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Amoxicillin Tablets, USP | Amoxicillin [RedPharm Drug Inc.] | BioPortfolio

12:18 EST 27th January 2019 | 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.
* Administered at the start of a light meal.
Mean values of 24 normal volunteers. Peak concentrations occurred approximately 1 hour after the dose.
Dose*
   AUC0-∞ (mcg•hr/mL)
   Cmax (mcg/mL)†   
   Amoxicillin
Amoxicillin
(±S.D.)
Amoxicillin
(±S.D.)
   400 mg (5 mL of suspension)    
17.1 (3.1)
5.92 (1.62)
   400 mg (1 chewable tablet)    
17.9 (2.4)
5.18 (1.64)
   MIC (mcg/mL)   
Interpretation
≤8
   Susceptible (S)   
≥16
   Resistant (R)   
   MIC (mcg/mL)   
   Interpretation   
≤0.25
   Susceptible (S)   
≥0.5
   Resistant (R)   
   MIC (mcg/mL)   
   Interpretation   
≤0.25
   Susceptible (S)   
0.5 to 4
   Intermediate (I)   
≥8
   Resistant (R)   
   MIC (mcg/mL)   
   Interpretation   
≤2
   Susceptible (S)
4
   Intermediate (I)   
≥8
   Resistant (R)   
   MIC (mcg/mL)   
   Interpretation   
≤8
   Susceptible (S)   
16
   Intermediate (I)   
≥32
   Resistant (R)   
   MIC (mcg/mL)   
   Interpretation   
≤1
   Susceptible (S)   
2
   Intermediate (I)   
≥4
   Resistant (R)   
Microorganism
   MIC Range (mcg/mL)   
   E. coli                        ATCC 25922   
2 to 8
   E. faecalis                 ATCC 29212
0.5 to 2
   H. influenzae            ATCC 49247d   
2 to 8
   S. aureus                   ATCC 29213   
0.25 to 1
Microorganism
   MIC Range (mcg/mL)   
   S. pneumoniae         ATCC 49619e   
0.03 to 0.12
   Zone Diameter (mm)   
   Interpretation   
≥17
   Susceptible(S)   
≤16
   Resistant (R)   
   Zone Diameter (mm)   
   Interpretation   
≥29
   Susceptible (S)   
≤28
   Resistant (R)   
   Zone Diameter (mm)   
   Interpretation   
≥26
   Susceptible (S)   
19 to 25
   Intermediate (I)   
≤18
   Resistant  (R)   
   Zone Diameter (mm)   
   Interpretation   
≥17
   Susceptible  (S)   
14 to 16
   Intermediate (I)   
≤13
   Resistant (R)   
   Zone Diameter (mm)   
   Interpretation   
≥22
   Susceptible (S)   
19 to 21
   Intermediate (I)   
≤18
   Resistant (R)   
Microorganism
Zone Diameter (mm)
                        E. coli                     ATCC 25922 
16 to 22
                        H. influenzae          ATCC 49247h   
13 to 21
                        S. aureus                ATCC 25923 
27 to 35
Microorganism
  Zone Diameter (mm) 
                      S. pneumoniae          ATCC 49619
8 to 12
* Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.
†  The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
‡  Each strength of the suspension of amoxicillin is available as a chewable tablet for use by older children.
Infection
Severity*
Usual Adult Dose
Usual Dose for Children
   >3 Months†‡
   Ear/Nose/Throat
   Mild/Moderate
   500 mg every 12 hours
   or
   250 mg every 8 hours
   25 mg/kg/day in divided
   doses every 12 hours
   or
   20 mg/kg/day in divided
   doses every 8 hours
   Severe
   875 mg every 12 hours 
   or
   500 mg every 8 hours
   45 mg/kg/day in divided
   doses every 12 hours
   or
   40 mg/kg/day in divided
   doses every 8 hours
   Lower Respiratory Tract   
   Mild/Moderate 
   or Severe  
   875 mg every 12 hours 
   or
   500 mg every 8 hours
   45 mg/kg/day in divided
   doses every 12 hours
   or
   40 mg/kg/day in divided
   doses every 8 hours
   Skin/Skin Structure
   Mild/Moderate
   500 mg every 12 hours 
   or
   250 mg every 8 hours
   25 mg/kg/day in divided
   doses every 12 hours
   or
   20 mg/kg/day in divided
   doses every 8 hours
   Severe
   875 mg every 12 hours 
   or
   500 mg every 8 hours
   45 mg/kg/day in divided
   doses every 12 hours
   or
   40 mg/kg/day in divided
   doses every 8 hours
   Genitourinary Tract    
   Mild/Moderate
   500 mg every 12 hours 
   or
   250 mg every 8 hours
   25 mg/kg/day in divided
   doses every 12 hours
   or
   20 mg/kg/day in divided
   doses every 8 hours
   Severe
   875 mg every 12 hours 
   or
   500 mg every 8 hours
   45 mg/kg/day in divided
   doses every 12 hours
   or
   40 mg/kg/day in divided
   doses every 8 hours
   Gonorrhea Acute,
   uncomplicated
   ano-genital and
   urethral infections
   in males and females

 
   3 grams as single oral 
   dose   
   Prepubertal children:
   50 mg/kg amoxicillin,    
   combined with 25 mg/kg   
   probenecid as a single   
   dose.
   NOTE: SINCE
   PROBENECID IS
   CONTRAINDICATED
   IN CHILDREN UNDER   
   2 YEARS, DO NOT USE   
   THIS REGIMEN IN
   THESE CASES.
H. pylori Eradication Rates – Triple Therapy (amoxicillin/clarithromycin/lansoprazole) Percent of Patients Cured [95% Confidence Interval] (Number of Patients)
* This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest®, (Delta West Ltd., Bentley, Australia), histology, and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy.
Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy.
(p<0.05) versus lansoprazole/amoxicillin and lansoprazole/clarithromycin dual therapy.
§ (p<0.05) versus clarithromycin/amoxicillin dual therapy.
Study
Triple Therapy
Triple Therapy
Evaluable Analysis*
Intent-to-Treat Analysis
Study 1
92
[80 - 97.7]
(n = 48)
86
[73.3 - 93.5]
(n = 55)
Study 2
86§
[75.7 - 93.6]
(n = 66)
83§
[72 - 90.8]
(n = 70)
H. pylori Eradication Rates – Dual Therapy (amoxicillin/lansoprazole) Percent of Patients Cured [95% Confidence Interval] (Number of Patients)
* This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest®, histology, and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy.
Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy.
(p<0.05) versus lansoprazole alone.
§ (p<0.05) versus lansoprazole alone or amoxicillin alone.
Study
Dual Therapy
Dual Therapy
Evaluable Analysis*
Intent-to-Treat Analysis
Study 1
77
[62.5 - 87.2]
(n = 51)
70
[56.8 - 81.2]
(n = 60)
Study 2
66§
[51.9 - 77.5]
(n = 58)
61§
[48.5 - 72.9]
(n = 67)

Manufacturer

RedPharm Drug Inc.

Active Ingredients

Source

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