AUGMENTIN XR SUMMARY
AUGMENTIN XR is an oral antibacterial combination consisting of
the semisynthetic antibiotic amoxicillin (present as amoxicillin trihydrate and
amoxicillin sodium) and the β-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.
AUGMENTIN XR Extended Release Tablets are indicated for the
treatment of patients with community-acquired pneumonia or acute bacterial
sinusitis due to confirmed, or suspected β-lactamase?producing pathogens (i.e.,
H. influenzae, M. catarrhalis, H.
parainfluenzae, K. pneumoniae, or
methicillin-susceptible S. aureus) and S. pneumoniae with reduced susceptibility to penicillin
(i.e., penicillin MICs = 2 mcg/mL). AUGMENTIN XR is not indicated for the
treatment of infections due to S. pneumoniae with
penicillin MICs ≥ 4Â mcg/mL. Data are limited with regard to infections due to
S. pneumoniae with penicillin MICs ≥ 4 mcg/mL (see
CLINICAL STUDIES).
Of the common epidemiological risk factors for patients with resistant
pneumococcal infections, only age > 65 years was studied. Patients with other
common risk factors for resistant pneumococcal infections (e.g., alcoholism,
immune-suppressive illness, and presence of multiple co-morbid conditions) were
not studied.
In patients with community-acquired pneumonia in whom
penicillin-resistant S. pneumoniae is suspected,
bacteriological studies should be performed to determine the causative organisms
and their susceptibility when AUGMENTIN XR is prescribed.
Acute bacterial sinusitis or community-acquired pneumonia due to a
penicillin-susceptible strain of S. pneumoniae plus a
β-lactamase?producing pathogen can be treated with another AUGMENTIN® (amoxicillin/clavulanate potassium) product containing lower
daily doses of amoxicillin (i.e., 500Â mg every 8 hours or 875Â mg every 12
hours). Acute bacterial sinusitis or community-acquired pneumonia due to S. pneumoniae alone can be treated with amoxicillin.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of AUGMENTINÂ XR and other antibacterial drugs, AUGMENTINÂ XR 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 HIGHLIGHTS
Published Studies Related to Augmentin XR (Amoxicillin / Clavulanate)
Response of feline eosinophilic plaques and lip ulcers to amoxicillin
trihydrate-clavulanate potassium therapy: a randomized, double-blind
placebo-controlled prospective study. [2012] In this study, we evaluated the treatment of feline eosinophilic plaques and lip
ulcers with amoxicillin trihydrate-potassium clavulanate (Clavamox(®); Pfizer
Animal Health). Nineteen cats with clinical and cytological findings consistent
with eosinophilic plaques and/or lip ulcers were enrolled...
Single-dose extended-release azithromycin versus a 10-day regimen of amoxicillin/clavulanate for the treatment of children with acute otitis media. [2011.04] OBJECTIVES: A randomized, double-blind, double-dummy, multicenter international study was conducted to assess the clinical and bacteriologic response, safety, and compliance of a single 60-mg/kg dose of azithromycin extended-release (ER) versus a 10-day regimen of amoxicillin/clavulanate 90/6.4 mg/kg per day in children with acute otitis media at high risk of persistent or recurrent middle ear infection... CONCLUSIONS: A single 60-mg/kg dose of azithromycin ER provides near equivalent effectiveness to a 10-day regimen of amoxicillin/clavulanate 90/6.4 mg/kg per day in the treatment of children with acute otitis media. Copyright (c) 2011 International Society for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
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.
Azithromycin extended release vs amoxicillin/clavulanate: symptom resolution in acute sinusitis. [2010.01] OBJECTIVE: The aim of the study was to compare early symptom resolution with a single 2-g dose of azithromycin extended release or 10 days of amoxicillin/clavulanate 875 mg/125 mg every 12 hours in patients with acute sinusitis... CONCLUSIONS: More patients randomized to azithromycin extended release experienced symptom resolution at day 5 than those randomized to amoxicillin/clavulanate, without experiencing differences in second antibiotic use at 28 days.
Fosfomycin in a single dose versus a 7-day course of amoxicillin-clavulanate for the treatment of asymptomatic bacteriuria during pregnancy. [2009.12] The purpose of this paper was to compare the efficacy of a single dose of 3 g of fosfomycin to that of a 7-day regimen of amoxicillin-clavulanate in the treatment of asymptomatic bacteriuria during pregnancy. A randomised, prospective, interventional, analytical, longitudinal study was undertaken, in which the efficacy of two antibiotic regimens (one short and the other long) in the treatment of pregnant women with asymptomatic bacteriuria is compared...
Clinical Trials Related to Augmentin XR (Amoxicillin / Clavulanate)
Amoxicillin-Clavulanic Acid 400 mg-57 mg Chewable Tablets Under Fasting Conditions [Completed]
The objective of this study is to compare the rate and extent of absorption of
amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets (test) versus Augmentin®
(reference) administered as 1 x 400 mg-57 mg chewable tablet under fasting conditions.
Amoxicillin-Clavulanic Acid 400 mg-57 mg Chewable Tablets Under Non-Fasting Conditions [Completed]
The objective of this study is to compare the rate and extent of absorption of
amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets (test) versus Augmentin®
(reference) administered as 1 x 400 mg-57 mg chewable tablet under fed conditions.
Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry [Completed]
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.
Bioequivalence Study of Amoxicillin-Clavulanic Acid 600 mg-42.9 mg/ 5 mL Oral Suspension Under Fed Conditions [Completed]
The objective of this study was to compare the rate and extent of absorption of Ranbaxy
Laboratories Limited, India, Amoxicillin-Clavulanic acid and GlaxoSmithKline, U. S.A.
(Augmentin ES-600), amoxicillin-clavulanic acid, administered as a 1 x 5 mL (600 mg - 42. 9
mg) oral suspension, under fed conditions.
Bioequivalence Study of Amoxicillin-Clavulanic Acid 600 mg - 42.9 mg/ 5 mL Oral Suspension Under Fasting Conditions [Completed]
The objective of this study was to compare the rate and extent of absorption Ranbaxy
Laboratories Limited, India, amoxicillin - clavulanic acid and GlaxoSmithKline, U. S.A.
(Augmentin ES-600), amoxicillin - clavulanic acid, administered as a 1 x 5 mL (600 mg - 42. 9
mg) oral suspension, under fasting conditions.
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Page last updated: 2013-02-10
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