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Indications/Uses
Short term treatment for gastric and duodenal ulcer; also used in combination with antibacterials for eradication of Helicobacter pylori; treatment for gastro-oesophageal reflux disease and Zollinger-Ellison syndrome.
Dosage/Direction for Use
Benign gastric ulcer: 20 mg daily in the morning for 6 weeks, continued for further 6 weeks if not fully healed.
Duodenal ulcer: 20 mg/day in the morning for 4 weeks, continued for further 4 weeks if not fully healed.
Ulcerative or Erosive Gastroesophageal reflux disease: 20 mg once daily for 4-8 weeks; maintenance 10-20 mg daily; symptomatic treatment in the absence of oesophagitis, 10 mg daily for up to 4 weeks, then 10 mg daily when required.
Duodenal and benign gastric ulcer associated with: 20 mg twice daily + clarithromycin 500 mg twice daily and amoxicillin 1 gram twice daily for 7 days.
Duodenal ulcer: 20 mg/day in the morning for 4 weeks, continued for further 4 weeks if not fully healed.
Ulcerative or Erosive Gastroesophageal reflux disease: 20 mg once daily for 4-8 weeks; maintenance 10-20 mg daily; symptomatic treatment in the absence of oesophagitis, 10 mg daily for up to 4 weeks, then 10 mg daily when required.
Duodenal and benign gastric ulcer associated with: 20 mg twice daily + clarithromycin 500 mg twice daily and amoxicillin 1 gram twice daily for 7 days.
Overdosage
Give supportive measures and symptoms treatment.
Administration
May be taken with or without food: Swallow whole, do not chew/crush.
Contraindications
Rabeprazole is contraindicated in patients with known hypersensitivity to Rabeprazole, substituted benzimidazole or lo any component of the formulation.
Warnings
Contains FD & C yellow No. 5 (Tartrazine) which may cause allergic type reactions (including bronchial asthma) in certain susceptible individuals.
Special Precautions
Special precautions are to be exercised specifically in the event of Hepatic impairment.
Monitor gastric malignancy.
Monitor gastric malignancy.
Use In Pregnancy & Lactation
Pregnancy: This drug should be used during pregnancy only if clearly needed.
Nursing Mother: A decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Nursing Mother: A decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Adverse Reactions
Most common adverse effects observed with Rabeprazole are Diarrhea, Nausea, Headache, Vomiting, Abdominal pain, Dizziness, Flatulence, Constipation, Dyspepsia, Flu like syndrome, Insomnia, Back pain, Cough, Rhinitis, Pharyngitis and Rash.
Drug Interactions
Patients receiving proton-pump inhibitors, including Rabeprazole and warfarin concomitantly may lead to abnormal bleeding and even death because of increased in INR and prothrombin time. Co-administration of Rabeprazole sodium results in a 33% decrease in ketoconazole levels.
Rabeprazole-Digoxin co-administration results in increased through digoxin levels in normal subjects.
Rabeprazole-Digoxin co-administration results in increased through digoxin levels in normal subjects.
Storage
Store at a temperature not exceeding 30°C.
Action
Pharmacology: Rabeprazole sodium is a proton-pump inhibitor. II is prodrug. After administration it diffuses into the parietal cell of the stomach and accumulates in the secretory canaliculi. In the acidic medium Rabeprazole is converted to sulfonamide. This sulfonamide covalently interacts with sulfhydryl (SH) group in the proton pump (H+ K+ ATPase) and inhibits the exchange of extra cellular K+ for intracellular H+ ion.
Rabeprazole sodium irreversibly inhibits proton pump activity and decreases gastric acid secretion. Rabeprazole produces fastest acid suppression and helps in mucin synthesis.
Pharmacokinetics: Peak plasma-rabeprazole concentrations reach about 3.5 hours after a dose by mouth. The oral bioavailability is about 52% with the enteric-coaled tablet formulation, because of first-pass metabolism, and does not appear lo vary after single or repealed doses. Rabeprazole is 97% bound lo plasma proteins. It is extensively metabolized in the liver by cytochrome P450 isoenzymes CYP2C19 and CYP3A4 lo the thioether, thioether carboxylic acid, sulfone, and desmethyl thioether. Metabolites are excreted principally in the urine about 90% with the remainder in the feces. The plasma half-life is about 1 hour, increased two or threefold in hepatic impairment, 1.6 times in CYP2C19 slow metabolizers and by 30% in the elderly.
Rabeprazole sodium irreversibly inhibits proton pump activity and decreases gastric acid secretion. Rabeprazole produces fastest acid suppression and helps in mucin synthesis.
Pharmacokinetics: Peak plasma-rabeprazole concentrations reach about 3.5 hours after a dose by mouth. The oral bioavailability is about 52% with the enteric-coaled tablet formulation, because of first-pass metabolism, and does not appear lo vary after single or repealed doses. Rabeprazole is 97% bound lo plasma proteins. It is extensively metabolized in the liver by cytochrome P450 isoenzymes CYP2C19 and CYP3A4 lo the thioether, thioether carboxylic acid, sulfone, and desmethyl thioether. Metabolites are excreted principally in the urine about 90% with the remainder in the feces. The plasma half-life is about 1 hour, increased two or threefold in hepatic impairment, 1.6 times in CYP2C19 slow metabolizers and by 30% in the elderly.
MedsGo Class
Antacids, Antireflux Agents & Antiulcerants
Features
Dosage
20mg
Ingredients
- Rabeprazole
Packaging
Enteric-Coated Tablet 1's
Generic Name
Rabeprazole Sodium
Registration Number
DRP-4245-01
Classification
Prescription Drug (RX)
Product Questions
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