RABIROL 20 Tablet

For the relief of signs and symptoms of:

1) Active duodenal ulcer

2) Active benign gastric ulcer

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

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

5) Zollinger-Ellison Syndrome

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

Dosage

Posology and Method of administration

Oral

Adults/elderly

Active Duodenal Ulcer and Active Benign Gastric Ulcer:

20mg to be taken once daily in the morning.

Most patients with active duodenal ulcer heal within 4weeks and with active benign gastric ulcer heal within 6 weeks. However a few patients may require an additional 4/6 weeks of therapy to achieve healing.

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

20mg to be taken once daily for 4-8 weeks.

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

A maintenance dose of 20mg or 10mg once daily can be used depending upon patient response.

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

10mg once daily in patients without oesophagitis. If symptom control has not been achieved during 4 weeks, the patient should be further investigated.

Zollinger-Ellison Syndrome:

60mg once a day. The dose may be titrated upwards to 120mg/day based on individual patient needs. Single daily doses up to 100mg/day may 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 20mg twice daily + clarithromycin 500mg twice daily and amoxicillin 1g twice daily.

Renal and hepatic impairment:

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

Children:

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

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 breast feeding.

(See the package insert about the details.)

CNS

Dermatologic

GI

Hepatic

Hematologic-Lymphatic

Metabolic-Nutritional

Musculoskeletal

Miscellaneous

(See the package insert about the details.)

1) Ketoconazole or itraconazole

2) Antacids

3) Atazanavir

Pregnancy

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.

Lactation

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.

1) 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.

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

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

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

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

6) 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.

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

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

1) 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).

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

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.