Nexium/Nexium MUPS

Nexium/Nexium MUPS Special Precautions

esomeprazole

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Full Prescribing Info
Special Precautions
In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrentvomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present,malignancy should be excluded, as treatment with Nexium may alleviate symptoms and delaydiagnosis.Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinalinfections such as Salmonella and Campylobacter (see Pharmacology: "Pharmacodynamics" under Actions).Co-administration of esomeprazole with atazanavir is not recommended (see "Interactions"). Ifthe combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinicalmonitoring is recommended in combination with an increase in the dose of atazanavir to 400mg with 100 mg of ritonavir; 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 esomeprazole (see "Interactions"). Theclinical relevance of this interaction is uncertain. As a precaution, concomitant use ofesomeprazole and clopidogrel should be discouraged.
Subacute Cutaneous Lupus Erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of subacute cutaneous lupus erythematosus (SCLE). If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping esomeprazole. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Hypomagnesaemia: Severe hypomagnesaemia has been reported in patients treated with PPI like esomeprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as 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 PPI with digoxin or drugs that may cause hypomagnesaemia (e.g. diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.
Fracture: 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.
Absorption of Vitamin B12: Esomeprazole, as all acid-blocking medicines, may reduce the absorption of Vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced Vitamin B12 absorption on long-term therapy.
Interference with laboratory tests: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, esomeprazole treatment should be stopped for at least 5 days before CgA measurements (see Pharmacology: Pharmacodynamics under Actions). If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of PPI treatment.
Nexium: Regular Surveillance: Patients on proton pump inhibit treatment (particularly those treated for long term) should be kept under regular surveillance.
Nexium MUPS: Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance.
Patients on on-demand treatment should be instructed to contact their physician if their symptoms change in character. 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").
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 drugs metabolised via CYP3A4 such as cisapride.
This medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Effects on Ability to Drive and Use Machines: No effects have been observed.
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