Rabaris

Rabaris

rabeprazole

Manufacturer:

Aristopharma

Distributor:

KTZ
Full Prescribing Info
Contents
Rabeprazole sodium.
Action
Pharmacology: 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.
Indications/Uses
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/Direction for Use
Adults: Healing of Erosive or Ulcerative GERD: Recommended Dose: 1 tablet once daily for 4-8 weeks.
For patients who have not healed after 8 weeks of treatment, an additional 8-week course of Rabaris tablet may be considered.
Maintenance of Healing of Erosive or Ulcerative GERD: Recommended Dose: 1 tablet once daily.
Treatment of Symptomatic GERD: Recommended Dose: 1 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: Recommended Dose: 1 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. (See table.)

Click on icon to see table/diagram/image

Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome: The dosage of Rabaris tablet in patients with pathological hypersecretory conditions varies with the individual patient. Recommended Starting Dose: 60 mg once daily. 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 Rabaris tablet for up to 1 year.
Administration: Tablet should be swallowed whole, may be taken with or without food.
Contraindications
Known hypersensitivity to rabeprazole or to any component of Rabaris.
Special 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.
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 lactation: 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 Rabaris to the mother.
Use in the elderly: No overall differences in safety or effectiveness were observed.
Use In Pregnancy & Lactation
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 lactation: 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 Rabaris to the mother.
Adverse Reactions
Rabeprazole tablets are 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 Interactions
Rabeprazole like other PPIs is metabolized through cytochrome P-450 drug metabolizing enzyme system. But rabeprazole does not have clinically significant interaction with other drugs metabolized by CYP450 system eg, 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 eg, ketoconazole, iron salts and digoxin.
In studies, no interaction with liquid antacid or foods was observed.
Storage
Store in a cool and dry place. Protect from light.
ATC Classification
A02BC04 - rabeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
EC tab 20 mg x 5 x 10's.
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