MILRINONE

Posology Milrinone therapy should begin as an initial weight dependent dose reaching saturation and subsequently followed by a continuous, efficacy based maintenance dose according to the guidelines below. 05 mg) of milrinone/kg. It is administered slowly over a period of 10 minutes.

This is usually followed by a continuous maintenance infusion. 5 micrograms of milrinone /kg /minute. 75 micrograms of milrinone/kg/minute. (Table 2) The level of maintenance dose should be selected based on the hemodynamic effect and clinical efficacy.

13 mg milrinone/kg. Table 1. 0 Table 2. 05 mg/kg BW) To administer the maintenance dose, prepare an infusion solution containing 200 micrograms of milrinone/ml. It is prepared by adding 40 ml of a carrier solution to 10 ml undiluted milrinone solution for injection.

9% Sodium Chloride Infusion and 5% Glucose Infusion. Depending on the required maintenance dose (in micrograms/kg/minute), the following infusion rates (in milliliters/kg/hour) are obtained for the prepared infusion solution at a concentration of 200 microgram/ml (see Table 3).

22 * calculated for an infusion solution containing 200 micrograms of milrinone per milliliter. Infants and Children The published studies revealed that the following doses were used in infants and children: - Intravenous initial dose: 50 to 75 microgram/kg over 30 to 60 minutes.

75 microgram/kg/ min over a period of up to 35 hours. 75 microgram/kg/min over 35 hours reduced the risk of a low-cardiac output syndrome. 2) must be taken into account. 4 for more information). 3). Elderly patients Based on current knowledge, it is to be expected that in case of normal renal function no special dosage recommendations are necessary for this patient group.

Patients with renal impairment:

In patients with renal impairment, excretion of milrinone is limited. Therefore, a dose adjustment is required. The following recommendation is based on data from patients with renal impairment without cardiac insufficiency, in whom a significant prolongation of terminal half-life of milrinone was observed.

The initial dose is unchanged. The maintenance dose should be reduced depending on the extent of functional impairment (see Table 4). 73 m2), Maintenance dose (microgram/kg /minute) Maintenance dose (microgram/kg/hour) Infusion rate * (milliliter/kg/hour).

4), supraventricula r arrhythmia 2) hypotension fibrillation, angina pectoris, chest pain pointes Disorders of the respiratory tract, of the chest and mediastinum Bronchospas m Liver and biliary disorders Liver function tests abnormal Disorders of the skin and subcutaneou s Skin reactions like exanthema Disorders of the kidneys and urinary tract Renal failure as a result of a accomp anying hypoten sion General disorders and administratio n site conditions Infusio n site reaction s 1) In infants and children, the risk of thrombocytopenia increased significantly with the duration of infusion.

4). 2) The frequency of supraventricular and ventricular arrhythmias did not appear to be dose or plasma concentration related. Life threatening arrhythmias occurred in particular due to history of arrhythmias and/or metabolic abnormalities (eg, hypokalemia) and/or increased digitalis levels or catheterization.

Clinical data suggest that milrinone related arrhythmias are less common in children than in adults. Milrinone leads to a slight shortening of the AV conduction time. This can lead to an increased ventricular rate in patients with atrial flutter/fibrillation.

4). 3). According to literature the critical consequences of a persistent ductus arteriosus based on the combination of pulmonary hyperperfusion with pulmonary edema and pulmonary hemorrhage and reduced organ perfusion followed by intraventricular hemorrhage and necrotizing enterocolitis, may be fatal.

Data on long-term use in children 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.

uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Patients with atrial flutter / fibrillation should always be digitalized or treated with other effective antiarrhythmic drugs prior to administration of milrinone, unless no other contraindications exist, as milrinone accelerates AV node conduction and thus may favor the ventricular arrhythmia.

8). Therefore, patients especially those with complex ventricular arrhythmias, should be continuously monitored electrocardiographically and clinically during milrinone therapy and the dosage must be carefully adjusted. If cardiac filling pressures are suspected to have decreased (eg due to previous treatment with diuretics), then milrinone may be administered only after previous measurement and correction of ventricular filling pressures (ZVD, PCWP) and patients are to be administered under clinical observation.

Milrinone injection should be used with caution in patients with severe renal impairment. 2). During therapy with milrinone, both renal function (serum creatinine) and fluid and electrolyte status should be checked. It should also be considered that the improvement in cardiac output induced by milrinone which in turn associated with improvement in renal perfusion with increased diuresis may require a reduction in diuretics.

Potassium loss due to excessive diuresis may favor the onset of arrhythmias. At low potassium levels, potassium replacement should be performed before or during milrinone therapy. Milrinone may be hypotensive because of its vasodilatory activity.

Therefore, the use of milrinone injection in hypotensive patients should be considered carefully and therapy should be started with a low dose. If there is excessive hypotension during milrinone therapy, the infusion should be stopped until the blood pressure returns to normal.

If re-use of milrinone injection is considered, a lower dose should be chosen. 8). In patients with decreased hemoglobin concentrations (<10 g/l), milrinone injection should only be used with careful monitoring of the red blood cell count, as there may be a further decrease in hemoglobin concentration (and erythrocyte count).

1, - Severe obstructive aortic or pulmonary valve disease, - Hypertrophic obstructive cardiomyopathy, - Ventricular aneurysm, - Severe, previously untreated hypovolemia, - Acute myocardial infarction. Milrinone must not be used in patients with cardiac failure due to hyperthyroidism, acute myocarditis or Amyloid cardiomyopathy, as there is insufficient therapy experience.