AMOCLAN 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:
- –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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NEWS HIGHLIGHTSMedia Articles Related to Amoclan (Amoxicillin / Clavulanic Acid)
FDA Panel Votes in Favor of New Strep Pneumoniae Vaccine
Source: MedPage Today Infectious Disease [2009.11.18]
BETHESDA, Md. (MedPage Today) -- A Food and Drug Administration (FDA) advisory panel has voted to recommend approval of an updated version of the Streptococcus pneumoniae vaccine Prevnar.
FDA Panel to Vote on Updated Strep pneumoniae Vaccine
Source: MedPage Today Infectious Disease [2009.11.17]
WASHINGTON (MedPage Today) -- A Food and Drug Administration (FDA) advisory panel will decide Wednesday whether to recommend approval of a new version of the popular Streptococcus pneumoniae children's vaccine Prevnar.
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Source: MedicineNet Pneumonia Specialty [2009.11.13]
Title: Pneumonia Drug Promising Against Form of Muscular Dystrophy
Category: Health News
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Last Editorial Review: 11/13/2009
Inhaled Corticosteroids Boost Pneumonia Risk in COPD
Source: MedicineNet fluticasone and salmeterol oral inhaler Specialty [2009.02.10]
Title: Inhaled Corticosteroids Boost Pneumonia Risk in COPD
Category: Health News
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Last Editorial Review: 2/10/2009
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Source: MedicineNet Dengue Fever Specialty [2008.04.07]
Title: Pneumonia
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 4/7/2008
Published Studies Related to Amoclan (Amoxicillin / Clavulanic Acid)
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...
Pre- and post-exposure prophylaxis of experimental Burkholderia pseudomallei infection with doxycycline, amoxicillin/clavulanic acid and co-trimoxazole. [2008.03]
OBJECTIVES: Melioidosis, a potentially fatal disease of humans and animals, is caused by the gram-negative bacterium, Burkholderia pseudomallei. There is no approved vaccine or effective prophylaxis. Given its potential as a bioterrorism agent and a cause of serious laboratory-acquired infection, we studied the efficacy of pre- and post-exposure oral antibiotic prophylaxis in BALB/c mice infected with aerosolized B. pseudomallei through the inhalational route... CONCLUSIONS: Co-trimoxazole appears to be an effective oral antibiotic both as pre- and post-exposure prophylaxis to B. pseudomallei. Data derived from this study have important implications on the management of laboratory accidents or following an intentional release of B. pseudomallei, a potential bioterrorism agent.
Tissue depletion of amoxicillin and its major metabolites in pigs: influence of the administration route and the simultaneous dosage of clavulanic acid. [2008.01.23]
A residue depletion study of amoxicillin (AMO) and its major metabolites, amoxicilloic acid (AMA) and amoxicillin diketopiperazine-2',5'-dione, was performed after a single oral (p.o.) and intravenous (i.v.) administration of amoxicillin (20 mg kg (-1)) and amoxicillin/clavulanic acid (20 and 5 mg kg (-1)) to pigs...
Adverse drug reactions related to amoxicillin alone and in association with clavulanic acid: data from spontaneous reporting in Italy. [2007.07]
OBJECTIVES: To analyse an Italian database of spontaneous reporting of suspected adverse drug reactions in order to compare the safety profile of amoxicillin and amoxicillin/clavulanic acid... CONCLUSIONS: Analysis shows a different safety profile for the two selected drugs. The combination of amoxicillin/clavulanic acid has been increasingly used in Italy and now represents the most frequently antibiotic prescribed by Italian general practitioners. Given the documented level of inappropriate use of beta-lactams in Italy, these results should be taken into account by physicians before prescribing amoxicillin/clavulanic acid to patients.
Clinical Trials Related to Amoclan (Amoxicillin / Clavulanic Acid)
Pharmacodynamic Drug Interaction Between Warfarin and Amoxicillin-Clavulanic Acid [Recruiting]
Several case reports indicate that the use of the antibiotic combination amoxicillin and
clavulanic acid (AM-CLAVAC) can interact with warfarin pharmacodynamics. However, fever per
se might also be responsible of these warfarin overdose reports, as well as the use of high
dose paracetamol.
The aim of the present study is to determine if AM-CLAVAC can increase the pharmacodynamics
of warfarin among patients at steady state Double blinded cross over controlled study vs
placebo performed in 12 evaluable patients treated with warfarin with an INR target 2 to 3
and a stable INR and a stable dose.
Moxifloxacin for the Treatment of Acute Exacerbation of Chronic Bronchitis [Recruiting]
A study to assess the safety and efficacy of moxifloxacin compared to that of
amoxicillin-clavulanic acid for the treatment of subjects with acute exacerbation of chronic
bronchitis.
Middle Meatal Bacteriology During Acute Respiratory Infection in Children [Not yet recruiting]
The purpose of this study is to find out whether the children with respiratory infection and
the presence of pathogenic bacteria (S. pneumoniae, H. influenzae or M. catarrhalis) in the
nasal middle meatus benefit from antimicrobial treatment.
Monotherapy Versus Bitherapy in Non-severe Hospitalized Community-acquired Pneumonia [Recruiting]
The purpose of this study is to determine whether a monotherapy with a Beta-Lactam is not
inferior to an association of a Beta-Lactam and a macrolide in treating adult patients with
community-acquired pneumonia.
Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis [Recruiting]
The purpose of this study is to evaluate the effectiveness of maxillary sinus saline
irrigation in conjunction with systemic antibiotic therapy versus systemic antibiotic
therapy alone in the management of chronic rhinosinusitis, a prospective randomized
controlled trial.
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