ZOPRAL

What it is

ZOPRAL is a medicine containing lansoprazole, available in 15 mg and 30 mg enteric capsules. ZOPRAL ODT is also available as 15 mg and 30 mg orally disintegrating tablets. Lansoprazole reduces gastric acid secretions by inhibiting the H+/K+-ATPase (proton pump) of the parietal cells in the gastric mucosa, the terminal phase of acid secretion.

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. **Paediatric patients (6 to 17 years of age)** — Treatment of gastro-oesophageal reflux disease, including all grades of oesophagitis. — Healing of erosive oesophagitis.

Dosing overview

For paediatric patients 6 to 11 years, the recommended dose is 15 mg once daily for up to 12 weeks for children weighing ≤30 kg or 30 mg once daily for up to 12 weeks for children weighing >30 kg for erosive oesophagitis. For paediatric patients 12 to 17 years, the recommended dose is 30 mg once daily for up to 8 weeks for erosive oesophagitis, or 15 mg once daily for up to 8 weeks for non-erosive gastro-oesophageal reflux disease.

Key safety warnings

The possibilities of malignancy should be excluded when a gastric ulcer is suspected, since treatment with lansoprazole may alleviate symptoms and possibly delay diagnosis; similarly, 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. Decreased gastric acidity increases gastric counts of bacteria normally present in the gastrointestinal tract, and treatment with acid-reducing drugs may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter. 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 (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in the presence of other recognised risk factors. Acute tubulointerstitial nephritis has been observed in patients taking proton pump inhibitors including lansoprazole; it may occur at any point during therapy and is generally attributed to an idiopathic hypersensitivity reaction, and lansoprazole should be discontinued if acute tubulointerstitial nephritis develops. Severe hypomagnesaemia, symptomatic and asymptomatic, has been reported rarely in patients treated with proton pump inhibitors for at least three months; serious adverse events include fatigue, tetany, brief psychotic disorder with marked stressors, seizures, dizziness and ventricular arrhythmias. 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 proton pump inhibitors; lansoprazole should be discontinued at the first signs or symptoms of severe cutaneous adverse reactions.

Contraindications

ZOPRAL is contraindicated in patients with hypersensitivity to lansoprazole, other proton pump inhibitors or any of the excipients in the capsules or tablets. ZOPRAL is also contraindicated in severe hepatic impairment. Lansoprazole should not be co-administered with atazanavir due to a significant reduction in atazanavir exposure.

PBS listing

ZOPRAL 30 mg capsule is listed on the PBS with 7 items under streamlined and authority-required restrictions, with an ex-manufacturer price of A$4.00. ZOPRAL 15 mg capsule is listed on the PBS with 2 items under restricted listing, with an ex-manufacturer price of A$3.50.

Regulatory history

ZOPRAL lansoprazole 15 mg and 30 mg enteric capsules were first registered on the Australian Register of Therapeutic Goods on 8 January 2010. ZOPRAL ODT lansoprazole 15 mg and 30 mg orally disintegrating tablets were first registered on 14 November 2012.