Ezoprole Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Esomeprazole Mg

Indications/Uses

GERD; NSAID associate ulceration; Zollinger-Ellison syndrome. Erosive reflux esophagitis; NSAID-induced gastric & duodenal ulcers & upper GI symptoms. Prevention of gastric & duodenal ulcers associated w/ low dose aspirin therapy. H. pylori associated peptic & duodenal ulcers; idiopathic hypersecretion. Maintenance of hemostasis & prevention of rebleeding of gastric & duodenal ulcers following IV treatment.

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Dosage/Direction for Use

GERD 20 mg once daily for 4 wk in patients w/o esophagitis. Erosive reflux esophagitis 40 mg once daily for 4 wk. Long-term management of patients w/ healed esophagitis 20 mg once daily to prevent relapse. Gastric ulcers 20 mg or 40 mg once daily for 4-8 wk. Prevention of gastric & duodenal ulcers 20 mg or 40 mg once daily. Upper GI symptoms 20 mg once daily. Prevention of gastric & duodenal ulcers associated w/ low dose aspirin (75-325 mg) therapy 20 mg or 40 mg once daily. H. pylori eradication regimen in gastric & duodenal ulcers 20 mg esomeprazole + 1 g amoxicillin + 500 mg clarithromycin bid for 7 days. Zollinger-Ellison syndrome & idiopathic hypersecretion Initially 40 mg bid. Max: Up to 120 mg bid. Maintenance of hemostasis & prevention of rebleeding of gastric & duodenal ulcers following IV treatment 40 mg once daily for 4 wk. Oral treatment should be preceded by acid-suppression therapy w/ esomeprazole IV 80 mg by bolus infusion over 30 min followed by continuous IV infusion of 8 mg/hr for 3 days.

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Overdosage

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Administration

Should be taken on an empty stomach: Take 1 hr before meal. Swallow whole, do not chew/crush.

Contraindications

Hypersensitivity to esomeprazole or other PPIs. Concomitant use w/ nelfinavir.

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Special Precautions

Possibility of malignancy should be excluded prior to starting treatment. Discontinue if acute interstitial nephritis develops. C. difficile-associated diarrhea. Increased risk for osteoporosis-related fractures of the hip, wrist or spine in patients receiving high-dose (multiple daily dose & long-term therapy). Hypomagnesemia; monitor Mg levels prior to initiation of treatment & periodically. Malabsorption of vit B₁₂ in prolonged use. Atrophic gastritis. Increased risk of developing community acquired pneumonia. Subacute cutaneous lupus erythematosus. Stop treatment 14 days before chromogranin A measurement. May affect ability to drive or operate machines. Pregnancy & lactation. Ped <1 mth.

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Use In Pregnancy & Lactation

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Adverse Reactions

Headache, diarrhea, nausea, flatulence, abdominal pain, constipation, dry mouth.

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Drug Interactions

Not recommended w/ concomitant use of atazanavir, nelfinavir, rilpivirine, saquinavir or raltegravir. Decreased clearance w/ diazepam. Increased INR & prothrombin time w/ warfarin. Decrease platelet inhibitory effects w/ clopidogrel. Doubling of AUC w/ citalopram/escitalopram. May reduce absorption of ketoconazole, atazanavir, nelfinavir, Fe salts, erlotinib & mycophenolate mofetil; decreased absorption w/ digoxin. Increased plasma conc w/ clarithromycin & voriconazole; tacrolimus; citalopram, imipramine, clomipramine, cilostazol & phenytoin. Risk of hypomagnesemia w/ loop or thiazide diuretics. May elevate & prolong serum levels of MTX. Delayed absorption & decreased bioavailability w/ sucralfate. Increased AUC w/ cisapride.

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Storage

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Description

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Action

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MIMS Class

Antacids, Antireflux Agents & Antiulcerants

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).

Regulatory Classification

Presentation/Packing

Form

Ezoprole DR cap 20 mg

Packing/Price

14's

Form

Ezoprole DR cap 40 mg

Packing/Price

14's

Ezoprole

esomeprazole

Manufacturer:

KRKA

Distributor:

UNILAB, Inc

Marketer:

Westmont