pharmacopeia
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Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Phosphodiesterase 3 Inhibitors.

Phosphodiesterase 3

Indications

Sourced from openFDA
  • 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.ICD-10: I50.9

Contraindications

Sourced from openFDA
  • Milrinone Lactate Injection is contraindicated in patients who are hypersensitive to it.contraindicated

Dosage & administration

Sourced from openFDA

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). Loading Dose (mL) Using 1 mg/mL Concentration Patient Body Weight (kg) kg 30 40 50 60 70 80 90 100 110 120 mL 1.5 2 2.5 3 3.5 4 4.5 5 5.5 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. MAINTENANCE DOSE Infusion Rate Total Daily Dose (24 Hours) Minimum 0.375 mcg/kg/min 0.59 mg/kg Administer as a continuous intravenous infusion Standard 0.5 mcg/kg/min 0.77 mg/kg Maximum 0.75 mcg/kg/min 1.13 mg/kg Milrinone lactate drawn from vials should be diluted prior to maintenance dose administration. The diluents that may be used are 0.45% Sodium Chloride Injection USP, 0.9% 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.

Warnings & precautions

Sourced from openFDA

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.

Adverse reactions

Sourced from openFDA

Cardiovascular Effects In patients receiving milrinone lactate 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% (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. 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 lactate was not shown to be arrhythmogenic in an electrophysiology study. Supraventricular arrhythmias were reported in 3.8% 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. 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 lactate. Other Effects Other adverse reactions reported, but not definitely related to the administration of milrinone lactate include hypokalemia, 0.6%; tremor, 0.4%; and thrombocytopenia, 0.4%.

Overdosage

Sourced from openFDA

Doses of milrinone lactate may produce hypotension because of its vasodilator effect. If this occurs, administration of milrinone lactate should be reduced or temporarily discontinued until the patient’s condition stabilizes. No specific antidote is known, but general measures for circulatory support should be taken.

Approval history

Sourced from openFDA
  • May 28, 2002ANDAANDA075936Fresenius Kabi Usa
  • May 28, 2002ANDAANDA075834Baxter Hlthcare
  • Jan 21, 2010ANDAANDA090038Hikma Farmaceutica
  • Dec 3, 2010ANDAANDA077966Hikma Farmaceutica
  • Sep 3, 2014ANDAANDA203280Hospira
  • Mar 24, 2020ANDAANDA211671Meitheal
  • Jul 16, 2020ANDAANDA213585Gland
  • Sep 3, 2020ANDAANDA209666Eugia Pharma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
271 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective8933%
  2. 2Hypotension165.9%
  3. 3Renal Failure134.8%
  4. 4Cardiac Failure124.4%
  5. 5Dyspnoea114.1%
  6. 6Cardiac Arrest103.7%
  7. 7Off Label Use103.7%
  8. 8Ventricular Tachycardia103.7%
  9. 9Haemorrhage93.3%
  10. 10Multi-organ Failure93.3%
  11. 11Nausea93.3%
  12. 12Respiratory Failure93.3%
  13. 13Cardiac Failure Congestive83.0%
  14. 14Cardiogenic Shock83.0%
  15. 15Pain83.0%

Literature

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Recent PubMed references pinned to Milrinone as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 81 ClinicalTrials.gov registrations naming Milrinone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Milrinone work?
Mechanism-of-action class: Phosphodiesterase 3 Inhibitors.
What is Milrinone used for?
According to FDA labeling, Milrinone carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Milrinone?
Milrinone is classified as Phosphodiesterase inhibitors, Phosphodiesterase 3 Inhibitor, Phosphodiesterase 3 Inhibitors, Increased Blood Pressure, Positive Inotropy, Vasodilation.
What are the contraindications for Milrinone?
Milrinone labeling lists contraindications including: Milrinone Lactate Injection is contraindicated in patients who are hypersensitive to it.. Always consult the full prescribing information and a clinician.
Note. Data for milrinone is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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