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| Amoxicillin and Clavulanate Potassium

12:56 EDT 24th July 2014 | BioPortfolio
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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

 

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Manufacturer

NorthStar Rx LLC

Active Ingredients

Source

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