Milrinone Lactate
Generic: MILRINONE LACTATE
Basic Information
Manufacturer
Fresenius Kabi USA, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
ac43ba6b-635d-4129-8eea-96f3f5a4785e
Indications & Usage
INDICATIONS AND USAGE: Milrinone lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure.
Patients receiving milrinone 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 has been in patients receiving digoxin and diuretics.
There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours.
Patients receiving milrinone 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 has been in patients receiving digoxin and diuretics.
There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours.
Warnings
WARNINGS: Whether given orally or by continuous or intermittent intravenous infusion, milrinone 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 1,088 patients with Class III and IV heart failure, long-term oral treatment with milrinone 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 given by long-term continuous or intermittent infusion does not carry a similar risk.
The use of milrinone 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 should be observed closely with the use of continuous electrocardiographic monitoring to allow the prompt detection and management of ventricular arrhythmias.
In a multicenter trial of 1,088 patients with Class III and IV heart failure, long-term oral treatment with milrinone 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 given by long-term continuous or intermittent infusion does not carry a similar risk.
The use of milrinone 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 should be observed closely with the use of continuous electrocardiographic monitoring to allow the prompt detection and management of ventricular arrhythmias.
Adverse Reactions
ADVERSE REACTIONS: To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Cardiovascular Effects In patients receiving milrinone in Phase II and III clinical trials, ventricular arrhythmias were reported in 12.1%: Ventricular ectopic activity, 8.5%; nonsustained ventricular tachycardia, 2.8%; sustained ventricular tachycardia, 1% and ventricular fibrillation, 0.2% (two patients experienced more than one type of arrhythmia).
Holter recordings demonstrated that in some patients injection of milrinone increased ventricular ectopy, including nonsustained ventricular tachycardia.
Life-threatening arrhythmias were infrequent and when present have been associated with certain underlying factors such as preexisting arrhythmias, metabolic abnormalities (e.g.
hypokalemia), abnormal digoxin levels and catheter insertion.
Milrinone was not shown to be arrhythmogenic in an electrophysiology study.
Supraventricular arrhythmias were reported in 3.8% of the patients receiving milrinone.
The incidence of both supraventricular and ventricular arrhythmias has not been related to the dose or plasma milrinone concentration.
Other cardiovascular adverse reactions include hypotension, 2.9% and angina/chest pain, 1.2%.
In the post-marketing experience, there have been rare cases of “torsades de pointes” reported.
CNS Effects Headaches, usually mild to moderate in severity, have been reported in 2.9% of patients receiving milrinone.
Other Effects Other adverse reactions reported, but not definitely related to the administration of milrinone include hypokalemia, 0.6%; tremor, 0.4%; and thrombocytopenia, 0.4%.
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.
Cardiovascular Effects In patients receiving milrinone in Phase II and III clinical trials, ventricular arrhythmias were reported in 12.1%: Ventricular ectopic activity, 8.5%; nonsustained ventricular tachycardia, 2.8%; sustained ventricular tachycardia, 1% and ventricular fibrillation, 0.2% (two patients experienced more than one type of arrhythmia).
Holter recordings demonstrated that in some patients injection of milrinone increased ventricular ectopy, including nonsustained ventricular tachycardia.
Life-threatening arrhythmias were infrequent and when present have been associated with certain underlying factors such as preexisting arrhythmias, metabolic abnormalities (e.g.
hypokalemia), abnormal digoxin levels and catheter insertion.
Milrinone was not shown to be arrhythmogenic in an electrophysiology study.
Supraventricular arrhythmias were reported in 3.8% of the patients receiving milrinone.
The incidence of both supraventricular and ventricular arrhythmias has not been related to the dose or plasma milrinone concentration.
Other cardiovascular adverse reactions include hypotension, 2.9% and angina/chest pain, 1.2%.
In the post-marketing experience, there have been rare cases of “torsades de pointes” reported.
CNS Effects Headaches, usually mild to moderate in severity, have been reported in 2.9% of patients receiving milrinone.
Other Effects Other adverse reactions reported, but not definitely related to the administration of milrinone include hypokalemia, 0.6%; tremor, 0.4%; and thrombocytopenia, 0.4%.
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.
Cardiovascular Effects In patients receiving milrinone in Phase II and III clinical trials, ventricular arrhythmias were reported in 12.1%: Ventricular ectopic activity, 8.5%; nonsustained ventricular tachycardia, 2.8%; sustained ventricular tachycardia, 1% and ventricular fibrillation, 0.2% (two patients experienced more than one type of arrhythmia).
Holter recordings demonstrated that in some patients injection of milrinone increased ventricular ectopy, including nonsustained ventricular tachycardia.
Life-threatening arrhythmias were infrequent and when present have been associated with certain underlying factors such as preexisting arrhythmias, metabolic abnormalities (e.g.
hypokalemia), abnormal digoxin levels and catheter insertion.
Milrinone was not shown to be arrhythmogenic in an electrophysiology study.
Supraventricular arrhythmias were reported in 3.8% of the patients receiving milrinone.
The incidence of both supraventricular and ventricular arrhythmias has not been related to the dose or plasma milrinone concentration.
Other cardiovascular adverse reactions include hypotension, 2.9% and angina/chest pain, 1.2%.
In the post-marketing experience, there have been rare cases of “torsades de pointes” reported.
CNS Effects Headaches, usually mild to moderate in severity, have been reported in 2.9% of patients receiving milrinone.
Other Effects Other adverse reactions reported, but not definitely related to the administration of milrinone include hypokalemia, 0.6%; tremor, 0.4%; and thrombocytopenia, 0.4%.
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.
Cardiovascular Effects In patients receiving milrinone in Phase II and III clinical trials, ventricular arrhythmias were reported in 12.1%: Ventricular ectopic activity, 8.5%; nonsustained ventricular tachycardia, 2.8%; sustained ventricular tachycardia, 1% and ventricular fibrillation, 0.2% (two patients experienced more than one type of arrhythmia).
Holter recordings demonstrated that in some patients injection of milrinone increased ventricular ectopy, including nonsustained ventricular tachycardia.
Life-threatening arrhythmias were infrequent and when present have been associated with certain underlying factors such as preexisting arrhythmias, metabolic abnormalities (e.g.
hypokalemia), abnormal digoxin levels and catheter insertion.
Milrinone was not shown to be arrhythmogenic in an electrophysiology study.
Supraventricular arrhythmias were reported in 3.8% of the patients receiving milrinone.
The incidence of both supraventricular and ventricular arrhythmias has not been related to the dose or plasma milrinone concentration.
Other cardiovascular adverse reactions include hypotension, 2.9% and angina/chest pain, 1.2%.
In the post-marketing experience, there have been rare cases of “torsades de pointes” reported.
CNS Effects Headaches, usually mild to moderate in severity, have been reported in 2.9% of patients receiving milrinone.
Other Effects Other adverse reactions reported, but not definitely related to the administration of milrinone include hypokalemia, 0.6%; tremor, 0.4%; and thrombocytopenia, 0.4%.
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.