LANZOPRAN

What it is

LANZOPRAN contains lansoprazole, available as 15 mg and 30 mg enteric capsules.

Approved indications

**Adults** — Healing and long-term management of reflux oesophagitis. — Healing and long-term management for patients with duodenal ulcer. — Healing of benign gastric ulcer. — Treatment of benign peptic lesions that do not respond to H2-receptor antagonists. — Eradication of H. pylori from the upper gastrointestinal tract in patients with peptic ulcer or chronic gastritis when used in combination with appropriate antibiotics. — Relief of reflux-like and/or ulcer-like symptoms associated with acid-related dyspepsia.

Dosing overview

To achieve optimal acid inhibitory effect and most rapid healing and symptom relief, LANZOPRAN should be taken in the morning before food.

Key safety warnings

Malignancy should be excluded when a gastric ulcer is suspected, since treatment with lansoprazole may alleviate symptoms of a malignancy and possibly delay its diagnosis. The possibility of serious underlying disease such as malignancy should be excluded before treatment for dyspepsia commences, particularly in patients of middle age or older who have new or recently changed dyspeptic symptoms. Proton pump inhibitor therapy may be associated with an increased risk of Clostridium difficile infection. Daily treatment with any acid-suppressing medications over a long period of time (longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B12) caused by hypo- or achlorhydria. Proton pump inhibitors, especially if used in high doses and over long durations (more than 1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Acute tubulointerstitial nephritis has been observed in patients taking PPIs including lansoprazole. Acute TIN may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Severe hypomagnesaemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include fatigue, tetany, brief psychotic disorder with marked stressors, seizures, dizziness, ventricular arrhythmias, but onset may be insidious and be overlooked. Severe cutaneous adverse reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalised exanthematous pustulosis and erythema multiforme have been reported in association with the use of PPIs.

Contraindications

— Hypersensitivity to lansoprazole, other proton pump inhibitors or any of the excipients in the capsules. — Severe hepatic impairment. — LANZOPRAN should not be co-administered with atazanavir due to a significant reduction in atazanavir exposure.

Regulatory history

LANZOPRAN lansoprazole 15 mg and 30 mg capsule blister packs were first listed on the Australian Register of Therapeutic Goods on 12 February 2010.