AMOXICILLIN
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amoxicillin powder, for suspension
Aurobindo Pharma Limited
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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 for oral suspension, 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. |
Strength | Bottle Size | Amount of Water
Required for Reconstitution |
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Oral Suspension 200 mg/5 mL | 50 mL | 35 mL |
75 mL | 52 mL |
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100 mL | 69 mL |
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Oral Suspension 400 mg/5 mL | 50 mL | 35 mL |
75 mL | 52 mL |
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100 mL | 69 mL |
The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients.
Oral ampicillin is poorly absorbed during labor. It is not known whether use of amoxicillin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention.
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# | MICRange (mcg/mL) | DiskDiffusionZoneRange (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 |
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 powder, for suspension |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA065334 | 12/28/2006 |
AMOXICILLIN
amoxicillin powder, for suspension |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA065334 | 12/28/2006 |
Labeler - Aurobindo Pharma Limited (650082092) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Aurobindo Pharma Limited | 918917683 | MANUFACTURE, MANUFACTURE, ANALYSIS, ANALYSIS |
Revised: 05/2012 Aurobindo Pharma Limited