PANTOPRAZOLE SANDOZ

What it is

Pantoprazole Medsurge is pantoprazole sodium sesquihydrate 40 mg powder for solution for injection supplied in a vial. 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.

Approved indications

Pantoprazole Medsurge is indicated for short-term use where oral therapy is not appropriate for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion, including: — Duodenal ulcer — Gastric ulcer — Reflux oesophagitis — Gastrointestinal lesions refractory to H2 blockers — Zollinger-Ellison Syndrome Pantoprazole Medsurge is also indicated for maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis.

Dosing overview

For duodenal ulcer, gastric ulcer, gastrointestinal lesions refractory to H2 blockers, and Zollinger-Ellison syndrome, the dose is 40 mg per day. For reflux oesophagitis, the dose is 20–40 mg per day. Intravenous Pantoprazole Medsurge should be replaced with oral therapy as soon as practicable.

Key safety warnings

In the presence of alarm symptoms such as significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena, and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with 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 pantoprazole may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella, Campylobacter and Clostridium difficile. 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 pantoprazole should be discontinued at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity. Proton pump inhibitors are associated in rare cases with subacute cutaneous lupus erythematosus, and if lesions occur, especially in sun-exposed areas with accompanying arthralgia, the patient should seek medical help promptly and the healthcare professional should consider stopping the product. 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 of one year or longer. Acute interstitial nephritis has been observed in patients taking pantoprazole and may occur at any point during proton pump inhibitor 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 and serious consequences include tetany, arrhythmia, and seizure, with hypomagnesaemia potentially leading to hypocalcaemia and/or hypokalaemia.

Contraindications

Pantoprazole Medsurge is contraindicated in 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.

Regulatory history

Pantoprazole Medsurge was first listed on the Australian Register of Therapeutic Goods on 15 January 2025.