Rabeca™ 20 Tablet: Each enteric coated tablet contains Rabeprazole Sodium INN 20 mg.
Rabeprazole Sodium (Rabeca™) 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. After oral administration of 20 mg, rabeprazole is absorbed and can be detected in plasma by 1 hour. The effects of food on the absorption of Rabeprazole have not been evaluated. Rabeprazole is 96.3% bound to human plasma proteins. Following a single 20 mg oral dose of Rabeprazole, approximately 90% of the drug is eliminated in the urine. The remainder of the dose is recovered in the faeces.
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.
Rabeprazole is metabolized mainly by nonenzymatic pathway. 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.
PREGNANT WOMEN:
Rabeprazole is FDA pregnancy category C. No data are available on administration of Rabeprazole to pregnant women. However this drug should be used during pregnancy, only if clearly needed.
NURSING MOTHERS:
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.
PEDIATRIC USE:
The safety and effectiveness of Rabeprazole in pediatric patients have not been established.
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.
Store below 25°C, protected from light and moisture.