NNA-PANTOPRAZOLE

What it is

NNA-PANTOPRAZOLE is a proton pump inhibitor that inhibits specifically and dose proportionately H+/K+-ATPase, the enzyme which is 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 as the active ingredient.

Approved indications

— Symptomatic improvement and healing of duodenal ulcer — Symptomatic improvement and healing of gastric ulcer — Symptomatic improvement and healing of gastro-oesophageal reflux disease (GORD) — Symptomatic improvement and healing 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 nonselective NSAIDs in increased risk patients with a need for continuous nonselective NSAID treatment

Dosing overview

For Zollinger-Ellison syndrome, the number of tablets should be individually adjusted so that the acid output remains below 10 mmol/L. Tablets should not be chewed or crushed, but swallowed whole with a little water.

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, and 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 hypochlorhydria or achlorhydria, which should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy and in patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions. 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 NNA-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, with the risk of fracture 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 and may occur at any point during PPI therapy; discontinue pantoprazole if acute interstitial nephritis develops. Hypomagnesaemia has been rarely reported in patients treated with PPIs for at least three months, with serious consequences including tetany, arrhythmia, and seizure.

Contraindications

NNA-PANTOPRAZOLE 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 coadministered with HIV protease inhibitors, such as atazanavir or nelfinavir.

Regulatory history

NNA-PANTOPRAZOLE pantoprazole 20 mg enteric coated tablets were first listed on the ARTG on 2009-12-09 (ARTG 156339). NNA-PANTOPRAZOLE pantoprazole 40 mg enteric coated tablets were first listed on the ARTG on 2009-12-09 (ARTG 156341).