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Aciphex
Clinical Pharmacology
Aciphex
Studies in humans for up to one year have not revealed clinically significant effects on the endocrine system. In healthy male volunteers treated with ACIPHEX® for 13 days, no clinically relevant changes have been detected in the following endocrine parameters examined: 17 β-estradiol, thyroid stimulating hormone, tri-iodothyronine, thyroxine, thyroxine-binding protein, parathyroid hormone, insulin, glucagon, renin, aldosterone, follicle-stimulating hormone, luteotrophic hormone, prolactin, somatotrophic hormone, dehydroepiandrosterone, cortisol-binding globulin, and urinary 6β-hydroxycortisol, serum testosterone and circadian cortisol profile.
Other Effects
In humans treated with ACIPHEX® for up to one year, no systemic effects have been observed on the central nervous, lymphoid, hematopoietic, renal, hepatic, cardiovascular, or respiratory systems. No data are available on long-term treatment with ACIPHEX® and ocular effects.
Microbiology
Rabeprazole sodium, amoxicillin and clarithromycin as a three drug regimen has been shown to be active against most strains of Helicobacter pylori in vitro and in clinical infections as described in the CLINICAL STUDIES and INDICATIONS AND USAGE sections. Helicobacter pylori
Susceptibility testing of H. pylori isolates was performed for amoxicillin and clarithromycin using agar dilution methodology1, and minimum inhibitory concentrations (MICs) were determined. The clarithromycin and amoxicillin MIC values should be interpreted according to the following criteria:
| Clarithromycin MIC ( µg/mL) a | Interpretation |
| ≤ 0.25 | Susceptible (S) |
| 0.5 | Intermediate (I) |
| ≥ 1.0 | Resistant (R) |
| Amoxicillin MIC ( µg/mL) a,b | Interpretation |
| ≤ 0.25 | Susceptible (S) |
| a These are breakpoints for the agar dilution
methodology and they should not be used to interpret results usingalternative
methods. b There were not enough organisms with MICs > 0.25 µg/mL to determine a resistance breakpoint. |
|
Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard clarithromycin and amoxicillin powders should provide the following MIC values:
| Microorganism | Antimicrobial Agent | MIC (µg/mL) a |
| H. pylori ATCC 43504 | Clarithromycin | 0.015 – 0.12 µg/mL |
| H. pylori ATCC 43504 | Amoxicillin | 0.015 – 0.12 µg/mL |
| a These are quality control ranges for the agar dilution methodology and they should not be used to control test results obtained using alternative methods. | ||
Incidence of Antibiotic-Resistant Organisms Among Clinical Isolates
Pretreatment Resistance: Clarithromycin pretreatment resistance rate (MIC > 1 (xg/mL) to H. pylori was 9% (51/ 560) at baseline in all treatment groups combined. A total of > 99% (558/560) of patients had H. pylori isolates which were considered to be susceptible (MIC < 0.25 fig/mL) to amoxicillin at baseline. Two patients had baseline H. pylori isolates with an amoxicillin MIC of 0.5 (xg/mL
Generic Name: Rabeprazole Sodium
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