BPA-PANTOPRAZOLE

What it is

BPA-PANTOPRAZOLE is a proton pump inhibitor that inhibits specifically and dose-proportionately H+/K+-ATPase, the enzyme responsible for gastric acid secretion in the parietal cells of the stomach. BPA-PANTOPRAZOLE contains pantoprazole as sodium sesquihydrate and is available as enteric-coated tablets in 20 mg and 40 mg strengths.

Approved indications

— Symptomatic improvement and healing of duodenal ulcer — Symptomatic improvement and healing of gastric ulcer — Treatment of symptomatic gastro-oesophageal reflux disease (GORD), including symptomatic GORD (treatment of heartburn and other symptoms) and reflux oesophagitis — Symptomatic improvement and healing of gastrointestinal lesions refractory to H2 blockers — Zollinger-Ellison Syndrome — Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis — Prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in increased risk patients with a need for continuous non-selective NSAID treatment

Dosing overview

For duodenal ulcer, BPA-PANTOPRAZOLE 40 mg should be given once daily. For gastric ulcer, BPA-PANTOPRAZOLE 40 mg should be given once daily. For symptomatic GORD, the recommended dosage is 20 mg once daily. For treatment of reflux oesophagitis, the recommended oral dosage is 20 or 40 mg once daily, and this dosage may be increased up to 80 mg daily. For maintenance of healed reflux oesophagitis, a maintenance dose of 20 or 40 mg once daily is recommended, dependent on patient response. For prevention of NSAID-associated gastroduodenal lesions, the recommended oral dosage is 20 mg once daily. For Zollinger-Ellison syndrome, the number of tablets should be individually adjusted so that acid output remains below 10 mmol/L.

Key safety warnings

When gastric ulcer is suspected or present, malignancy should be excluded, as treatment with BPA-PANTOPRAZOLE may alleviate symptoms and delay diagnosis. Proton pump inhibitor therapy may be associated with an increased risk of Clostridium difficile infection, and treatment with BPA-PANTOPRAZOLE may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella, Campylobacter and Clostridium difficile. BPA-PANTOPRAZOLE, as an acid-blocking medicine, may reduce the absorption of cyanocobalamin (vitamin B12) due to hypochlorhydria or achlorhydria, and this should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy. Severe cutaneous adverse reactions, including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalised exanthematous pustulosis have been reported with proton pump inhibitors, and BPA-PANTOPRAZOLE should be discontinued at the first signs or symptoms of severe cutaneous adverse reactions. Proton pump inhibitor therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine, particularly in patients who received high-doses and long-term therapy of one year or longer. Acute interstitial nephritis has been observed in patients taking proton pump inhibitors including BPA-PANTOPRAZOLE, and the medicine should be discontinued if acute interstitial nephritis develops. Hypomagnesaemia has been rarely reported in patients treated with proton pump inhibitors for at least three months, and serious consequences include tetany, arrhythmia and seizure.

Contraindications

BPA-PANTOPRAZOLE is contraindicated in cases of known hypersensitivity to pantoprazole, substituted benzimidazoles or any other components of the formulation, or in cases of cirrhosis or severe liver disease. BPA-PANTOPRAZOLE should not be coadministered with HIV protease inhibitors such as atazanavir or nelfinavir.

Regulatory history

BPA-PANTOPRAZOLE was first registered on the Australian Register of Therapeutic Goods on 7 June 2018, with pantoprazole 20 mg and 40 mg enteric-coated tablet formulations registered under licence category RE.