SOZOL

What it is

SOZOL 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 improvement and healing of symptomatic gastro-oesophageal reflux disease — 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 in increased risk patients with a need for continuous non-selective NSAID treatment

Dosing overview

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 SOZOL may alleviate symptoms and delay diagnosis. PPI therapy may be associated with an increased risk of Clostridium difficile infection, and treatment with SOZOL may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella, Campylobacter and Clostridium difficile. SOZOL 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. 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 proton pump inhibitors. Discontinue SOZOL at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity. PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine, particularly in patients who received high doses defined as multiple daily doses and long-term PPI therapy of a year or longer. Acute interstitial nephritis has been observed in patients taking pantoprazole and is generally associated with an idiopathic hypersensitivity reaction. Discontinue SOZOL if acute interstitial nephritis develops. Hypomagnesaemia has been rarely reported in patients treated with PPIs for at least three months, and serious consequences of hypomagnesaemia include tetany, arrhythmia and seizure.

Contraindications

SOZOL 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. SOZOL should not be co-administered with HIV protease inhibitors such as atazanavir or nelfinavir.

Regulatory history

SOZOL pantoprazole 20 mg and 40 mg enteric-coated tablets were first listed on the Australian Register of Therapeutic Goods on 21 March 2012.