Brand Name: Gastrazole 20
Generic Name: Rabeprazole Sodium BP
Therapeutic Class: Anti-Ulcerant
- Additional information
- Dose and Administration
- Side Effects
- Warning & Precaution
- Use In Pregnancy And Lactation
- Drug Interaction
- Reviews (0)
Gastrazole 20 Tablet: Each enteric coated tablet contains Rabeprazole Sodium INN 20 mg.
Rabeprazole sodium is an antiulcer drug in the class of proton pump inhibitors. Rabeprazole Sodium is a substituted benzimidazole which suppresses gastric acid secretion by inhibiting the gastric H+/K+-ATPase enzyme at the secretory surface of the gastric parietal cell. It is an enteric coated tablet, because of its coated formulation, it is highly stable in stomach and because of higher pka value of Rabeprazole Sodium it provides faster onset of action. It blocks the final step of gastric acid secretion. Rabeprazole is absorbed and can be detected in plasma by 1 hour. Rabeprazole is 96.3% bound to human plasma proteins. Approximately 90% of the drugs is eliminated in the urine. The remainder of the dose is recovered in the faeces.
• Short-term treatment in healing and symptomatic relief of duodenal ulcers and erosive.
• Maintaining healing and reducing relapse rates of heartburn symptoms in patients with GERD.
• Long-term treatment of pathological hyper secretory conditions, including Zollinger Ellison Syndrome.
• In combination with Amoxicillin and Clarithromycin indicated to eradicate Helicobacter pylori.
Dose and Administration
• Healing of Erosive or Ulcerative Gastro Esophageal 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.
• Healing of Duodenal Ulcers: The recommended adult oral dose is 20 mg once daily 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:
Twice Daily for 7 Days
Twice Daily for 7 Days
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 hyper secretory conditions including Zollinger-Ellison Syndrome: The dosage of Rabeprazole Sodium in patients with pathologic hyper secretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once a day. Doses should be adjusted according 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.
a) Common: Rabeprazole Sodium may sometimes cause headache, diarrhoea, abdominal pain, vomiting, constipation, dry mouth, increased or decreased appetite, muscle pain, drowsiness and dizziness.
b) Rare: The less common adverse effects are abdominal pain, asthenia, flatulence, rash, dry mouth etc.
Warning & Precaution
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 Sodium is contraindicated in patient with known hypersensitivity to Rabeprazole, substituted benzimidazoles or to any component in the product.
Use In Pregnancy And 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. Use in children & adolescents: For 1 to 11 years: Less than 15 kg: 5 mg orally once a day, with the option to increase to 10 mg if inadequate response.15 kg or more: 10 mg orally once a day Up to 12 weeks. For 12 years or older: 20 mg orally once a day Up to 8 weeks.
Each box contains 5 x 10’s tablets in Alu-Alu blister pack.
a) With medicine: Rabeprazole is metabolized mainly non enzymatic pathway. 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.
b) With Food and others: Rabeprazole should not take with alcohol, it can upset stomach and cause an increase in the side effects of medication.
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 over dosage, treatment should be symptomatic and supportive.