NEXIUM

What it is

NEXIUM Hp7 is a combination pack containing esomeprazole magnesium trihydrate, amoxicillin trihydrate, and clarithromycin. The pack consists of NEXIUM 20 mg enteric coated tablets (light pink, oblong, biconvex, film-coated), AMOXIL 500 mg capsules (red/yellow, hard, gelatin), and KLACID 500 mg tablets (pale yellow, film-coated ovaloid).

Approved indications

— Healing of duodenal ulcer associated with Helicobacter pylori. — Eradication of Helicobacter pylori in patients with active or healed peptic ulcer.

Dosing overview

The recommended dosage regimen is NEXIUM 20 mg twice daily, amoxicillin 1000 mg twice daily, and clarithromycin 500 mg twice daily for 7 days.

Key safety warnings

Serious, and occasionally fatal, hypersensitivity (including anaphylaxis, anaphylactoid and severe cutaneous reactions) have been reported in patients using β-lactam antibiotics and macrolide therapy. Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in atopic individuals. Antibiotic-associated pseudomembranous colitis has been reported with many antibiotics including amoxicillin and macrolides. A toxin produced by Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life-threatening. Clostridium difficile-associated diarrhoea has been reported with the use of nearly all antibacterial agents and may range in severity from mild diarrhoea to fatal colitis. Acute tubulointerstitial nephritis has been observed in patients taking proton pump inhibitors including esomeprazole. Acute tubulointerstitial nephritis may occur at any point during PPI therapy and is generally attributed to idiopathic hypersensitivity reaction. Acute tubulointerstitial nephritis can progress to renal failure. Prolonged cardiac repolarisation and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with macrolides, including clarithromycin.

Contraindications

NEXIUM Hp7 is contraindicated in patients with hypersensitivity to esomeprazole, substituted benzimidazoles, β-lactam antibiotics (such as penicillins or cephalosporins), clarithromycin, or any other constituents of the formulations, or in patients with a history of allergic reaction to penicillins or any macrolide antibiotic drugs. Clarithromycin is contraindicated as concurrent therapy with astemizole, terfenadine, cisapride, domperidone and pimozide as this may result in QT prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, and torsades de pointes. Concomitant administration of clarithromycin and ergotamine or dihydroergotamine is contraindicated, as this may result in ergot toxicity. Concomitant administration of clarithromycin with lovastatin or simvastatin is also contraindicated due to the increased risk of myopathy, including rhabdomyolysis.

Regulatory history

NEXIUM Hp7 (esomeprazole tablet, amoxicillin capsule and clarithromycin tablet composite pack) was first listed on the ARTG on 7 December 2016.