Læknablaðið : fylgirit - 01.06.2005, Blaðsíða 44

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Clinically proven to heol more reflux
esophagitis potíentS compared to
omeprazole'-2, lansoprazole3 and pantoprazole
Fasterand sustained freedom from
CERD symptoms in more patients than
omeprazole'-2, lansoprazole3 andpantoprazole
More effective acid control
compared to all other PPIs \
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Néxium
esomeprazole
ABBREVIATED PRESCRIBING INFORMATION: Nexiunv (esonieprazole magnesium). See local prescribing information for full details. PHARMACODYNAMIC PROPERTIES:
Nexium reduces gastric acid secretion through a highly targeted mechanism of action by being a specific inhibitor of the acid pump in the parietal cell.
INDICATIONS AND DOSAGE: Treatment of erosive reflux esophagitis: Nexium 40 mg once daily for 4-8 weeks. Long-term management of patients with healed esophagitis
to prevent relapse: Nexium 20 mg once daily. Symptomatic treatment of gastro-esophageal reflux disease: Nexium 20 mg once daily in patients without esophagitis. Once
symptoms have resolved, an on demand regimen of 20 mg once daily can be used wlien needed, to control subsequent symptoms. Helicobacter pylori-associated peptic ulcer
disease: Healing of H pylori-associated duodenal ulcer, prevention of relapse of peptic ulcers in patients with H py/ori-associated ulcers: Nexium 20 mg, amoxicillin 1 g and
darithromycin 500 mg, all bid for 1 week. USA - Nexium 40 mg once daily, amoxicillin 1 g and clarithromycin 500 mg twice daily, all for 10 days CONTRAINDICATIONS:
Known hypersensitivity to esomeprazole, substituted benzimidazoles or any other constituents of the formulation. WARNINGS AND PRECAUTIONS: In the presence of any
alarm symptoms (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melena) and wlien gastric ulcer is suspected or present, the
possibility of gastric malignancy should be excluded before treatment is initiated. INTERACTIONS: Due to the decreased intragastric acidity, the absorption of ketoconazole
and itraconazole can decrease during esomeprazole treatment. Concomitant administration of esomeprazole resulted in a 45% decrease in clearance of diazepam.
Concomitant administration of esomeprazole resulted in a 13% increase in trough plasma levels of phenytoin in epileptic patients; but dose adjustments were not required in
this study. In healthy volunteers, combined therapy with esomeprazole and cisapride resulted in a 32% increase in AUC and a 31% prolongation of elimination half-life but 110
significant increase in peak plasma levels of cisapride. Concomitant administration of 40 mg esomeprazole to warfarin-treated patients showed that, despite a slight elevation
in the trough plasma concentration of the less potent R-isomer of warfarin, the coagulation times were within the accepted range. However, as with all patients receiving
warfarin, monitoring is recommended during concomitant treatment with esomeprazole. PREGNANCY AND LACTATION: Caution should be exercised wlien prescribing
Nexium' to pregnant women. Nexium' should not be used during breast-feeding. UNDESIRABLE EFFECTS: The following adverse drug reactions have been identified
or suspected in the clinical trials programme. None was found to be dose related. Common: Nausea/vomiting, diarrhoea, constipation, abdominal pain, flatulence
and headache. Uncommon: Dermatitis, prurltus, urticaria, dizziness and dry mouth. From marketed use, there have been rare reports of increased liver
enzymes and of hypersensitivity reactions e.g. angioedema, anaphylactic reaction. For further information please contact AstraZeneca, SE-431 83 Mölndal or the local
AstraZeneca subsidiary.
NexiunV is a registered trademark of the AstraZeneca group of companies.
References: 1. Richter ]E et al. Am j Gastroenterol 2001;96:656-65. 2. Kahrilas Pj et al. Aliment Pharmacol Ther 2000;14:1249-58. 3. Castell DO et al. Am | Gastroenterol
2002;97:575-83 4. Labenz J et al. Can J Gastroenterol 2004; vol 18 Suppl A 5. Miner P et al. Am J Gastroenterol 2003;98:2616-20.
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