial as possible to the patient but
also cost-effective for NHS.