PANTHRON

What it is

Panthron 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. Panthron contains pantoprazole as sodium sesquihydrate, supplied as 20 mg or 40 mg enteric-coated tablets.

Approved indications

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

Panthron tablets are intended for oral administration and should not be chewed or crushed but swallowed whole with a little water.

Key safety warnings

In the presence of any 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 Panthron may alleviate symptoms and delay diagnosis. Proton pump inhibitor therapy may be associated with an increased risk of Clostridium difficile infection. Panthron, like all proton pump inhibitors, might be expected to increase the counts of bacteria normally present in the upper gastrointestinal tract. Treatment with Panthron may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella, Campylobacter and Clostridium difficile. Panthron, 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 (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in association with the use of proton pump inhibitors. Discontinue Panthron at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. Proton pump inhibitors are associated in rare cases with the occurrence of subacute cutaneous lupus erythematosus (SCLE). 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 Panthron. Proton pump inhibitor 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 proton pump inhibitor therapy (a year or longer). Acute interstitial nephritis has been observed in patients taking Panthron. Acute interstitial nephritis may occur at any point during proton pump inhibitor therapy and is generally associated to an idiopathic hypersensitivity reaction. Discontinue Panthron if acute interstitial nephritis develops. Hypomagnesaemia has been rarely reported in patients treated with proton pump inhibitors for at least three months (in most cases after a year of therapy). Serious consequences of hypomagnesaemia include tetany, arrhythmia, and seizure.

Contraindications

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

Regulatory history

Panthron 20 mg and 40 mg enteric-coated tablets were first listed on the Australian Register of Therapeutic Goods on 17 February 2010.