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Parenteral routes of administration other than intravenous are not recommended. No dosage adjustment is necessary in patients with renal impairment, hepatic impairment, or for elderly patients. Doses higher than 40 mg/day have not been studied in hepatically impaired patients. No dosage adjustment is necessary in patients undergoing hemodialysis. The recommended adult dose, as an alternative to continued oral therapy, is 20 mg Rabeprazole Sodium given once daily by intravenous bolus over 15 min or by intravenous infusion for 7 to 10 days.
Rabeprazole Sodium must not be given via intramuscular route.
Adults/Elderly: Active Duodenal Ulcer and Active Benign Gastric Ulcer: 20 mg to be taken once daily in the morning. Most patients with active duodenal ulcer heal within four weeks. However 2% of patients may require an additional four weeks of therapy to achieve healing. Some patients with active duodenal ulcer may respond to one 10 mg tablet to be taken once daily in the morning. Most patients with active benign gastric ulcer heal within six weeks. However 9% of patients may require an additional six weeks of therapy to achieve healing.
Erosive or Ulcerative Gastro-Esophageal Reflux Disease (GORD): 20 mg to be taken once daily for four to eight weeks.
Gastro-Esophageal Reflux Disease Long-term Management (GORD Maintenance): For long-term management up to 12 months, a maintenance dose of Rabeprazole Sodium 10 mg or 20 mg once daily can be used. Some patients may respond to a maintenance dose of 10 mg/day.
Eradication of H. Pylori: It is indicated for H.Pylori-positive duodenal ulcers, as part of the eradication programme with appropriate antibiotics. Rabeprazole Sodium tablets should be taken in the morning, before eating; and although neither the time of day nor food intake was shown to have any effect on Rabeprazole Sodium activity, this regimen will facilitate treatment compliance.
Zollinger Ellison Syndrome: 60 mg per day range=20-120 mg per day. Patients should be cautioned that the Rabeprazole Sodium tablets should not be chewed or crushed, but should be swallowed whole.
Special Populations: The extent of Rabeprazole sodium concentration increase by old age, poor metabolizer status for CYP2C19 and impairment of liver function is not greater than two-fold, impaired renal function does not affect the elimination. Even in patients with delayed elimination, no relevant accumulation of Rabeprazole sodium was observed upon long-term administration. In in-vivo studies, Rabeprazole sodium had no noteworthy effect on the metabolism of other drugs.
Renal and hepatic impairment: No dosage adjustment is necessary for patients with renal or hepatic impairment. Caution is however advised when Rabeprazole Sodium is first initiated in patients with severe hepatic dysfunction.
Children: It is not recommended for use in children, as there is little experience of its use in this group.
