MILRINONE LACTATE INJECTION USP SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

MILRINONE (MILRINONE LACTATE)

Tilgængelig fra:

MARCAN PHARMACEUTICALS INC

ATC-kode:

C01CE02

INN (International Name):

MILRINONE

Dosering:

1MG

Lægemiddelform:

SOLUTION

Sammensætning:

MILRINONE (MILRINONE LACTATE) 1MG

Indgivelsesvej:

INTRAVENOUS

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

CARDIOTONIC AGENTS

Produkt oversigt:

Active ingredient group (AIG) number: 0131285001; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2021-10-15

Produktets egenskaber

PRODUCT MONOGRAPH
PR
MILRINONE LACTATE INJECTION USP
SOLUTION, 1 MG MILRINONE / ML, INTRAVENOUS
Inotrope / Vasodilator
Marcan Pharmaceuticals Inc. Date of Preparation: October 14, 2021
2 Gurdwara Road, Suite #112
Ottawa, ON K2E 1A2
Control No.: 236960
Milrinone Lactate Injection USP
2
PR
MILRINONE LACTATE INJECTION USP
1 mg milrinone / mL
Inotrope/Vasodilator
ACTION AND 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 it is not a beta-
adrenergic agonist, nor does it inhibit
sodium-potassium
adenosine triphosphatase activity as do
the digitalis glycosides.
Clinical studies in patients with congestive heart failure have shown
that milrinone
produces dose
and plasma level-related increase in left ventricular dP/dt, increase
in forearm blood flow indicating
a direct arterial vasodilator activity of the drug, and improves
diastolic function as evidenced by
improvement in left ventricular diastolic relaxation.
Studies in normal subjects have shown that milrinone
produces increases in the slope of the left
ventricular pressure-dimension
relationship,
indicating
a direct inotropic
effect of the drug. Both
the inotropic and vasodilatory effects have been observed over the
therapeutic range of milrinone
plasma concentrations of 100 - 300 ng/mL.
PHARMACOKINETICS
Following
intravenous loading injections
of 12.5 to 125 mcg/kg to congestive heart failure patients,
intravenous milrinone had a volume of distribution of 0.3