APO-LANSOPRAZOLE

What it is

APO-LANSOPRAZOLE contains lansoprazole as the active ingredient and is available as enteric capsules in 15 mg and 30 mg strengths. The 15 mg and 30 mg enteric capsules each contain 15 mg and 30 mg of lansoprazole active ingredient, respectively. 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 —

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

For adults, the dosing varies by indication: reflux oesophagitis requires 30 mg lansoprazole once daily for 4 weeks, with a maintenance dose of 15 mg or 30 mg once daily dependent upon patient response; duodenal ulcer requires 30 mg once daily for 4 weeks with a 15 mg once daily maintenance dose; gastric ulcer requires 30 mg once daily for 8 weeks; and acid-related dyspepsia requires 15 mg or 30 mg once daily for 2–4 weeks 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: amoxicillin 1 g twice daily, metronidazole 400 mg twice daily, or clarithromycin 250 mg twice daily.

Key safety warnings

The possibility of malignancy should be excluded when a gastric ulcer is suspected, since treatment with lansoprazole may alleviate symptoms of malignancy and possibly delay its 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. Acute tubulointerstitial nephritis has been observed in patients taking PPIs including lansoprazole. Acute tubulointerstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue lansoprazole if acute tubulointerstitial nephritis develops. 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, seizures, dizziness and ventricular arrhythmias. In most patients, treatment of hypomagnesaemia required magnesium replacement and discontinuation of the PPI. 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. Discontinue lansoprazole at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.

Contraindications

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

Regulatory history

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