Rabeprazole Sodium INN
20 mg Tablet

Rabeprazole suppresses gastric acid secretion by inhibiting the gastric H+/K+-ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, Rabeprazole has been characterized as a gastric proton-pump inhibitor.

  • Composition

    Each enteric coated tablet contains Rabeprazole Sodium INN 20 mg.
  • Indication

  • Dosage & Administration

    1) Duodenal ulcer: Rablet 20 mg tablet in the morning is indicated for 4 weeks treatment in the healing and symptomatic relief of duodenal ulcer. Most patients heal within 4 weeks.

    2) Healing of erosive or ulcerative Gastroesophageal Reflux Disease (GERD): Rablet 20 mg daily in the morning for 4 to 8 weeks. Those patients who have not healed after 8 weeks of treatment, an additional 8-week course of Rablet may be considered.

    3) Treatment of symptomatic GERD: The recommended adult oral dose of Rablet is 20 mg once daily in the morning for 4 weeks. If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered.

    4) Zollinger-Ellison Syndrome: The recommended adult oral starting dose is 60 mg once a day. Doses should be adjusted according to individual patient needs and should continue for as long as clinically indicated. Some patients may require divided doses. Doses up to 100 mg once daily and 60 mg twice daily have been administered.

    5) Maintenance of healing of erosive or ulcerative GERD: Rablet is indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative GERD maintenance. Controlled studies do not extend beyond 12 months.
  • Contraindication

    Rabeprazole is contraindicated in patients with known hypersensitivity to Rabeprazole, other PPIs or to any component of the formulation.
  • Precaution

    Rablet tablets should not be splited, chewed or crushed.
  • 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.
  • Drug Interaction

    Rabeprazole is metabolized by the cytochrome P-450 (CYP-450) enzyme system. Studies in healthy subjects have shown that Rabeprazole does not have clinically significant interactions with other drugs metabolized by the CYP-450 system, such as warfarin and theophylline given as single oral doses, diazepam as a single intravenous dose, and phenytoin given as a single intravenous dose.
  • Overdose

    There is no experience with large overdoses with Rabeprazole. The maximum reported overdose is 80 mg. There are no clinical signs or symptoms associated with any reported overdose. Patients with Zollinger-Ellison syndrome have been treated with up to 120 mg Rabeprazole once daily. No specific antidote for Rabeprazole is known.
  • 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.
  • Storage Condition

    Keep in a dry place away from light and heat. Keep out of the reach of children.
  • How Supplied

    Each box contains 50 tablets in Alu-Alu blister pack in Alu-Alu sachet.