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Fintas Center - مركز الفنطاسFarwaniya Center - مركز الفروانية
الفنطاس، قطعة 3، أبراج الشاهين برج رقم 4، الدور ا�ول والثاني
ضاحية صباح السالمقطعــــة 3، شـــــارع 3
الفــــروانيـــــةالحمراء مول، الدور الخامس
مجلة طبية دورية تصدر عن مستشفى طيبةالعدد ا�ول - سبتمبر 2010
ABBREVIATED PRESCRIBING INFORMATION: Nexium® (esomeprazole magnesium).See local Prescribing Information for full details, as Prescribing Information may varyfrom country to country. PHARMACODYNAMIC PROPERTIES: Nexium® reduces gastricacid secretion through a highly targeted mechanism of action by being a specificinhibitor of the acid pump in the parietal cell. INDICATIONS AND DOSAGE ADULTS: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 gastroesophageal refluxdisease (GERD): Nexium® 20 mg once daily in patients without esophagitis.Treatment of upper gastrointestinal symptoms associated with non-steroidalanti-inflammatory drug (NSAID) therapy: 20 mg once daily in patients requiringNSAID therapy. Healing of gastric ulcers associated with non-steroidal anti-inflammatory drug (NSAID) therapy, including COX-2 selective NSAIDs: 20 mg or 40 mg once daily for 4 to 8 weeks. Prevention of gastric and duodenal ulcersassociated with non-steroidal anti-inflammatory drug (NSAID) therapy, includingCOX-2 selective NSAIDs, in patients at risk: 20 mg or 40 mg once daily. In combi-nation with an appropriate antibacterial therapeutic regimen for the eradicationof Helicobacter pylori, healing of Helicobacter pylori associated duodenal ulcer andprevention of relapse of peptic ulcers in patients with Helicobacter pylori associatedulcers: Nexium® 20 mg, amoxicillin 1g and clarithromycin 500mg, all b.i.d. for oneweek. USA – Nexium® 40 mg once daily, amoxicillin 1 g and clarithromycin 500 mgtwice daily, all for 10 days. Pathological hypersecretory conditions includingZollinger-Ellison syndrome and idiopathic hypersecretion. The recommended ini-tial dose is Nexium® 40 mg twice daily.The dosage should be individually adjustedand treatment continued as long as clinically indicated. INDICATIONS AND DOSAGECHILDREN 12–18 YEARS: Treatment of erosive reflux esophagitis: Nexium® 40 mgonce daily for 4–8 weeks. Long-term management of patients with healedesophagitis to prevent relapse: Nexium® 20 mg once daily. Symptomatic treat-ment of gastroesophageal reflux disease: Nexium® 20 mg in patients withoutesophagitis. INDICATIONS AND DOSAGE CHILDREN 1–11 YEARS NB. ONLY USA: Treat-ment of erosive reflux esophagitis: Weight < 20 kg: Nexium® 10 mg once daily for 8weeks. Weight ≥ 20 kg: Nexium® 10 mg or 20 mg once daily for 8 weeks. Symptomatictreatment of gastroesophageal reflux disease: Nexium® 10 mg once daily for up to8 weeks. CONTRAINDICATIONS: Known hypersensitivity to esomeprazole, substi-tuted benzimidazoles or any other constituents of the formulation. WARNINGS ANDPRECAUTIONS: In the presence of any alarm symptoms (eg, significant unintentionalweight loss, recurrent vomiting, dysphagia, haematemesis or melena) and whengastric ulcer is suspected or present, the possibility of gastric malignancy should beexcluded before treatment is initiated. Patients on long-term treatment should be
kept under regular surveillance. The risk of drug interaction should be consideredespecially when prescribing esomeprazole in combination with antibiotics for eradication of H. pylori or as on demand therapy. INTERACTIONS: Due to thedecreased intragastric acidity, the absorption of ketoconazole and itraconazole candecrease during esomeprazole treatment. Concomitant administration ofesomeprazole resulted in a 45% decrease in clearance of diazepam. Concomitantadministration of esomeprazole resulted in a 13% increase in trough plasma levels ofphenytoin in epileptic patients; but dose adjustments were not required in thisstudy. In healthy volunteers, combined therapy with esomeprazole and cisaprideresulted in a 32% increase in AUC and a 31% prolongation of elimination half-life butno significant increase in peak plasma levels of cisapride. Concomitant administra-tion of 40 mg esomeprazole to warfarin-treated patients showed that, despite aslight elevation in the trough plasma concentration of the less potent R-isomer ofwarfarin, the coagulation times were within the accepted range. However, frompost marketed use cases of elevated INR of clinical significance have been reportedduring concomitant treatment with warfarin. Close monitoring is recommendedwhen initiating and ending treatment with warfarin or other coumarin derivatives.Concomitant administration of esomeprazole may reduce the plasma levels ofatazanavir. Concomitant administration of esomeprazole and a combined inhibitorof CYP2C19 and CYP3A4, such as voriconazole, may result in more than doubling ofthe esomeprazole exposure. PREGNANCY AND LACTATION: Caution should be exer-cised when prescribing Nexium® to pregnant women. Nexium® should not be usedduring breast-feeding. UNDESIRABLE EFFECTS: The following adverse drug reac-tions have been identified or suspected in the clinical trials programme and/or frompost-marketing use. None was found to be dose related. Common: Nausea/vomit-ing, diarrhoea, constipation, abdominal pain, flatulence and headache. Uncommon:Dermatitis, pruritus, urticaria, rash, dizziness, insomnia, paraesthesia, somnolence,vertigo, increased liver enzymes, peripheral oedema and dry mouth. Rare: Blurredvision, hypersensitivity reactions eg, angioedema, anaphylactic reaction/shock,myalgia, arthralgia, leukopenia, thrombocytopenia, hyponatraemia, agitation, con-fusion, depression, taste disturbance, bronchospasm, stomatitis, gastrointestinalcandidiasis, hepatitis with or without jaundice, alopecia, photosensitivity, malaiseand hyperhidrosis. Very rare: Erythema multiforme, Stevens-Johnson syndrome,toxic epidermal necrolysis, agranulocytosis, pancytopenia, aggression, hallucina-tion, hepatic failure, hepatic encephalopathy, muscular weakness, interstitial nephritisand gynaecomastia. Date of preparation: June 2006
Further information is available on request from AstraZeneca, SE-431 83Mölndal, Sweden or the local AstraZeneca.