Esopac 40

Esopac 40

esomeprazole

Manufacturer:

Pacific Pharma (Korea)

Distributor:

AA Medical
Concise Prescribing Info
Contents
Esomeprazole
Indications/Uses
Erosive reflux esophagitis; long-term management of patients w/ healed esophagitis to prevent relapse; symptomatic treatment of GERD. Eradication & healing of H. pylori-associated duodenal ulcer & prevention of relapse of peptic ulcer relapse in patients w/ H. pylori-associated ulcers; healing of gastric ulcers associated w/ NSAID therapy; prevention of gastric & duodenal ulcers associated w/ NSAID therapy in patients at risk. Prolonged treatment after IV-induced prevention of rebleeding of peptic ulcers. Zollinger-Ellison syndrome.
Dosage/Direction for Use
Adult & adolescent ≥12 yr GERD 40 mg once daily for 4 wk. May give additional 4 wk treatment for patients in whom esophagitis has not healed or who have persistent symptoms. Long-term management of patients w/ healed esophagitis to prevent relapse 20 mg once daily. Symptomatic treatment of GERD w/o esophagitis 20 mg once daily. Adult Eradication of H. pylori & healing of H. pylori-associated duodenal ulcer & prevention of relapse of peptic ulcer in patients w/ H. pylori-associated ulcer: Combination therapy: Esomeprazole tab 20 mg w/ amoxicillin 1 g & clarithromycin 500 mg, all bd for 7 days. Healing of gastric ulcer associated w/ NSAID therapy 20 mg once daily for 4-8 wk. Prevention of gastric & duodenal ulcer associated w/ NSAID therapy in patients at risk 20 mg once daily. Prolonged treatment after IV-induced prevention of rebleeding of peptic ulcers 40 mg once daily for 4 wk. Zollinger-Ellison syndrome Initial dose: 40 mg bd. Individually adjust dose & continue treatment as clinically indicated. Severe hepatic impairment Max dose: 20 mg.
Administration
Should be taken on an empty stomach: Take at least 1 hr before meals. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity to esomeprazole & substituted benzimidazoles. Should not be used concomitantly w/ nelfinavir.
Special Precautions
Exclude malignancy in the presence of any alarm symptoms (eg, significant unintentional wt loss, recurrent vomiting, dysphagia, haematemesis or melaena), as it may alleviate symptoms & delay diagnosis. Patients on long-term treatment (>1 yr). Slightly increased risk of GI infections eg, Salmonella, Campylobacter. May interfere w/ lab test for neuroendocrine tumours. Pregnancy. Do not use during breastfeeding.
Adverse Reactions
Headache, abdominal pain, diarrhea & nausea/vomiting, constipation, flatulence, fundic gland polyps (benign).
Drug Interactions
May decrease serum level of atazanavir & nelfinavir. May increase methotrexate levels when given w/ PPIs. May increase serum levels of tacrolimus. May decrease absorption of ketoconazole, itraconazole, erlotinib. May increase absorption of digoxin. May increase plasma conc of diazepam, citalopram, imipramine, clomipramine, phenytoin (dose reduction may be needed). Monitor plasma phenytoin conc upon esomeprazole introduction or withdrawal. Monitoring is recommended during treatment w/ warfarin & other coumarin derivatives. Concomitant use w/ clopidogrel is discouraged as a precaution.
ATC Classification
A02BC05 - esomeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Form
Esopac 40 EC tab 40 mg
Packing/Price
10 × 10's
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