Nexium/Nexium MUPS

Nexium/Nexium MUPS

esomeprazole

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Esomeprazole
Indications/Uses
Healing of gastric ulcers associated w/ NSAID therapy. Prevention of gastric & duodenal ulcers associated w/ NSAID therapy in patients at risk. Nexium Gastric antisecretory treatment when oral route is not possible eg, GERD in patients w/ esophagitis &/or severe reflux symptoms. Prevention of rebleeding following therapeutic endoscopy for acute bleeding of gastric or duodenal ulcers. Nexium MUPS Erosive reflux esophagitis & Zollinger-Ellison syndrome. Long-term management of patients w/ healed esophagitis to prevent relapse. Symptomatic treatment of GERD. In combination w/ antibacterial regimen for eradication & healing of H pylori-associated duodenal ulcer & prevention of peptic ulcer relapse in patients w/ H pylori-associated ulcers. Prevention of peptic ulcer rebleeding after prolonged IV treatment.
Dosage/Direction for Use
Nexium Reflux oesophagitis 40 mg once daily. Symptomatic treatment of reflux disease, healing of gastric ulcers associated w/ NSAID therapy & prevention of gastric & duodenal ulcers associated w/ NSAID therapy 20 mg once daily. Prevention of gastric & duodenal ulcer rebleeding 80 mg as bolus infusion over 30 min followed by continuous IV infusion of 8 mg/hr over 3 days. Severe hepatic impairment GERD Max daily dose: 20 mg. Bleeding ulcers 80 mg as bolus dose followed by 4 mg/hr continuous IV infusion dose for 71.5 hr. Nexium MUPS Adult & adolescent from 12 yr Erosive reflux esophagitis 40 mg once daily for 4-8 wk. Long-term management of patient w/ healed esophagitis to prevent relapse & prevention of gastric & duodenal ulcers associated w/ NSAID therapy in patient at risk 20 mg once daily. Symptomatic treatment of GERD 20 mg once daily in patients w/o esophagitis. Continue w/ 20 mg once daily on demand if control has been achieved. Adult Eradication & healing of H pylori-associated duodenal ulcer & prevention of peptic ulcer relapse in patient w/ H pylori-associated ulcers 20 mg w/ amoxicillin 1 g & clarithromycin 500 mg bd for 7 days. Healing of gastric ulcers associated w/ NSAID therapy 20 mg once daily for 4-8 wk. Prevention of peptic ulcer rebleeding after prolonged IV treatment 40 mg once daily for 4 wk. Zollinger-Ellison syndrome Initially 40 mg bd, individually adjusted & continued as clinically indicated. Dose range: 80-160 mg daily. Doses >80 mg should be divided & given bd. Severe hepatic impairment Max: 20 mg.
Administration
May be taken with or without food: For patients w/ swallowing difficulties, disperse tab in a 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.
Contraindications
Hypersensitivity to esomeprazole, substituted benzimidazoles. Not to be used concomitantly w/ nelfinavir.
Special Precautions
Exclude gastric malignancy prior to treatment. Increased risk of GI infections eg, Salmonella & Campylobacter; subacute cutaneous lupus erythematosus; hip, wrist & spine fracture. Hypomagnesaemia. Discontinue use for at least 5 days before CgA measurements. Long-term use. Not recommended in concomitant use w/ atazanavir. Concomitant use w/ CYP2C19 inhibitor eg, clopidogrel; vit B12; digoxin; drugs causing hypomagnesaemia eg, diuretics. Severe renal insufficiency. Pregnancy. Not to be used during lactation. Not to be used in childn <12 yr & adolescents. Nexium MUPS Concomitant use w/ clarithromycin. Fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase insufficiency.
Adverse Reactions
Headache; abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting, benign fundic gland polyps. Nexium Administration site reactions.
Drug Interactions
Increased absorption of ketoconazole, itraconazole, erlotinib; digoxin. Decreased serum levels of atazanavir, nelfinavir. Increased serum levels of saquinavir. Increased plasma conc of CYP2C19-metabolised drugs eg, diazepam, citalopram, imipramine, clomipramine, phenytoin. Elevated INR w/ warfarin or other coumarine derivatives. Increased AUC & prolonged t½ of cisapride. Decreased exposure to clopidogrel. Increased Cmax & AUC of cilostazol. Increased serum levels of tacrolimus. Increased methotrexate levels. Doubled exposure by CYP3A4 inhibitors eg, clarithromycin. Increased AUC by voriconazole. Decreased serum levels by 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 DR-FC tab (MUPS) 40 mg
Packing/Price
14's (RM118.6/blister)
Form
Nexium powd for soln for inj 40 mg
Packing/Price
1's
Form
Nexium DR-FC tab (MUPS) 20 mg
Packing/Price
14's (RM77.15/blister)
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