MedPath

Milrinone

Generic Name
Milrinone
Drug Type
Small Molecule
Chemical Formula
C12H9N3O
CAS Number
78415-72-2
Unique Ingredient Identifier
JU9YAX04C7

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)

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

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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