Overview
Heart failure is a multifactorial condition that affects roughly 1-2% of the adult population. Often the result of long-term myocardial ischemia, cardiomyopathy, or other cardiac insults, heart failure results from an inability of the heart to perfuse peripheral tissues with sufficient oxygen and metabolites, resulting in complex systemic pathologies. Heart failure is underpinned by numerous physiological changes, including alteration in β-adrenergic signalling and cyclic adenosine monophosphate (cAMP) production, which affects the heart's contractile function and cardiac output. Milrinone is a second-generation bipyridine phosphodiesterase (PDE) inhibitor created through chemical modification of amrinone. As a PDE-III inhibitor, milrinone results in increased cAMP levels and improves cardiac function and peripheral vasodilation in acute decongested heart failure. Milrinone was originally synthesized at the Sterling Winthrop Research Institute in the 1980s. It was approved by the FDA on December 31, 1987, and was marketed under the trademark PRIMACOR® by Sanofi-Aventis US before being discontinued.
Indication
Milrinone is indicated for the short-term (48 hours or less) treatment of patients with acute decompensated heart failure. Milrinone administration should occur together with close monitoring using appropriate electrocardiographic equipment and should occur in a facility equipped for the immediate treatment of potential cardiac events, including ventricular arrhythmias.
Associated Conditions
- Acute Decompensated Heart Failure (ADHF)
- Congestive Heart Failure (CHF)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/08/27 | Not Applicable | Not yet recruiting | |||
2024/11/08 | Phase 3 | Recruiting | NICHD Neonatal Research Network | ||
2024/08/20 | Not Applicable | Completed | Muhammad Aamir Latif | ||
2023/10/11 | N/A | Recruiting | |||
2023/05/03 | Phase 2 | Completed | |||
2022/03/04 | Phase 4 | Recruiting | |||
2021/11/24 | Phase 4 | UNKNOWN | |||
2021/11/17 | Phase 2 | Recruiting | |||
2021/01/22 | Not Applicable | Completed | |||
2020/07/23 | Phase 4 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Gland Pharma Limited | 68083-410 | INTRAVENOUS | 0.2 mg in 1 mL | 8/25/2021 | |
Hikma Pharmaceuticals USA Inc. | 0143-9374 | INTRAVENOUS | 1 mg in 1 mL | 11/20/2023 | |
Eugia US LLC | 55150-287 | INTRAVENOUS | 0.2 mg in 1 mL | 6/17/2023 | |
Mullan Pharmaceutical Inc. | 83301-0016 | INTRAVENOUS | 1 mg in 1 mL | 12/14/2023 | |
Hikma Pharmaceuticals USA Inc. | 0143-9373 | INTRAVENOUS | 1 mg in 1 mL | 11/20/2023 | |
Sagent Pharmaceuticals | 25021-313 | INTRAVENOUS | 0.2 mg in 1 mL | 11/20/2020 | |
Caplin Steriles Limited | 65145-120 | INTRAVENOUS | 1 mg in 1 mL | 4/22/2021 | |
Hikma Pharmaceuticals USA Inc. | 0143-9709 | INTRAVENOUS | 1 mg in 1 mL | 12/6/2023 | |
Somerset Therapeutics, LLC | 70069-807 | INTRAVENOUS | 1 mg in 1 mL | 9/24/2022 | |
Baxter Healthcare Corporation | 0338-6010 | INTRAVENOUS | 0.2 mg in 1 mL | 4/1/2014 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
MILRINONE-BAXTER CONCENTRATED SOLUTION FOR INJECTION 10MG/10ML | SIN15249P | INJECTION, SOLUTION, CONCENTRATE | 1mg/mL | 5/26/2017 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
MILRINONE LACTATE INJECTION USP 10MG/10ML | N/A | N/A | N/A | 2/24/2025 | |
MILRICOR SOLUTION FOR INJECTION/INFUSION 10MG/10ML | N/A | N/A | N/A | 6/19/2023 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
MILRINONE-BAXTERmilrinone (as lactate) 10 mg/10 mL concentrated injection ampoule | 223707 | Medicine | A | 4/17/2015 | |
Milrinone GH 10mg/10 mL Concentrated Injection milrinone (as lactate)10mg/10 mL ampoule | 204795 | Medicine | A | 11/29/2013 | |
Milrinone Horizon 10mg/10 mL Concentrated Injection milrinone (as lactate)10mg/10 mL ampoule | 204796 | Medicine | A | 11/29/2013 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
COROTROPE 1 mg/ml SOLUCIÓN INYECTABLE | Sanofi Aventis S.A. | 58849 | SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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