Amoxicillin Tablets, USP
DESCRIPTION
CLINICAL PHARMACOLOGY
| 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
Aerobic Gram-Positive Microorganisms
Aerobic Gram-Negative Microorganisms
Helicobacter
Susceptibility Tests
Dilution Techniques
| 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 |
Diffusion Techniques
| 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 49619i | 8 to 12 |
Susceptibility Testing for Helicobacter pylori
INDICATIONS AND USAGE
H. pylori eradication to reduce the risk of duodenal ulcer recurrence
Triple Therapy
Amoxicillin/clarithromycin/lansoprazole
Dual Therapy
Amoxicillin/lansoprazole
CONTRAINDICATIONS
WARNINGS
PRECAUTIONS
General
Laboratory Tests
Drug Interactions
Drug/Laboratory Test Interactions
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Pregnancy
Teratogenic Effects
Labor and Delivery
Nursing Mothers
Pediatric Use
Geriatric Use
Information for Patients
ADVERSE REACTIONS
Combination Therapy with Clarithromycin and Lansoprazole
Triple Therapy
Amoxicillin/Clarithromycin/Lansoprazole
Dual Therapy
Amoxicillin/Lansoprazole
OVERDOSAGE
DOSAGE AND ADMINISTRATION
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†‡ |
| 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. |
General
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy
Amoxicillin/clarithromycin/lansoprazole
Dual Therapy
Amoxicillin/lansoprazole
Dosing Recommendations for Adults with Impaired Renal Function
HOW SUPPLIED
CLINICAL STUDIES
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy
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) |
| 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.