Amoxicillin description, usages, side effects, indications, overdosage, supplying and lots more!

Amoxicillin

H.J. Harkins Company, Inc.

Amoxicillin Capsules, USP

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION


DESCRIPTION


SRRRp
DESCRIPTION
1619352





CLINICAL PHARMACOLOGY






0-∞max




* 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)

Microbiology


in vitro INDICATIONS AND USAGE

Aerobic Gram-Positive Microorganisms


Enterococcus faecalis
Staphylococcus
Streptococcus pneumoniae
Streptococcus

Aerobic Gram-Negative Microorganisms


Escherichia coli
Haemophilus influenzae
Neisseria gonorrhoeae
Proteus mirabilis

Helicobacter


Helicobacter pylori

Susceptibility Tests

Dilution Techniques

1ampicillinS. pneumoniaeS. pneumoniae



Enterococcus

   MIC (mcg/mL)   
Interpretation
≤8
   Susceptible   (S)   
≥16
   Resistant       (R)   

Staphylococcusa
   MIC (mcg/mL)   
Interpretation
≤0.25
   Susceptible   (S)   
≥0.5
   Resistant       (R)   

Streptococcus S. pneumoniae
   MIC (mcg/mL)   
Interpretation
≤0.25
   Susceptible    (S)   
0.5 to 4
   Intermediate  (I)   
≥8
   Resistant       (R)   

S. pneumoniaeb  

Amoxicillin
   MIC (mcg/mL)   
Interpretation
≤2
   Susceptible     (S)   
4
   Intermediate   (I)   
≥8
   Resistant        (R)   

NOTE:




   MIC (mcg/mL)   
Interpretation
≤8
   Susceptible     (S)   
16
   Intermediate   (I)   
≥32
   Resistant        (R)   

H. influenzaec
   MIC (mcg/mL)   
Interpretation
≤1
   Susceptible    (S)   
2
   Intermediate  (I)   
≥4
   Resistant       (R)   



H. influenzae Haemophilus1



ampicillin
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

amoxicillin
Microorganism
   MIC Range (mcg/mL)   
   S. pneumoniae         ATCC 49619e   
0.03 to 0.12

H. influenzae1
S. pneumoniae
Diffusion Techniques

2S. pneumoniaeampicillin





Enterococcus
   Zone Diameter (mm)   
Interpretation
≥17
   Susceptible   (S)   
≤16
   Resistant       (R)   

Staphylococcusf
   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)   

NOTE:Spneumoniae

S. pneumoniae


S. pneumoniae
S. pneumoniae



Enterobacteriaceae
   Zone Diameter (mm)   
Interpretation
≥17
   Susceptible     (S)   
14 to 16
   Intermediate   (I)   
≤13
   Resistant        (R)   

H. influenzaeg
   Zone Diameter (mm)   
Interpretation
≥22
   Susceptible      (S)   
19 to 21
   Intermediate    (I)   
≤18
   Resistant         (R)   


H. influenzaeHaemophilus2



ampicillin
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

oxacillin
Microorganism
   Zone Diameter (mm)   
   S. pneumoniae          ATCC 49619i   
8 to 12

H. influenzae2
S. pneumoniae2

Susceptibility Testing for Helicobacter pylori


In vitroH. pylori

INDICATIONS AND USAGE




Infections of the ear, nose, and throat
StreptococcusS. pneumoniaeStaphylococcusH. influenzae

Infections of the genitourinary tract
E. coli, P. mirabilisE. faecalis

Infections of the skin and skin structure
StreptococcusStaphylococcusE. coli

Infections of the lower respiratory tract
StreptococcusS. pneumoniae, StaphylococcusH. influenzae

Gonorrhea, acute uncomplicated (ano-genital and urethral infections)
N. gonorrhoeae

H. pylori eradication to reduce the risk of duodenal ulcer recurrence

Triple Therapy

Amoxicillin/clarithromycin/lansoprazole

H. pyloriH. pyloriH. pylori CLINICAL STUDIES DOSAGE AND ADMINISTRATION

Dual Therapy

Amoxicillin/lansoprazole

H. pyloriwho are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected.H. pylori CLINICAL STUDIES DOSAGE AND ADMINISTRATION



CONTRAINDICATIONS


WARNINGS


SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.

Clostridium difficile C. difficile.

C. difficile
C. difficile

C. difficileC. difficile

PRECAUTIONS

General






Laboratory Tests




Drug Interactions




in vitro

Drug/Laboratory Test Interactions


®®

Carcinogenesis, Mutagenesis, Impairment Of Fertility


2

Pregnancy

Teratogenic Effects


Labor and Delivery


Nursing Mothers


Pediatric Use


DOSAGE AND ADMINISTRATION: Neonates and Infants

Geriatric Use




Information for Patients






ADVERSE REACTIONS




Infections and Infestations




Gastrointestinal




WARNINGS

Hypersensitivity Reactions


WARNINGS



NOTE: 


Liver




Renal


OVERDOSAGE

Hemic and Lymphatic Systems




Central Nervous System




Miscellaneous


Combination Therapy with Clarithromycin and Lansoprazole


Triple Therapy

Amoxicillin/Clarithromycin/Lansoprazole

Dual Therapy

Amoxicillin/Lansoprazole



OVERDOSAGE


3





DOSAGE AND ADMINISTRATION


Neonates and Infants Aged ≤12 Weeks (≤3 Months)


Adults and Pediatric Patients >3 Months


* 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.


PRECAUTIONS: Laboratory Tests

General


Streptococcus pyogenes

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple Therapy

Amoxicillin/clarithromycin/lansoprazole

INDICATIONS AND USAGE

Dual Therapy

Amoxicillin/lansoprazole

INDICATIONS AND USAGE

Dosing Recommendations for Adults with Impaired Renal Function






There are currently no dosing recommendations for pediatric patients with impaired renal function.

HOW SUPPLIED


Amoxicillin Capsules, USP

                                                   250 mg Capsule










                                                   500 mg Capsule










Store at


CLINICAL STUDIES

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence


H. pyloriH. pylori

Triple Therapy


Dual Therapy




H. pylori

H. pylori
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)

REFERENCES


  • National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically – Fourth Edition; Approved Standard NCCLS Document M7-A4, Vol. 17, No. 2. NCCLS, Wayne, PA, January 1997.
  • National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests – Sixth Edition; Approved Standard NCCLS Document M2-A6, Vol. 17, No. 1. NCCLS, Wayne, PA, January 1997.
  • Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children less than six years of age. Vet Hum Toxicol. 1988;30:66-67.     







Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited



H.J. Harkins Company, Inc.


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg (20 Capsule Bottle)


NDC 65862-016-20
Amoxicillin Capsules, USP
250 mg
Rx only           20 Capsules
AUROBINDO
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg (20 Capsule Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg (20 Capsule Bottle)


NDC 65862-017-20
Amoxicillin Capsules, USP
500 mg
Rx only           20 Capsules
AUROBINDO
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg (20 Capsule Bottle)

Amoxicillin

Amoxicillin CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52959-011(NDC:65862-016)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AMOXICILLIN amoxicillin anhydrous 250 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
MAGNESIUM STEARATE
titanium dioxide
SODIUM LAURYL SULFATE

Product Characteristics

Color Size Imprint Code Shape
PINK 19 mm A44 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52959-011-20 20 in 1 BOTTLE
2 NDC:52959-011-21 21 in 1 BOTTLE
3 NDC:52959-011-24 24 in 1 BOTTLE
4 NDC:52959-011-30 30 in 1 BOTTLE
5 NDC:52959-011-40 40 in 1 BOTTLE
6 NDC:52959-011-60 60 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065271 2005-09-11


Amoxicillin

Amoxicillin CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52959-020(NDC:65862-017)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AMOXICILLIN amoxicillin anhydrous 500 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
MAGNESIUM STEARATE
titanium dioxide
SODIUM LAURYL SULFATE

Product Characteristics

Color Size Imprint Code Shape
PINK 23 mm A45 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52959-020-04 4 in 1 BOTTLE
2 NDC:52959-020-05 5 in 1 BOTTLE
3 NDC:52959-020-06 6 in 1 BOTTLE
4 NDC:52959-020-18 18 in 1 BOTTLE
5 NDC:52959-020-20 20 in 1 BOTTLE
6 NDC:52959-020-21 21 in 1 BOTTLE
7 NDC:52959-020-24 24 in 1 BOTTLE
8 NDC:52959-020-28 28 in 1 BOTTLE
9 NDC:52959-020-30 30 in 1 BOTTLE
10 NDC:52959-020-40 40 in 1 BOTTLE
11 NDC:52959-020-42 42 in 1 BOTTLE
12 NDC:52959-020-60 60 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065271 2005-09-11


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