Description

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.

Presentation

    Rabe-20 Tablet: Each enteric coated tablet contains Rabeprazole Sodium BP 20 mg.
    Rabe-20 Capsule: Each vegetable capsule shell contains Rabeprazole Sodium BP 20 mg as enteric coated pellets.

Indications

    - Healing of Erosive or Ulcerative GERD
    - Maintenance of Healing of Erosive or Ulcerative GERD
    - Treatment of Symptomatic GERD
    - Healing of Duodenal Ulcers
    - Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
    - Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome

Dosage & Administration

    Rabe-20 Tablet or Capsule should be swallowed whole. Rabe-20 Tablet or Capsule can be taken with or without food.

    Healing of Erosive or Ulcerative GERD:
    The recommended adult oral dose of Rabe-20 Tablet or Capsule is once daily for four to eight weeks. For those patients who have not healed after 8 weeks of treatment, an additional 8-weeks course of Rabe-20 Tablet or Capsule may be considered.

    Maintenance of Healing of Erosive or Ulcerative GERD:
    The recommended adult oral dose is one Rabe-20 Tablet or Capsule once daily.

    Treatment of Symptomatic GERD:
    The recommended adult oral dose is one Rabe-20 Tablet or Capsule 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 Ulcer:
    The recommended adult oral dose is one Rabe-20 Tablet or Capsule once daily after the morning meal for a period up to 4 weeks. Most patients with duodenal ulcer heal within 4 weeks. A few patients may require additional therapy to achieve healing.

    Helicobacter pylori eradication to reduce the risk of Duodenal Ulcer Recurrence:
    Rabe-20 (20 mg), Amoxicillin (1000 mg) & Clarithromycin (500 mg) twice daily with the morning and evening meals for 7 days.

    Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome:
    The dosage of Rabe-20 Tablet or Capsule in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once a day. Doses should be adjusted to individual patients need and should continue for as long as clinically indicated. Some patients may require divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with Rabe-20 Tablet or Capsule for up to one year.

Contrainidications

    Rabeprazole is contraindicated in patients with known hypersensitivity to Rabeprazole or to any component of the formulation.

Warning & Precautions

    Administration of Rabeprazole to patients with mild to moderate liver impairment results in increased exposure and decreased elimination. Caution should be exercised in patients with severe hepatic impairment.

Side effects

    Rabeprazole is generally well tolerated. The observed undesirable effects have been generally mild/moderate and transient in nature. The most common adverse events are headache, diarrhea and nausea. The less common adverse effects are abdominal pain, asthenia, flatulence, rash, dry mouth etc.

Drug interaction

    Rabeprazole like other PPIs is metabolized through Cytochrome P450 drug metabolizing enzyme system. But Rabeprazole does not have clinically significant interaction with other drugs metabolized by CYP P450 system, such as warfarin, theophylline, diazepam and phenytoin. Rabeprazole inhibits gastric acid secretion and may interfere with absorption of drugs where gastric pH is an important determinant of bioavailability e.g. ketoconazole, iron salts and digoxin. In studies no interaction with liquid antacid or foods was observed.

Use in special groups

    Use in Pregnancy:
    Pregnancy:
    Pregnancy category C. There are no adequate well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.

    Nursing mother:
    Since many drugs are excreted in milk and because of the potential for adverse reactions to nursing infants from Rabeprazole, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

    Geriatric patients:
    No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals can not be ruled out.

Packing

    Rabe-20 Tablet:Each box contains 140 tablets in Alu-Alu blister within Alu-Alu pillow pack.
    Rabe-20 Capsule: Each box contains 60 capsules in Alu-Alu blister within Alu-Alu pillow pack.