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Augmentin (Amoxicillin / Clavulanate Potassium) - Summary

 
 



AUGMENTIN SUMMARY

AUGMENTIN is an oral antibacterial combination consisting of amoxicillin 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.

To reduce the development of drug?resistant bacteria and maintain the effectiveness of AUGMENTIN (amoxicillin/clavulanate potassium) and other antibacterial drugs, AUGMENTIN should be used only to treat 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.

AUGMENTIN® is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:

Lower Respiratory Tract Infections

caused by beta?lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis.

Acute Bacterial Otitis Media

caused by beta?lactamase–producing isolates of H. influenzae and M. catarrhalis.

Sinusitis

caused by beta?lactamase–producing isolates of H. influenzae and M. catarrhalis.

Skin and Skin Structure Infections

caused by beta?lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.

Urinary Tract Infections

caused by beta?lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species.

Limitations of Use

When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, AUGMENTIN should not be used.


See all Augmentin indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Augmentin (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...

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Clinical Trials Related to Augmentin (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.

AUGMENTIN 1gm In Skin And Soft Tissue Infection [Completed]

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 an Amoxicillin-Clavulanic [Completed]
The objective of this study was to confirm if two formulations of amoxicillin and clavulanic acid (suspension) are bioequivalent. Test product was AUGMENTIN 12H (400 mg Amoxicillin and 57 mg Clavulanic acid/ 5 ml; Glaxo Wellcome France) and reference product AUGMENTIN 12H (400 mg Amoxicillin and 57 mg Clavulanic acid/ 5 ml; GlaxoSmithKline Mexico). The single dosage was 10 ml of suspension. The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. The population was composed of 35 healthy volunteers, both genders, adults between 18-50 years. The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.

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Reports of Suspected Augmentin (Amoxicillin / Clavulanate) Side Effects

Pyrexia (13)Skin Exfoliation (11)Malaise (11)Renal Failure (10)Confusional State (9)Eosinophilia (9)Blister (8)Jaundice (7)Hepatitis (7)Loss of Consciousness (7)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 24 ratings/reviews, Augmentin has an overall score of 6.04. The effectiveness score is 7.75 and the side effect score is 6.92. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Augmentin review by care giver of 3 year old male patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   ear infection
Dosage & duration:   3/4t (dosage frequency: twice daily) for the period of 10 days
Other conditions:   pneumonia
Other drugs taken:   none
  
Reported Results
Benefits:   Ear infection is gone.
Side effects:   No side effects.
Comments:   Take the medicine.

 

Augmentin review by care giver of 13 year old male patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   tonsilitis, possible strep, and ear infection
Dosage & duration:   875 mg taken twice a day for the period of 5 days
Other conditions:   possible strep throat, and ear infection
Other drugs taken:   none
  
Reported Results
Benefits:   Cleared up infection
Side effects:   diarrhea for weeks later
Comments:   Pills my son had to swallow were horse pills. Too big for a kid, even an adult would have trouble taking them.

 

Augmentin review by care giver of 1 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   ear infection
Dosage & duration:   600 mg - 2 ml twice a day taken twice a day for the period of 2 days
Other conditions:   diarrhea, rash/ reaction, no sleep, horrible diaper rash
Other drugs taken:   benadryl due rash from the medication
  
Reported Results
Benefits:   None/ had to many painful side effects.
Side effects:   Cranky, horrible diaper rash immediately following 2nd day of medicine, she couldn't sleep, they diaper rash and diarrhea came on very quickly and the diaper rash hurt her so bad it made her catch her breath if she moved a certain way. I have never seen such a bad diaper rash on either of my babies. I took her in on the 3rd day of treatment and had the medication changed and both of her rashes went away in two days. The rash on her body looked like round welts and they were very itchy. They spread very fast starting as a ring around her whole waist, around her chest and behind her ears. It was blistered. It also looked like round mosquito bites the size of a dime on her arms and legs. They also lost their appetite.
Comments:   This was to treat an ear infection in both ears. The side effects from this medication were way worse than the ear infestion itself. It was extrememly scary to see how this medicine took hold of my 1 year old daughter's body. My son who is 2 was perscribed this medication on Friday due to a bronchial virus, he was also given a shot of antibiotics and given a cough suppressent. The augmenton did not give him the skin rash but he has a horrible diaper rash and it is extremely painful. He is not sleeping very well either and also has diarrhea. He was percribed the medicine on Friday and I didn't realize it was the same medication my daughter had two weeks ago. I will be calling my doctor this morning to explore other options of medication to get him better. This augmenton is bad for my babies. I hope it helps other people. The side effects have definately out weighed the benefits of helping my children heal. I am dissapointed. It is tough thinking you are giving your kids something that will help them and then they are in more pain than before you sought medical care.

See all Augmentin reviews / ratings >>

Page last updated: 2013-02-10

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