APO-MILRINONE INJECTABLE SOLUTION

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

MILRINONE (MILRINONE LACTATE)

Fáanlegur frá:

APOTEX INC

ATC númer:

C01CE02

INN (Alþjóðlegt nafn):

MILRINONE

Skammtar:

1.0MG

Lyfjaform:

SOLUTION

Samsetning:

MILRINONE (MILRINONE LACTATE) 1.0MG

Stjórnsýsluleið:

INTRAVENOUS

Einingar í pakka:

10/20ML

Gerð lyfseðils:

Prescription

Lækningarsvæði:

CARDIOTONIC AGENTS

Vörulýsing:

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

Leyfisstaða:

CANCELLED POST MARKET

Leyfisdagur:

2013-08-02

Vara einkenni

PRODUCT MONOGRAPH
APO-MILRINONE INJECTABLE
MILRINONE LACTATE INJECTION
10 ML AND 20 ML (1 MG MILRINONE/ML)
INOTROPE / VASODILATOR
APOTEX INC.
DATE OF PREPARATION:
150 SIGNET DRIVE
April 30, 2004
WESTON, ONTARIO
M9L 1T9
Submission Control No.: 083487
- 1 -
PRODUCT MONOGRAPH
APO-MILRINONE Injectable
Milrinone Lactate Injection
10 mL and 20 mL (1 mg milrinone/mL)
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 to 300 ng/mL.
- 2 -
PHARMACOKINETICS
Following intravenous loading injections of 12