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Augmentin (Amoxicillin / Clavulanate Potassium) - Summary

 



AUGMENTIN SUMMARY

AUGMENTINŽ
(amoxicillin/clavulanate potassium)
Tablets

AUGMENTIN is an oral antibacterial combination consisting of the semisynthetic antibiotic 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.

AUGMENTIN is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:

Lower Respiratory Tract Infections -caused by (beta)-lactamase-producing strains of H. influenzae andM. catarrhalis.

Otitis Media -caused by (beta)-lactamase-producing strains of H. influenzae and M. catarrhalis.

Sinusitis -caused by (beta)-lactamase-producing strains of H. influenzae and M. catarrhalis.

Skin and Skin Structure Infections -caused by (beta)-lactamase-producing strains of S. aureus, E. coli and Klebsiella spp.

Urinary Tract Infections -caused by (beta)-lactamase-producing strains of E. coli, lebsiella spp. and Enterobacter spp.

While AUGMENTIN is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with AUGMENTIN due to its amoxicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and (beta)-lactamase-producing organisms susceptible to AUGMENTIN should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and AUGMENTIN. (See Microbiology.)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN 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.

Bacteriological studies, to determine the causative organisms and their susceptibility to AUGMENTIN, should be performed together with any indicated surgical procedures.
See all indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Augmentin (Amoxicillin / Clavulanate)

Use Of Omega-3 With Treatment For Depression In Patients With Heart Disease Does Not Appear To Provide Benefit
Source: Complementary Medicine / Alternative Medicine News From Medical News Today [2009.10.22]
Contrary to the findings of some studies, new research indicates that augmenting antidepressant therapy with an omega-3 fatty acid supplement does not result in improvement in levels of depression in patients with coronary heart disease, according to a study in the October 21 issue of JAMA.

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Published Studies Related to Augmentin (Amoxicillin / Clavulanate)

Randomized controlled trial comparing oral amoxicillin-clavulanate and ofloxacin with intravenous ceftriaxone and amikacin as outpatient therapy in pediatric low-risk febrile neutropenia. [2009.09]
BACKGROUND: Outpatient oral therapy is infrequently used in pediatric low-risk febrile neutropenia (LRFN) as there is insufficient data regarding its equivalence as compared with parenteral therapy... CONCLUSIONS: Outpatient therapy is efficacious and safe in pediatric LRFN. There was no difference in outcome in oral versus IV outpatient therapy. Amoxycillin-clavulanate and ofloxacin may be the oral regimen of choice.

Effectiveness of amoxicillin/clavulanate potassium in the treatment of acute bacterial sinusitis in children. [2009.07]
OBJECTIVE: The role of antibiotic therapy in managing acute bacterial sinusitis (ABS) in children is controversial. The purpose of this study was to determine the effectiveness of high-dose amoxicillin/potassium clavulanate in the treatment of children diagnosed with ABS... CONCLUSIONS: ABS is a common complication of viral upper respiratory infections. Amoxicillin/potassium clavulanate results in significantly more cures and fewer failures than placebo, according to parental report of time to resolution of clinical symptoms.

Patients' perception of recovery after third molar surgery following postoperative treatment with moxifloxacin versus amoxicillin and clavulanic acid: a randomized, double-blind, controlled study. [2009.02]
PURPOSE: To analyze the impact of the postoperative administration of moxifloxacin (MXF) on oral function and quality of life after third molar (TM) surgery... CONCLUSIONS: Moxifloxacin shortens the period of postoperative recovery in terms of oral function and return to work. Therefore, MXF could be a useful option in TM surgery when antibiotics are indicated, particularly if patients are allergic to beta-lactams, their oral flora is resistant to macrolides, or they are intolerant of either of these antibiotics.

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.

Antibiotic prophylaxis for orthognathic surgery: a prospective, comparative, randomized study between amoxicillin-clavulanic acid and penicillin. [2008.11]
CONCLUSION: There were no differences in infection between the two groups of antibiotics. Based on the present study, short-term penicillin is still the most appropriate choice for prophylactic antibiotic in orthognathic surgery.

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Clinical Trials Related to Augmentin (Amoxicillin / Clavulanate)

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

A Multicentre, Randomised, Open-Label Study To Compare The Efficacy And Safety Of Azithromycin For 5 Days With Those Of Amoxicillin-Clavulanic Acid In Patients With Chronic Bronchitis [Completed]
This study compared the clinical efficacy and safety of azithromycin with that of amoxicillin-clavulanic acid, in patients between the ages of 35 and 75 years, presenting with an exacerbation of chronic bronchitis.

Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis [Completed]
To compare the safety/tolerability and efficacy of a 14-day course of clarithromycin extended-release tablets (2 x 500 mg QD) with that of a 14-day course of amoxicillin-clavulanate tablets (875/125 mg BID) for the treatment of ambulatory subjects with Acute Bacterial Sinusitis (ABS).

Amoxicillin Clavulanate in Treatment of Acute Otitis Media [Recruiting]
This is a prospective, randomized, double-blind, placebo controlled one-center study carried out in primary care setting of the health center of City of Turku, Finland. The study patients will be allocated to one of the two parallel treatment groups (amoxicillin-clavulanate or placebo). The hypothesis is that the symptoms and signs of acute otitis media are resolved more effectively with antimicrobial treatment than with placebo. Furthermore, this study aims at finding out prognostic factors that could help to direct antimicrobial treatment for correct subgroups of young patients.

AOM Therapy Trial in Young Children [Recruiting]
The purpose of this study is to learn whether or not all children with ear infections (acute otitis media or AOM) should be treated with antibiotics. The study will compare two treatment strategies, "watchful waiting" or treatment with antibiotics, to determine which is more appropriate for children with AOM. About 268 children in Pittsburgh, between the ages of 6-23 months, with AOM will be enrolled in the study. They will be treated either with Augmentin (an antibiotic) or placebo for 10 days and closely followed for about 1 month. Parents will be asked to write information about their child in a Patient Diary. A general physical exam, including an ear exam, will be performed 4 times during the study. A mucus sample will be collected from the back of each child's nose. Parents will be asked questions during phone calls and at every visit. If a child has not improved or has worsened, the investigators will prescribe a different antibiotic that is known to kill resistant germs.

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PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 12 ratings/reviews, Augmentin has an overall score of 6.58. The effectiveness score is 8.83 and the side effect score is 7.17. 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 19 year old male patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   tonsilitis
Dosage & duration:   875g? (dosage frequency: 2 times a day) for the period of 10 days
Other conditions:   none
Other drugs taken:   nasal steroid of some sort
  
Reported Results
Benefits:   Cleared up most of the symptoms for the 10 day period for both periods on it. Both terms that i took the drug, the symptoms returned 2 days later with very intense pain then weakened over the next week... still sick now for the 7th straight
Side effects:   None. Actually felt pretty good compared to off the drug
Comments:   Normal 10 day 2 times a day dosage

See all reviews / ratings >>

Page last updated: 2009-10-22

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