Indications - Rabeprazole Gastro-resistant tablets are indicated for the treatment of: Active duodenal ulcer Active benign gastric ulcer Symptomatic erosive or ulcerative gastro-esophageal reflux disease (GERD). Gastro-esophageal Reflux Disease Long-term Management (GERD Maintenance) Symptomatic treatment of moderate to very severe gastro-esophageal reflux disease (symptomatic GERD) Zollinger-Ellison Syndrome In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori in patients with peptic ulcer disease.
Dosage & Administration - Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD): 20 mg to be taken once daily for 4 to 8 weeks. For those patients who have not healed after 8 weeks of treatment, an additional 8 week course may be considered. > Maintenance of Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD Maintenance): The recommended adult oral dose is 20 mg once daily. > Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD): The recommended adult oral dose is 20 mg 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 20 mg once daily after the morning meal for a period up to four weeks. Most patients with duodenal ulcer heal
Side Effects - In general, Rabeprazole is well-tolerated in both short-term and long-term studies. Rabeprazole may sometimes cause headache, diarrhoea, abdominal pain, vomiting, constipation, dry mouth, increased or decreased appetite, muscle pain, drowsiness, dizziness.
Contraindications - Hypersensitivity to the active substance or to any of the excipients. Rabeprazole is contra-indicated in pregnancy and during breastfeeding.
Others - Pregnancy & Lactation US FDA pregnancy category 'C'. Studies have been performed in animals and have revealed no evidence of impaired fertility or harm to the fetus due to Rabeprazole. There are however, no adequate and well-controlled studies in pregnant women. Rabeprazole is likely to be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.