Composition: Esomeprazole (as magnesium trihydrate) 20mg and 40mg.
Presentation: Film-coated tablets, 20mg light pink, 40mg pink.
Storage and stability: Store in original package.
Action: Proton pump inhibitor.
Indications: Gastro-oesopha-geal reflux disease (GORD) (see dosage and administration). In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori (H pylori) and healing of H pylori associated duodenal ulcers and prevention of relapse of peptic ulcers in patients with H pylori associated ulcers.
Contraindications: Hypersensitivity to active substance, substituted benzimidazoles or any other constituents.
Dosage and administration: Tablets should be swallowed whole with liquid and not chewed or crushed. Treatment of erosive reflux oesophagitis, 40mg once daily for four weeks. An additional four weeks treatment is recommended for patients in whom oesophagitis has not healed or those who have persistent symptoms. Long-term management of patients with healed oesophagitis to prevent relapse, 20mg daily. Symptomatic treatment of GORD, 20mg daily (in patients without oesophagitis). If symptoms have not been controlled after four weeks, the patient should be further investigated. Once symptoms have been resolved, subsequent symptom control can be achieved using "on-demand" esomeprazole 20mg daily, when needed.
Eradication of H pylori, and healing of H pylori associated duodenal ulcer and prevention of relapse of peptic ulcers in patients with H pylori associated ulcer disease, esomeprazole 20mg, amoxycillin 1g, clarithromycin 500mg, all twice daily for seven days.
Elderly, no dose adjustment.
Renal impairment, no dose adjustment. Patients with severe renal insufficiency should be treated with caution.
Mild to moderate hepatic impairment, no dose adjustment. A maximum daily dose of 20mg should not be exceeded in patients with severe liver impairment.
Children, should not be used.
Pregnancy, use with caution.
Lactation, should not be used.
Overdosage: Data limited, but single doses of 80mg were uneventful. No specific antidote.
Precautions: In the presence of any "alarm" symptom (eg, significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded as treatment may alleviate symptoms and delay diagnosis. Patients on long-term treatment should be regularly monitored.
Drug interactions: Absorption of ketoconazole and itraconazole can decrease during treatment with esomeprazole. A dose reduction of drugs metabolised by CYP2C19, such as diazepam, citalopram, imipramine, clomipramine and phenytoin, could be needed and should be considered especially when prescribing esomeprazole for on-demand therapy. It is recommended that plasma concentrations of phenytoin are monitored when esomeprazole is introduced or withdrawn. With triple therapy, interactions for all components should be considered.
Side effects: In trials for esomeprazole the following were identified or suspected: common adverse effects (greater than 1 per cent, less than 10 per cent), headache, abdominal pain, diarrhoea, flatulence, nausea/vomiting, constipation; uncommon (greater than 0.1 per cent, less than 1 per cent), dermatitis, pruritus, urticaria, dizziness, dry mouth. Adverse effects observered for omepzaole might occur with esomeprazole.
Net price: 20mg 7 £4.63, 28 £18.50; 40mg 7 £7.14, 28 £28.56.
Supplier: Astra Zeneca UK, Home Park, Kings Langley, Herts WD4 8DH. Tel 01923 266191, fax 01923 260431.
Legal class: POM.