Nexium/Nexium IV

Erosive reflux esophagitis; long-term management of patients w/ healed esophagitis to prevent relapse; symptomatic treatment of GERD. Healing of gastric ulcers associated w/ NSAIDs therapy. Prevention of gastric &/or duodenal ulcers associated w/ NSAIDs or low dose aspirin therapy in patients at risk. Maintenance of hemostasis & prevention of rebleeding in patients following therapeutic endoscopy for acute bleeding of gastric or duodenal ulcer. Tab: Upper GI symptoms associated w/ NSAID therapy. In combination w/ an appropriate antibacterial therapeutic regimen for the eradication of H. pylori & healing of H. pylori associated duodenal ulcer & prevention of relapse of peptic ulcer in patients w/ H. pylori-associated ulcers. Pathological hypersecretory conditions including Zollinger-Ellison syndrome & idiopathic hypersecretion. Granules: GERD in childn 1-11 yr. Patients having difficulty swallowing dispersed tab. Inj: Alternative to oral therapy when oral route is not appropriate. For GERD in patients w/ erosive reflux esophagitis &/or severe symptoms of reflux in childn & adolescents 1-17 yr.

Tab GERD: Erosive reflux esophagitis Adult & childn 12-18 yr 40 mg once daily for 4-8 wk. Childn 1-11 yr weighing ≥20 kg 10-20 mg once daily for 8 wk, <20 kg 10 mg once daily for 8 wk. Long-term management of patient w/ healed esophagitis to prevent relapse Adult & childn 12-18 yr 20 mg once daily. Childn 1-11 yr 10 mg once daily. Symptomatic treatment of GERD in patient w/o esophagitis Adult & childn 12-18 yr 20 mg once daily for 4 wk. Adult Upper GI symptoms associated w/ NSAID therapy 20 mg once daily for 4 wk. Healing of gastric ulcers associated w/ NSAID therapy 20-40 mg once daily for 4-8 wk. Prevention of gastric &/or duodenal ulcers associated w/ NSAID therapy or low dose aspirin in patient at risk 20-40 mg once daily. Maintenance of hemostasis & prevention of rebleeding of gastric or duodenal ulcers 40 mg once daily for 4 wk. The oral treatment period should be preceded by acid-suppression therapy w/ esomeprazole IV 80 mg administered as bolus infusion over 30 min followed by a continuous IV infusion of 8 mg/hr given over 3 days. In combination w/ an appropriate antibacterial therapeutic regimen for the eradication of H. pylori 20 mg w/ amoxicillin 1 g & clarithromycin 500 mg, all bid for 7 days. Pathological hypersecretory conditions including Zollinger-Ellison syndrome & idiopathic hypersecretion Initially 40-120 mg bid. Childn 12-18 yr Duodenal ulcer caused by H. pylori 20 mg bid. Duration: Most commonly 7 days but may be up to 14 days. Childn 1-11 yr Symptomatic treatment of GERD 10 mg once daily for up to 8 wk. Severe liver impairment Max: 20 mg daily. Granules for oral susp Erosive reflux esophagitis Childn 1-11 yr weighing ≥20 kg 10-20 mg once daily for 8 wk, <20 kg 10 mg once daily for 8 wk. Long-term management of patient w/ healed esophagitis to prevent relapse 10 mg once daily. Symptomatic treatment of GERD 10 mg once daily for up to 8 wk. GERD diagnostically confirmed through pH probe or endoscopy Childn 1-11 mth weighing >7.5-12 kg 10 mg, >5-7.5 kg 5 mg, 3-5 kg 2.5 mg, all doses to be taken once daily for up to 6 wk. Childn 0-1 mth weighing ≥2.5 kg 2.5 mg once daily for up to 4 wk. Severe liver impairment Max: 20 mg daily. Inj Erosive reflux esophagitis Adult & childn 12-17 yr 40 mg once daily. Childn 1-11 yr weighing ≥20 kg 10-20 mg once daily, <20 kg 10 mg once daily, 1-11 mth 1 mg/kg once daily, 0-1 mth 0.5 mg/kg once daily. Adult Long-term management of patient w/ healed esophagitis to prevent relapse 20 mg once daily. Symptomatic treatment of GERD Adult 20 mg once daily in patient w/o esophagitis. Childn 12-17 yr 20 mg once daily, 1-11 yr 10 mg once daily, 1-11 mth 1 mg/kg once daily, 0-1 mth 0.5 mg/kg once daily. Adult Healing of gastric ulcers associated w/ NSAID therapy 20 mg once daily. Prevention of gastric & duodenal ulcers associated w/ NSAID therapy in patient at risk 20 mg once daily. Maintenance of hemostasis & prevention of rebleeding of gastric or duodenal ulcers 80 mg as bolus infusion over 30 min followed by continuous IV infusion of 8 mg/hr given over 3 days. Parenteral treatment should be followed by 40-mg tab once daily for 4 wk. Severe liver impairment GERD Max: 20 mg daily. Bleeding ulcers Initial bolus: 80 mg, followed by continuous IV infusion of 4 mg/hr.

May be taken with or without food: Tab: Swallow whole w/ liqd. Do not chew/crush. May also be dispersed in ½ glass of non-carbonated water. No other liqd should be used. Stir until the tab disintegrate & 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 pellets. For patients who cannot swallow, the tab contents can be dispersed in non-carbonated water & administered through a gastric tube. Granules: Empty contents of a 10 mg sachet into a container w/ 1 tbsp of non-carbonated water & stir. Leave for a few min to thicken. Stir again & take w/in 30 min. Rinse remaining contents w/ water & drink immediately. For patients who cannot swallow, the mixt can be administered through a nasogastric tube (≥6 French) w/ a syringe w/in 30 min. Refill syringe w/ 15 mL of water, shake & flush any remaining contents from the nasogastric tube.

Hypersensitivity to esomeprazole & substituted benzimidazoles.

Not recommended in concomitant use w/ atazanavir & nelfinavir; clopidogrel. Exclude malignancy in the presence of significant unintentional wt loss, recurrent vomiting, dysphagia, haematemesis or melaena; & when gastric ulcer is suspected or present. Concurrent therapy of CYP3A4-metabolized drugs eg, cisapride. Monitor patients on long-term & on-demand treatment. Risk for developing osteoporosis or osteoporotic fractures. Severe renal or hepatic impairment. Pregnancy. Not to be used during lactation. Granules: Rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

Headache; abdominal pain, diarrhoea, flatulence, nausea/vomiting, constipation. Inj: Administration site reactions.

May decrease (eg, ketoconazole, itraconazole & erlotinib) or increase (eg, digoxin) absorption of drugs. Decreased clearance of diazepam. Increased trough plasma levels of phenytoin in epileptic patients. Elevated INR w/ warfarin or other coumarine derivatives. Decreased max inhibition of platelet aggregation of clopidogrel. Increased C_max & AUC of cilostazol. Increased AUC & prolonged elimination t_½ of cisapride. Increased serum levels of tacrolimus & other antiretroviral drugs eg, saquinavir. Increased MTX levels. Decreased serum levels of antiretroviral drugs eg, atazanavir & nelfinavir. May double the exposure w/ clarithromycin & voriconazole. Decreased serum levels 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).

Rx