Nexium/Nexium IV

Esomeprazole

Prevention of gastric & duodenal ulcers associated w/ NSAID therapy in patients at risk. Healing of gastric ulcers associated w/ NSAID therapy. Gastro-resistant tab: Erosive reflux esophagitis; long-term management of patients w/ healed esophagitis to prevent relapse; symptomatic treatment of GERD. In combination w/ appropriate antibacterial therapeutic regimen for H. pylori eradication & healing of H. pylori-associated duodenal ulcer & prevention of peptic ulcer relapse in patients w/ H. pylori-associated ulcers. Prevention of gastric &/or duodenal ulcers associated w/ low dose aspirin therapy in patients at risk. Prevention of rebleeding of gastric or duodenal ulcers following treatment w/ Nexium IV. Zollinger-Ellison syndrome. Powd for soln for inj: Alternative to oral therapy when oral intake is not appropriate for GERD in patients w/ esophagitis &/or severe symptoms of reflux; prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers.

PO Adult & adolescent from 12 yr Erosive reflux esophagitis 40 mg once daily for 4 wk. Additional 4 wk treatment for those in whom esophagitis has not healed or who have persistent symptoms. Long-term management of patient w/ healed esophagitis to prevent relapse 20 mg once daily. Symptomatic treatment of GERD 20 mg once daily in patients w/o esophagitis. Subsequently, 20 mg once daily when needed. Adult Healing of H. pylori-associated duodenal ulcer & prevention of relapse of peptic ulcer in patient w/ H. pylori-associated ulcer 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 patient at risk 20 mg once daily. Prevention of gastric &/or duodenal ulcer associated w/ low dose aspirin therapy in patient at risk 20 or 40 mg once daily. Prevention of rebleeding of gastric or duodenal ulcers following treatment w/ Nexium IV 40 mg once daily for 4 wk after IV-induced prevention of rebleeding of peptic ulcers. Zollinger-Ellison syndrome 40 mg bd. Patients can be controlled on doses between 80-160 mg daily. Doses >80 mg daily should be divided & given bd. Severe liver impairment Max: 20 mg. IV Reflux oesophagitis 40 mg once daily. Symptomatic treatment of reflux disease, healing of gastric ulcer associated w/ NSAID therapy & prevention of gastric & duodenal ulcer associated w/ NSAID therapy 20 mg once daily. Prevention of rebleeding of gastric & duodenal ulcer 80 mg as bolus infusion over 30 min, followed by continuous IV infusion of 8 mg/hr given over 3 days. Inj: 20 or 40 mg IV over a period of at least 3 min. Infusion: 20 or 40 mg IV infusion over a period of 10-30 min. 80 mg bolus dose should be given as continuous IV infusion over 30 min. 8 mg/hr dose should be given as continuous IV infusion over a period of 71.5 hr. Severe liver impairment GERD Max: 20 mg daily. Bleeding ulcer Initial bolus dose of 80 mg for infusion, continuous IV infusion dose of 4 mg/hr for 71.5 hr may be sufficient.

May be taken with or without food: For patients w/ swallowing difficulties, the tab may also be dispersed in ½ glass of non-carbonated water. No other liqd should be used. Stir gently until the tab dissolves into little pellets & drink the liqd w/ the pellets immediately or w/in 30 min. Rinse the glass w/ ½ glass of water & drink. Do not chew/crush the tab or the pellets. The dispersion may also be administered via a nasogastric tube.

Hypersensitivity to esomeprazole or other substituted benzimidazoles.

Exclude malignancy in the presence of any alarm symptom (eg, significant unintentional wt loss, recurrent vomiting, dysphagia, haematemesis or melaena) & when gastric ulcer is suspected or present. Instruct patients on-demand treatment to contact their physician if symptoms change in character. Monitor patients at risk for developing osteoporosis or osteoporotic fractures. Increased risk of Clostridium difficile-associated diarrhoea. Use the lowest dose & shortest duration of therapy appropriate to the condition being treated. Symptomatic & asymptomatic hypomagnesaemia. Consider monitoring of Mg levels prior to treatment initiation & periodically for patients expected to be on prolonged treatment or those who are taking digoxin or hypomagnesaemia-causing medications (eg, diuretics). Discontinue use & refer patient to a specialist for evaluation, if signs or symptoms consistent w/ cutaneous lupus erythematosus or SLE occur. Not recommended to concomitantly administer w/ atazanavir & nelfinavir. Concomitant use w/ clopidogrel; MTX. Patients are considered to be at risk due to age ≥60 yr, documented history of gastric &/or duodenal ulcers. Controlled studies do not extend beyond 6 mth. Patients w/ severe renal insufficiency. Pregnancy. Not to be used during breast-feeding. Not to be used in childn <12 yr. Gastro-resistant tab: Regular surveillance on patients on long-term treatment (>1 yr). Not to be taken by patients w/ rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

Headache; abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting. Potentially, SJS & TEN. Powd for soln for inj: Administration site reactions.

Decreased absorption of ketoconazole, itraconazole & erlotinib. Increased bioavailability of digoxin. May increase plasma conc of drugs metabolised by CYP2C19 (eg, diazepam, citalopram, imipramine, clomipramine, phenytoin). Possible elevated INR w/ warfarin or other coumarine derivatives. Decreased max inhibition of platelet aggregation of clopidogrel. May increase C_max & AUC of cilostazol. Increased AUC & prolonged elimination t_½ of cisapride. Increased serum levels of tacrolimus & other antiretroviral drugs (eg, saquinavir). May elevate & prolong serum levels of MTX &/or its metabolite hydroxymethotrexate primarily at high doses. Decreased serum levels of some antiretroviral drugs (eg, atazanavir & nelfinavir). May double esomeprazole exposure w/ clarithromycin & voriconazole. Serum levels may be decreased by 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).

POM