Rabetem 20 Tablet: Each enteric coated tablet contains Rabeprazole Sodium INN 20 mg.
Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD): 20 mg to be taken once daily for 4 to 8 weeks. For those patients who have not healed after 8 weeks of treatment, an additional 8 week course may be considered.
Maintenance of Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD Maintenance):The recommended adult oral dose is 20 mg once daily.
Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD):The recommended adult oral dose is 20 mg 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 20 mg once daily after the morning meal for a period up to four weeks. Most patients with duodenal ulcer heal within four weeks. A few patients may require additional therapy to achieve healing.
Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer
|Rabeprazole Sodium||20 mg||Twice Daily for 7 Days|
|Amoxicillin||1000 mg||Twice Daily for 7 Days|
|Clarithromycin||500 mg||Twice Daily for 7 Days|
All three medications should be taken twice daily with the morning and evening meals. It is important that patients comply with the full 7-day regimen.
Treatment of Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome: The dosage of Rabeprazole Sodium in patients with pathologic 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 patient needs and should continue for as long as clinically indicated. Some patients may require divided doses. Doses up to 100 mg QD and 60 mg BID have been administered. Some patients with Zollinger-Ellision syndrome have been treated continuously with Rabeprazole Sodium for up to one year.
Rabeprazole Sodium is contraindicated in patient with known hypersensitivity to Rabeprazole or to any component in the product.
Administration of Rabeprazole Sodium to patients with mild to moderate liver impairment resulted in increased exposure and decreased elimination. Caution should be exercised in patients with severe hepatic impairment.
Rabeprazole is metabolized by the Cytochrome P-450 (CYP-450) drug metabolizing enzyme system. 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 dose, Diazepam as a single intravenous
dose, and Phenytoin given as a single intravenous dose. In normal subjects, co-administration of Rabeprazole 20 mg QD resulted in an approximately 30%
decrease in the bioavailability of Ketoconazole and increase in the AUC and Cmax for digoxin of 90% and 29% respectively.
Use in pregnancy & lactation:
Rabeprazole is FDA Pregnancy Category C. No data is available on administration of Rabeprazole to pregnant women. However this drug should be used
during pregnancy, only if clearly needed. There are no data on the excretion of Rabeprazole into the breast milk. A decision should be made whether to
discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.
The safety and effectiveness of Rabeprazole in pediatric patients have not been established.
Rabeprazole Sodium may sometimes cause headache, diarrhoea, abdominal pain, vomiting, constipation, dry mouth, increased or decreased appetite, muscle pain, drowsiness and dizziness.
There has been no experience with large overdoses with Rabeprazole. No specific antidote for Rabeprazole is known. Rabeprazole is extensively protein
bound and is not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive.
Rabetem 20 Tablet: Each box contains 5x10’s tablet in alu-alu blister pack.