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| Amoxicillin and Clavulanate Potassium

04:40 EDT 27th August 2014 | BioPortfolio

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IMAGE amoxiclav-str1.jpgIMAGE amoxiclav-str2.jpg
Dose* AUC0-∞ (mcg•hr/mL) Cmax (mcg/mL)
(amoxicillin and clavulanate
potassium)
amoxicillin
(±S.D.)
clavulanate
potassium
(±S.D.)
amoxicillin
(±S.D.)
clavulanate
potassium
(±S.D.)
* Administered at the start of a light meal.
Mean values of 28 normal volunteers. Peak concentrations occurred approximately 1 hour after the dose.
   400 mg/57 mg
   (5 mL of suspension)
17.29 ± 2.28
2.34 ± 0.94
6.94 ± 1.24
1.1 ± 0.42
   400 mg/57 mg
   (1 chewable tablet)
17.24 ± 2.64
2.17 ± 0.73
6.67 ± 1.37
1.03 ± 0.33
 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)
 Microorganism
 MIC Range (mcg/mL) ‡‡ 
   E. coli ATCC 25922
2 to 8
   E. coli ATCC 35218
4 to 16
   H. influenzae ATCC 49247
2 to 16
   S. aureus ATCC 29213
0.12 to 0.5
   S. 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) 
   E. coli ATCC 25922
18 to 24 mm
   E. coli ATCC 35218
17 to 22 mm
   S. aureus ATCC 25923 
28 to 36 mm
   H. influenza ATCC 49247 15 to 23 mm
INFECTIONS DOSING REGIMEN
q 12 h* q 8 h
* The q 12 h regimen is recommended as it is associated with significantly less diarrhea. (See CLINICAL STUDIES .) However, the q 12 h formulations (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics.
Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.
Duration of therapy studied and recommended for acute otitis media is 10 days.
 
200 mg/28.5 mg per 5 mL
or
400 mg/57 mg per 5 mL
oral suspension
125 mg/31.25 mg per 5 mL
or
250 mg/62.5 mg per 5 mL
oral suspension
   Otitis media, sinusitis, lower respiratory tract infections,
   and more severe infections
45 mg/kg/day q 12 h
40 mg/kg/day q 8 h
   Less severe infections
25 mg/kg/day q 12 h
20 mg/kg/day q 8 h
Amoxicillin and Clavulanate Potassium
200 mg/28.5 mg per 5 mL Suspension
Bottle Size Amount of Water
Required for Suspension
50 mL
52 mL
75 mL
73 mL
100 mL
98 mL
Amoxicillin and Clavulanate Potassium
400 mg/57 mg per 5 mL Suspension
Bottle Size Amount of Water
Required for Suspension
50 mL
49 mL
75 mL
70 mL
100 mL
94 mL
IMAGE amoxiclav-fig1.jpgIMAGE amoxiclav-fig2.jpg

Manufacturer

NorthStar Rx LLC

Active Ingredients

Source

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