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Xorel

Rabeprazole Sodium INN

NAME STRENGTH PACK SIZE DOSAGE FORM
Xorel-20 20 mg 10X10 Tablet
Xorel 20 20 mg 10X10 Capsule

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.

Xorel-20 Tablet: Each enteric coated tablet contains Rabeprazole Sodium INN 20 mg. Xorel-20 Capsule: Each capsule contains Rabeprazole Sodium INN 20 mg in enteric coated pellets.

• 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

Xorel-20 should be swallowed whole. Xorel-20 can be taken with or without food. Healing of Erosive or Ulcerative GERD The recommended adult oral dose is Xorel-20 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 may be considered. Maintenance of Healing of Erosive or Ulcerative GERD The recommended adult oral dose is one Xorel-20 once daily. Treatment of Symptomatic GERD The recommended adult oral dose is one Xorel-20 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 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 Xorel-20 20 mg Amoxicillin 1000 mg Twice daily with the morning and evening Clarithromycin 500 mg meals for 7 days Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome: The dosage of Rabeprazole 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 for up to one year.

Rabeprazole 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.

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.

Use in Pregnancy: 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.

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.

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

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

Xorel-20 Tablet: Each box contains 10 X 10 tablets in Alu-Alu blister strips. Xorel-20 Capsule: Each box contains 10 X 10 capsules in Alu-Alu blister strips.