RAZIT

What it is

RAZIT is an enteric-coated tablet containing 10 mg or 20 mg rabeprazole sodium . Rabeprazole sodium is a substituted benzimidazole and belongs to the class of proton pump inhibitors . Oral administration of a 20 mg dose of rabeprazole provides rapid and effective reduction of gastric acid secretion, with the onset of the anti-secretory effect occurring within one hour and maximum effect occurring within two to four hours .

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

Key safety warnings

Symptomatic response to therapy with RAZIT 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, may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction; discontinue rabeprazole sodium if acute interstitial nephritis develops . 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 . Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs; serious adverse events include tetany, arrhythmias and seizures, and in most patients treatment required magnesium replacement and discontinuation of the PPI . 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 in patients who received high-dose and long-term PPI therapy . Concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities; a temporary withdrawal of the PPI may be considered in some patients .

Contraindications

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

Regulatory history

RAZIT 10 mg rabeprazole sodium enteric coated tablets was first listed on the ARTG on 5 April 2012 . RAZIT 20 mg rabeprazole sodium enteric coated tablets was first listed on the ARTG on 5 April 2012 .