In the presence of any alarm symptom (eg, significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with Nexium may alleviate symptoms and delay diagnosis.
Patients on long-term treatment (particularly those treated for >1 year) should be kept under regular surveillance. For granules, long-term treament is indicated in adults and adolescents ≥12 years (see Interactions).
Patients on on-demand treatment should be instructed to contact their physician if their symptoms change in character. In granules, on-demand treatment has not been investigated in children and is, therefore, not recommended in this patient group. When prescribing esomeprazole for on-demand therapy, the implications for interactions with other pharmaceuticals, due to fluctuating plasma concentrations of esomeprazole should be considered (see Interactions).
Nexium contains sucrose and glucose (for granules). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take Nexium.
Treatment with PPIs may lead to slightly increased risk of gastrointestinal infections eg, Salmonella and Campylobacter (see Pharmacology: Pharmacodynamics under Actions).
Co-administration of esomeprazole with atazanavir is not recommended (see Interactions). If the combination of atazanavir with a PPI is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with ritonavir 100 mg; esomeprazole 20 mg should not be exceeded.
Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with drugs metabolised through CYP2C19 should be considered. An interaction is observed between clopidogrel and omeprazole (see Interactions). The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of esomeprazole and clopidogrel should be discouraged.
Severe hypomagnesaemia has been reported in patients treated with PPIs like esomeprazole for at least 3 months, and in most cases for a year. Serious manifestations of hypomagnesaemia eg, fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI.
For patients expected to be on prolonged treatment or who take PPIs with medications eg, digoxin or drugs that may cause hypomagnesaemia (eg, diuretics), healthcare professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically during treatment.
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.
Interference with Laboratory Tests: Increased CgA level may interfere with investigations for neuroendocrine tumours. To avoid this interference, esomeprazole treatment should be temporarily stopped for at least 5 days before CgA measurements.
Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least 3 months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.
For patients expected to be on prolonged treatment or who take PPIs with medications eg, digoxin or drugs that may cause hypomagnesemia (eg, diuretics), healthcare professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
Tablet: Pain or indigestion, vomiting blood or food, passing black (blood-stained) motions. Severe liver and kidney problems. Low magnesium levels in the blood. Triple therapy for eradication of H. pylori.
Effects on the Ability to Drive or Operate Machinery: No effects have been observed.
Use in pregnancy: For Nexium, clinical data on exposed pregnancies are insufficient. With the racemic mixture omeprazole, data on a larger number of exposed pregnancies from epidemiological studies indicate no malformative nor foetotoxic effect. Animal studies with esomeprazole do not indicate direct or indirect harmful effects with respect to embryonal/foetal development. Animal studies with the racemic mixture do not indicate direct or indirect harmful effects with respect to pregnancy, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.
Use in lactation: It is not known whether esomeprazole is excreted in human breast milk. No studies in lactating women have been performed. Therefore, Nexium should not be used during breastfeeding.