Jane S. Ricciuti, RPh, MS

Disclosures

December 27, 2002

In This Article

Gastrointestinal Agents

Aciphex
(rabeprazole) Delayed-Release Tablets

Manufacturer: Eisai Medical Research Inc.

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 11/8/02)

New Indication: Aciphex (rabeprazole) is now indicated for the eradication of Helicobacter pylori. Previously, Aciphex was indicated for the treatment of gastroesophageal reflux disease (GERD).

Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence:

Aciphex, in combination with amoxicillin and clarithromycin as a 3-drug regimen, is indicated for the treatment of patients with H pylori infection and duodenal ulcer disease (active or history within the past 5 years) to eradicate H pylori. Eradication of H pylori has been shown to reduce the risk of duodenal ulcer recurrence. In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted.

Dosing: H pylori eradication requires a 3-drug regimen to be taken twice daily with the morning and evening meals.

Aciphex 20 mg twice daily for 7 days

  • Amoxicillin 1000 mg twice daily for 7 days

  • Clarithromycin 500 mg twice daily for 7 days

  • Clinical Summary: A US multicenter, double-blind, parallel-group comparison of rabeprazole, amoxicillin, and clarithromycin for 3, 7, or 10 days vs omeprazole, amoxicillin, and clarithromycin for 10 days was conducted. 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). The eradication rates in the 7-day and 10-day RAC regimens were found to be similar to the 10-day OAC regimen using either the intent-to-treat or per-protocol populations.

    Adverse Effects: In clinical trials of the 3-drug regimen, the most frequently reported adverse events were diarrhea and taste perversion.

    Reference

    Aciphex (rabeprazole) Delayed-Release Tablets labeling

    Medscape DrugInfo

    Aciphex (rabeprazole) Delayed-Release Tablets

    Comments

    3090D553-9492-4563-8681-AD288FA52ACE
    Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.

    processing....