MILRINONE LACTATE INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MILRINONE (MILRINONE LACTATE)

Available from:

AURO PHARMA INC

ATC code:

C01CE02

INN (International Name):

MILRINONE

Dosage:

1MG

Pharmaceutical form:

SOLUTION

Composition:

MILRINONE (MILRINONE LACTATE) 1MG

Administration route:

INTRAVENOUS

Units in package:

10ML/20ML

Prescription type:

Prescription

Therapeutic area:

CARDIOTONIC AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2017-11-24

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
MILRINONE LACTATE INJECTION
1 mg/mL
House Standard
Inotrope/Vasodilator
AURO PHARMA INC.
Date of Preparation:
3700 Steeles Avenue West, Suite # 402 November 22, 2017
Woodbridge, Ontario, L4L 8K8,
Canada
Control No.: 195743
PR
MILRINONE LACTATE INJECTION
1 mg/mL
House Standard
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 125.0 mcg/kg to
congestive heart failure
patients, intravenous milrinone had a volume of distribution of 0.38
L/kg, a mean terminal
elimination half-l