ESOMEPRAZOLE

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 oesophagitis 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. ). 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. ). 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 GORD: Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, a maximum daily dose of 20 mg Esomeprazol should not be exceeded. ) 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 GORD (see doses in table below).

The following adverse drug 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) Rare: Arthralgia, myalgia Very rare: Muscular weakness Renal and urinary disorders Very rare: Interstitial nephritis Reproductive system and breast disorders Very rare: Gynaecomastia General disorders and administration site conditions Rare: Malaise, increased sweating *Administration site reactions have mainly been observed in a study with high-dose exposure over 3 days (72 hours).

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.

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. 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.

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 Esomeprazole may alleviate symptoms and delay diagnosis.

1). 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, 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.

Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with drugs 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. 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. 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.

Hypersensitivity to the active substance esomeprazole or to other substituted benzimidazoles or to any of the excipients of this medicinal product. 5).