Rabeprazole Sodium (Page 10 of 12)

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 1,000 mg twice daily, and clarithromycin 500 mg twice daily (RAC) or omeprazole 20 mg twice daily, amoxicillin 1,000 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

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, 6.0) in the PP population and (- 9.0, 7.5) in the ITT population.

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) 4.0 [- 4.4, 12.5]
10-day RAC* 10-day OAC
Per Protocol a 86.0% (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) – 46.0 [- 54.8, — 37.2]

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 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 also prevented recurrence of gastric hypersecretion and manifestations of acid-peptic disease in all patients. The high doses of rabeprazole sodium 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 20 mg is supplied as yellow colored, round, biconvex delayed-release tablets imprinted with ‘107’ on one side in black ink and plain on other side.

Bottles of 30 NDC 13668-107-30

Bottles of 90 NDC 13668-107-90

Bottles of 500 NDC 13668-107-05

Bottles of 4000 NDC 13668-107-40

100 Unit dose Tablets NDC 13668-107-74

Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Acute Tubulointerstitial Nephritis

Advise the patient or caregiver to call the patient’s healthcare provider immediately if they experience signs and/or symptoms associated with acute tubulointerstitial nephritis [see Warnings and Precautions ( 5.3)].

Clostridium difficile-Associated Diarrhea

Advise the patient or caregiver to immediately call the patient’s healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions ( 5.4)].

Bone Fracture

Advise the patient or caregiver to report any fractures, especially of the hip, wrist or spine, to the patient’s healthcare provider [see Warnings and Precautions ( 5.5)].

Cutaneous and Systemic Lupus Erythematosus

Advise the patient or caregiver to immediately call the patient’s healthcare provider for any new or worsening of symptoms associated with cutaneous or systemic lupus erythematosus [see Warnings and Precautions ( 5.6)].

Cyanocobalamin (Vitamin B-12) Deficiency

Advise the patient or caregiver to report any clinical symptoms that may be associated with cyanocobalamin deficiency to the patient’s healthcare provider if they have been receiving rabeprazole sodium delayed-release tablets for longer than 3 years [see Warnings and Precautions ( 5.7)].

Hypomagnesemia

Advise the patient or caregiver to report any clinical symptoms that may be associated with hypomagnesemia to the patient’s healthcare provider, if they have been receiving rabeprazole sodium delayed-release tablets for at least 3 months [see Warnings and Precautions ( 5.8)].

Drug Interactions

Advise patients to report to their healthcare provider if they are taking rilpivirine-containing products [see Contraindications ( 4)], warfarin, digoxin or high-dose methotrexate [see Warnings and Precautions ( 5.2, 5.8, 5.9)].

Administration

  • Swallow rabeprazole sodium delayed-release tablets whole. Do not chew, crush or split the tablets.
  • For the treatment of duodenal ulcers take rabeprazole sodium delayed-release tablets after a meal.
  • For Helicobacter pylori eradication take rabeprazole sodium delayed-release tablets with food.
  • For all other indications rabeprazole sodium delayed-release tablets can be taken with or without food.
  • Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to the normal schedule. Do not take two doses at the same time.
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Manufactured by:

TORRENT PHARMACEUTICALS LTD., INDIA.

For:

TORRENT PHARMA INC., Basking Ridge, NJ 07920.

8081001 Revised December 2020

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