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Rabeprazole Sodium Tablets 20 mg



Each enteric coated tablet contains:

Rabeprazole Sodium 20 mg

Excipients: q.s

Colour: Iron oxide red, Titanium Dioxide BP



i) Rabeprazole sodium belongs to the class of anti-secretory compounds, the substituted benzimidazoles, that do not exhibit anticholinergic or H2 histamine antagonist properties, but suppress gastric acid secretion by the specific inhibition of the H+/K+-ATPase enzyme (the acid or proton pump).

ii) The effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus.

iii) Animal studies indicate that after administration, Rabeprazole sodium rapidly disappears from both the plasma and gastric mucosa. As a weak base, Rabeprazole is rapidly absorbed following all doses and is concentrated in the acid environment of the parietal cells. Rabeprazole is converted to the active sulphenamide form through protonation and it subsequently reacts with the available cysteines on the proton pump.



i) Rabeprazole Sodium is an enteric-coated (gastro-resistant) tablet formulation of rabeprazole sodium. This presentation is necessary because rabeprazole is acid-labile. Absorption of rabeprazole therefore begins only after the tablet leaves the stomach.

ii) Absorption is rapid, with peak plasma levels of rabeprazole occurring approximately 3.5 hours after a 20 mg dose. Peak plasma concentrations (Cmax) of rabeprazole and AUC are linear over the dose range of 10 mg to 40 mg.

iii) Absolute bioavailability of an oral 20 mg dose (compared to intravenous administration) is about 52% due in large part to pre-systemic metabolism.

iv) Additionally the bioavailability does not appear to increase with repeat administration. In healthy subjects the plasma half-life is approximately one hour (range 0.7 to 1.5 hours), and the total body clearance is estimated to be 283 ± 98 ml/min.

v) There was no clinically relevant interaction with food. Neither food nor the time of day of administration of the treatment affect the absorption of rabeprazole sodium.



Rabeprazole is approximately 97% bound to human plasma proteins.


Metabolism and excretion:

i) Rabeprazole sodium, as is the case with other members of the proton pump inhibitor (PPI) class of compounds, is metabolized through the cytochrome P450 (CYP450) hepatic drug metabolizing system.

ii) In vitro studies with human liver microsomes indicated that rabeprazole sodium is metabolised by isoenzymes of CYP450 (CYP2C19 and CYP3A4).

iii) In these studies, at expected human plasma concentrations rabeprazole neither induces nor inhibits CYP3A4; and although in vitro studies may not always be predictive of in vivo status these findings indicate that no interaction is expected between rabeprazole and cyclosporin.

iv) In humans the thioether (M1) and carboxylic acid (M6) are the main plasma metabolites with the sulphone (M2), desmethyl-thioether (M4) and mercapturic acid conjugate (M5) minor metabolites observed at lower levels. Only the desmethyl metabolite (M3) has a small amount of anti-secretory activity, but it is not present in plasma.



Adjusted for body mass and height, there are no significant gender differences in pharmacokinetic parameters following a single 20mg dose of rabeprazole.

Renal dysfunction:

i) In patients with stable, end-stage, renal failure requiring maintenance haemodialysis (creatinine clearance s 5ml/min/1.73m2), the disposition of rabeprazole was very similar to that in healthy volunteers. The AUC and the Cmax in these patients was about 35% lower than the corresponding parameters in healthy volunteers.

ii) The mean half-life of rabeprazole was 0.82 hours in healthy volunteers, 0.95 hours in patients during haemodialysis and 3.6 hours post dialysis.

iii) The clearance of the drug in patients with renal disease requiring maintenance haemodialysis was approximately twice that in healthy volunteers.

Hepatic dysfunction:

i) Following a single 20mg dose of rabeprazole 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 compared to the healthy volunteers. However, following a 20mg dose daily for 7 days the AUC had increased to only 1.5-fold and the Cmax to only 1.2-fold.

ii) The half-life of rabeprazole in patients with hepatic impairment was 12.3 hours compared to 2:1 hours in healthy volunteers. The pharmacodynamic response (gastric pH control) in the two groups was clinically comparable.


i) Elimination of rabeprazole was somewhat decreased in the elderly.

Following 7 days of daily dosing with 20mg of rabeprazole sodium, the AUC approximately doubled, the Cmax increased by 60% and 1½ increased by approximately 30% as compared to young healthy volunteers. However there was no evidence of rabeprazole accumulation.



Therapeutic Category: Proton pump inhibitor

Therapeutic Indications:

For the relief of signs and symptoms of:

i) Active duodenal ulcer

ii) Active benign gastric ulcer

iii) Symptomatic erosive or ulcerative gastro-oesophageal reflux disease (GORD)

iv) Long term management of gastro-oesophageal reflux disease (GORD)

v) Zollinger-Ellison Syndrome

vi) In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori in patients with peptic ulcer disease.



It is contraindicated in patients with known hypersensitivity to Rabeprazole sodium or to any excipients used in the formulation. 

It is contraindicated in pregnancy and during breastfeeding.


Warning & Precautions:

i) Symptomatic response to therapy with rabeprazole sodium does not preclude the presence of gastric or oesophageal malignancy, therefore the possibility of malignancy should be excluded prior to commencing treatment with Rabeprazole Sodium.

ii) Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance.

iii) A risk of cross-hypersensitivity reactions with other substituted benzimidazoles cannot be excluded.

iv) Patients should be cautioned that Rabeprazole Sodium tablets should not be chewed or crushed, but should be swallowed whole.

v) Rabeprazole Sodium is not recommended for use in children, as there is no experience of its use in this group.

vi) In the treatment of patients with severe hepatic dysfunction the prescriber is advised to exercise caution when treatment with Rabeprazole Sodium is first initiated in such patients.

vii) Co-administration of atazanavir with Rabeprazole is not recommended.

viii) Treatment with proton pump inhibitors may possibly increase the risk of gastrointestinal infections such as Salmonella, Campylobacter and Clostridium difficile.


Pregnancy & Lactation:


There are no data on the safety of Rabeprazole in human pregnancy. Reproduction studies performed in rats and rabbits have revealed no evidence of impaired fertility or harm to the foetus due to Rabeprazole sodium, although low foeto-placental transfer occurs in rats.

Rabeprazole Sodium is contraindicated during pregnancy.


It is not known whether Rabeprazole sodium is excreted in human breast milk. No studies in lactating women have been performed. Rabeprazole sodium is however excreted in rat mammary secretions. Therefore Rabeprazole Sodium should not be used during breast feeding.

Adverse effects:


Headache (10%); dizziness; coma, disorientation/delirium


Bullous eruptions, severe dermatologic eruptions including erythema multiforme, Stevens-Johnson syndrome, TEN


Diarrhea, nausea (5%); abdominal pain, vomiting (4%); flatulence (3%); constipation (2%); dry mouth.


Hepatic encephalopathy; hepatitis; increased hepatic enzymes; jaundice.


Agranulocytosis, hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia.


Hyperammonemia, TSH elevations


Arthralgia; myalgia; bone fractures, rhabdomyolysis


Pain, pharyngitis (3%); infection (2%); peripheral edema; anaphylaxis, angioedema, interstitial nephritis, interstitial pneumonia, sudden death.

Drug interactions:

i) Co-administration of Rabeprazole sodium with Ketoconazole or itraconazole may result in a significant decrease in antifungal plasma levels. Therefore individual patients may need to be monitored to determine if a dosage adjustment is necessary when Ketoconazole or itraconazole are taken concomitantly with Rabeprazole.

ii) In clinical trials, antacids were used concomitantly with the administration of Rabeprazole and, in a specific drug-drug interaction study, no interaction with liquid antacids was observed.

iii) Co-administration of atazanavir 300mg/ritonavir 100mg with omeprazole (40 mg once daily) or atazanavir 400mg with lansoprazole (60mg once daily) to healthy volunteers resulted in a substantial reduction in atazanavir exposure. Therefore PPls, including rabeprazole, should not be co-administered with atazanavir.

Dosage Regimen

Posology and Method of Administration:

Route of Administration: Oral

Adults / elderly:

Active Duodenal Ulcer and Active Benign Gastric Ulcer:

The recommended dose is 20 mg to be taken once daily in the morning.

Most patients with active duodenal ulcer heal within four weeks and with active benign gastric ulcer heal within six weeks.

However a few patients may require an additional four / six weeks of therapy to achieve healing.

Erosive or Ulcerative Gastro-Oesophageal Reflux Disease (GORD):

The recommended oral dose for this condition is 20 mg to be taken once daily for four to eight weeks.

Gastro-Oesophageal Reflux Disease Long-term Management (GORD Maintenance):

For long-term management, a maintenance dose of 20 mg or 10 mg once daily can be used depending upon patient response.

Symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease:

10 mg once daily in patients without oesophagitis. If symptom control has not been achieved during four weeks, the patient should be further investigated.

Zollinger-Ellison Syndrome:

The recommended adult starting dose is 60 mg once a day. The dose may be titrated upwards to 120mg/day based on individual patient needs. Single daily doses up to 100mg/day mạy be given. 120mg dose may require divided doses, 60mg twice daily.
Treatment should continue for as long as clinically indicated.

Eradication of H. pylori:

The following combination given for 7 days is recommended.
Rabirol 20 mg twice daily + clarithromycin 500 mg twice daily and amoxicillin 1 g twice daily.

Renal and hepatic impairment:

No dosage adjustment is necessary for patients with renal or hepatic impairment.


It is not recommended for use in children, as there is no experience of its use in this group.


i) Experience to date with deliberate or accidental overdose is limited. The maximum established exposure has not exceeded 60 mg twice daily, or 160mg once daily.
ii) Effects are generally minimal, representative of the known adverse event profile and reversible without further medical intervention. No specific antidote is known. Rabeprazole sodium is extensively protein bound and is, therefore, not dialysable.



Store in a cool and dry place below 30°C.
Protect from light and moisture.
Keep Medicine away from children.


Shelf Life: 24 months


Pack size: Blister pack of 10 tablets


Updated on February 9, 2024.

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