Esoferr 40 mg
Indication
Gastroesophageal Reflux Disease (GERD)
- Treatment of erosive reflux esophagitis
- Long-term management of patients with healed esophagitis to prevent relapse
- Symptomatic treatment of gastroesophageal reflux disease (GERD)
In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori
- Healing of Helicobacter pylori associated duodenal ulcer
Patients requiring continued NSAID therapy
- Healing of gastric ulcers associated with NSAID therapy
- Prevention of gastric and duodenal ulcers associated with continous NSAID therapy in patient at risk. Patients are considered to be at risk due to their age (>60 years) and documented history of peptic ulcer. Available clinical controlled study do not extend beyond 6 months.
Treatment of Zollinger-Ellison syndrome
Composition
Esomeprazole 40 mg
Package
Dosage Forms
ATC Classification
Warning
Dosage
0 to 11 Years Old
Esomeprazole should not be used in children younger than 12 years since no data is available.
12 to 18 Years Old
Symptomatic treatment of gastroesophageal reflux disease (GERD):
20 mg once daily in patients without esophagitis. If symptom control has not been achieved after four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using 20 mg once daily, under medical supervision.
18 Years Old and Above
Treatment of erosive reflux esophagitis:
40 mg once daily for 4 weeks. An additional 4 weeks treatment is recommended for patients in whom esophagitis has not healed or who have persistent symptoms.
Esomeprazole 40 mg should only be administered for patients with mucosal break of grade C and D under the LA classification system, the grade of which should be confirmed by endoscopical or radiological diagnosis. Patients who have GERD with erosive esophagitis of Grade A and B are recommended to be treated with esomeprazole 20 mg.
Long-term management of patients with healed esophagitis to prevent relapse:
20 mg once daily.
Symptomatic treatment of gastroesophageal reflux disease (GERD):
20 mg once daily in patients without esophagitis. If symptoms control has not been achieved after four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using 20 mg once daily. In adults, an on-demand regimen taking 20 mg once daily, when needed, can be used. In NSAID treated patients at risk of developing gastric and duodenal ulcers, subsequent symptom control using an on-demand regimen is not recommended.
In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori:
Healing of Helicobacter pylori associated duodenal ulcer:
20 mg esomeprazole with 1 g amoxicillin and 500 mg clarithromycin, all twice daily for 7 days.
Patients requiring continued NSAID therapy:
Healing of gastric ulcers associated with NSAID therapy:
The usual dose is 20 mg once daily. The treatment duration is 4-8 weeks.
Prevention of gastric and duodenal ulcers associated with NSAID therapy in patient at risk:
20 mg once daily.
Treatment of Zollinger-Ellison syndrome:
The recommended initial dosage is esomeprazole 40 mg twice daily. The dosage should then be individually adjusted and treatment continued as long as clinically indicated. The majority of patients can be controlled on doses between 80 to 160 mg esomeprazole daily. With doses above 80 mg daily, the dose should be divided and given twice daily.
Impaired Renal Function
Dose adjustment is not required in patients with impaired renal function. Due to limited experience in patients with severe renal insufficiency, such patients should be treated with caution.
Impaired Hepatic Function
Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, a maximum dose of 20 mg esomeprazole should not be exceeded.