NEXIUM I.V.

Posology Adults Gastric antisecretory treatment when the oral route is not possible Patients who cannot take oral medication may be treated parenterally with 20–40 mg once daily. Patients with reflux esophagitis should be treated with 40 mg once daily.

Patients treated symptomatically for reflux disease should be treated with 20 mg once daily. For healing of gastric ulcers associated with NSAID therapy the usual dose is 20 mg once daily. For prevention of gastric and duodenal ulcers associated with NSAID therapy, patients at risk should be treated with 20 mg once daily.

Usually the intravenous treatment duration is short and transfer to oral treatment should be made as soon as possible. Prevention of rebleeding of gastric and duodenal ulcers Following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers, 80 mg should be administered as a bolus infusion over 30 minutes, followed by a continuous intravenous infusion of 8 mg/h given over 3 days (72 hours).

The parenteral treatment period should be followed by oral acid-suppression therapy. 6. Injection 40 mg dose 5 ml of the reconstituted solution (8 mg/ml) should be given as an intravenous injection over a period of at least 3 minutes.

5 ml or half of the reconstituted solution (8 mg/ml) should be given as an intravenous injection over a period of at least 3 minutes. Any unused solution should be discarded. Infusion 40 mg dose The reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes.

20 mg dose Half of the reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes. Any unused solution should be discarded. 80 mg bolus dose The reconstituted solution should be given as a continuous intravenous infusion over 30 minutes.

5 hours (calculated rate of infusion of 8 mg/h. 3 for shelf- life of the reconstituted solution). Special Populations Renal impairment Dose adjustment is not required in patients with impaired renal function. 2).

Hepatic impairment GERD:

Dose adjustment is not required in patients with mild to moderate liver impairment. V. 2).

Bleeding ulcers:

Dose adjustment is not required in patients with mild to moderate liver impairment. 2). Elderly Dose adjustment is not required in the elderly. Paediatric population Posology Children and adolescents aged 1-18 years Gastric antisecretory treatment when the oral route is not possible Patients who cannot take oral medication may be treated parenterally once daily, as a part of a full treatment period for GERD (see doses in table below).

Usually the intravenous treatment duration should be short and transfer to oral treatment should be made as soon as possible. 6. Injection 40 mg dose 5 ml of the reconstituted solution (8 mg/ml) should be given as an intravenous injection over a period of at least 3 minutes.

5 ml or half of the reconstituted solution (8 mg/ml) should be given as an intravenous injection over a period of at least 3 minutes. Any unused solution should be discarded. 25 ml of the reconstituted solution (8 mg/ml) should be given as an intravenous injection over a period of at least 3 minutes.

Any unused solution should be discarded. Infusion 40 mg dose The reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes. 20 mg dose Half of the reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes.

Any unused solution should be discarded. 10 mg dose A quarter of the reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes. Any unused solution should be discarded.

Summary of the safety profile Headache, abdominal pain, diarrhoea and nausea are among those adverse reactions that have been most commonly reported in clinical trials (and also from post- marketing use). In addition, the safety profile is similar for different formulations, treatment indications, age groups and patient populations.

No dose-related adverse reactions have been identified. Tabulated list of adverse reactions The following adverse medicinal product reactions have been identified or suspected in the clinical trials programme for esomeprazole administered orally or intravenously and post-marketing when administered orally.

The reactions are classified according to frequency: very common >1/10; common >1/100 to <1/10; uncommon >1/1,000 to <1/100; rare >1/10,000 to <1/1,000; very rare <1/10,000; not known (cannot be estimated from the available data). g.

4); severe hypomagnesaemia can correlate with hypocalcaemia. Hypomagnesaemia may also be associated with hypokalaemia. 3). Irreversible visual impairment has been reported in isolated cases of critically ill patients who have received omeprazole (the racemate) intravenous injection, especially at high doses, but no causal relationship has been established.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

2). A total of 57 patients (8 children in the age group 1–5 years) were included for safety evaluation. The safety results are consistent with the known safety profile of esomeprazole, and no new safety signals were identified.

g. 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.

Long term use Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance. On demand treatment Patients on on-demand treatment should be instructed to contact their physician if their symptoms change in character.

Helicobacter pylori eradication 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.

1). 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.

Hypomagnesaemia Severe hypomagnesaemia has been reported in patients treated with proton pump inhibitors (PPIs) 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. g. diuretics), healthcare professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

Risk of 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.

Subacute cutaneous lupus erythematosus (SCLE) Proton pump inhibitors are associated with very infrequent cases of 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 Nexium.

SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors. 5). 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.

Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with medicinal products metabolised through CYP2C19 should be considered. 5). The clinical relevance of this interaction is uncertain.

As a precaution, concomitant use of esomeprazole and clopidogrel should be discouraged. 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 section

1. 5).