Amoxicillin
Rx only
DESCRIPTION
CLINICAL PHARMACOLOGY
Microbiology
Staphylococcusa
| 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 |
| 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 |
INDICATIONS AND USAGE
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
Pediatric Use
Geriatric Use
ADVERSE REACTIONS
OVERDOSAGE
DOSAGE AND ADMINISTRATION
| 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. |
HOW SUPPLIED
Amoxicillin for Oral Suspension, USP: Each 5 mL of reconstituted bubble-gum-flavored pink suspension contains 200 or 400 mg amoxicillin as the trihydrate.
Amoxicillin is supplied as follows:
Store dry powder at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
| 55045-2992-2 | 400 mg/5 mL | 100 mL |
CLINICAL STUDIES
| 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
CLINITEST is a registered trademark of Miles, Inc.CLINISTIX is a registered trademark of Bayer Corporation.CLOtest is a registered trademark of Kimberly-Clark Corporation.
- 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.
Manufacturer Information
Manufactured By:
Aurobindo Pharma LimitedHyderabad-500 072, IndiaManufactured for:Aurobindo Pharma USA, Inc.2400 Route 130 NorthDayton, NJ 08810
As NDC:
65862-0071-01 For 55045-2992-2 Amoxicillin 400 mg
Repackaged By:
Dispensing Solutions Inc.
3000 West Warner Ave
Santa Ana, CA 92704
United States