Nexium

Esomeprazole (tab: Mg; vial: Na)

Symptomatic treatment of GERD. Erosive reflux esophagitis. Long-term management of patients w/ healed esophagitis to prevent relapse. Upper GI symptoms associated w/ NSAIDs therapy. Gastric ulcers associated w/ NSAIDs therapy, including COX-2 selective NSAIDs. Prevention of gastric & duodenal ulcers associated w/ NSAIDs therapy, including COX-2 selective NSAIDs, in patients at risk. In combination w/ appropriate antibacterial therapeutic regimen for eradication of H. pylori. Pathological hypersecretory conditions including Zollinger-Ellison syndrome & idiopathic hypersecretion. Maintenance of haemostasis & prevention of rebleeding of gastric or duodenal ulcers following treatment w/ soln for infusion.

Tab Adult & adolescent ≥12 yr Erosive reflux esophagitis 40 mg once daily for 4 wk, continue for further 4 wk if esophagitis has not healed or if there are persistent symptom. Long-term management of patients w/ healed esophagitis to prevent relapse 20 mg once daily. Symptomatic treatment of GERD in patients w/o esophagitis 20 mg once daily for 4 wk. If symptom control has not been achieved after 4 wk, patient should be further investigated. Once symptoms have resolved, administer 20 mg once daily when needed. Adult requiring continued NSAID therapy Upper GI symptoms 20 mg once daily. Gastric ulcers 20 mg or 40 mg once daily for 4-8 wk. Prevention of gastric & duodenal ulcers in patients at risk 20 mg or 40 mg once daily. Eradication of H. pylori & H. pylori-associated duodenal ulcer, & prevention of peptic ulcers relapse in patients w/ H. pylori-associated ulcers 20 mg bid in combination w/ 1 g amoxicillin bid & 500 mg clarithromycin bid for 7 days. Pathological hypersecretory conditions including Zollinger-Ellison syndrome & idiopathic hypersecretion Initially 40 mg bid. Adjust dose 80-160 mg daily. Doses >80 mg daily should be divided & given bid. Maintenance of haemostasis & prevention of rebleeding of gastric or duodenal ulcers following treatment w/ infusion 40 mg once daily for 4 wk. Patient w/ severe liver impairment Max: 20 mg daily. IV Reflux esophagitis 40 mg once daily given as IV inj over a period of at least 3 min or as IV infusion over a period of 10-30 min. Symptomatic treatment of reflux disease 20 mg once daily. ½ of the reconstituted soln should be given as IV inj over a period of approx 3 min or as IV infusion over a period of 10-30 min. Healing of gastric ulcer associated w/ NSAID therapy, prevention of gastric & duodenal ulcers associated w/ NSAID therapy 20 mg once daily. Maintenance of haemostasis & prevention of rebleeding of gastric & duodenal ulcers 80 mg as bolus infusion over 30 min, followed by a continuous IV infusion of 8 mg/hr given over 3 days (72 hr). Treatment duration is usually short & transfer to oral treatment should be made as soon as possible.

May be taken with or without food: Swallow whole w/ liqd, do not chew/crush. For patients w/ swallowing difficulties, disperse tab in ½ glass of non-carbonated water. No other liqd should be used. Stir until tab disintegrates then, drink w/in 30 min. Dispersed pellets in the liqd should not be chewed/crushed. Rinse glass w/ another ½ glass of water & drink. Dispersed liqd may also be administered via gastric tube.

Hypersensitivity to esomeprazole or substituted benzimidazoles.

May delay diagnosis of malignancy; exclude malignancy in the presence of any alarming symptoms (eg, significant unintentional wt loss, recurrent vomiting, dysphagia, haematemesis or melaena) & in suspected or present gastric ulcer. Patients on long-term treatment (>1 yr). Symptomatic change in character in patients on on-demand treatment. Slightly increased risk of GI infections eg, Salmonella & Campylobacter; osteoporosis related fractures. Monitor patients at risk for developing osteoporosis or osteoporotic fractures. Fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Essentially Na free. Consider fluctuating plasma conc in concomitant use w/ other drugs. Concomitant use w/ triple therapy eg, clarithromycin in H. pylori eradication. Not recommended in concomitant use w/ atazanavir & nelfinavir. Avoid concomitant use w/ clopidogrel. Not required to adjust dose in patients w/ impaired renal & mild to moderate liver impairment. Not to exceed 20 mg in patients w/ severe liver impairment. Pregnancy. Not to be used during lactation. Not to be used in childn <12 yr.

Headache; abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting. Erythema multiforme, SJS, TEN, acute generalized exanthematous pustulosis, DRESS.

Decreased absorption of ketoconazole, itraconazole & erlotinib. Increased absorption of digoxin. Decreased clearance of CYP2C19 substrate diazepam. Increased trough plasma levels of phenytoin. Elevated INR w/ warfarin. Decreased exposure of clopidogrel. Increased C_max & AUC of cilostazol. Increased AUC & t_½ of cisapride. Increased serum levels of tacrolimus & MTX. Not recommended in concomitant use w/ atazanavir & nelfinavir. Doubled exposure w/ CYP3A4 inhibitor (eg, clarithromycin) & combined CYP2C19 & CYP3A4 inhibitors eg, voriconazole. Decreased serum level w/ CYP2C19 or CYP3A4 inducers eg, rifampicin & St. John's wort.

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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