Simendan 12.5 mg/5 ml

Warnings & Precautions

Simendan can cause a drop in systolic and diastolic blood pressure at the start of treatment. So use it with caution in patients whose baseline systolic or diastolic pressure is low, or who are at risk of a hypotensive episode. More conservative dosing regimens are recommended for these patients. The doctor should tailor the dose and the duration of therapy to the patient's condition and response. Severe hypovolaemia should be corrected before the Simendan infusion is started. If blood pressure or heart rate changes too much, reduce the rate of infusion or stop it. The exact duration of all the haemodynamic effects has not been determined, but they generally last for 7 to 10 days. This is partly because of the active metabolites, which reach their maximum plasma concentrations about 48 hours after the infusion has stopped. Non-invasive monitoring is recommended for at least 4 to 5 days after the end of the infusion. It should go on until the fall in blood pressure has reached its maximum and the pressure starts to rise again. Monitoring may need to be longer than 5 days if there are any signs of a continuing fall in blood pressure, and it can be shorter than 5 days if the patient is clinically stable. In patients with mild to moderate renal impairment or mild to moderate hepatic impairment, a longer period of monitoring may be needed. Simendan should be used cautiously in patients with mild to moderate renal impairment. Data on how the active metabolites are eliminated in impaired renal function are limited. Impaired renal function may raise the concentrations of the active metabolites, and this may give a more pronounced and prolonged haemodynamic effect. Simendan should also be used cautiously in patients with mild to moderate hepatic impairment. Impaired hepatic function may prolong exposure to the active metabolites, which may again give a more pronounced and prolonged haemodynamic effect. Simendan infusion may lower serum potassium. Low serum potassium should therefore be corrected before Simendan is given, and serum potassium should be monitored during treatment. As with other medicines for heart failure, Simendan infusions may be accompanied by a fall in haemoglobin and haematocrit. Take caution in patients with ischaemic cardiovascular disease and concurrent anaemia. Use the infusion cautiously in patients with tachycardia, atrial fibrillation with rapid ventricular response, or potentially life-threatening arrhythmias. Experience with repeated administration of Simendan is limited. Experience with the concomitant use of vasoactive agents, including inotropic agents (except digoxin), is also limited. Benefit and risk should be assessed for each patient individually. Simendan should be used cautiously, with close ECG monitoring, in patients with ongoing coronary ischaemia, in those with a long QTc interval whatever the cause, or when it is given together with medicines that prolong the QTc interval. The use of Simendan in cardiogenic shock has not been studied. No information is available on its use in these disorders: restrictive cardiomyopathy, hypertrophic cardiomyopathy, severe mitral valve insufficiency, myocardial rupture, cardiac tamponade and right ventricular infarction. Simendan should not be given to children, because there is very limited experience of its use in children and adolescents under 18 years of age. Experience is also limited in patients with heart failure after surgery, and in severe heart failure in patients awaiting heart transplantation.