RABEPRAZOLE SODIUM

Posology Adults/elderly:

Active duodenal ulcer and active benign gastric ulcer: The recommended oral dose for both active duodenal ulcer and active benign gastric ulcer is 20 mg to be taken once daily in the morning. Most patients with active duodenal ulcer heal within four weeks.

However a few patients may require an additional four weeks of therapy to achieve healing. Most patients with active benign gastric ulcer heal within six weeks. However again a few patients may require an additional 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 (symptomatic GORD): 10 mg once daily in patients without oesophagitis.

If symptom control has not been achieved during four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10 mg once daily when needed.

Zollinger-Ellison syndrome:

The recommended adult starting dose is 60 mg once a day. The dose may be titrated upwards to 120 mg/day based on individual patient needs. Single daily doses up to 100 mg/day may be given. 120 mg dose may require divided doses, 60 mg twice daily.

Treatment should continue for as long as clinically indicated. Eradication of H. pylori: Patients with H. pylori infection should be treated with eradication therapy. The following combination given for 7 days is recommended. Rabeprazole sodium 20 mg twice daily + clarithromycin 500 mg twice daily and amoxicillin 1 g twice daily.

For indications requiring once daily treatment Rabeprazole sodium tablets should be taken in the morning, before eating; and although neither the time of day nor food intake was shown to have any effect on rabeprazole sodium activity, this regimen will facilitate treatment compliance.

Summary of the safety profile The most commonly reported adverse drug reactions, during controlled clinical trials with rabeprazole were headache, diarrhoea, abdominal pain, asthenia, flatulence, rash and dry mouth. The majority of adverse events experienced during clinical studies were mild or moderate in severity, and transient in nature.

Tabulated list of adverse reactions The following adverse reactions have been reported from clinical trial and post- marketing experience. 4). Musculoskelet al and connective tissue disorders non- specific pain, back pain myalgia, leg cramps, arthralgia Fracture of the hip, wrist or spine4 Renal and urinary disorders urinary tract infection tubulointerstitia l nephritis (with possible progression to renal failure) Reproductive system and breast disorders gynaecoma stia General disorders and administratio n site conditions asthenia, influenza like illness chest pain, chills, pyrexia Investigations increased hepatic enzymes3 weight increased 1 Includes facial swelling, hypotension and dyspnoea 2 Erythema, bullous reactions and hypersensitivity reactions have usually resolved after discontinuation of therapy.

3 Rare reports of hepatic encephalopathy have been received in patients with underlying cirrhosis. 4). 4) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

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.

Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance. A risk of cross-hypersensitivity reactions with other proton pump inhibitor (PPI) or substituted benzimidazoles cannot be excluded.

Patients should be cautioned that Rabeprazole sodium tablets should not be chewed or crushed, but should be swallowed whole. 8). Acute tubulointerstitial nephritis can progress to renal failure. Rabeprazole should be discontinued in case of suspected TIN, and appropriate treatment should be promptly initiated.

Paediatric population Rabeprazole sodium tablets is not recommended for use in children, as there is no experience of its use in this group. There have been post marketing reports of blood dyscrasias (thrombocytopenia and neutropenia).

In the majority of cases where an alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole. Hepatic enzyme abnormalities have been seen in clinical trials and have also been reported since market authorisation.

In the majority of cases where an alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole. No evidence of significant medicine related safety problems was seen in a study of patients with mild to moderate hepatic impairment versus normal age and sex matched controls.

However because there are no clinical data on the use of rabeprazole 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.

1. 6).