DOBUTREX SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

DOBUTAMINE (DOBUTAMINE HYDROCHLORIDE)

Disponible desde:

PHARMACEUTICAL PARTNERS OF CANADA INC

Código ATC:

C01CA07

Designación común internacional (DCI):

DOBUTAMINE

Dosis:

12.5MG

formulario farmacéutico:

SOLUTION

Composición:

DOBUTAMINE (DOBUTAMINE HYDROCHLORIDE) 12.5MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

20ML

tipo de receta:

Prescription

Área terapéutica:

SELECTIVE BETA 1-ADRENERGIC AGONISTS

Resumen del producto:

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

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2008-02-13

Ficha técnica

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