AUGMENTIN XR SUMMARY
AUGMENTIN XR®
(amoxicillin/clavulanate potassium)
Extended Release Tablets
AUGMENTIN XR is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin (present as amoxicillin trihydrate and amoxicillin sodium) and the (beta)-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 (beta)-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 >/=4 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 (beta)-lactamase-producing pathogen can be treated with another AUGMENTIN® (amoxicillin/clavulanate potassium) product containing lower daily doses of amoxicillin (i.e., 500 mg q8h or 875 mg q12h). 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 AUGMENTIN XR and other antibacterial drugs, AUGMENTIN 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-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
complications
- 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.
AUGMENTIN 1gm In Skin And Soft Tissue Infection [Completed]
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