RABEPRAZOLE VIATRIS

What it is

RABEPRAZOLE is rabeprazole sodium, available as enteric coated tablets containing 10 mg or 20 mg rabeprazole sodium. Rabeprazole sodium is a substituted benzimidazole belonging to the class of proton pump inhibitors that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase enzyme at the secretory surface of the gastric parietal cell.

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 amoxycillin. — Healing of peptic ulcers in patients with Helicobacter pylori associated ulcers, in combination with clarithromycin and amoxycillin.

Dosing overview

For symptomatic treatment without oesophagitis, treatment should commence at 10 mg once daily, increased to 20 mg once daily for four weeks if no response. RABEPRAZOLE tablets should not be chewed or crushed, but should be swallowed whole.

Key safety warnings

Symptomatic response to therapy with RABEPRAZOLE does not preclude the presence of gastric malignancy, therefore the possibility of malignancy should be excluded prior to commencing treatment. Acute interstitial nephritis has been observed in patients taking proton pump inhibitors including rabeprazole sodium, which may occur at any point during therapy and is generally attributed to an idiopathic hypersensitivity reaction. RABEPRAZOLE should be discontinued if acute interstitial 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. Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with proton pump inhibitors, with serious adverse events including tetany, arrhythmias and seizures. In most patients, treatment required magnesium replacement and discontinuation of the proton pump inhibitor. 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, particularly with high-dose and long-term therapy of one year or longer. Long-term use of RABEPRAZOLE is associated with an increased risk of fundic gland polyps, and patients with large or ulcerated polyps may be at risk of gastrointestinal bleeding or small intestinal blockage.

Contraindications

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

Regulatory history

RABEPRAZOLE was first approved on 22 March 2012. ARTG registrations include RABEPRAZOLE AN 20 mg enteric coated tablet (ARTG 189218) and 10 mg enteric coated tablet (ARTG 189233), both first listed on 5 April 2012.