Rabeprazole Sodium (Page 9 of 11)

14.5 Helicobacter pylori Eradication in Patients with Peptic Ulcer Disease or Symptomatic Non-Ulcer Disease in Adults

The U.S. multicenter study was a double-blind, parallel-group comparison of Rabeprazole Sodium Delayed-Release Tablets, amoxicillin, and clarithromycin for 3, 7, or 10 days vs. omeprazole, amoxicillin, and clarithromycin for 10 days. Therapy consisted of rabeprazole 20 mg twice daily, amoxicillin 1000 mg twice daily, and clarithromycin 500 mg twice daily (RAC) or omeprazole 20 mg twice daily, amoxicillin 1000 mg twice daily, and clarithromycin 500 mg twice daily (OAC). Patients with H. pylori infection were stratified in a 1:1 ratio for those with peptic ulcer disease (active or a history of ulcer in the past five years) [PUD] and those who were symptomatic but without peptic ulcer disease [NPUD], as determined by upper gastrointestinal endoscopy. The overall H. pylori eradication rates, defined as negative 13 C-UBT for H. pylori ≥6 weeks from the end of the treatment are shown in the following table. The eradication rates in the 7-day and 10-day RAC regimens were found to be similar to 10-day OAC regimen using either the Intent-to-Treat (ITT) or Per-Protocol (PP) populations. Eradication rates in the RAC 3-day regimen were inferior to the other regimens.

Table 13: Helicobacter pylori Eradication at ≥6 Weeks After the End of Treatment

Treatment Group

Percent (%) of Patients Cured

(Number of Patients)

Difference

(RAC – OAC)

[95% Confidence Interval]

7-day RAC*

10-day OAC

Per Protocol a

84.3%

(N=166)

81.6%

(N=179)

2.8

[-5.2, 10.7]

Intent-to-Treat b

77.3%

(N=194)

73.3%

(N=206)

4

[-4.4, 12.5]

10-day RAC*

10-day OAC

Per Protocol a

86%

(N=171)

81.6%

(N=179)

4.4

[-3.3, 12.1]

Intent-to-Treat b

78.1%

(N=196)

73.3%

(N=206)

4.8

[-3.6, 13.2]

3-day RAC

10-day OAC

Per Protocol a

29.9%

(N=167)

81.6%

(N=179)

-51.6

[-60.6, -42.6]

Intent-to-Treat b

27.3%

(N=187)

73.3%

(N=206)

-46

[-54.8, -37.2]

a Patients were included in the analysis if they had H. pylori infection documented at baseline, defined as a positive 13 C-UBT plus rapid urease test or culture and were not protocol violators. Patients who dropped out of the study due to an adverse event related to the study drug were included in the evaluable 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 took at least one dose of study medication. All dropouts were included as failures of therapy.

* The 95% confidence intervals for the difference in eradication rates for 7-day RAC minus 10-day RAC are (-9.3, 6) in the PP population and (-9, 7.5) in the ITT population.

The recommended dosage of Rabeprazole Sodium Delayed-Release Tablets is 20 mg twice daily with amoxicillin and clarithromycin for 7 days.

14.6 Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults

Twelve patients with idiopathic gastric hypersecretion or Zollinger-Ellison syndrome have been treated successfully with Rabeprazole Sodium Delayed-Release Tablets at doses from 20 to 120 mg for up to 12 months. Rabeprazole Sodium Delayed-Release Tablets produced satisfactory inhibition of gastric acid secretion in all patients and complete resolution of signs and symptoms of acid-peptic disease where present. Rabeprazole Sodium Delayed-Release Tablets also prevented recurrence of gastric hypersecretion and manifestations of acid-peptic disease in all patients. The high doses of Rabeprazole Sodium Delayed-Release Tablets used to treat this small cohort of patients with gastric hypersecretion were well tolerated.

The recommended starting dosage of Rabeprazole Sodium Delayed-Release Tablets is 60 mg once daily.

15 REFERENCES

1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard —Tenth Edition. CLSI Document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania, 19087, USA 2015.

16 HOW SUPPLIED/STORAGE AND HANDLING

Rabeprazole Sodium Delayed-Release Tablets 20 mg are supplied as delayed-release blue enteric-coated round tablets debossed with “KU” on one side and “7” on the other, supplied in bottles of 30 tablets and 90 tablets.

30 Tablets NDC 62135-503-30

90 Tablets NDC 62135-503-90

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture.

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