OZMEP

What it is

OZMEP is a proton pump inhibitor. Each capsule contains omeprazole 20 mg. OZMEP is supplied as opaque yellow hard gelatin capsules containing enteric coated off-white to cream-white spherical microgranules. Omeprazole reversibly reduces gastric acid secretion by specifically inhibiting the gastric enzyme H+, K+-ATPase, the proton pump, in the acid environment of the intracellular canaliculi within the parietal cell.

Approved indications

— Relief of heartburn and other symptoms associated with gastro-oesophageal reflux disease (GORD) — Treatment and prevention of relapse of erosive oesophagitis — Treatment of duodenal and gastric ulcer — Combination therapy for the treatment of peptic ulcer disease associated with Helicobacter pylori infection — Treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs — Prevention of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs in patients assessed as being at high risk of gastroduodenal ulcer or complications of gastroduodenal ulcer — Long-term prevention of relapse in gastric and duodenal ulceration in patients proven to be Helicobacter pylori negative, or in whom eradication is inappropriate, such as the elderly or ineffective — Treatment of Zollinger-Ellison Syndrome

Dosing overview

OZMEP should be swallowed whole, not broken or chewed, with liquid. Dosing varies by indication:

No dosage adjustment is necessary in elderly patients. No dosage adjustment is required in patients with reduced renal function. The normal dose of 20 mg omeprazole daily may be used in patients with severe liver disease.

Key safety warnings

As with all antisecretory agents, the presence of alarm symptoms such as significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena should prompt exclusion of malignancy, as treatment with omeprazole may alleviate symptoms and delay diagnosis. Concomitant use of omeprazole and clopidogrel should be avoided. Acute interstitial nephritis has been observed in patients taking proton pump inhibitors including omeprazole and may occur at any point during therapy. Daily treatment with acid-suppressing medicines over a long period of time, such as longer than 3 years, may lead to malabsorption of cyanocobalamin (vitamin B-12) caused by hypo- or achlorhydria. Published studies suggest that proton pump inhibitor therapy may be associated with an increased risk for osteoporosis-related fractures, particularly with high-dose and long-term therapy. Patients should use the lowest dose and shortest duration of proton pump inhibitor therapy appropriate to the condition being treated. Subacute cutaneous lupus erythematosus has been reported with proton pump inhibitors; if lesions occur especially in sun-exposed areas and are accompanied by arthralgia, the patient should seek medical help and the healthcare professional should consider stopping omeprazole.

Contraindications

OZMEP is contraindicated in patients with hypersensitivity to omeprazole, substituted benzimidazoles or any other ingredient. Omeprazole is contraindicated in patients taking cilostazol.

Regulatory history

OZMEP omeprazole 20 mg enteric-coated tablet in blister was first listed on the ARTG on 26 May 2009. OZMEP omeprazole 20 mg enteric-coated tablet in bottle was first listed on the ARTG on 8 December 2011.