Uni Drug
Concise Prescribing Info
In adults & adolescents from 12 yr, erosive reflux esophagitis, symptomatic treatment of GERD. Long-term management of healed esophagitis to prevent relapse. In combination w/ antibacterial regimen for duodenal ulcer caused by H. pylori. In adults, gastric ulcer associated w/ NSAID-therapy; Zollinger-Ellison syndrome; prolonged treatment after IV induced prevention of peptic ulcer rebleeding. Prevention of NSAID-associated gastric & duodenal ulcer.
Dosage/Direction for Use
Adult & adolescent from 12 yr Erosive reflux esophagitis 40 mg once daily for 4 wk. An additional 4 wk treatment is recommended for patients in whom esophagitis has not healed or who have persistent symptoms. Long-term management of healed esophagitis to prevent relapse 20 mg once daily. Symptomatic treatment of GERD 20 mg once daily. Adult H. pylori-associated duodenal ulcer & prevention of peptic ulcer relapse Emanera 20 mg w/ amoxicillin 1 g & clarithromycin 500 mg bd for 7 days. NSAID therapy-associated gastric ulcers 20 mg once daily for 4-8 wk. Prevention of NSAID-associated gastric & duodenal ulcers 20 mg once daily. Prolonged treatment after IV induced prevention of peptic ulcer rebleeding 40 mg once daily for 4 wk. Zollinger Ellison syndrome Initially 40 mg bd. Duodenal ulcer caused by H. pylori Adolescent from 12 yr, 30-40 kg Emanera 20 mg, amoxicillin 750 mg & clarithromycin 7.5 mg/kg bd for 1 wk, >40 kg Emanera 20 mg, amoxicillin 1 g & clarithromycin 500 mg bd for 1 wk.
Hypersensitivity to esomperazole, substituted benzimidazole. Concomitant use w/ nelfinavir.
Special Precautions
Exclude malignancy in the presence of alarm symptoms (significant unintentional wt loss, recurrent vomiting, dysphagia, haematemesis or melaena) prior to treatment. Monitor Mg levels before & periodically during treatment. Long-term use & high-dose treatment. Patients w/ reduced body stores or risk factors for reduced vit B12 absorption. Ensure adequate intake of vit D & Ca in patients at risk of osteoporosis. Increased risk of GI infections (eg, Salmonella & Campylobacter). Not recommended in co-administration w/ atazanavir, clopidogrel. Fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Severe renal insufficiency & severe hepatic impairment. Pregnancy. Not to be used during lactation. Not to be used in childn <12 yr. Elderly.
Adverse Reactions
Headache; abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting.
Drug Interactions
Decreased absorption of ketoconazole, itraconazole & erlotinib. Increased absorption of digoxin. Decreased serum levels of atazanavir & nelfinavir. Increased plasma conc of diazepam, citalopram, imipramine, clomipramine, phenytoin. Elevated INR w/ warfarin or other coumarin derivatives. Increased Cmax & AUC of voriconazole & cilostazol. Increased AUC & t½ of cisapride. Decreased exposure to the active metabolite of clopidogrel. Increased methotrexate levels. 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).
Emanera gastro-resistant cap 20 mg
Emanera gastro-resistant cap 40 mg
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