PANTOPRAZOLE GENERICHEALTH

What it is

Pantoprazole GENERICHEALTH 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. Each enteric coated tablet contains 20 mg or 40 mg pantoprazole as sodium sesquihydrate.

Approved indications

— Symptomatic improvement and healing of duodenal ulcer — Symptomatic improvement and healing of gastric ulcer — Symptomatic GORD (treatment of heartburn and other symptoms with gastro-oesophageal reflux disease) — Treatment of reflux oesophagitis — Symptomatic improvement and healing of gastrointestinal lesions refractory to H2 blockers — Symptomatic improvement and healing of 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

Key safety warnings

When gastric ulcer is suspected or present, malignancy should be excluded, as treatment with pantoprazole may alleviate symptoms and delay diagnosis. PPI therapy may be associated with an increased risk of Clostridium difficile infection. Treatment with pantoprazole may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella, Campylobacter and Clostridium difficile. Pantoprazole, as all acid blocking medicines, may reduce the absorption of cyanocobalamin (vitamin B12) due to hypochlorhydria or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption (such as the elderly) on long-term therapy and in patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions requiring long-term treatment if respective clinical symptoms are observed. 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 in association with the use of PPIs. Discontinue pantoprazole 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 the occurrence of subacute cutaneous lupus erythematosus. 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 healthcare professional should consider stopping the product. PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-doses; defined as multiple daily doses, and long-term PPI therapy (a year or longer). Acute interstitial nephritis has been observed in patients taking PPIs including pantoprazole. Acute interstitial nephritis may occur at any point during PPI therapy and is generally associated to an idiopathic hypersensitivity reaction. Discontinue pantoprazole if acute interstitial nephritis develops. Hypomagnesaemia has been rarely reported in patients treated with PPIs for at least three months (in most cases after a year of therapy). Serious consequences of hypomagnesaemia include tetany, arrhythmia, and seizure.

Contraindications

Pantoprazole GENERICHEALTH 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.

Regulatory history

Pantoprazole GENERICHEALTH 20 mg and 40 mg enteric-coated tablets were first registered on the Australian Register of Therapeutic Goods on 21 March 2012.