APO-MILRINONE INJECTABLE SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

MILRINONE (MILRINONE LACTATE)

Предлага се от:

APOTEX INC

АТС код:

C01CE02

INN (Международно Name):

MILRINONE

дозиране:

1.0MG

Лекарствена форма:

SOLUTION

Композиция:

MILRINONE (MILRINONE LACTATE) 1.0MG

Начин на приложение:

INTRAVENOUS

Броя в опаковка:

10/20ML

Вид предписание :

Prescription

Терапевтична област:

CARDIOTONIC AGENTS

Каталог на резюме:

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

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2013-08-02

Данни за продукта

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.
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PHARMACOKINETICS
Following intravenous loading injections of 12