TERLIPRESSIN ACETATE SUN

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.

5 to 17 ml of solution), administered by intravenous injection over a period of time. 75 ml) - weight exceeding 70 kg: 2 mg terlipressin acetate (17 ml). After the initial injection, the dose can be reduced to 1 mg terlipressin acetate every 4 to 6 hours.

12 is 120 μg terlipressin acetate per kg body weight. The therapy is to be limited to 2 – 3 days in adaptation to the course of the disease. 7 mg terlipressin. 4). 4). Hepatic insufficiency A dose adjustment is not required in patients with liver failure.

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 not known (cannot be estimated from the available data).

Treatment of bleeding oesophageal varices with terlipressin (1 mg intravenously and more) may be accompanied by the following adverse reactions: Metabolism and nutrition disorders Uncommon: hyponatraemia if fluid not monitored Very rare: hyperglycaemia Nervous system disorders Common: headache Uncommon: triggering of a convulsive disorder Very rare: stroke Cardiac disorders Common: ventricular and supra-ventricular arrhythmia, bradycardia, signs of ischaemia in the ECG Uncommon: angina pectoris, acute hypertension rise, in particular in patients already suffering from hypertension (generally, it decreases spontaneously), atrial fibrillation, ventricular extrasystoles, tachycardia, chest pain, myocardial infarction, fluid overload with pulmonary oedema, cardiac failure, Torsade de Pointes Very rare: myocardial ischemia Vascular disorders Common: hypertension, hypotension, peripheral ischaemia, peripheral vasoconstriction, facial pallor Uncommon: intestinal ischaemia, peripheral cyanosis, hot flushes Respiratory, thoracic and mediastinal disorders Uncommon: pain in the chest, bronchospasm, respiratory distress, respiratory failure Rare: dyspnoea Gastrointestinal disorders Common: transient abdominal cramps, transient diarrhoea Uncommon: transient nausea, transient vomiting Skin and subcutaneous tissue disorders Common: paleness Uncommon: lymphangitis, skin necrosis unrelated to the site of administration Reproductive system and breast disorders Common: abdominal cramps (in women) Pregnancy, puerperium and perinatal conditions Uncommon: uterine hypertonus, uterine ischemia Not known: uterine constriction, decreased uterine blood flow General disorders and administration site conditions Uncommon: local cutaneous necrosis.

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 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. 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. 8) have been reported. 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). 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.

7 mmol (or 361 mg) of sodium in its single maximum dose. To be taken into consideration by patients on a controlled sodium diet.

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