| Amoxicillin and Clavulanate Potassium
| 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 |
Manufacturer
NorthStar Rx LLC
Active Ingredients
Source
- U.S. National Library of Medicine
- DailyMed
- Last Updated: 18 May 2013
Drugs and Medications
Amoxicillin and clavulanate potassium [Aurobindo Pharma Limited]
Amoxicillin and Clavulanate Potassium Tablets, USP
Amoxicillin and clavulanate potassium [Aurobindo Pharma Limited]
Amoxicillin and clavulanate potassium [NorthStar Rx LLC]
Amoxicillin and clavulanate potassium [Aurobindo Pharma Limited]
Clinical Trials
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...
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...
The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an antibiotic, compared with amoxicillin/clavulanate potassium in the treatment of adults with rapid...
Acupuncture and Herbal Treatment of Chronic HIV Sinusitis
To compare Traditional Chinese Medicine versus standard antibiotic therapy consisting of pseudoephedrine ( Sudafed ) plus amoxicillin / clavulanate potassium combination ( Augmentin ) in r...
Amoxicillin Clavulanate in Treatment of Acute Otitis Media
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...
PubMed Articles
Systemic drug-related intertriginous and flexural exanthema (SDRIFE), also known as Baboon syndrome, is an uncommon, cutaneous reaction that occurs after the systemic administration of drug-relate...
INTRODUCTION|: Antibiotic treatment failure contributes to the economic and humanistic burdens of community-acquired pneumonia (CAP) by increasing morbidity, mortality, and healthcare costs. This stud...
Bacterial etiology and serotypes of acute otitis media in Mexican children.
Streptococcus pneumoniae and Haemophilus influenzae have been consistently reported to be the two major bacterial pathogens responsible for acute otitis media (AOM), mainly from studies in the US and...
Cholestatic hepatitis related to amoxicillin.
While it is well recognized that the combination of amoxicillin and clavulanic acid has been associated with hepatic adverse events, there are only a few reports about amoxicillin alone causing hepati...
