MILRINONE

e. 4). g. life-threatening ventricular arrhythmias). The infusion rate should be adjusted according to haemodynamic response. 5 μg/kg/min) according to haemodynamic and clinical response and the possible onset of undesirable effects such as hypotension and arrhythmias.

0 μg/kg/hr. The following provides a guide to maintenance infusion delivery rate based upon a solution containing milrinone 200 μg/ml prepared by adding 40 ml diluent per 10 ml ampoule. 9% saline or 5% glucose may be used as diluents.

22 Solutions of different concentrations may be used according to patient fluid requirements. The duration of therapy should depend upon the patient´s response. Elderly Experience so far suggests that no special dosage recommendations are necessary in patients with normal renal function.

Renal clearance may be reduced in elderly patients, lower Milrinone Injection doses may be required in such cases. Renal Impairment Dosage adjustment required. Dosage adjustment in patients with renal impairment is based on data obtained from patients with common renal impairment but without congestive heart failure, who show significant increases to the terminal elimination half-life of milrinone.

13 Paediatric population In published studies selected doses for infants and children were: - Intravenous loading dose: 50 to 75 μg/kg administered over 30 to 60 minutes. 75 μg/kg/min for a period up to 35 hours. 75 μg/kg/min infusion for 35 hours significantly reduced the risk of development of low cardiac output syndrome.

2) have to be taken into consideration. 4). 3). Method of administration For slow intravenous administration. To avoid local irritation, as large a vein as possible should be punctured. Extravascular injection must be avoided. 2). Solutions of different concentrations may be used according to patient fluid requirements.

After dilution the solution is a clear, colourless to pale yellow liquid. 4).

Adverse reactions have been ranked under heading of system-organ class and frequency using the following convention: - 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).

Blood and lymphatic system disorders: - Uncommon:

Thrombocytopenia - Not known: Reduction of red blood count and/or haemoglobin concentration Immune system disorders: - Very rare: Anaphylactic shock Metabolism and nutrition disorders: - Uncommon: Hypokalaemia Nervous system disorders: - Common: Headaches, usually mild to moderate in severity - Uncommon: Tremor Cardiac disorders: - Common: Ventricular ectopic activity, non-sustained or sustained ventricular tachycardia, supraventricular arrhythmias 1, hypotension 1 The incidence of arrhythmias has not been related to dose or plasma levels of milrinone.

g. hypokalaemia), elevated serum digoxin levels or catheter insertion. Clinical data suggest that milrinone-related arrhythmias are less common in children than in adults. 4). 3). The critical consequences of the patent ductus arteriosus are related to a combination of pulmonary overcirculation with consecutive pulmonary oedema and haemorrhage and of reduced organ perfusion with consecutive intraventricular haemorrhage and necrotizing enterocolitis with possible fatal outcome as described in literature.

Long-term safety data for paediatric population are not yet available. 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.

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e. serum creatinine). g. life threatening ventricular arrhythmias). In patients with severe obstructive aortic or pulmonary valvular disease, or hypertrophic subaortic stenosis (KMP), milrinone should not be used in lieu of surgical relief of the obstruction.

As with other drugs with inotropic / vasodilator properties, it may aggravate outflow obstruction in these conditions. Milrinone is not recommended immediately following acute myocardial infarction until safety and efficacy have been established in this situation.

Use of positive inotropic such as milrinone in the acute phase of post myocardial infarction may lead to an undesirable increase in myocardial oxygen consumption (MVO2). Heightened caution is needed in patients in the acute phase of myocardial infarction in spite of milrinone does not increase MVO2 in patients with chronic heart failure.

There is a possibility of an increased ventricular response rate in patients with atrial flutter or fibrillation. In these patients, prior digitalisation or treatment with other agents to prolong atrio-ventricular node conduction time should be considered, as milrinone produces a slight enhancement in A-V node conduction.

Supraventricular and ventricular arrhythmias have been observed in the high-risk population treated with milrinone. In some patients, an increase in ventricular ectopy including non-sustained ventricular tachycardia has been observed.

Patients, especially those with complex ventricular arrhythmias, should therefore be kept under continuous ECG and clinical monitoring during Milrinone Injection therapy and the dosage should be carefully adjusted. If prior vigorous diuretic therapy is suspected of having caused significant decreases in cardiac filling pressure, Milrinone Injection should be cautiously administered while monitoring blood pressure, heart rate and clinical symptomatology.

1). Severe hypovolaemia.