Amoxicillin for Oral Suspension, USP
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
DESCRIPTION
CLINICAL PHARMACOLOGY
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
Staphylococcusf
β-hemolytic streptococci
H. influenzaeg
Using 1 mcg oxacillin disk:
| 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
Information for Patients
Laboratory Tests
Drug Interactions
Drug/Laboratory Test Interactions
Carcinogenesis, Mutagenesis, Impairment of Fertility
Pregnancy
Teratogenic Effects
Labor and Delivery
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
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
Directions for Mixing Oral Suspension
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.