AMOXICILLIN by is a Prescription medication manufactured, distributed, or labeled by STAT Rx USA LLC, PSS World Medical Inc.. Drug facts, warnings, and ingredients follow.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules, USP and other antibacterial drugs, amoxicillin capsules, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 5/2012
Infection | Severitya | Usual Adult Dose | Usual Dose for Children > 3 Monthsb |
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a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. b 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. |
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Ear/Nose/Throat Skin/Skin Structure 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 |
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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 |
Gonorrhea Acute, uncomplicated ano -genital and urethral infections in males and females | | 3 grams as single oral dose | Prepubertal children: 50 mg/kg amoxicillin capsules, 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 children under 2 years of age. |
Dose * | AUC0-∞ (mcg●hr/mL) | Cmax (mcg/mL)† |
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* Administered at the start of a light meal. † Mean values of 24 normal volunteers. Peak concentrations occurred approximately 1 hour after the dose. |
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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) |
Gram-Positive Bacteria
| Gram-Negative Bacteria
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Enterococcus faecalis
Staphylococcus spp. Streptococcus pneumoniae Alpha and β-hemolytic streptococci. | Escherichia coli
Haemophilus influenzae Neisseria gonorrhoeae Proteus mirabilis Helicobacter pylori |
Minimum Inhibitory Concentration (mcg/mL) | Disk Diffusion (zone diameter in mm) |
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Susceptible | Intermediate | Resistant | Susceptible | Intermediate | Resistant | |
* S. pneumoniae should be tested using a 1 mcg oxacillin disk. Isolates with oxacillin zone sizes of ≥ 20 mm are susceptible to amoxicillin. An amoxicillin MIC should be determined on isolates of S. pneumoniae with oxacillin zone sizes of ≤ 19 mm. **A positive beta lactamase test indicates resistance to amoxicillin. Isolates that are resistant to penicillin by MIC testing are also expected to be resistant to amoxicillin. |
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Enterococcus spp. | ≤ 8 | - | ≥ 16 | ≥ 17 | - | ≤ 16 |
Staphylococcus spp. | ≤ 0.25 | ≥ 0.5 | ≥ 29 | ≤ 28 |
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Streptococci, viridians group (alpha-hemolytic streptococci) | ≤ 0.25 | 0.5 to 4 | ≥ 8 | - | - | - |
β-hemolytic streptococci | ≤ 0.25 | - | - | ≥ 24 | - | - |
Streptococcus pneumoniae
(non-meningitis isolates)* | ≤ 2 | 4 | ≥ 8 | - | - | - |
Enterobacteriaceae
| ≤ 8 | 16 | ≥ 32 | ≥ 17 | 14 to 16 | ≤ 13 |
Haemophilus influenzae
| ≤ 1 | 2 | ≥ 4 | ≥ 22 | 19 to 21 | ≤ 18 |
Neisseria gonorrhoeae**
| - | - | - | - | - | - |
Bacteria | ATCC# | MIC Range (mcg/mL) | Disk Diffusion Zone Range (mm) |
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# ATCC = American Type Culture Collection |
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Escherichia coli
| 25922 | 2 to 8 | 16 to 22 |
Enterococcus faecalis
| 29212 | 0.5 to 2 | |
Haemophilus influenzae
| 49247 | 2 to 8 | 13 to 21 |
Staphylococcus aureus
| 29213 | 0.5 to 2 | |
25923 | 27 to 35 |
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Streptococcus pneumoniae
| 49619 | 0.06 to 0.25 |
Susceptibility Testing for Helicobacter pylori: Amoxicillin in vitro susceptibility testing methods for determining minimum inhibitory concentrations (MICs) and zone sizes have not been standardized, validated, or approved for testing H. pylori. Specimens for H. pylori and clarithromycin susceptibility test results should be obtained on isolates from patients who fail triple therapy. If clarithromycin resistance is found, a non-clarithromycin-containing regimen should be used.
Study | Triple Therapy | Triple Therapy |
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Evaluable Analysisa
[95% Confidence Interval] (number of patients) | Intent-to-Treat Analysisb
[95% Confidence Interval] (number of patients) |
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a 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. b 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. |
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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 |
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Evaluable Analysisa
[95% Confidence Interval] (number of patients) | Intent-to-Treat Analysisb
[95% Confidence Interval] (number of patients) |
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a 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. b 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. |
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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) |
AMOXICILLIN
amoxicillin capsule |
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AMOXICILLIN
amoxicillin capsule |
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Labeler - STAT Rx USA LLC (786036330) |
Registrant - PSS World Medical Inc. (101822682) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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STAT Rx USA LLC | 786036330 | relabel, repack |