PROBITOR

What it is

Probitor is an omeprazole 20 mg enteric-coated capsule. The capsules contain 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 gastro-oesophageal reflux disease (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 (for example, the elderly) or ineffective. — Treatment of Zollinger-Ellison syndrome.

Dosing overview

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 H. pylori-associated peptic ulcer disease, omeprazole is administered at a dose of 40 mg once daily or 20 mg twice daily in association with antimicrobial combinations. 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 prevention of NSAID-associated gastric or duodenal ulcers or erosions, omeprazole 20 mg once daily is recommended. For Zollinger-Ellison syndrome, the recommended initial dose is omeprazole 60 mg once daily.

Key safety warnings

Undiagnosed malignancy should be excluded when alarm symptoms such as significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena are present or gastric ulcer is suspected, as treatment with omeprazole may alleviate symptoms and delay diagnosis. Concomitant use of omeprazole and clopidogrel should be avoided. Subacute cutaneous lupus erythematosus has been reported with 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. Treatment with acid-reducing drugs 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 acid-suppressing medicines over a long period of time (for example, longer than three 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 proton pump inhibitors; serious adverse events include tetany, delirium, arrhythmias and seizures, and in most patients treatment required magnesium replacement and discontinuation of the proton pump inhibitor. Proton pump inhibitors, 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; observational studies suggest that proton pump inhibitors may increase the overall risk of fracture. 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; omeprazole should be discontinued if acute interstitial nephritis develops. 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 omeprazole treatment; patients should seek medical advice immediately upon observing any indicative signs or symptoms, and omeprazole should be discontinued immediately.

Contraindications

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

Regulatory history

Probitor omeprazole 20 mg enteric capsules were first registered on the ARTG on 20 December 2001 (bottle pack, ARTG 78186) and 25 June 2002 (blister pack, ARTG 82757). In November 2017, the PBAC recommended an amendment to the PBS listing to allow omeprazole to be used for the treatment of gastro-oesophageal reflux disease in adult and paediatric patients.