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Amoclan (Amoxicillin / Clavulanate Potassium) - Summary



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:
      –age ≤2 years
    • –daycare attendance


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.

See all Amoclan indications & dosage >>


Media Articles Related to Amoclan (Amoxicillin / Clavulanic Acid)

Scientists Spot How Bacterial Pneumonia Damages the Heart
Source: MedicineNet ampicillin Specialty [2014.09.22]
Title: Scientists Spot How Bacterial Pneumonia Damages the Heart
Category: Health News
Created: 9/19/2014 12:35:00 PM
Last Editorial Review: 9/22/2014 12:00:00 AM

New antibiotic VIBATIV® (telavancin) now available in Europe for the treatment of adults with hospital acquired pneumonia
Source: Respiratory / Asthma News From Medical News Today [2014.09.19]
Clinigen Group plc has announced that the new first-in-class bactericidal, once-daily, injectable lipoglycopeptide antibiotic VIBATIV® (telavancin), is now available to prescribe in Europe for...

How pneumonia bacteria can compromise heart health
Source: Respiratory / Asthma News From Medical News Today [2014.09.18]
Bacterial pneumonia in adults carries an elevated risk for adverse cardiac events (such as heart failure, arrhythmias, and heart attacks) that contribute substantially to mortality - but how the...

Antibiotic Lowers Death Risk for Elderly Patients With Pneumonia: Study
Source: MedicineNet azithromycin Specialty [2014.06.04]
Title: Antibiotic Lowers Death Risk for Elderly Patients With Pneumonia: Study
Category: Health News
Created: 6/3/2014 4:36:00 PM
Last Editorial Review: 6/4/2014 12:00:00 AM

Source: MedicineNet Legionnaire Disease and Pontiac Fever Specialty [2014.01.13]
Title: Pneumonia
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 1/13/2014 5:56:50 PM

more news >>

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...

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.

Treatment of aseptic dogs with hemorrhagic gastroenteritis with amoxicillin/clavulanic acid: a prospective blinded study. [2011.09]
BACKGROUND: Antibiotics generally are recommended to treat hemorrhagic gastroenteritis (HGE)... CONCLUSIONS AND CLINICAL IMPORTANCE: In some dogs with HGE that show no signs of sepsis, antibiotics may not change the case outcome or time to recovery.

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Clinical Trials Related to Amoclan (Amoxicillin / Clavulanic Acid)

Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry [Recruiting]
The purpose of the study is to assess the efficacy of amoxicillin-clavulanate in treating acute otitis media in children. The primary end point is time to disappearance of middle ear effusion which monitored by daily tympanometry performed by families and study physicians.

A Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults [Recruiting]
The primary outcome measure is to compare efficacy of an association of Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid during 10 days for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults in clinical and biological cure.

The cure rate will be evaluated at the second visit (14 days after the inclusion visit).

Place of Antibiotics in the Postoperative Acute Lithiasic Cholecystitis [Recruiting]
Assess whether postoperative antibiotics after cholecystectomy for acute lithiasic cholecystitis little or moderately severe, is effective and therefore justified.

The main objective is to compare the occurrence of postoperative infectious complications including surgical site infections (SSI) and remote infections after early cholecystectomy (performed within 5 days after onset of symptoms) for acute lithiasic cholecystitis (ALC) little or moderately serious (without organ dysfunction) with and without postoperative antibiotics.

The secondary objectives are:

- Rates of infectious complications according to duration of preoperative antibiotic

- Influence of surgical drainage after surgery for occurrence of postoperative infectious


- Analysis of the nature of infectious complications (surgical site infections, remote

surgical site infections)

- Comparison of germs found in the bile during the postoperative infectious complications

- Duration of hospitalization

- Readmission rate for surgical site infections

- Rate of reoperation for surgical site infection

- Overall mortality rate at 30 days

- Mortality rates specific to 30 days

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 12-14, 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).

more trials >>

Page last updated: 2014-09-22

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