RABEPRAZOLE-WGR

What it is

RABEPRAZOLE-WGR contains rabeprazole sodium, with each enteric coated tablet containing either 10 mg rabeprazole sodium (equivalent to 9.42 mg rabeprazole) or 20 mg rabeprazole sodium (equivalent to 18.85 mg rabeprazole). Rabeprazole sodium is a substituted benzimidazole belonging to the class of proton pump inhibitors, which suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase enzyme at the secretory surface of the gastric parietal cell, thereby blocking the final step of acid production.

Approved indications

— Treatment and prevention of relapse of gastro-oesophageal reflux disease — Symptomatic treatment of gastro-oesophageal reflux disease — Treatment of duodenal ulcers — Treatment of gastric ulcers — Eradication of Helicobacter pylori in patients with peptic ulcer disease or chronic gastritis, in combination with clarithromycin and amoxicillin — Healing of peptic ulcers in patients with Helicobacter pylori associated ulcers, in combination with clarithromycin and amoxicillin

Dosing overview

RABEPRAZOLE-WGR tablets should not be chewed or crushed, but should be swallowed whole and taken at the same time each day.

Key safety warnings

Acute tubulointerstitial nephritis has been observed in patients taking proton pump inhibitors including rabeprazole sodium, may occur at any point during therapy and is generally attributed to an idiopathic hypersensitivity reaction, and can progress to renal failure. Discontinue rabeprazole sodium if acute tubulointerstitial nephritis develops. Daily treatment with acid-suppressing medicines over a long period of time (longer than three years) may lead to malabsorption of cyanocobalamin (vitamin B-12) caused by hypo- or achlorhydria. Hypomagnesaemia, symptomatic and asymptomatic, has been reported rarely in patients treated with proton pump inhibitors, with serious adverse events including tetany, arrhythmias and seizures, and in most patients treatment required magnesium replacement and discontinuation of the PPI. Healthcare professionals may consider monitoring magnesium levels prior to initiation of treatment and then periodically while treatment continues for patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesaemia. Observational studies suggest that proton pump inhibitor therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine, with increased risk in patients who received high-dose and long-term therapy of one year or longer. Subacute cutaneous lupus erythematosus has been reported with the use of proton pump inhibitors, and if lesions occur, especially in sun-exposed areas of the skin and if accompanied by arthralgia, the patient should seek medical help promptly and healthcare professionals should consider stopping rabeprazole sodium.

Contraindications

RABEPRAZOLE-WGR is contraindicated in patients with known hypersensitivity to rabeprazole sodium, proton pump inhibitors, or any ingredient of this product.

Regulatory history

RABEPRAZOLE-WGR 10 mg enteric coated tablets and 20 mg enteric coated tablets were first listed on the ARTG on 9 July 2012.