PANTOPRAZOLE-WGR

What it is

PANTOPRAZOLE-WGR 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 —

Duodenal ulcer requiring a reduction in acid secretion — Gastric ulcer requiring a reduction in acid secretion — Symptomatic gastro-oesophageal reflux disease (GORD): treatment of heartburn and other symptoms — Reflux oesophagitis — Gastrointestinal lesions refractory to H2 blockers — 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

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

Key safety warnings

Proton pump inhibitor 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, as all acid blocking medicines, 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. 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 proton pump inhibitors, and pantoprazole should be discontinued at the first signs or symptoms of severe cutaneous adverse reactions. Proton pump inhibitors are associated in rare cases with the occurrence of subacute cutaneous lupus erythematosus, and if lesions occur especially in sun exposed areas of the skin and accompanied by arthralgia, the patient should seek medical help promptly. Proton pump inhibitor 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 and long-term therapy. Acute interstitial nephritis has been observed in patients taking proton pump inhibitors including pantoprazole and may occur at any point during therapy, and pantoprazole should be discontinued if acute interstitial nephritis develops. Hypomagnesaemia has been rarely reported in patients treated with proton pump inhibitors for at least three months, with serious consequences including tetany, arrhythmia, and seizure.

Contraindications

PANTOPRAZOLE-WGR is contraindicated in 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-WGR was first registered on the Australian Register of Therapeutic Goods on 21 March 2012, with two variants: the 20 mg enteric-coated tablet (ARTG 191036) and the 40 mg enteric-coated tablet (ARTG 191037).