DOBUTREX SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

DOBUTAMINE (DOBUTAMINE HYDROCHLORIDE)

Beschikbaar vanaf:

PHARMACEUTICAL PARTNERS OF CANADA INC

ATC-code:

C01CA07

INN (Algemene Internationale Benaming):

DOBUTAMINE

Dosering:

12.5MG

farmaceutische vorm:

SOLUTION

Samenstelling:

DOBUTAMINE (DOBUTAMINE HYDROCHLORIDE) 12.5MG

Toedieningsweg:

INTRAVENOUS

Eenheden in pakket:

20ML

Prescription-type:

Prescription

Therapeutisch gebied:

SELECTIVE BETA 1-ADRENERGIC AGONISTS

Product samenvatting:

Active ingredient group (AIG) number: 0112000001; AHFS:

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2008-02-13

Productkenmerken

Dobutamine, USP – Product Monograph
Page 1 of 13
PRODUCT MONOGRAPH
PR
DOBUTREX
®
(DOBUTAMINE, USP)
SOLUTION FOR INJECTION
SYMPATHOMIMETIC
Pharmaceutical Partners of Canada Inc.
Date of Preparation:
45 Vogell Road, Suite 200
January 14, 2008
Richmond Hill, ON L4B 3P6
Control No.: 119232
Dobutamine, USP – Product Monograph
Page 2 of 13
PRODUCT MONOGRAPH
DOBUTREX
® SOLUTION
(DOBUTAMINE INJECTION, USP)
SYMPATHOMIMETIC
ACTION AND CLINICAL PHARMACOLOGY
DOBUTREX SOLUTION (dobutamine) is a direct-acting inotropic agent
whose primary
activity results from stimulation of the β-receptors of the heart
while producing less
marked chronotropic, hypertensive, arrhythmogenic or vasodilatory
effects. It does not
cause the release of endogenous norepinephrine as does dopamine. No
specific effect on
the renal vasculature was observed. In both animal and human studies
dobutamine
produces less increase in heart rate and less decrease in peripheral
vascular resistance for
a given inotropic effect than does isoproterenol.
The onset of action is within one to two minutes, the peak effect of a
particular infusion
may not be reached for ten minutes. The plasma half-life in humans is
two minutes.
INDICATIONS AND CLINICAL USE
DOBUTREX SOLUTION (dobutamine) is indicated in the treatment of adults
with
cardiac decompensation due to depressed contractility resulting from
organic heart
disease or following cardiac surgical procedures in which parenteral
therapy is necessary
for inotropic support.
Most clinical experience with DOBUTREX SOLUTION is short-term – up
to several
hours in duration. In the limited number of patients who were studied
for 24, 48, and 72
hours, a persistent increase in cardiac output occurred in some,
whereas the output of
others returned toward base-line values.
CONTRAINDICATIONS
DOBUTREX SOLUTION (dobutamine) is contraindicated in patients with
pheochromocytoma, in patients with idiopathic hypertrophic subaortic
stenosis, and in
those patients with hypersensitivity to dobutamine.
WARNINGS
DOBUTREX SOLUTION (dob