MILRINONE LACTATE INJECTION SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

MILRINONE (MILRINONE LACTATE)

Disponible depuis:

STERIMAX INC

Code ATC:

C01CE02

DCI (Dénomination commune internationale):

MILRINONE

Dosage:

1MG

forme pharmaceutique:

SOLUTION

Composition:

MILRINONE (MILRINONE LACTATE) 1MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

10ML/20ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

CARDIOTONIC AGENTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2015-10-30

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
PR
MILRINONE LACTATE INJECTION
(MILRINONE LACTATE INJECTION)
1 MG/ML MILRINONE
(AS MILRINONE LACTATE)
INOTROPE - VASODILATOR
Sterimax Inc.
Date of Preparation
2770 Portland Drive
October 21, 2015
Oakville, ON
L6H 6R4
Control # 182944
Milrinone Lactate Injection Page 2 of 16
PRODUCT MONOGRAPH
PR
MILRINONE LACTATE INJECTION (MILRINONE LACTATE INJECTION)
1 MG/ML MILRINONE
(AS MILRINONE LACTATE)
THERAPEUTIC CLASSIFICATION
Inotrope/Vasodilator
ACTIONS AND CLINICAL PHARMACOLOGY
Milrinone lactate injection 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 lactate
injection
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 lactate injection
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
Followi