TERLIPRESSIN ACETATE

The administration of terlipressin serves the emergency care for acute bleeding oesophageal varices until endoscopic therapy is available. Afterwards the administration of terlipressin for the treatment of oesophageal varices is usually an adjuvant therapy to the endoscopic haemostasis.

Adults Initially 1-2 mg terlipressin acetate (equivalent to 1-2 ampoules of Terlipressin Acetate 1 mg solution for injection) are administered. 5 ml). After the initial injection, the dose can be reduced to 1 mg every 4 to 6 hours. The approximate value for the maximum daily dose of Terlipressin Acetate 1 mg solution for injection is 120 μg/kg body weight.

The therapy is to be limited to 2 – 3 days in adaptation to the course of the disease. Terlipressin Acetate 1 mg solution for injection is injected intravenously and should be given during the period of one minute. 4). Hepatic insufficiency A dose adjustment is not required in patients with liver failure

Treatment of bleeding oesophageal varices with Terlipressin Acetate 1 mg solution for injection (1 mg intravenously and more) may be accompanied by the adverse reactions in Table 1.

The assessment of undesirable effects is based on the following frequencies:

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 Frequency not known: cannot be estimated from the available data Table 1. 5). 4). 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.

In principle the use of the product should be confined to specialist supervision in units with facilities for regular monitoring of the cardiovascular system, haematology and electrolytes. 6). Also hypovolaemic patients often react with an increased vasoconstriction and atypical cardiac reactions.

Due to the weak antidiuretic effect of terlipressin (only 3% of the antidiuretic effect of native vasopressin) especially patients with already disturbed electrolyte metabolism should be monitored for a possible hyponatraemia and hypokalaemia.

In emergency situations which require an immediate treatment before sending the patient to a hospital, symptoms of hypovolaemia have to be considered. Terlipressin has no effect on arterial bleeding. To avoid local necrosis at the injection site, the injection must be administered intravenously exclusively.

8). Patients with peripheral venous hypertension or morbid obesity seem to have a greater tendency to this reaction. Therefore, extreme caution should be exercised when administering terlipressin in these patients. 8). In most cases, patients had predisposing factors such as basal prolongation of the QT interval, electrolyte abnormalities (hypokalemia, hypomagnesemia) or medications with concomitant effect on QT prolongation.

g. 5).

Special populations:

Particular caution should be exercised in the treatment of children, adolescents and elderly patients, as experience is limited and there is no data available regarding dosage recommendation in these special patient categories. 53% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

1.