Distribution The apparent volume of distribution at steady state in healthy subjects is approximately 0. Reporting suspected adverse reactions after authorisation of the medicinal product is important. The dosage should then be individually adjusted and treatment continued as long as clinically indicated. For patients with severe liver impairment, a maximum dose of 20 mg Nexium should not be exceeded see section 5. This is to allow CgA levels that might be spuriously elevated following PPI treatment to return to reference range.
Helicobacter pylori eradication When prescribing esomeprazole for eradication of Helicobacter pyloripossible drug interactions for all components in the triple therapy should be considered. Concomitant administration of esomeprazole and a combined inhibitor of CYP2C19 and CYP3A4 may result in more than doubling of the esomeprazole exposure. It is a specific inhibitor of the acid pump in the parietal cell. Tacrolimus Concomitant administration of esomeprazole has been reported to increase the serum levels of tacrolimus.
Put the tablet into an appropriate syringe and fill the syringe with approximately 25 ml water and approximately 5 ml air. Paediatric population Adolescents years: Omeprazole has been reported to interact with some protease inhibitors. Patients on on-demand treatment should be instructed to contact their physician if their symptoms change in character.
Treatment with omeprazole 20 mg qd had no effect on the exposure of darunavir with concomitant ritonavir and amprenavir with concomitant ritonavir. Esomeprazole should not be used during breast-feeding. Date of first authorisation: Name of the medicinal product 2. It is recommended to monitor the plasma concentrations of phenytoin when treatment with esomeprazole is introduced or withdrawn.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
The plasma elimination half-life is about 1. Special patient populations Poor metabolisers Approximately 2. Patients on long-term treatment particularly those treated for more than a year should be kept under regular surveillance.
When given together with PPIs, methotrexate levels have been reported to increase in some patients. With doses above 80 mg daily, the dose should be divided and given twice daily. As a precaution concomitant use of clopidogrel should be discouraged.
Using AUC as a surrogate parameter for plasma concentration, a relationship between inhibition of acid secretion and exposure has been shown. As with other medicinal products that decrease intragastric acidity, the absorption of medicinal products such as ketoconazole, itraconazole and erlotinib can decrease and the absorption of digoxin can increase during treatment with esomeprazole.
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Animal studies with the racemic mixture omeprazole, given by oral administration do not indicate effects with respect to fertility. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and, in hospitalised patients, possibly also Clostridium difficile. Other possible interaction mechanisms are via inhibition of CYP2C