APO-RABEPRAZOLE

What it is

APO-RABEPRAZOLE contains rabeprazole sodium and is available as enteric coated tablets in strengths of 10 mg (equivalent to 9.42 mg rabeprazole) and 20 mg (equivalent to 18.85 mg rabeprazole). Rabeprazole sodium is a substituted benzimidazole that belongs to the class of proton pump inhibitors and suppresses gastric acid secretion by the specific inhibition of the H+/K+-ATPase enzyme (proton pump) 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

For treatment of active gastro-oesophageal reflux disease, the recommended oral dose is one 20 mg tablet taken once daily for four to eight weeks. For prevention of relapse of gastro-oesophageal reflux disease, the recommended dose is one 10 mg tablet taken once daily, which should be increased to one 20 mg tablet once daily if needed. For symptomatic treatment of gastro-oesophageal reflux disease, treatment should commence at 10 mg once daily in patients without oesophagitis, and if no response, the dose should be increased to 20 mg once daily for four weeks. For treatment of active duodenal ulcer and gastric ulcer, the recommended oral dose is one 20 mg tablet taken once daily, although some patients with duodenal ulcer may respond to one 10 mg tablet taken once daily. For eradication of *H. pylori*, the recommended dose is rabeprazole sodium 20 mg twice daily in combination with clarithromycin 500 mg twice daily and amoxicillin 1 g twice daily for seven days.

Key safety warnings

Acute tubulointerstitial nephritis (TIN) has been observed in patients taking proton pump inhibitors including rabeprazole sodium, may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction, and can progress to renal failure. Daily treatment with acid-suppressing medicines over a long period of time (longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B-12) caused by hypo- or achlorhydria. Hypomagnesaemia has been reported rarely in patients treated with proton pump inhibitors, with serious adverse events including tetany, arrhythmias, and seizures. 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 PPI therapy (a year or longer). Subacute cutaneous lupus erythematosus (SCLE) has been reported with the use of proton pump inhibitors; if lesions occur, especially in sun-exposed areas, and if accompanied by arthralgia, the patient should seek medical help promptly and healthcare professionals should consider stopping rabeprazole sodium. Long-term use of rabeprazole sodium 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

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

Regulatory history

APO-RABEPRAZOLE 10 mg enteric coated tablets (ARTG 245232) and 20 mg enteric coated tablets (ARTG 245233) were first listed on the Australian Register of Therapeutic Goods on 6 January 2016.