Dosage & Administration

Adults/Elderly:

Active Duodenal Ulcer, Active Benign Gastric Ulcer and Anastomotic Ulcer: The recommended oral dose for both active duodenal ulcer, active benign gastric ulcer and anastomotic ulcer is 10 mg or 20 mg lo 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-Esophageal Reflux Disease (GERD): The recommended oral dose for this condition is 10 mg or 20 mg to be taken once daily for four to eight weeks. Doses of 10 mg or 20 mg twice daily may be administered orally for another eight weeks in reflux esophagitis patients who are not responding to the usual dose of proton pump inhibitors. However, a dose of 20 mg twice daily should only be administered to patients with severe mucosa injury.

 

Gastro-Esophageal Reflux Disease Long-term Management (GERD maintenance): For long-term management, a maintenance dose of Rabeprazole sodium (PARIET®) 10 mg or 20 mg once daily can be used depending upon patient response. For the maintenance therapy when proton pump inhibitor treatment is ineffective, dose of 10 mg twice daily may be administered orally.

 

Symptomatic Treatment of Moderate to Very Severe Gastro-Esophageal Reflux Disease (symptomatic GERD): 10 mg once daily in patients without esophagitis. 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 10 mg once daily when needed.

 

Zollinger-Ellison Syndrome and Other Pathological Hypersecretory Conditions: The dose varies with the individual patient. A starting dose of 60 mg daily, and doses of up to 100 mg once daily, or 60 mg 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. For the prevention of gastric and duodenal ulcer recurrences associated with low-dose aspirin therapy, the usual dosage for adults is 10 mg administered orally once a day.

 

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 sodium (PARIET®) 10 mg or 20 mg twice daily + clarithromycin 500 mg twice daily and amoxicillin 1g twice daily.

**For indications requiring once daily treatment, Rabeprazole sodium Rabeprazole sodium (PARIET®) 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 sodium (PARIET®) tablets should not be chewed or crushed but should be swallowed whole.

 

Renal and hepatic impairment:

No dosage adjustment is necessary for patients with renal or hepatic impairment.

 

Children:

Safety and effectiveness of Rabeprazole sodium (PARIET®) for the short-term (up to eight weeks) treatment of GERD in adolescents 12 years of age and above is supported by

  1. a) extrapolation of results from adequate and well-controlled studies that supported the effectiveness of Rabeprazole sodium (PARIET®) for adults.
  2. 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 eight weeks.

 

Rabeprazole sodium (PARIET®) is not recommended for the treatment of GERD in children <12 years of age, as there is no experience of its use in this group. The safety and effectiveness of rabeprazole sodium for other uses have not been established in pediatric patients.