Farma Iberica


Metro Drug


Concise Prescribing Info
Esomeprazole Mg trihydrate
Duodenal ulcer associated w/ H. pylori & GERD.
Dosage/Direction for Use
Adult Erosive reflux esophagitis 40 mg once daily for 4 wk. Additional 4 wk in patients whom esophagitis has not healed or have persistent symptoms. Long-term management of patients w/ healed esophagitis to prevent relapse 20 mg once daily. Symptomatic treatment of GERD 20 mg once daily in patients w/o esophagitis. Subsequent symptom control can be achieved w/ 20 mg once daily. Eradication of H. pylori-associated ulcers 20 mg in combination w/ amoxicillin 1 g & clarithromycin 500 mg, all bid for 7 days. Healing of gastric ulcers associated w/ NSAID therapy 20 mg once daily for 4-8 wk. Prevention of gastric & duodenal ulcers associated w/ NSAID therapy in patients at risk 20 mg once daily. Zollinger-Ellison syndrome Initially 40 mg bid. Maintenance: 80-160 mg daily. Doses >80 mg should be given in divided doses as bid.
May be taken with or without food: Swallow whole, do not chew/crush.
Hypersensitivity to esomeprazole or substituted benzimidazoles. Should not be administered w/ atazanavir.
Special Precautions
Malignancy should be excluded if gastric ulcer is suspected or present. Long-term treatment for >1 yr. Fluctuating plasma conc of esomeprazole in on-demand therapy. Increased risk of GI infections eg, Salmonella & Campylobacter. Pregnancy & lactation.
Adverse Reactions
Headache, abdominal pain, diarrhea, flatulence, nausea, vomiting, constipation.
Drug Interactions
Decreased absorption of ketoconazole & itraconazole. Substantial reduction in atazanavir exposure. Increased plasma conc of drugs metabolized by CYP2C19 eg, diazepam, citalopram, imipramine, clomipramine & phenytoin. Elevated INR of warfarin or other coumarin derivatives. Increased AUC & prolonged elimination half-life of cisapride. Doubling of exposure (AUC) w/ clarithromycin & voriconazole.
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).
S-Gastriloc EC tab 40 mg
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