Zoton FasTabs

What it is

ZOTON FasTabs is an orally disintegrating tablet formulation of lansoprazole available in 15 mg and 30 mg strengths. Lansoprazole is a proton pump inhibitor supplied as enteric-coated delayed release pellets. 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. — Patients with 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 and adolescent patients 1 to 17 years of age** — Treatment of gastro-oesophageal reflux disease, including all grades of oesophagitis. — Healing of erosive oesophagitis.

Dosing overview

**Adults** For reflux oesophagitis, the initial dose is 30 mg lansoprazole once daily for 4 weeks, with long-term maintenance using 15 mg or 30 mg once daily depending on patient response. For duodenal ulcer, 30 mg lansoprazole once daily for 4 weeks is used, with a maintenance dose of 15 mg once daily recommended for prevention of relapse. For gastric ulcer, 30 mg lansoprazole once daily for 8 weeks is used. For acid-related dyspepsia, lansoprazole 15 mg or 30 mg once daily for 2–4 weeks is used, depending on symptom severity and persistence. For H. pylori eradication, lansoprazole 30 mg twice daily is used for 7 days in combination with two of the following antibiotics: amoxycillin 1 g twice daily, metronidazole 400 mg twice daily or clarithromycin 250 mg twice daily. **Paediatric and adolescent patients (1–17 years)** For patients aged 1–17 years with gastro-oesophageal reflux disease, the recommended initial dosage is 15 mg lansoprazole once daily for body weight ≤30 kg or 30 mg lansoprazole once daily for body weight >30 kg. After 2 weeks, the dose may be increased up to 60 mg lansoprazole daily for patients not responding satisfactorily.

Key safety warnings

Malignancy should be excluded when a gastric ulcer is suspected, since lansoprazole treatment may alleviate symptoms and 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 with new or recently changed dyspeptic symptoms. Proton pump inhibitor therapy may be associated with an increased risk of Clostridium difficile infection. Daily treatment with 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. Hypomagnesaemia, symptomatic and asymptomatic, has been reported rarely in patients treated with proton pump inhibitors for at least three months. Serious adverse events include tetany, arrhythmias and seizures. In most patients, treatment of hypomagnesaemia required magnesium replacement and discontinuation of the proton pump inhibitor. 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 with proton pump inhibitor use. Lansoprazole should be discontinued at the first signs or symptoms of severe cutaneous adverse reactions.

Contraindications

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

PBS listing

The 15 mg orally disintegrating tablet is listed on the PBS with 2 items under restricted access, with an ex-manufacturer price of A$7.89. The 30 mg orally disintegrating tablet is listed on the PBS with 7 items requiring authority-required and streamlined restrictions, with an ex-manufacturer price of A$8.35.

Regulatory history

ZOTON FasTabs lansoprazole was first listed on the ARTG on 14 January 2009 for both the 15 mg and 30 mg orally disintegrating tablet strengths. In November 2017, the PBAC recommended an amendment to the PBS listing to allow lansoprazole to be used for the treatment of gastro-oesophageal reflux disease in adult and paediatric patients.