Nexium/Nexium IV

Nexium/Nexium IV

esomeprazole

Manufacturer:

AstraZeneca

Distributor:

Zuellig
Concise Prescribing Info
Contents
Esomeprazole
Indications/Uses
Erosive reflux esophagitis; long-term management of patient w/ healed esophagitis to prevent relapse; symptomatic treatment of GERD. Upper GI symptoms or healing of gastric ulcers associated w/ NSAIDs therapy. Prevention of gastric &/or duodenal ulcers associated w/ NSAIDS or low dose aspirin therapy. Maintenance of hemostasis & prevention of rebleeding of gastric or duodenal ulcers. Tab: 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.
Dosage/Direction for Use
Tab 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 Adult & childn 12-18 yr 20 mg once daily for 4 wk. Maintenance: 20 mg once daily. Childn 1-11 yr 10 mg once daily for up to 8 wk. Adult Treatment of 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 & duodenal ulcers associated w/ NSAID therapy in patient at risk 20-40 mg once daily. Prevention of gastric &/or duodenal ulcers associated w/ low-dose aspirin therapy in patient at risk Patient requiring continued low-dose aspirin therapy 20-40 mg once daily. Maintenance of hemostasis & prevention of rebleeding of gastric or duodenal ulcers following treatment w/ IV esomeprazole 40 mg once daily for 4 wk. In combination w/ an appropriate antibacterial therapeutic regimen for the eradication of H. pylori & H. pylori-associated duodenal ulcer & prevention of peptic ulcer relapse in patient w/ H. pylori-associated ulcer disease 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. Treatment of duodenal ulcer caused by H. pylori 20 mg bid for 1 wk. Treatment of 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 10 mg, 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. Granules Erosive reflux esophagitis Childn 1-11 yr weighing ≥20 kg 10-20 mg once daily for 8 wk, <20 kg 10 once daily for 8 wk. Long-term management of patients w/ healed esophagitis to prevent relapse Childn 1-11 yr 10 mg once daily. Symptomatic treatment of GERD Childn 1-11 yr 10 mg once daily for up to 8 wk. Treatment of 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, 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. Inj Erosive reflux esophagitis Adult & childn 12-17 yr 40 mg once daily. Childn 1-11 yr ≥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. Long-term management of patient w/ healed esophagitis to prevent relapse 20 mg once daily. Symptomatic treatment of GERD Adult 20 mg once daily 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. 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 Nexium 40-mg tab once daily for 4 wk.
Administration
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 and stir. Leave for a few minutes to thicken. Stir again and take w/in 30 min. Rinse remaining contents w/ water and drink immediately. For patients who cannot swallow, the mixt can be administered through a nasogastric tube w/ a syringe. Refill syringe w/ water, shake and flush any remaining contents from the nasogastric tube.
Contraindications
Hypersensitivity to esomeprazole & substituted benzimidazoles.
Special Precautions
Exclude malignancy in the presence of significant unintentional wt loss, recurrent vomiting, dysphagia, hematemesis or melena; & when gastric ulcer is suspected or present. Patients on long-term & on-demand treatment. Concurrent therapy of CYP3A4-metabolized drugs eg, cisapride. Concomitant use w/ atazanavir & nelfinavir is not recommended; clopidogrel. Monitor patients at risk for developing osteoporosis or osteoporotic fractures. Severe renal or hepatic impairment. Pregnancy. Do not use during lactation. Granules: Rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
Adverse Reactions
Headache; abdominal pain, diarrhea, flatulence, nausea, vomiting, constipation. Inj: Administration site reactions.
Drug Interactions
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 Cmax & AUC of cilostazol. Increased AUC & prolonged elimination t½ of cisapride. Increased serum levels of tacrolimus & other antiretroviral drugs eg, saquinavir. Increased methotrexate 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).
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).
Presentation/Packing
Form
Nexium MUPS tab 40 mg
Packing/Price
14's
Form
Nexium granules for oral susp 10 mg
Packing/Price
28 × 1's
Form
Nexium MUPS tab 20 mg
Packing/Price
14's
Form
Nexium IV powd for inj 40 mg
Packing/Price
1's
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