MAXOR

What it is

MAXOR contains omeprazole 20 mg in enteric-coated capsules. The medicine comprises enteric-coated, off-white to cream-white spherical pellets contained in opaque yellow hard gelatin capsules.

Approved indications —

Relief of heartburn and other symptoms associated with GORD — Treatment and prevention of relapse in 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 (NSAIDs) — Prevention of gastric and duodenal ulcers and erosions associated with NSAIDs 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 (e.g. the elderly) or ineffective — Treatment of Zollinger-Ellison syndrome

Dosing overview

Dosing varies by indication. For symptomatic GORD, the recommended dose is omeprazole 10 mg 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 commenced with omeprazole 10 mg once daily, 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, omeprazole 20 mg once daily for four to eight weeks is recommended. 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. MAXOR should be swallowed whole with water.

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, and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with omeprazole may alleviate symptoms and delay diagnosis. Subacute cutaneous lupus erythematosus (SCLE) 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 the health care professional should consider stopping omeprazole. Decreased gastric acidity due to omeprazole increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with omeprazole may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and, in hospitalised patients, possibly also Clostridium difficile. Daily treatment with omeprazole over a long period of time (e.g. longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B12) caused by hypo- or achlorhydria. Hypomagnesaemia, symptomatic and asymptomatic, has been reported rarely in patients treated with omeprazole. Serious adverse events include tetany, delirium, arrhythmias, and seizures. In most patients, treatment of hypomagnesaemia required magnesium replacement and discontinuation of the proton pump inhibitor. Omeprazole, especially if used in high doses and over long durations, may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in the presence of other recognised risk factors. Acute interstitial nephritis has been observed in patients taking omeprazole. Acute interstitial nephritis may occur at any point during omeprazole therapy and is generally attributed to idiopathic hypersensitivity reaction. Severe cutaneous adverse reactions (SCARs) 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 omeprazole treatment.

Contraindications

MAXOR is contraindicated in patients with hypersensitivity to omeprazole, substituted benzimidazoles or any other ingredient of the product. Omeprazole is contraindicated in patients taking cilostazol. Omeprazole must not be used concomitantly with nelfinavir.

PBS listing

MAXOR 20 mg is listed on the PBS with a streamlined authority required restriction. Eight PBS items are available at an ex-manufacturer price of A$4.00.

Regulatory history

MAXOR received ARTG registration for two formulations: MAXOR HEARTBURN RELIEF omeprazole 20 mg enteric capsule (ARTG 180913) first listed on 7 March 2011, and MAXOR omeprazole 20 mg capsule (ARTG 173994) first listed on 11 March 2011.