MILRINONE LACTATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MILRINONE LACTATE (UNII: 9K8XR81MO8) (MILRINONE - UNII:JU9YAX04C7)

Available from:

Hospira, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Milrinone is contraindicated in patients who are hypersensitive to it.

Product summary:

Milrinone Lactate Injection is supplied as 10 mL, 20 mL and 50 mL single-dose vials containing a sterile, clear, colorless to pale yellow solution. Each mL contains milrinone lactate equivalent to 1 mg milrinone. Discard unused portion after initial use. Store between 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Avoid freezing. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Manufactured by: Gland Pharma Limited, Hyderabad 500043, India Manufactured for: Hospira Inc. Lake Forest, IL 60045, USA LAB-1255-2.0 Revised: 02/2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MILRINONE LACTATE- MILRINONE LACTATE INJECTION, SOLUTION
HOSPIRA, INC.
----------
MILRINONE
LACTATE INJECTION
RX ONLY
DESCRIPTION
Milrinone Lactate Injection, is a member of a new class of bipyridine
inotropic/vasodilator
agents with phosphodiesterase inhibitor activity, distinct from
digitalis glycosides or
catecholamines. Milrinone lactate is designated chemically as
1,6-Dihydro-2-methyl-6-
oxo[3,4'-bipyridine]-5-carbonitrile lactate and has the following
structural formula:
Milrinone is an off-white to tan crystalline compound with a molecular
weight of 211.2
and a molecular formula of C
H N O. It is slightly soluble in methanol, and very slightly
soluble in chloroform and in water. As the lactate salt, it is stable
and colorless to pale
yellow in solution. Milrinone lactate injection is available as a
sterile aqueous solution of
the lactate salt of milrinone for injection or infusion intravenously.
Sterile, single-dose vials: Single-dose vials of 10, 20 and 50 mL
contain in each mL
milrinone lactate equivalent to 1 mg milrinone and 47 mg Dextrose,
Anhydrous in Water
for Injection. The pH is adjusted to between 3.2 and 4.0 with lactic
acid and/or sodium
hydroxide. The total concentration of lactic acid can vary between
0.95 mg/mL and 1.29
mg/mL. These vials require preparation of dilutions prior to
administration to patients
intravenously.
CLINICAL PHARMACOLOGY
Milrinone is a positive inotrope and vasodilator, with little
chronotropic activity different in
structure and mode of action from either the digitalis glycosides or
catecholamines.
Milrinone, at relevant inotropic and vasorelaxant concentrations, is a
selective inhibitor of
peak III cAMP phosphodiesterase isozyme in cardiac and vascular
muscle. This inhibitory
action is consistent with cAMP mediated increases in intracellular
ionized calcium and
contractile force in cardiac muscle, as well as with cAMP dependent
contractile protein
12
9
3
phosphorylation and relaxation in vascular muscle. Additional
experimental evidence also
indicates that milrinone i