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Esomeprazole tablets are indicated for:
Adults
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 appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and
– Healing of Helicobacter pylori associated duodenal ulcer and
– Prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers
Patients requiring continued NSAID therapy
– Healing of gastric ulcers associated with NSAID therapy.
– Prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk.
Prolonged treatment after i.v. induced prevention of rebleeding of peptic ulcers.
Treatment of Zollinger Ellison Syndrome
Adolescents from the age of 12 years
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 antibiotics in treatment of duodenal ulcer caused by Helicobacter pylori
Dosage
Adults and adolescents from the age of 12 years
Gastroesophageal Reflux Disease (GERD
– 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.
– 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 oesophagitis. If symptom control has not been achieved after 4 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.
Adults
In combination with appropriate antibacterial therapeutic regimens for the
eradication of Helicobacter pylori and
– Healing of Helicobacter pylori associated duodenal ulcer and
– Prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers.
Esomeprazole 20 mg 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 patients at risk: 20 mg once daily.
Prolonged treatment after i.v. induced prevention of rebleeding of peptic ulcers.
40 mg once daily for 4 weeks after i.v. induced prevention of rebleeding of peptic ulcers.
Treatment of Zollinger Ellison Syndrome
The recommended initial dose is 40 mg twice daily. The dose should then be individually adjusted and treatment continued as long as clinically indicated. Based on the clinical data available, 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.
Adolescents from the age of 12 years
Treatment of duodenal ulcer caused by Helicobacter pylori
When selecting appropriate combination therapy, consideration should be given to official national, regional and local guidance regarding bacterial resistance, duration of treatment (most commonly 7 days but sometimes up to 14 days), and appropriate use of antibacterial agents. The treatment should be supervised by a specialist.
Children below the age of 12 years
Esomeprazole should not be used in children younger than 12 years since no data is available.
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.
Elderly
Dose adjustment is not required in the elderly.
Direction for use
The tablets should be swallowed whole with glass of water. The tablets should not be chewed or crushed.
The following adverse drug reactions have been identified or suspected in the clinical trials programme for esomeprazole and post-marketing. None was found to be dose related. Leukopenia, thrombocytopenia, Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock, Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting, Malaise, increased sweating
When prescribing esomeprazole for eradication of Helicobacter pylori possible drug interactions for all components in the triple therapy should be considered. Clarithromycin is a potent inhibitor of CYP3A4 and hence contraindications and interactions for clarithromycin should be considered when the triple therapy is used in patients concurrently taking other active substances metabolised via CYP3A4 such as cisapride.
Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter
Co-administration of esomeprazole with atazanavir is not recommended. If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; esomeprazole 20 mg should not be exceeded.
Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.
Store below 30°C temperature and protect from light.
Keep the medicine out of reach of children.
Alu-Alu blister packs.
Esomeprazole Tablets 40 mg is available in an Alu-Alu blister of 10 tablets. Such 10 blisters in a unit carton with package insert.
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