Esoferr

Esomeprazole

DR cap: Treatment of erosive reflux esophagitis, long term management of patients w/ healed esophagitis to prevent relapse, symptomatic treatment of GERD. In combination w/ an appropriate antibacterial therapeutic regimen for the healing of H. pylori-associated duodenal ulcer. Healing of gastric ulcers associated w/ NSAID therapy & prevention of gastric & duodenal ulcers associated w/ continuous NSAID therapy in patient at risk. Treatment of Zollinger-Ellison syndrome. Powd for inj: Gastric antisecretory when PO is not possible eg, GERD in patients w/ esophagitis &/or severe symptoms of reflux, healing of gastric ulcers associated w/ NSAID therapy. Short-term maintenance of hemostasis & prevention of rebleeding in patients following therapeutic endoscopy for acute bleeding, gastric or duodenal ulcers.

DR cap Adult Treatment of erosive reflux esophagitis 40 mg once daily for 4 wk. Additional 4 wk is recommended in patients whom esophagitis has not healed or who have persistent symptoms. Patient w/ mucosal break of grade C & D 40 mg. GERD w/ erosive esophagitis of grade A & B 20 mg. 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. On-demand regimen 20 mg once daily when needed. Healing of H. pylori-associated duodenal ulcer 20 mg esomeprazole w/ 1 g amoxicillin & 500 mg clarithromycin, all twice daily 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 patient at risk 20 mg once daily. Treatment of Zollinger-Ellison syndrome 40 mg twice daily. Individually adjust & treatment continued as clinically indicated. For doses >80 mg daily, divide dose & give twice daily. Severe liver impairment Max dose: 20 mg. Childn 12-18 yr Symptomatic treatment of GERD 20 mg once daily in patients w/o esophagitis. Powd for inj Gastric antisecretory 20-40 mg IV once daily. Reflux esophagitis 40 mg once daily. Symptomatic treatment for reflux disease 20 mg once daily. Gastric ulcer associated w/ NSAID therapy 20 mg once daily. Maintenance of hemostasis & prevention of rebleeding of gastric & duodenal ulcers 80 mg bolus infusion over 30 min, followed by continuous IV infusion of 8 mg/hr given over 3 days (72 hr). Parenteral treatment period should be followed by acid-suppression therapy w/ 40 mg once daily PO for 4 wk. Severe liver impairment Bleeding ulcer Initial bolus infusion of 80 mg followed by continuous IV infusion of 4 mg/hr for 71.5 hr. Inj Add 5 mL of 0.9% NaCl for IV use to the vial. Soln should be given over a period of at least 3 min. Infusion Dissolve the content of 1 vial in up to 100 mL 0.9% NaCl for IV use. Soln shoud be given over a period 10-30 min. Infusion 80 mg Dissolve the content of 2 vial in up to 100 mL 0.9% NaCl for IV use.

DR cap: Should be taken on an empty stomach: Swallow whole w/ liqd, do not chew/crush. For patients w/ swallowing difficulties, disperse DR cap in ½ glass of non-carbonated water. Do not use other liqd. Stir & drink the liqd w/ the pellets immediately or w/in 30 min. Do not chew/crush pellets. Rinse glass w/ ½ glass of water & drink. Mixt may be given via a gastric tube.

Hypersensitivity to esomeprazole or substituted benzimidazoles. Should not be administered w/ atazanavir & nelfinavir.

Exclude malignancy in the presence of significant unintentional wt loss, recurrent vomiting, dysphagia, hematemesis or melena & if gastric ulcer is suspected or present. Pregnancy. Not to be used during breast-feeding. DR cap: Long-term treatment. Consider interactions w/ other pharmaceuticals when on on-demand therapy due to fluctuating plasma conc of esomeprazole; for clarithromycin (potent inhibitor of CYP3A4) when the triple therapy is used in patients concurrently taking other drugs metabolized via CYP3A4 eg, cisapride. Not to be taken in patients w/ rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. PPI may be associated w/ small increased risk of osteoporosis related fractures. Severe renal insufficiency. Not to be used in childn <12 yr. Powd for inj: Treatment w/ PPIs may lead to slightly increased risk of GI infections eg, Salmonella & Campylobacter. Concomitant use w/ atazanavir is not recommended; w/ clopidogrel should be discouraged. Not to be used in childn & adolescents.

Headache, abdominal pain, constipation, diarrhea, flatulence, nausea & vomiting, administration site reactions (for inj).

Decreased absorption of ketoconazole, itraconazole. Not to be administered w/ atazanavir. Increased plasma conc w/ drugs metabolized by CYP2C19 (eg, diazepam, citalopram, imipramine, clomipramine & phenytoin). Monitor when initiating & ending concomitant esomeprazole treatment w/ warfarin or other coumarin derivatives. DR cap: Gastric acid suppression of esomeprazole & other PPIs may decrease or increase absorption of drugs w/ gastric pH dependent absorption. Decreased absorption of erlotinib. Increased digoxin absorption. Not to be administered w/ nelfinavir. Doubling of clarithromycin (CYP3A4 inhibitor) AUC to esomeprazole. Decreased esomeprazole serum level & increased metabolism w/ CYP2C19 or CYP3A4 inducers (eg, rifampicin, St. John's wort). Powd for inj: Doubling of esomeprazole exposure in concomitant administration of a combined inhibitor of CYP2C19 & CYP3A4 eg, voriconazole.

Antacids, Antireflux Agents & Antiulcerants

A02BC05 - esomeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

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