Composition:
Each enteric coated tablet contains 10mg or 20mg Rabeprazole sodium.
Properties:
Rabeprazole sodium is a substituted benzimidazoles proton pump inhibitor that suppresses gastric acid secretion and doesn't exhibit anticholinergic or H2 histamine antagonist properties.
After oral administration of a dose of rabeprazole sodium, the onset of anti-secretory occurs within one hour with the maximum effect occurring within two to four hours, and the duration of inhibition lasts up to 48 hours. The inhibitory effect of rabeprazole sodium on acid secretion increases slightly with repeated once-daily dosing achieving steady state inhibition after three days.
Pharmacokinetics:
Rabiral is an enteric-coated (gastro resistant) tablet; this presentation is necessary because rabeprazole sodium is acid-labile. Absorption of rabeprazole sodium therefore begins only after the tablet leaves the stomach. Absorption is rapid, with peak plasma levels occurring approximately 3.5 hours after a 20mg dose. Absolute bioavailability is about 52% due in large part to pre-systemic metabolism. Rabeprazole sodium is approximately 97% bound to human plasma protein. It is metabolized by iso-enzymes of CYP 450 to five metabolites and its plasma half-life is approximately one hour. Nearly 90% of the dose is eliminated in urine as the metabolites: mercapturic acid conjugate and carboxylic acid plus two unknown metabolites. The remainder of the dose is recovered in faeces. Neither food nor the timing of administration affect the absorption of Rabeprazole sodium. Elderly: elimination of Rabeprazole sodium decreases in the elderly. Hepatic dysfunction: following a single 20mg dose of Rabeprazole sodium to patients with chronic mild to moderate hepatic impairment, the AUC doubled and there was a 2-3 fold increase in half-life of Rabeprazole sodium compared to healthy volunteers.
Renal dysfunction: No clinically significant differences were observed in the pharmacokinetics of Rabiral after a single dose when compared to healthy people.
Indications:
Rabiral is indicated for the treatment of:
Active duodenal ulcer
Active benign gastric ulcer
Symptomatic erosive or ulcerative gastro-oesophageal reflux disease
Contraindications:
Patients with known hypersensrtivity to Rabeprazole sodium or to one of the components
Pregnancy and lactation
Children
Side Effects:
Rabiral tablets were generally well tolerated, but may cause headache, diarrhea, include rhinitis , abdominal pain, vomiting, flatulence, dizziness, dry mouth, and rash.
Precautions:
The possibility of malignancy should be excluded prior to treatment to Rabiral. Care should be taken when treatment with Rabiral is first initiated in patients with severe hepatic dysfunction.
Drug Interactions:
Rabiral doesn't have clinically significant interactions with drugs as such Warfarin, Phenytoin, Theophylline or Diazepam that are metabolized by the CYP 450 system.
Co-administration of Rabiral results in a 33% decrease in Ketoconazole levels and a 22% increase in through digoxin levels in normal subjects. Therefore, individual patients may need to be monitored to determine if a dosage adjustment is necessary when such drugs are taken concomitantly with Rabiral.
Dosage and Administration:
a. Active duodenal ulcer and active benign gastric ulcer. The recommended dose for both is 20mg to be taken once daily in the morning.Some patients with active duodenal ulcer may respond to one 1umg tablet to be taken once daily in the morning. Most patients with active duodenal ulcer heal with 2 - 4 weeks.
A few patients may need an additional 4 weeks of therapy to achieve healing.
b. Rabiral is indicated fore the long-term of pathological hyper secretory conditions; including Zollinger-Ellison syndrome.
c. Ulcerative gastro-oesophageal reflux disease . The recommended dose is 20 mg to be taken once daily for 4 - 8 weeks. Rabiral tablets should be taken in the morning before eating and should be swallowed whole.                                                  
Presentation:
Boxes of 20 E. ctd tablets 10mg.
Boxes of 20 E. ctd tablets 20mg.