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Clinical Pharmacology
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Clinical Pharmacology

f. Staphylococci which are susceptible to amoxicillin but resistant to methicillin/oxacillin should be considered as resistant to amoxicillin.
g. These interpretive standards are applicable only to disk diffusion susceptibility tests with H. influenzae using Haemophilus Test Medium (HTM).2

Interpretation should be as stated above for results using dilution techniques.

As with standard dilution techniques, disk diffusion susceptibility test procedures require the use of laboratory control microorganisms. The 10-mcg ampicillin disk should provide the following zone diameters in these laboratory test quality control strains:

  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

Using 1-mcg oxacillin disk:

  Microorganism Zone Diameter (mm)
S. pneumoniae ATCC 49619I 8 to 12

h. This quality control range is applicable to only H. influenzae ATCC 49247 tested by a disk diffusion procedure using HTM.2
i. This quality control range is applicable to only S. pneumoniae ATCC 49619 tested by a disk diffusion procedure using Mueller-Hinton agar supplemented with 5% sheep blood and incubated in 5% CO2.

Susceptibility Testing for Helicobacter pylori

In vitro susceptibility testing methods and diagnostic products currently available for determining minimum inhibitory concentrations (MICs) and zone sizes have not been standardized, validated, or approved for testing H. pylori microorganisms.

Culture and susceptibility testing should be obtained in patients who fail triple therapy. If clarithromycin resistance is found, a non-clarithromycin-containing regimen should be used.

Clinical Studies

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence: Randomized, double-blind clinical studies performed in the United States in patients with H. pylori and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within 1 year) evaluated the efficacy of lansoprazole in combination with amoxicillin capsules and clarithromycin tablets as triple 14-day therapy, or in combination with amoxicillin capsules as dual 14-day therapy, for the eradication of H. pylori. Based on the results of these studies, the safety and efficacy of 2 different eradication regimens were established:

Triple Therapy: Amoxicillin 1 gram twice daily/clarithromycin 500 mg twice daily/lansoprazole 30 mg twice daily.

Dual Therapy: Amoxicillin 1 gram three times daily/lansoprazole 30 mg three times daily.

All treatments were for 14 days. H. pylori eradication was defined as 2 negative tests (culture and histology) at 4 to 6 weeks following the end of treatment.

Triple therapy was shown to be more effective than all possible dual therapy combinations. Dual therapy was shown to be more effective than both monotherapies. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

H. pylori Eradication Rates – Triple Therapy (amoxicillin/clarithromycin/lansoprazole) Percent of Patients Cured [95% Confidence Interval] (Number of Patients)

Study Triple Therapy Triple Therapy
  Evaluable Analysis* Intent-to-Treat Analysis†
Study 1 92‡ 86‡
[80.0 - 97.7] [73.3 - 93.5]
(n = 48) (n = 55)
Study 2 86§ 83§
[75.7 - 93.6] [72.0 - 90.8]
(n = 66) (n = 70)
* 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®, (Delta West Ltd., Bentley, Australia), 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.
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.
‡ (p<0.05) versus lansoprazole/amoxicillin and lansoprazole/clarithromycin dual therapy.
§(p<0.05) versus clarithromycin/amoxicillin dual therapy.
Brand Name: Amoxil
Generic Name: Amoxicillin
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