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:

Mullan Pharmaceutical 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 lactate 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 lactate has been in patients receiving digoxin and diuretics. Milrinone Lactate Injection is contraindicated in patients who are hypersensitive to it.

Product summary:

Milrinone Lactate Injection, USP is supplied as 10 mL single-dose vials in a box of 10, NDC 83301-0016-2; as 20 mL single-dose vials box of 10, NDC 83301-0017-2, containing a sterile, clear, colorless to pale yellow solution. Each mL contains milrinone lactate equivalent to 1 mg milrinone. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing. Discard unused portion after initial use. Manufactured for: Mullan Pharmaceutical Inc. Pasadena, CA 91101 Manufactured by: Shandong New Time Pharmaceutical Co., Ltd., No. 1, North Outer Ring Road, Feixian, Shandong 273400, China. Rev. 10/2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MILRINONE LACTATE- MILRINONE LACTATE INJECTION, SOLUTION
MULLAN PHARMACEUTICAL INC.
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MILRINONE LACTATE INJECTION, USP
DESCRIPTION
Milrinone lactate injection is a member of a 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
structure:
Milrinone is an off-white to tan crystalline compound with a molecular
weight of 211.2
and an empirical 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 is available as sterile
aqueous solutions of the
lactate salt of milrinone for injection or infusion intravenously.
Sterile, single-dose vials:Single-dose vials of 10 and 20 mL contain
in each mL milrinone
lactate equivalent to 1 mg milrinone and 47 mg Dextrose, Anhydrous,
USP, in Water for
Injection, USP. The pH is adjusted to between 3.2 and 4.0 with lactic
acid 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 lactate 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 lactate, 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 phosphorylation and relaxation in vascular muscle.
Additional
experimental evidence also indicates that milrinone lac