OMEPRAZOLE-WGR

What it is

Omeprazole-WGR is an enteric-coated tablet containing 20 mg of omeprazole. The tablets are brown capsule-shaped and debossed with "20" on one side. 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 H. 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 H. pylori negative, or in whom eradication is inappropriate, such as the elderly or ineffective. — Treatment of Zollinger-Ellison syndrome.

Dosing overview

For symptomatic GORD, the recommended dose is omeprazole 10 to 20 mg once daily for a maximum of four weeks. For erosive oesophagitis, the recommended healing dosage is omeprazole 20 mg once daily for four to eight weeks. After healing, maintenance therapy is recommended at omeprazole 10 mg once daily, which should be increased to omeprazole 20 mg once daily if needed. For duodenal ulcer, the recommended healing dosage is omeprazole 20 mg once daily for four to eight weeks. For gastric ulcer, the recommended healing dosage is omeprazole 20 mg once daily for four to eight weeks. For NSAID-associated gastric or duodenal ulcers or erosions, the recommended dose is omeprazole 20 to 40 mg daily. For Zollinger-Ellison syndrome, the recommended initial dose is omeprazole 60 mg once daily. Tablets must be swallowed whole (not broken, halved or chewed) with liquid.

Key safety warnings

Malignancy should be excluded before therapy with Omeprazole-WGR, as treatment may alleviate symptoms and delay diagnosis when alarm symptoms such as significant unintentional weight loss, recurring vomiting, dysphagia, haematemesis, or melaena are present or when gastric ulcer is suspected. Concomitant use of omeprazole and clopidogrel should be avoided. Acute interstitial nephritis has been observed in patients taking proton pump inhibitors including omeprazole, may occur at any point during therapy, and is generally attributed to idiopathic hypersensitivity reaction. Discontinue omeprazole if acute interstitial nephritis develops. 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. Some published case controlled and observational studies suggest that proton pump inhibitor therapy may be associated with an increased risk for osteoporosis-related fractures, particularly in patients who received high-dose (multiple daily doses) and long-term therapy (a year or longer). Patients should use the lowest dose and shortest duration of therapy appropriate to the condition being treated. Hypomagnesaemia, symptomatic or 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 requires magnesium replacement and discontinuation of the proton pump inhibitor. For patients expected to be on prolonged treatment or who take proton pump inhibitors with medications such as digoxin or drugs that may cause hypomagnesaemia (e.g., diuretics), healthcare professionals may consider monitoring magnesium levels prior to initiation and periodically during treatment.

Contraindications

Omeprazole-WGR is contraindicated in patients with hypersensitivity to omeprazole, substituted benzimidazoles or any other ingredients in the tablets, and in patients taking cilostazol.

Regulatory history

Omeprazole-WGR was first approved on 2 January 2025. Two variants are registered on the ARTG: ARTG 444410 for omeprazole 20 mg enteric-coated tablets in bottles and ARTG 444390 for omeprazole 20 mg enteric-coated tablets in blister packs, both first listed on 2 January 2025 in licence category RE.