Adults/elderly: Active Duodenal Ulcer, Active Benign Gastric Ulcer and Anastomotic ulcer: The recommended oral dose is 10mg or 20mg to be taken once daily in the morning.
Most patients with active duodenal ulcer heal within four weeks. However a few patients may require an additional four weeks of therapy to achieve healing. Most patients with active benign gastric ulcer heal within six weeks. However again a few patients may require an additional six weeks of therapy to achieve healing.
Erosive or Ulcerative Gastro-Oesophageal Reflux Disease (GERD): The recommended oral dose for this condition is 10mg or 20mg to be taken once daily for four to eight weeks.
Gastro-Oesophageal Reflux Disease Long-term Management (GERD Maintenance): For long-term management, a maintenance dose of Rabeprazole Sandoz 20 mg or 10 mg once daily can be used depending upon patient response.
Symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease (symptomatic GERD): 10mg once daily in patients without oesophagitis. If symptom control has not been achieved during four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10mg once daily when needed.
Zollinger-Ellison Syndrome: The dose necessary varies with the individual patient. A starting dose of 60mg daily, and doses of up to 100mg once daily, or 60mg twice daily have been used. Some patients may require divided doses. Dosing should continue for as long as clinically necessary. Some patients with Zollinger-Ellison syndrome have been treated continuously for up to one year.
Eradication of H. pylori: Patients with H. pylori infection should be treated with eradication therapy. The following combination given for 7 days is recommended.
Rabeprazole Sandoz 20mg twice daily + clarithromycin 500mg twice daily and amoxicillin 1g twice daily.
For indications requiring once daily treatment Rabeprazole Sandoz 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.
Renal and hepatic impairment: No dosage adjustment is necessary for patients with renal or hepatic impairment.
See Precautions for Use of Rabeprazole Sandoz in the treatment of patients with severe hepatic impairment.
Children: Safety and effectiveness of rabeprazole sodium 20 mg for the short-term (up to 8 weeks) treatment of GERD in adolescents 12 years of age and above is supported by a) extrapolation of results from adequate and well-controlled studies that supported the effectiveness of rabeprazole sodium for adults; b) safety and pharmacokinetic studies performed in adolescent patients. The recommended oral dose for adolescents 12 years of age and above is 20 mg once daily for up to 8 weeks.
The safety and effectiveness of rabeprazole sodium for the treatment of GERD in children < 12 years of age have not been established. The safety and effectiveness of rabeprazole sodium for other users have not been established in pediatric patients.
Method of administration: For indications requiring once daily treatment Rabeprazole Sandoz 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.
Patients should be cautioned that the Rabeprazole Sandoz tablets should not be chewed or crushed, but should be swallowed whole.
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