Rabigut 20 Tablet: Each delayed release tablet contains 20 mg Rabeprazole Sodium BP.
The active ingredient in Rabigut delayed release tablet is Rabeprazole Sodium, a substituted benzimidazole that inhibits gastric acid secretion.
Mechanism of Action:
Rabeprazole belongs to a class of antisecretory compounds (substituted benzimidazole proton-pump inhibitors) that suppress 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. Rabeprazole blocks the final step of gastric acid secretion.
Pharmacokinetics:
Absorption: Absolute bioavailability for a 20 mg oral tablet of Rabeprazole (compared to intravenous administration) is approximately 52%.
Distribution: Rabeprazole is 96.3% bound to human plasma proteins.
Metabolism: Rabeprazole is extensively metabolized. The thioether and sulphone are the primary metabolites measured in human plasma. These metabolites were not observed to have significant antisecretory activity. In vitro studies have demonstrated that Rabeprazole is metabolized in the liver primarily by cytochromes P450 3A (CYP3A) to a sulphone metabolite and cytochrome P450 2C19 (CYP2C19) to desmethyl Rabeprazole. The thioether metabolite is formed nonenzymatically by reduction of Rabeprazole.
Elimination: Following a single 20 mg oral dose of Rabeprazole, approximately 90% of the drug was eliminated in the urine, primarily as thioether carboxylic acid; its glucuronide, and mercapturic acid metabolites. The remainder of the dose was recovered in the feces. No unchanged Rabeprazole was recovered in the urine or feces.
Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD): Rabigut is indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of Rabigut may be considered.
Maintenance of Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD): Rabigut is indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD Maintenance). Controlled studies do not extend beyond 12 months.
Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD): The recommended adult oral dose is one Rabigut 20 mg delayed-release tablet to be taken 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 Rabigut 20 mg delayed-release tablet to be taken 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**: Rabigut in combination with Amoxicillin and Clarithromycin as a three drug regimen, is indicated for the treatment of patients with *H. pylori* infection and duodenal ulcer disease (active or history within the past 5 years) to eradicate *H. pylori*. Eradication of *H. pylori* has been shown to reduce the risk of duodenal ulcer recurrence.
Three Drug Regimen:
Rabeprazole 20 mg Twice Daily for 7 Days.
Amoxicillin 1000 mg Twice Daily for 7 Days.
Clarithromycin 500 mg Twice Daily for 7 Days.
Treatment of Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome. The dosage of Rabigut 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-Ellison syndrome have been treated continuously with Rabigut for up to one year.
*Prescription only*
Rabeprazole is metabolized by the cytochrome P450 (CYP450) drug metabolizing enzyme system. Studies in healthy subjects have shown that Rabeprazole does not have clinically significant interactions with other drugs metabolized by the CYP450 system, such as Warfarin and Theophylline given as single oral doses, Diazepam as a single intravenous dose and Phenyltoin 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 increases in the AUC and Cmax for Digoxin of 19% and 29%, respectively.
Pregnancy Category B: There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. A decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
The safety and effectiveness of Rabeprazole in pediatric patients have not been established.
Administration of Rabeprazole to patients with mild to moderate liver impairment resulted in increased exposure and decreased elimination. Due to the lack of clinical data on Rabeprazole in patients with severe hepatic impairment, caution should be exercised in those patients.
Store at below 30°C in a dry place protected from light. Keep out of reach of children.