Indication
- Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD)
- Maintenance of Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD)
- Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD)
- Healing of Duodenal Ulcers
- Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
- Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome
Dosage & Administration
Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) Rabigut is indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of Rabigut may be considered. Maintenance of Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) Rabigut is indicated for maintaining healing and reduction in relapse rates of heartburn
symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance). Controlled studies do not extend beyond 12 months. Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD) The recommended adult oral dose is one Rabigut 20 mg delayed-release tablet to be taken once daily for 4 weeks. If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered.
Healing of Duodenal Ulcers
The recommended adult oral dose is one Rabigut 20 mg delayed-release tablet to be taken once daily after the morning meal for a period up to 4 weeks. Most patients with duodenal ulcer heal within 4 weeks. A few patients may require additional therapy to achieve healing.
Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Rabigut in combination with amoxicillin and clarithromycin as a three 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.
Three Drug Regimen:
Rabeprazole 20 mg Twice Daily for 7 Days
Amoxicillin 1000 mg Twice Daily for 7 Days
Clarithromycin 500 mg Twice Daily for 7 Days
Treatment of Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome The dosage of Rabigut in patients with pathologic hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once a day. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Some patients may require divided doses. Doses up to 100 mg QD and 60 mg BID have been administered. Some patients with Zollinger-Ellison syndrome have been treated continuously with Rabigut for up to one year.
Precautions
Administration of Rabeprazole to patients with mild to moderate liver impairment resulted in increased exposure and decreased elimination. Due to the lack of clinical data on Rabeprazole in patients with severe hepatic impairment, caution should be exercised in those patients.
Use in Pregnancy and Lactation
Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. A decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
The safety and effectiveness of Rabeprazole in pediatric patients have not been established.
