PARIET

What it is

PARIET 10 is available as enteric coated tablets containing 10 mg rabeprazole sodium (equivalent to 9.42 mg rabeprazole). Rabeprazole sodium is a substituted benzimidazole and belongs to the class of proton pump inhibitors. Rabeprazole sodium 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

— Symptomatic relief of heartburn and other symptoms of gastro-oesophageal reflux disease

Dosing overview

The recommended dose for adults 18 years of age and over is one tablet per day to be taken at the same time each day (to facilitate treatment compliance) for at least 7 days and up to 14 days. If symptom control has not been achieved after two weeks of continuous treatment with PARIET 10, patients should be referred to their doctor. PARIET 10 tablets should not be chewed or crushed, but should be swallowed whole.

Key safety warnings

Symptomatic response to therapy with PARIET 10 does not preclude the presence of gastric malignancy, therefore the possibility of malignancy should be excluded prior to commencing treatment with PARIET 10. Patients on PARIET 10 should be further reviewed and/or investigated if symptoms persist or recur within 2 weeks of completing the course. Acute tubulo interstitial nephritis (TIN) has been observed in patients taking proton-pump inhibitors (PPIs) including rabeprazole sodium. Acute tubulo interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Acute tubulointerstitial nephritis can progress to renal failure. Daily treatment with acid-suppressing medicines over a long period of time (e.g. longer than 3 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 PPIs. Serious adverse events include tetany, arrhythmias, and seizures. Observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased 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 PPIs. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping rabeprazole.

Contraindications

PARIET 10 is contraindicated in patients with known hypersensitivity to rabeprazole sodium, proton pump inhibitors, or any ingredient of this product.

PBS listing

No source document provides information about the PBS listing, including strength, item number, restriction type, or ex-manufacturer price for PARIET 10.

Regulatory history

PARIET rabeprazole sodium 10mg tablet blister pack was first listed on the ARTG on 31 October 2000. PARIET 10 rabeprazole sodium 10 mg enteric-coated tablet blister pack was first listed on the ARTG on 8 April 2010. In November 2017, the PBAC recommended an amendment to the current PBS listing to allow rabeprazole to be used for the treatment of gastro-oesophageal reflux disease (GORD) in adult and paediatric patients.