MILRINONE LACTATE INJECTION SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

MILRINONE (MILRINONE LACTATE)

Sẵn có từ:

EUGIA PHARMA INC.

Mã ATC:

C01CE02

INN (Tên quốc tế):

MILRINONE

Liều dùng:

1MG

Dạng dược phẩm:

SOLUTION

Thành phần:

MILRINONE (MILRINONE LACTATE) 1MG

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2023-05-31

Đặc tính sản phẩm

PRODUCT MONOGRAPH
PR
MILRINONE LACTATE INJECTION
1 mg/mL
Solution, Intravenous
House Standard
Inotrope/Vasodilator
EUGIA PHARMA INC. Date of Preparation:
3700 Steeles Avenue West, Suite 402 May 31, 2023
Woodbridge, Ontario, L4L 8K8,
Canada
Control No.: 274341
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
el