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Aciphex (Rabeprazole) tablets are indicated for the treatment of:
. Active duodenal ulcer
. Active benign gastric ulcer
. Symptomatic erosive or ulcerative gastro-oesophageal reflux disease (GORD).
. Gastro-Oesophageal Reflux Disease Long-term Management (GORD Maintenance)
. Symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease (symptomatic GORD)
. Zollinger-Ellison Syndrome
. In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori in patients with peptic ulcer disease.
Aciphex tablets were generally well tolerated during clinical trials. The observed undesirable effects have been generally mild/moderate and transient in nature. The most common adverse events are headache, diarrhoea and nausea. Adverse reactions reported as more than isolated cases are listed below, by system organ class and by frequency.
Aciphex is contra-indicated in patients with known hypersensitivity to rabeprazole sodium, substituted benzimidazoles or to any excipient used in the formulation. Aciphex is contra-indicated in pregnancy and during breast feeding.
Active Duodenal Ulcer and Active Benign Gastric Ulcer: The recommended oral dose for both active duodenal ulcer and active benign gastric ulcer is Aciphex 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 (GORD): The recommended oral dose for this condition is Aciphex 20mg to be taken once daily for four to eight weeks.
Gastro-Oesophageal Reflux Disease Long-term Management (GORD Maintenance): For long-term management, a maintenance dose of Aciphex 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 GORD): 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 recommended adult starting dose is Aciphex 60 mg once a day. The dose may be titrated upwards to 120 mg/d based on individual patient needs. Single daily doses up to Aciphex 100 mg/day may be given. Aciphex 120 mg dose may require divided doses, 60 mg twice daily. Treatment should continue for as long as clinically indicated.
Eradication of H. pylori: Patients with H. pylori infection should be treated with eradication therapy. The following combination given for 7 days is recommended.
Aciphex 20mg twice daily + clarithromycin 500mg twice daily and amoxicillin 1g twice daily.
For indications requiring once daily treatment Aciphex 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 Aciphex 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.
Aciphex (Rabeprazole) is not recommended for use in children, as there is no experience of its use in this group.