OZPAN

What it is

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

Approved indications

— Symptomatic improvement and healing of duodenal ulcer — Symptomatic improvement and healing of gastric ulcer — Symptomatic improvement and healing of symptomatic gastro-oesophageal reflux disease (GORD), including treatment of heartburn and other symptoms — 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 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, the dose is 40 mg once daily. For gastric ulcer, the dose is 40 mg once daily. For lesions refractory to H2-receptor antagonists, the dose is 40 mg once daily. For Zollinger-Ellison syndrome, the number of tablets should be individually adjusted so that acid output remains below 10 mmol/L. For symptomatic GORD, the recommended dosage is one 20 mg tablet per day. For treatment of reflux oesophagitis, the recommended oral dosage is one 20 or 40 mg tablet per day, with a four-week period usually required for healing; this dosage may be increased up to 80 mg per day. For maintenance of healed reflux oesophagitis, a maintenance dose of one 20 or 40 mg tablet per day is recommended, dependent upon patient response. For prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective NSAIDs in increased risk patients, the recommended oral dosage is one 20 mg tablet per day.

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 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 in association with PPI use; discontinue pantoprazole at the first signs or symptoms of severe cutaneous adverse reactions. 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 and long-term PPI therapy of a year or longer. Acute interstitial nephritis has been observed in patients taking PPIs including pantoprazole; it may occur at any point during PPI therapy and is generally associated with an idiopathic hypersensitivity reaction. Hypomagnesaemia has been rarely reported in patients treated with PPIs for at least three months; serious consequences include tetany, arrhythmia and seizure.

Contraindications

OZPAN 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

OZPAN pantoprazole 40 mg enteric coated tablets were first listed on the ARTG on 13 July 2009. OZPAN pantoprazole 20 mg enteric coated tablets were first listed on the ARTG on 13 July 2009.