SALPRAZ

What it is

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

Approved indications

**Adults** — Symptomatic improvement and healing of duodenal ulcer. — Symptomatic improvement and healing of gastric ulcer. — Symptomatic improvement and healing of gastro-oesophageal reflux disease (GORD). — Treatment of heartburn and other symptoms associated with GORD. — Treatment of reflux oesophagitis. — Treatment of gastrointestinal lesions refractory to H2 blockers. — Treatment of Zollinger-Ellison Syndrome. — Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. — Eradication of Helicobacter pylori in combination with antibiotics in cases of duodenal ulcer and gastric ulcer. — 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. **Children aged 5 to 17 years** — Symptomatic GORD and treatment of heartburn and other symptoms associated with GORD. — Reflux oesophagitis.

Dosing overview

SALPRAZ tablets should not be chewed or crushed but swallowed whole with a little water. For H. pylori eradication, SALPRAZ 40 mg is given twice daily in combination with antibiotics for 7 days, with specific regimens depending on the antibiotic combination used. For Zollinger-Ellison Syndrome, the dose is 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 pantoprazole may alleviate symptoms and delay diagnosis. Treatment with pantoprazole may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella, Campylobacter and Clostridium difficile. Pantoprazole may reduce the absorption of cyanocobalamin (vitamin B12) due to reduced acid secretion, which should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy. Proton pump inhibitor therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine, particularly in patients receiving high-doses and 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; pantoprazole should be discontinued at the first signs or symptoms of severe cutaneous adverse reactions. Proton pump inhibitors are associated in rare cases with subacute cutaneous lupus erythematosus; if lesions occur especially in sun-exposed areas accompanied by arthralgia, medical help should be sought promptly. Acute interstitial nephritis has been observed in patients taking pantoprazole and may occur at any point during therapy; pantoprazole 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, with serious consequences including tetany, arrhythmia, and seizure.

Contraindications

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

PBS listing

SALPRAZ is not listed on the Pharmaceutical Benefits Scheme according to the provided source documents.

Regulatory history

SALPRAZ pantoprazole 20 mg and 40 mg enteric-coated tablets were first registered on the Australian Register of Therapeutic Goods on 23 June 2020. A reformulated variant, SALPRAZ HEARTBURN RELIEF pantoprazole 20 mg, was subsequently registered on 12 November 2020.