Advertisement

Topics

| Amoxicillin and Clavulanate Potassium

12:56 EDT 24th July 2014 | BioPortfolio
Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.
IMAGE amoxiclav-str1.jpgIMAGE amoxiclav-str2.jpg
Dose and regimen AUC0-24 (mcg•hr/mL) Cmax (mcg/mL)
amoxicillin/clavulanate potassium amoxicillin (±S.D.) clavulanate potassium (±S.D.) amoxicillin (±S.D.) clavulanate potassium (±S.D.)
* Mean values of 14 normal volunteers (n = 15 for clavulanate potassium in the low-dose regimens). Peak concentrations occurred approximately 1.5 hours after the dose.
  Administered at the start of a light meal.
   250 mg/125 mg q 8 h
26.7 ± 4.56
12.6 ± 3.25
3.3 ± 1.12
1.5 ± 0.7
  500  mg/125 mg q 12 h
33.4 ± 6.76
8.6 ± 1.95
6.5 ± 1.41
1.8 ± 0.61
500  mg/125 mg q 8 h
53.4 ± 8.87
15.7 ± 3.86
7.2 ± 2.26
2.4 ± 0.83
  875  mg/125 mg q 12 h
53.5 ± 12.31
10.2 ± 3.04
11.6 ± 2.78
2.2 ± 0.99
MIC (mcg/mL)
Interpretation
≤8/4
Susceptible (S)
16/8
Intermediate (I)
≥32/16
Resistant (R)
MIC (mcg/mL)
Interpretation
≤4/2
Susceptible (S)
≥8/4
Resistant (R)
MIC (mcg/mL)
Interpretation
≤2/1
Susceptible (S)
4/2
Intermediate (I)
≥8/4
Resistant (R)
†† Expressed as concentration of amoxicillin in the presence of clavulanic acid at a constant 2 parts amoxicillin to 1 part clavulanic acid.
Microorganism
MIC Range (mcg/mL)††
   Escherichia coli ATCC 25922
2 to 8
   Escherichia coli ATCC 35218
4 to 16
   Haemophilus influenzae ATCC 49247
2 to 16
   Staphylococcus aureus ATCC 29213
0.12 to 0.5
   Streptococcus  pneumoniae ATCC 49619
0.03 to 0.12
Zone Diameter (mm)
 Interpretation
≥18
 Susceptible  (S)
14 to 17
 Intermediate (I)
≤13
 Resistant (R)
Zone Diameter (mm)
 Interpretation
≥20
 Susceptible (S)
≤19
 Resistant (R)
 Microorganism
Zone Diameter (mm)
   Escherichia coli ATCC 25922
18 to 24
   Escherichia coli ATCC 35218
17 to 22
   Staphylococcus aureus ATCC 25923
28 to 36
   Haemophilus influenzae ATCC 49247
15 to 23

Amoxicillin and clavulanate potassium tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets should be taken at the start of a meal.

The number of bacteriologically evaluable patients was comparable between the 2 dosing regimens. Amoxicillin and clavulanate potassium produced comparable bacteriological success rates in patients assessed 2 to 4 days immediately following end of therapy. The bacteriologic efficacy rates were comparable at 1 of the follow-up visits (5 to 9 days post-therapy) and at a late post-therapy visit (in the majority of cases, this was 2 to 4 weeks post-therapy), as seen in the table below: 

875 mg/125 mg q 12 h 500 mg/125 mg q 8 h
   Pyelonephritis
   173 patients
   188 patients
   Complicated UTI
   135 patients
   133 patients
   Total patients
   308
   321
  875 mg/125 mg q 12 h 500 mg/125 mg q 8 h
   2 to 4 days
   81%, n = 58
   80%, n = 54
   5 to 9 days
   58.5%, n = 41
   51.9%, n = 52
   2 to 4 weeks
   52.5%, n = 101
   54.8%, n = 104

 

IMAGE amoxiclav-fig1.jpgIMAGE amoxiclav-fig2.jpgIMAGE amoxiclav-fig3.jpg

Manufacturer

NorthStar Rx LLC

Active Ingredients

Source

Clinical Trials [400 Associated Clinical Trials listed on BioPortfolio]

Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media

To evaluate the safety profile of amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3...

Phase 2a Study Early Bactericidal Activity of Rifampin + Meropenem + Amoxicillin/Clavulanate in Adults With Pulmonary TB

The overall goal of this exploratory proof-of-concept study is to determine whether, in participants with pulmonary tuberculosis caused by M. tuberculosis (MTB) with or without rifampin re...

Pharmacokinetic Profiles Of Amoxicillin 2000 mg And Clavulanate 125 mg In Adolescent Patients

Clinical research study to test amoxicillin and clavulanate tablet formulation for use in Acute Bacterial Sinusitis (ABS) in adolescent patients weighing at least 40 kilogram (kg) and no m...

An Oral Amoxicillin-Clavulanate Regimen to Prevent Bacteremia Following Dental Procedures

Although controversy exists regarding the efficacy of antibiotic prophylaxis for patients at risk of infective endocarditis, expert committees continue to publish recommendations for antib...

600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fed Conditions

The purpose of this study is to assess the bioequivalence between Amoxicillin/Clavulanate Potassium Oral Suspension 600/42.9 mg/5 mL and Augmentin ES-600 Oral Suspension, 600/42.9 mg/5 mL ...

PubMed Articles [654 Associated PubMed Articles listed on BioPortfolio]

Poor efficacy of preemptive amoxicillin clavulanate for preventing secondary infection from Bothrops snakebites in the Brazilian Amazon: A randomized controlled clinical trial.

Secondary bacterial infections from snakebites contribute to the high complication rates that can lead to permanent function loss and disabilities. Although common in endemic areas, routine empirical ...

Quality Attributes and In Vitro Bioequivalence of Different Brands of Amoxicillin Trihydrate Tablets.

Bacterial resistance and antibiotic drug effectiveness can be related to administering generic products with a subtherapeutic dose or poor in vivo drug release. The aim of this study was to investigat...

If You Give Amoxicillin/Clavulanate to Six- to 23-Month-Olds with AOM, 10 Days Is Preferable to Five days.

Pharmacokinetics and relative bioavailability of an oral amoxicillin-apramycin combination in pigs.

A new compound granular premix of amoxicillin (20% w/w dry mass)/apramycin (5% w/w dry mass) was developed, and its pharmacokinetics and relative bioavailability were determined in pigs following oral...

Impact of amoxicillin resistance on the efficacy of amoxicillin-containing regimens for Helicobacter pylori eradication: analysis of five randomized trials.

The impact of amoxicillin resistance on the efficacy of regimens containing amoxicillin for Helicobacter pylori eradication remains unknown.

Quick Search
Advertisement
 

Drugs and Medication Quicklinks


Searches Linking to this Drug Record