Milrinone is an active pharmaceutical ingredient in the Phosphodiesterase Inhibitors group (C01CE). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[1]
2%). 5% The following adverse events have also been reported in postmarketing experience: Adverse reactions that have occurred very rarely (<1/10,000) include torsades de points, anaphylactic shock, bronchospasm and skin reactions such as rash.
Liver function tests abnormalities have been reported but are uncommon (≥1/1,000, <1/100). Reporting Suspected Side Effects You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada.
Your report may help to identify new side effects and change the product safety information. 3 ways to report: Online at MedEffect; By calling 1-866-234-2345 (toll-free); By completing a Consumer Side Effect Reporting Form and sending it by: - Fax to 1-866-678-6789 (toll-free), or - Mail to: Canada Vigilance Program Health Canada, Postal Locator 0701E Ottawa, ON K1A 0K9 Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.
GBUnited Kingdom· MHRA
5 products
Uses
GBOfficial regulatory label· revised December 12, 2025[2]
Adults Milrinone is indicated for the short-term treatment (48 hours) of severe congestive heart failure unresponsive to conventional maintenance therapy (glycosides, diuretics, vasodilators and/or angiotensin converting enzyme (ACE) inhibitors).
Children Milrinone is indicated for the short-term treatment (up to 35 hours) of: - Severe congestive heart failure unresponsive to conventional maintenance therapy (glycosides, diuretics, vasodilators and/or angiotensin converting enzyme (ACE) inhibitors), - Acute heart failure, including low output states following cardiac surgery.
How to take
USUnited States· FDA
2 products
Uses
USOfficial regulatory label· revised January 15, 2025[3]
INDICATIONS AND USAGE
Milrinone Lactate Injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone lactate should be observed closely with appropriate electrocardiographic equipment.
The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone lactate has been in patients receiving digoxin and diuretics.
How to take
Drug interactions
Known interactions involving Milrinone. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]Health Canada (DPD) · 02447908 · revised March 22, 2025
[2]MHRA (UK) · PL218440024 · revised December 12, 2025
[3]FDA DailyMed · 07dddead-22ed-00… · revised January 15, 2025 [PDF]
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
NOTE:
Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. Milrinone Lactate Injection Page 7 of 16 SYMPTOMS AND TREATMENT OF OVERDOSAGE No specific antidote to milrinone is known, but general measures for circulatory support should be taken.
Milrinone lactate injection may produce hypotension and cardiac arrhythmia because of its vasodilator effect. In case of overdose, administration of milrinone lactate injection should be discontinued until the patient’s condition stabilizes.
DOSAGE AND ADMINISTRATION General Information Prior correction or adjustment of fluid/electrolytes may be necessary to obtain a satisfactory response with milrinone lactate injection (see PRECAUTIONS). Milrinone lactate injection is a clear colourless to pale yellow solution.
As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discolouration and leakage prior to administration whenever solution and container permit. Solutions showing haziness, particulate matter, precipitate, discolouration or leakage should not be used.
Discard unused portions. 45 % or dextrose injection USP 5 % in polyvinylchloride (PVC) bags. Milrinone lactate injection may be used undiluted if suitable equipment is available. Diluted solutions should be maintained at room temperature and should be used within 24 hours.
Precipitation occurs immediately when furosemide is mixed with milrinone solution. Therefore, furosemide should not be administered in intravenous lines containing milrinone lactate injection. 13 mg/kg Administer as a continuous intravenous infusion Milrinone Lactate Injection Page 8 of 16 The infusion rate should be adjusted according to hemodynamic and clinical response.
Patients should be closely monitored. In controlled clinical studies, most patients showed an improvement in hemodynamic status as evidenced by increases in cardiac output and reduction in pulmonary capillary wedge pressure. 13 mg/kg/day.
Duration of therapy should depend upon patient responsiveness. 22 In order to calculate flow rate (mL/hr), multiply infusion delivery rate by patient weight in kilograms. * Prepare by adding 180 mL diluent per 20 mg vial (20 mL) milrinone lactate injection.
** Prepare by adding 113 mL diluent per 20 mg vial (20 mL) milrinone lactate injection. + Prepare by adding 80 mL diluent per 20 mL vial (20 mL) milrinone lactate injection. Dosage Adjustment in Renally Impaired Patients The loading dosage is not affected, but reductions in the maintenance infusion rate may be necessary according to the following table.
(See PRECAUTIONS, Use in Renally Impaired Patients). 13 In order to calculate flow rate […]
This is not medical advice. Consult a qualified healthcare professional.
GBOfficial regulatory label· revised December 12, 2025[2]
For intravenous administration only. 6. Extravenous administration must be avoided. For prevention of local irritation the largest vein should be used. e. serum creatinine). g. life-threatening ventricular arrhythmias). The infusion rate should be adjusted according to haemodynamic response.
Length of treatment should be determined on the basis of clinical response. 4). 5 μg/kg/min) according to haemodynamic response and the possible onset of undesirable effects such as hypotension and arrhythmias. 13mg/kg/day total dose.
The following provides a guide to maintenance infusion delivery rate based upon a solution containing milrinone 200μg/ml prepared by adding 400ml diluent per 100ml solution for injection (40ml diluent per 10ml ampoule or respectively 80ml per an ampoule of 20ml).
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, and lower Milrinone 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 severe 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).
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised December 12, 2025[2]
Adverse reactions have been ranked under heading of system-organ class and frequency using the following convention: very common (>= 1/10); common (>= 1/100, <1/10); uncommon (>= 1/1,000, <1/100); rare (>= 1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
System Organ Class Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,00 0 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Blood and the lymphati c system disorders : Thrombocyto penia* Immune system disorder: Anaphylactic shock Metaboli sm and nutrition disorders : hypokalemia Nervous system disorders : Headaches, usually mild to moderate in severity Tremor Cardiac disorders : Ventricular ectopic activity Ventricular tachycardia (non sustained or sustained) Supra– ventricular arrhythmias Ventricular fibrillation Angina pectoris/chest pain Torsades de pointes System Organ Class Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,00 0 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Hypotension Respirato ry, thoracic and mediastin al disorders : Bronchospas m Hepato- biliary disorders : Liver function tests abnormal Skin and subcutan eous tissue disorders : Skin reactions such as rash.
General disorders and administr ation site condition s:
Infusion site reaction *In infants and children, risk of thrombocytopenia increased significantly with duration of infusion. 4). No relationship has been established between the incidence of supraventricular or ventricular arrhythmias, and the plasma level of milrinone.
g. hypokalemia), elevated serum digoxin levels or catheter insertion. Clinical data suggest that milrinone-related arrhythmias are less common in children than in adults. 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.
GBOfficial regulatory label· Warnings and precautions· revised December 12, 2025[2]
Milrinone is not recommended immediately following acute myocardial infarction until safety and efficacy have been established in this situation. The use of positive inotropic agents 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 not increasing MVO2 in patients with chronic heart failure. 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 place of surgical relief of the obstruction.
As with other drugs with inotropic / vasodilator properties, it may aggravate outflow obstruction in these conditions. 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. As the potential for arrhythmia, already prevalent in heart failure, may be increased by many drugs or combination of drugs, patients receiving milrinone should be closely monitored during infusion and the infusion should be stopped if arrhythmias develop.
There is possibility of an increased ventricular response rate in patients with 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.
Milrinone may induce hypotension as a consequence of its vasodilatory activity, therefore caution should be exercised when Milrinone is administered to patients who are hypotensive prior to treatment. In patients showing excessive decreases in blood pressure after Milrinone administration, the treatment should be discontinued until the hypotensive effect has been resolved and then resumed, if necessary, at a lower rate of infusion.
If prior vigorous diuretic therapy is suspected to have caused significant decreases in cardiac filling pressure, milrinone should be administered with caution while monitoring blood pressure, heart rate, and other clinically relevant symptoms.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised December 12, 2025[2]
1 - Severe hypovolemia.
This is not medical advice. Consult a qualified healthcare professional.
USOfficial regulatory label· revised January 15, 2025[3]
DOSAGE AND ADMINISTRATION
Milrinone Lactate Injection, USP should be administered with a loading dose followed by a continuous infusion (maintenance dose) according to the following guidelines: LOADING DOSE 50 mcg/kg: Administer slowly over 10 minutes The table below shows the loading dose in milliliters (mL) of milrinone lactate (1mg/mL) by patient body weight (kg).
5 6 The loading dose may be given undiluted, but diluting to a rounded total volume of 10 or 20 mL (see Maintenance Dose for diluents) may simplify the visualization of the injection rate. 13 mg/kg Milrinone lactate drawn from vials should be diluted prior to maintenance dose administration.
9% Sodium Chloride Injection USP, or 5% Dextrose Injection USP. The table below shows the volume of diluent in milliliters (mL) that must be used to achieve 200 mcg/mL concentration for infusion, and the resultant total volumes. Desired Infusion Concentration mcg/mL Milrinone Lactate Injection 1 mg/mL (mL) Diluent (mL) Total Volume (mL) 200 10 40 50 200 20 80 100 The infusion rate should be adjusted according to hemodynamic and clinical response.
Patients should be closely monitored. In controlled clinical studies, most patients showed an improvement in hemodynamic status as evidenced by increases in cardiac output and reductions in pulmonary capillary wedge pressure.
Note:
See Dosage Adjustment in Renally Impaired Patients . 13 mg/kg/day. Duration of therapy should depend upon patient responsiveness. The maintenance dose in mL/hr by patient body weight (kg) may be determined by reference to the following table.
8 27 When administering milrinone lactate by continuous infusion, it is advisable to use a calibrated electronic infusion device. Intravenous drug products should be inspected visually and should not be used if particulate matter or discoloration is present.
Dosage Adjustment in Renally Impaired Patients Data obtained from patients with severe renal impairment (creatinine clearance = 0 to 30 mL/min) but without congestive heart failure have demonstrated that the presence of renal impairment significantly increases the terminal elimination half-life of milrinone lactate.
Reductions in infusion rate may be necessary in patients with renal impairment. 43
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised January 15, 2025[3]
ADVERSE REACTIONS
2% (2 patients experienced more than one type of arrhythmia). Holter recordings demonstrated that in some patients injection of milrinone lactate increased ventricular ectopy, including nonsustained ventricular tachycardia. g. hypokalemia), abnormal digoxin levels and catheter insertion.
Milrinone lactate was not shown to be arrhythmogenic in an electrophysiology study. 8% of the patients receiving milrinone lactate. The incidence of both supraventricular and ventricular arrhythmias has not been related to the dose or plasma milrinone concentration.
2%. In the post marketing experience, there have been rare cases of “torsades de pointes” reported. 9% of patients receiving milrinone lactate. 4%. Isolated spontaneous reports of bronchospasm and anaphylactic shock have been received; and in the post-marketing experience, liver function test abnormalities and skin reactions such as rash have been reported.
Post-Marketing Adverse Event Reports In addition to adverse events reported from clinical trials, the following events have been reported from worldwide post-marketing experience with milrinone: Isolated spontaneous reports of bronchospasm and anaphylactic shock.
Liver function test abnormalities and skin reactions such as rash.
Administration site conditions:
Infusion site reaction. gov/medwatch.
USOfficial regulatory label· Warnings and precautions· revised January 15, 2025[3]
WARNINGS
Whether given orally or by continuous or intermittent intravenous infusion, milrinone lactate has not been shown to be safe or effective in the longer (greater than 48 hours) treatment of patients with heart failure. In a multicenter trial of 1088 patients with Class III and IV heart failure, long-term oral treatment with milrinone lactate was associated with no improvement in symptoms and an increased risk of hospitalization and death.
In this study, patients with Class IV symptoms appeared to be at particular risk of life-threatening cardiovascular reactions. There is no evidence that milrinone lactate given by long-term continuous or intermittent infusion does not carry a similar risk.
The use of milrinone lactate both intravenously and orally has been associated with increased frequency of ventricular arrhythmias, including nonsustained ventricular tachycardia. Long-term oral use has been associated with an increased risk of sudden death.
Hence, patients receiving milrinone lactate should be observed closely with the use of continuous electrocardiographic monitoring to allow the prompt detection and management of ventricular arrhythmias.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised January 15, 2025[3]
CONTRAINDICATIONS
Milrinone Lactate Injection is contraindicated in patients who are hypersensitive to it.
This is not medical advice. Consult a qualified healthcare professional.
Fluid and electrolyte changes, as well as serum creatinine levels should be carefully monitored during treatment. Improvement in cardiac output and consequently, diuresis, may require reduction in the dose of a diuretic agent. Potassium loss due to excessive diuresis may predispose digitalised patients to arrhythmias.
Therefore, hypokalemia should be corrected by potassium supplementation in advance, of or during, Milrinone use. Decrease in haemoglobin, including anaemia, often takes place in the setting of cardiac failure. Due to the risk of thrombocytopenia or anaemia, careful monitoring of the corresponding laboratory parameters is required in patients with decreased platelet count or decreased haemoglobin.
There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours. 8). Consequently, careful monitoring of the infusion site should be maintained so as to avoid possible extravasation.
Paediatric population:
The following should be considered in addition to the warnings and precautions described for adults: In neonates, following open heart surgery during Milrinone therapy, monitoring should include heart rate and rhythm, systemic arterial blood pressure via umbilical artery catheter or peripheral catheter, central venous pressure, cardiac index, cardiac output, systemic vascular resistance, pulmonary artery pressure, and atrial pressure.
Laboratory values that should be followed are platelet count, serum potassium, liver function, and renal function. Frequency of assessment is determined by baseline values, and it is necessary to evaluate the neonate’s response to changes in therapy.
2). In paediatric patients milrinone should be initiated only if the patient is hemodynamically stable. e. preterm infant, low birth weight) since milrinone may induce thrombocytopenia. In clinical studies in paediatric patients, risk of thrombocytopenia increased significantly with duration of infusion.
8). In clinical studies milrinone appeared to slow the closure of the ductus arteriosus in paediatric population. 3). 2). No age related effects on the incidence of adverse events have been observed. Controlled pharmacokinetic studies have not shown changes of pharmacokinetic in elderly.
Milrinone should be used with caution in patients with hepatic impairment. In patients with severe renal impairment […]