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:

Caplin Steriles Limited

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 lactate injectioniscontraindicatedinpatientswhoarehypersensitive to it.

Product summary:

Milrinone Lactate Injection USP, is a sterile, clear, colorless to pale yellow solution. Each mL contains milrinone lactate equivalent to 1 mg milrinone. Supplied in single-dose vials as follows: Storage Store at 20° to 25°C (68° 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.  Discard unused portion. Manufactured by: Caplin Steriles Limited, Gummidipoondi - 601 201, India. January, 2021 131XXXXX

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MILRINONE LACTATE - MILRINONE LACTATE INJECTION, SOLUTION
CAPLIN STERILES LIMITED
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MILRINONE LACTATE INJECTION, USP
RX ONLY
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 a molecular formula of C12H9N3O. 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, 20 and 50 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 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
phosphorylation and relaxation in vascular muscle. Additional
experimental evidence also
indicates that milrinone is not a