ESOMEPRAZOLE-WGR

What it is

ESOMEPRAZOLE-WGR contains esomeprazole magnesium, a proton pump inhibitor. Each enteric-coated tablet comprises enteric-coated pellets with esomeprazole magnesium equivalent to esomeprazole 20 mg or 40 mg.

Approved indications

— Treatment of erosive reflux oesophagitis. — Long-term management of patients with healed oesophagitis to prevent relapse. — Symptomatic treatment of gastro-oesophageal reflux disease (GORD). — Short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug (NSAID) therapy. — Healing of gastric ulcers associated with NSAID therapy. — Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk. — Prevention of rebleeding of gastric or duodenal ulcers following treatment with esomeprazole solution administered by intravenous infusion. — Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion. — In combination with appropriate antibiotics for healing of duodenal ulcer associated with Helicobacter pylori. — In combination with appropriate antibiotics for eradication of Helicobacter pylori in patients with active or healed peptic ulcer.

Dosing overview

ESOMEPRAZOLE-WGR tablets should be swallowed whole with liquid and should not be chewed or crushed.

Key safety warnings

Alarm symptoms such as significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena warrant exclusion of malignancy, as treatment with esomeprazole may alleviate symptoms and delay diagnosis. Decreased gastric acidity due to proton pump inhibitors increases gastric counts of bacteria normally present in the gastrointestinal tract and may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter, and possibly also Clostridium difficile in hospitalised patients. Concomitant use of esomeprazole and clopidogrel results in decreased exposure to the active metabolite of clopidogrel by an average of 40% and decreased maximum inhibition of platelet aggregation by an average of 14%, and should be avoided. Acute tubulointerstitial nephritis has been observed in patients taking proton pump inhibitors including esomeprazole, may occur at any point during therapy, and can progress to renal failure. Daily treatment with acid-suppressing medicines over a long period (longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B-12) caused by hypo- or achlorhydria. Proton pump inhibitor therapy may be associated with an increased risk for osteoporosis-related fractures, particularly in patients receiving high-dose and long-term therapy (a year or longer). Hypomagnesaemia, symptomatic and asymptomatic, has been reported rarely in patients treated with proton pump inhibitors, with serious adverse events including tetany, arrhythmias and seizures. Severe cutaneous adverse reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms, which can be life-threatening or fatal, have been reported very rarely in association with esomeprazole treatment.

Contraindications

Known hypersensitivity to esomeprazole, substituted benzimidazoles or any other constituents of the formulation. Esomeprazole should not be administered with atazanavir. Esomeprazole is contraindicated in patients taking cilostazol.

Regulatory history

ESOMEPRAZOLE-WGR esomeprazole 20 mg enteric-coated tablets (ARTG 432110) and esomeprazole 40 mg enteric-coated tablets (ARTG 432111) were first listed on the ARTG on 29 May 2024.