Augmentin (Amoxicillin / Clavulanate Potassium) - Summary

AUGMENTIN SUMMARY

AUGMENTIN®
(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.

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AUGMENTIN NEWS HIGHLIGHTS

Published Studies Related to Augmentin (Amoxicillin / Clavulanate)

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.

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.

Comparative evaluation of efficacy and safety of cefotaxime-sulbactam with amoxicillin-clavulanic acid in children with lower respiratory tract infections. [2008.11]
OBJECTIVE: Beta-lactamase producing bacteria present a major problem in treating lower respiratory tract infections. The objective of this study was to evaluate efficacy and safety of cefotaxime-sulbactam combination versus amoxicillin-clavulanic acid injection as an alternative therapeutic option for treatment of lower respiratory tract infections in pediatric patients... CONCLUSION: In conclusion, cefotaxime-sulbactam administered 3 times a day for up to 7 days was found to be as effective as co-amoxiclav therapy. However, further studies with a large number of patients are required to confirm these findings with more robust microbiological evaluation.

A randomized comparative study of levofloxacin versus amoxicillin/clavulanate for treatment of infants and young children with recurrent or persistent acute otitis media. [2008.06]
BACKGROUND: The need for alternative antimicrobial therapy for recurrent and persistent acute otitis media (AOM) in children has raised interest in assessing the efficacy and safety of fluoroquinolones for treatment of these infections... CONCLUSIONS: Levofloxacin was not inferior to amoxicillin/clavulanate [generic for Augmentin] for the treatment of recurrent and/or persistent AOM in infants and children.

Efficacy and safety of azithromycin 1 g once daily for 3 days in the treatment of community-acquired pneumonia: an open-label randomised comparison with amoxicillin-clavulanate 875/125 mg twice daily for 7 days. [2008.02]
This randomised, open-label, non-inferiority study was designed to demonstrate that a 3-day course of oral azithromycin 1 g once daily was at least as effective as a standard 7-day course of oral amoxicillin-clavulanate 875/125 mg twice daily in the treatment of outpatients with community-acquired pneumonia (Fine class I and II)... Azithromycin 1g once daily for 3 days is at least as effective as amoxicillin-clavulanate 875/125 mg twice daily for 7 days in the treatment of adult patients with community-acquired pneumonia.

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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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AUGMENTIN PATIENT REVIEWS / RATINGS / COMMENTS

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 23 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		sinusitis
Dosage & duration:		500 mg taken twice daily for the period of 3 days
Other conditions:		ear infection
Other drugs taken:		orthocept
		Reported Results
Benefits:		Treatment quickly eliminated discomfort associated with the sinus infection. These included ear ache, sore throat, and fever. These symptoms were partially alleviated within 24 hours of the first dose. Within 48 hours, all symptoms were no longer present. However, the eliminated symptoms associated with the sinus infection were almost immediately replaced by negative side effects.
Side effects:		The treatment caused numerous side effects. These included severe stomach cramping and nausea, a severe yeast infection, vomiting, diarrhea and chills. These side effects began within approximately twelve to twenty four hours after first dose of augmentin was administered. These side effects were intolerable and somewhat worse than the symptoms from the initial infection.
Comments:		Augmentin was administered at a dosage of 500 mg to be taken two times a day. Total treatment time was to be 10 days, but within 24 hours, the side effects of the antibiotic were so intolerable that, after 3 days, the drug was terminated and a different antibiotic was administered.