Generic

Rabeprazole Sodium

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

Pharmacology

By blocking the gastric H+/K+-ATPase at the secretory membrane of the gastric parietal cell, rabeprazole reduces gastric acid production. Rabeprazole has been classified as a gastric proton-pump inhibitor since this enzyme is thought to be the acid (proton) pump within the parietal cell.

Dosage & Administration

Xorel-20 tablet should be swallowed whole. Xorel-20 tablet can be taken with or without food.

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

Maintenance of Healing of Erosive or Ulcerative GERD The recommended adult oral dose is one Xorel-20 tablet once daily.

Treatment of Symptomatic GERD The recommended adult oral dose is one Xorel-20 tablet 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 one Xorel-20 tablet 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.

Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome:
The dosage of Xorel-20 tablet 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 needs 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 Xorel-20 tablet for up to one year.

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.

Contraindications

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

Side Effects

Rabeprazole tablets are 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.

Pregnancy & Lactation

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

Use in 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.

Precautions & Warnings

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.

Therapeutic Class

Proton Pump Inhibitor

Storage Conditions

Store in a cool and dry place, protect from light.

Pharmaceutical Name

Ibn Sina Pharmaceuticals Ltd.