amoxicillin (Amoxicillincapsule 
[Aurobindo Pharma Limited]

Rx only


DESCRIPTION


S R R R p
Image from Drug Label Content

16 19 3 5 2





CLINICAL PHARMACOLOGY






Microbiology


in vitro INDICATIONS AND USAGE


 
Enterococcus faecalis
Staphylococcus
Streptococcus pneumoniae
Streptococcus






Escherichia coli

Haemophilus influenzae
Neisseria gonorrhoeae
Proteus mirabilis


 
Helicobacter pylori



Dilution Techniques

1 ampicillin S. pneumoniae S. 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. pneumoniae

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. influenzae c  

        MIC (mcg/mL)             

       Interpretation      

≤1

      Susceptible (S)   

2

      Intermediate (I)

≥4

      Resistant (R)




H. influenzae Haemophilus 1



ampicillin

                  Microorganism                      

         MIC Range mcg/mL)          

      E. coli                        ATCC 25922

2 to 8

      E. faecalis                 ATCC 29212

0.5 to 2

      H. influenzae             ATCC 49247

2 to 8

      S. aureus                   ATCC 29213

0.25 to 1

amoxicillin

                 Microorganism                         

         MIC Range (mcg/mL)        

      S. pneumoniae           ATCC 49619

0.03 to 0.12

H. influenzae 1
S. pneumoniae


Diffusion Techniques
 
2 S. pneumoniae ampicillin





Enterococcus


      Zone Diameter (mm)      

        Interpretation            

≥17

        Susceptible (S)

≤16

        Resistant (R)
Staphylococcus f

      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: S pneumoniae

S. pneumoniae

S. pneumoniae S. pneumoniae





      Zone Diameter (mm)      

      Interpretation         

≥17

      Susceptible (S)

14 to 16

      Intermediate (I)

≤13

      Resistant (R)
H. influenzae g

      Zone Diameter (mm)      

      Interpretation         

≥22

      Susceptible (S)

19 to 21

      Intermediate (I)

≤18

      Resistant (R)


H. influenzae Haemophilus
2



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. influenzae 2
S. pneumoniae
2

Helicobacter pylori

In vitro H. pylori

INDICATIONS AND USAGE




Infections of the ear, nose, and throat
Streptococcus S. pneumoniae Staphylococcus H. influenzae

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

Infections of the skin and skin structure
Streptococcus Staphylococcus E. coli

Infections of the lower respiratory tract
Streptococcus S. pneumoniae, Staphylococcus H. influenzae

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

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



Amoxicillin/clarithromycin/lansoprazole


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



Amoxicillin/lansoprazole


H. pylori who 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. difficile C. difficile

PRECAUTIONS

General






Laboratory Tests




Drug Interactions




in vitro

Drug/Laboratory Test Interactions


® ®

Carcinogenesis, Mutagenesis, Impairment of Fertility


Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to detect mutagenic potential of amoxicillin alone have not been conducted; however, the following information is available from tests on a 4:1 mixture of amoxicillin and potassium clavulanate (AUGMENTIN). AUGMENTIN was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. AUGMENTIN was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival. AUGMENTIN was negative in the mouse micronucleus test, and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micronucleus test, and was negative in each of these assays. In a multi-generation reproduction study in rats, no impairment of fertility or other adverse reproductive effects were seen at doses up to 500 mg/kg (approximately 3 times the human dose in mg/m2).   

Pregnancy

Teratogenic Effects


Labor and Delivery


Oral ampicillin-class antibiotics are poorly absorbed during labor. Studies in guinea pigs showed that intravenous administration of ampicillin slightly decreased the uterine tone and frequency of contractions but moderately increased the height and duration of contractions. However, it is not known whether use of amoxicillin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.

Nursing Mothers


Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman.

Pediatric Use


Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. Dosing of amoxicillin should be modified in pediatric patients 12 weeks or younger (≤3 months). (See 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





Amoxicillin/Clarithromycin/Lansoprazole
 



 
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.

   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




Amoxicillin/clarithromycin/lansoprazole

INDICATIONS AND USAGE



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. pylori H. pylori


 



 


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



  1. 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.
  2. 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.
  3. 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

Amoxicillin (Amoxicillin)
PRODUCT INFO
Product Code 65862-016 Dosage Form CAPSULE
Route Of Administration ORAL DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
Amoxicillin (Amoxicillin) Active 250 MILLIGRAM  In 1 CAPSULE
Microcrystalline Cellulose Inactive  
D&C Red No. 28 Inactive  
FD&C Blue No. 1 Inactive  
FD&C Red No. 40 Inactive  
Gelatin Inactive  
Magnesium Stearate Inactive  
Titanium Dioxide Inactive  
Sodium Lauryl Sulfate Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color blue, pink Score 1
Shape CAPSULE Symbol false
Imprint Code A44 Coating false
Size 19mm
PACKAGING
# NDC Package Description Multilevel Packaging
1 65862-016-20 20 CAPSULE In 1 BOTTLE None
2 65862-016-01 100 CAPSULE In 1 BOTTLE None
3 65862-016-05 500 CAPSULE In 1 BOTTLE None

Amoxicillin (Amoxicillin)
PRODUCT INFO
Product Code 65862-017 Dosage Form CAPSULE
Route Of Administration ORAL DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
Amoxicillin (Amoxicillin) Active 500 MILLIGRAM  In 1 CAPSULE
Microcrystalline Cellulose Inactive  
D&C Red No. 28 Inactive  
FD&C Blue No. 1 Inactive  
FD&C Red No. 40 Inactive  
Gelatin Inactive  
Magnesium Stearate Inactive  
Titanium Dioxide Inactive  
Sodium Lauryl Sulfate Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color blue, pink Score 1
Shape CAPSULE Symbol false
Imprint Code A45 Coating false
Size 23mm
PACKAGING
# NDC Package Description Multilevel Packaging
1 65862-017-20 20 CAPSULE In 1 BOTTLE None
2 65862-017-01 100 CAPSULE In 1 BOTTLE None
3 65862-017-05 500 CAPSULE In 1 BOTTLE None

Revised: 08/2008 Aurobindo Pharma Limited