ACEOMEZ

What it is

ACEOMEZ contains esomeprazole magnesium trihydrate, a substituted benzimidazole. ACEOMEZ is a proton pump inhibitor that reversibly reduces gastric acid secretion by specifically inhibiting the gastric enzyme H+, K+-ATPase proton pump in the parietal cell. ACEOMEZ 20 mg and 40 mg tablets are comprised of enteric coated pellets containing esomeprazole as magnesium trihydrate.

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 NEXIUM IV 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

For gastro-oesophageal reflux disease, treatment of erosive oesophagitis requires 40 mg once daily for four weeks (with an additional four weeks for patients in whom oesophagitis has not healed or symptoms persist). Long-term management of healed oesophagitis uses 20 mg once daily. Symptomatic treatment in patients with normal endoscopy is 20 mg once daily for four weeks, with an option for on-demand dosing of 20 mg once daily as needed after symptom resolution. For NSAID-related indications, the dose is 20 mg once daily for short-term treatment of upper gastrointestinal symptoms, 20 mg once daily for four to eight weeks for gastric ulcer healing, and 20 mg once daily for prevention of ulcers. For pathological hypersecretory conditions, the recommended initial dose is 40 mg twice daily, with individual adjustment and doses up to 120 mg twice daily reported. For Helicobacter pylori eradication in combination with antibiotics, the dose is 20 mg twice daily for seven days.

Key safety warnings

The presence of alarm symptoms such as significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena, and when gastric ulcer is suspected or present, requires 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 treatment 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, may occur at any point during therapy and is generally attributed to idiopathic hypersensitivity reaction. Acute tubulointerstitial nephritis can progress to renal failure. Esomeprazole should be discontinued if acute tubulointerstitial nephritis develops. Daily treatment with acid-suppressing medicines over a long period of time, such as longer than three 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 an increased risk for osteoporosis-related fractures, with increased risk in patients who received high-dose and long-term therapy of a year or longer. Patients should use the lowest dose and shortest duration of therapy appropriate to the condition being treated. Subacute cutaneous lupus erythematosus has been reported with the use of proton pump inhibitors. If lesions occur, especially in sun-exposed areas of the skin and if accompanied by arthralgia, the patient should seek medical help promptly and discontinuation should be considered. Hypomagnesaemia, symptomatic and 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 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 treatment. Patients should be advised of signs and symptoms and seek medical advice immediately when observing indicative signs. 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.

PBS listing

Information regarding PBS listing, including strengths, item counts, restriction type and ex-manufacturer price, is not available in the provided source documents.

Regulatory history

ACEOMEZ esomeprazole 20 mg and 40 mg enteric coated tablets in blister pack and bottle pack formulations were first registered on the Australian Register of Therapeutic Goods on 4 May 2020. Reformulated variants were subsequently registered on 22 September 2021. A heartburn relief formulation was registered on 8 October 2021, and a further reformulation was registered on 27 November 2024.