Amoxicillin
Amoxicillin Tablets for Oral Suspension, USP
FULL PRESCRIBING INFORMATION: CONTENTS*
- AMOXICILLIN DESCRIPTION
- CLINICAL PHARMACOLOGY
- AMOXICILLIN INDICATIONS AND USAGE
- AMOXICILLIN CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- AMOXICILLIN ADVERSE REACTIONS
- OVERDOSAGE
- AMOXICILLIN DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- CLINICAL STUDIES
- REFERENCES
- Patient Information Sheet
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablet Bottle)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg Bulk Tablet Label
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 400 mg (100 Tablet Bottle)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 400 mg Bulk Tablet Label
FULL PRESCRIBING INFORMATION
AMOXICILLIN DESCRIPTION
SRRRp
1619352
- See PRECAUTIONS
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 (±SD) |
amoxicillin (±SD) |
| 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) |
™
™
|
¶ Dosing was following an overnight fast. †† 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 |
amoxicillin |
| 400 mg (5 mL of suspension) |
18.5 |
8.4 |
| 400 mg (one tablet for oral suspension) |
17.9 |
7.5 |
Microbiology
in vitro INDICATIONS AND USAGE
Aerobic gram-positive microorganisms
Enterococcus faecalis
Staphylococcus †
Streptococcus pneumoniae
Streptococcus
should be considered as resistant to amoxicillin.
Aerobic gram-negative microorganisms:
Escherichia coli
Haemophilus influenzae
Neisseria gonorrhoeae
Proteus mirabilis
Helicobacter
Helicobacter pylori
Susceptibility tests
Dilution techniques
1ampicillinStreptococcus pneumoniaeStreptococcus pneumoniae
For gram-positive aerobes:
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) |
For gram-negative aerobes:
| 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) |
Haemophilus influenzae Haemophilus1
ampicillin
|
Microorganism |
MIC (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
For gram-positive aerobes:
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
For gram-negative aerobes:
| 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 |
S. pneumoniae2
Susceptibility testing for Helicobacter pylori
In vitroH. pylori
AMOXICILLIN INDICATIONS AND USAGE
Infections of the ear, nose, and throatStreptococcus Streptococcus pneumoniaeStaphylococcus H. influenzae
Infections of the genitourinary tractE. coliP. mirabilisE. faecalis
Infections of the skin and skin structureStreptococcus Staphylococcus E. coli
Infections of the lower respiratory tractStreptococcus Streptococcus pneumoniaeStaphylococcus H. 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. pylori H. pyloriH. pylori CLINICAL STUDIES DOSAGE AND ADMINISTRATION
Dual therapy: Amoxicillin/lansoprazole
H. pylori who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. MICROBIOLOGYH. pylori CLINICAL STUDIES DOSAGE AND ADMINISTRATION
AMOXICILLIN 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.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including amoxicillin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
Clostridium difficile
Clostridium difficile
PRECAUTIONS
General
Information for Patients
Phenylketonurics
Laboratory Tests
Drug Interactions
in vitro
Drug/Laboratory Test Interactions
®®
Carcinogenesis, Mutagenesis, Impairment of Fertility
2
Pregnancy
Teratogenic Effects
Pregnancy Category B.
Labor and Delivery
Nursing Mothers
Pediatric Use
DOSAGE AND ADMINISTRATION - Neonates and infants
Geriatric Use
AMOXICILLIN ADVERSE REACTIONS
Gastrointestinal:
WARNINGS
Hypersensitivity Reactions:
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
ADVERSE REACTIONS
OVERDOSAGE
3
AMOXICILLIN DOSAGE AND ADMINISTRATION
Direction for Amoxicillin Tablets for Oral Suspension
Do not chew or swallow the tablets.
ALL RECOMMENDED DOSAGES FOR AMOXICILLIN ARE INCLUDED IN THIS SECTION FOR INFORMATIONAL PURPOSES ONLY. THE 200 mg TABLET FOR ORAL SUSPENSION IS APPROPRIATE ONLY FOR A 200 mg DOSE AND THE 400 mg TABLET FOR ORAL SUSPENSION IS APPROPRIATE ONLY FOR A 400 mg DOSE.
Neonates and infants aged ≤ 12 weeks (≤ 3 months)
Adults and pediatric patients > 3 months
| Infection | Severity‡ | Usual Adult Dose | Usual Dose for Children >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. |
|||
| 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
CONTRAINDICATIONS WARNINGS
Dosing recommendations for adults with impaired renal function:
There are currently no dosing recommendations for pediatric patients with impaired renal function.
HOW SUPPLIED
Amoxicillin Tablets for Oral Suspension, USP
200 mg Tablets for Oral Suspension
400 mg Tablets for Oral Suspension
Store at
CLINICAL STUDIES
H. pylori eradication to reduce the risk of duodenal ulcer recurrence
H. pylori H. pylori
Triple therapy
Dual therapy
H. pylori
H. pylori
| Study | Triple Therapy | Triple Therapy |
|---|---|---|
| Evaluable Analysis† | Intent-to-Treat Analysis‡ | |
|
†analysis was based on evaluable patients with confirmed duodenal ulcer (active or within one year) and H. pylori infection at baseline defined as at least two of three 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 one 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 1 |
92§
[80 to 97.7] (n = 48) |
86§
[73.3 to 93.5] (n = 55) |
| Study 2 |
86¦
[75.7 to 93.6] (n = 66) |
83¦
[72 to 90.8] (n = 70) |
| Study | Dual Therapy | Dual Therapy |
|---|---|---|
| Evaluable Analysis¶ | Intent-to-Treat Analysis†† | |
| ¶ This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within one year) and H. pylori infection at baseline defined as at least two of three 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 1 |
77‡‡
[62.5 to 87.2] (n = 51) |
70‡‡
[56.8 to 81.2] (n = 60) |
| Study 2 |
66§§
[51.9 to 77.5] (n = 58) |
61§§
[48.5 to 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.
Dispermox™ is a registered trademark of Ranbaxy Pharmaceuticals Inc.
Patient Information Sheet
Amoxicillin Tablets for Oral Suspension
PATIENT’S DIRECTIONS FOR USE
- Remove one tablet from the bottle.
- Place the tablet in a small amount of water (approximately 2 teaspoonfuls).
- Swirl or stir until thoroughly mixed.
- Drink the mixture immediately after mixing. (The mixture is pink colored and has a strawberry flavor.)
- Be sure to drink the entire mixture.
- Rinse the container with an additional small amount of water and drink the contents to assure the whole dose is taken.
DO NOT CHEW or SWALLOW the amoxicillin tablets for oral suspension whole.
Aurobindo Pharma USA, Inc.
Aurobindo Pharma Limited
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablet Bottle)
NDC 65862-065-01
Amoxicillin Tablets for
Oral Suspension, USP
200 mg
MIX TABLET FOR ORAL SUSPENSION
IN WATER BEFORE INGESTION
Rx only 100 Tablets
AUROBINDO
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg Bulk Tablet Label
2000 Tablets
BULK SHIPMENT
PLEASE HANDLE CAREFULLY
Rx only
Amoxicillin Tablets for Oral Suspension, USP 200 mg
Each tablet for oral suspension contains:
CAUTION:
Store at
Aurobindo Pharma Limited
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 400 mg (100 Tablet Bottle)
NDC 65862-066-01
Amoxicillin Tablets for
Oral Suspension, USP
400 mg
MIX TABLET FOR ORAL SUSPENSION
IN WATER BEFORE INGESTION
Rx only 100 Tablets
AUROBINDO
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 400 mg Bulk Tablet Label
1200 Tablets
BULK SHIPMENT
PLEASE HANDLE CAREFULLY
Rx only
Amoxicillin Tablets for Oral Suspension, USP 400 mg
Each tablet for oral suspension contains:
CAUTION:
Store at
Aurobindo Pharma Limited
AmoxicillinAmoxicillin TABLET, FOR SUSPENSION
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AmoxicillinAmoxicillin TABLET, FOR SUSPENSION
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
