ESOPREZE

What it is

ESOPREZE is an enteric-coated tablet containing esomeprazole as magnesium dihydrate, available in 20 mg and 40 mg strengths. Esomeprazole reversibly reduces gastric acid secretion by specifically inhibiting the gastric enzyme H+, K+-ATPase proton pump in the parietal cell.

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 by intravenous infusion. — Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion. — Healing of duodenal ulcer associated with Helicobacter pylori in combination with appropriate antibiotics. — Eradication of Helicobacter pylori in patients with active or healed peptic ulcer in combination with appropriate antibiotics.

Dosing overview

ESOPREZE enteric-coated 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 should be investigated, as treatment with esomeprazole may alleviate symptoms and delay diagnosis of malignancy when gastric ulcer is suspected or present. Decreased gastric acidity due to proton pump inhibitors increases gastric bacterial counts and may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter, and in hospitalised patients, possibly also Clostridium difficile. Acute tubulointerstitial nephritis has been observed in patients taking proton pump inhibitors including esomeprazole and may occur at any point during therapy, generally attributed to idiopathic hypersensitivity reaction, and can progress to renal failure. 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. Some published studies suggest that proton pump inhibitor therapy may be associated with increased risk for osteoporosis-related fractures, particularly with high-dose and long-term therapy of a year or longer, and patients should use the lowest dose and shortest duration appropriate to the condition being treated. Subacute cutaneous lupus erythematosus has been reported with proton pump inhibitors, and if lesions occur especially in sun-exposed areas accompanied by arthralgia, the patient should seek medical help and the health care professional should consider stopping esomeprazole. Hypomagnesaemia, symptomatic and asymptomatic, has been reported rarely in patients treated with proton pump inhibitors with serious adverse events including tetany, arrhythmias and seizures, and in most patients treatment required magnesium replacement and discontinuation of the proton pump inhibitor. 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 with esomeprazole, and esomeprazole should be discontinued immediately upon signs and symptoms of severe skin reactions.

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

ESOPREZE esomeprazole 20 mg and 40 mg tablets were first listed on the ARTG on 2020-12-01.