DOBUTAMINE INJECTION USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DOBUTAMINE (DOBUTAMINE HYDROCHLORIDE)

Available from:

STERIMAX INC

ATC code:

C01CA07

INN (International Name):

DOBUTAMINE

Dosage:

12.5MG

Pharmaceutical form:

SOLUTION

Composition:

DOBUTAMINE (DOBUTAMINE HYDROCHLORIDE) 12.5MG

Administration route:

INTRAVENOUS

Units in package:

10X20ML

Prescription type:

Prescription

Therapeutic area:

SELECTIVE BETA 1-ADRENERGIC AGONISTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2015-07-09

Summary of Product characteristics

1
PRODUCT MONOGRAPH
PR
DOBUTAMINE INJECTION USP
DOBUTAMINE (AS DOBUTAMINE HYDROCHLORIDE)
12.5 MG/ML
STERILE SOLUTION FOR INJECTION
SYMPATHOMIMETIC
SteriMax Inc.
Date of Preparation:
2770 Portland Drive
July 6, 2015
Oakville, ON
Canada
L6H 6R4
Control No.: 180258
2
PRODUCT MONOGRAPH
PR
DOBUTAMINE INJECTION USP
DOBUTAMINE (AS DOBUTAMINE HYDROCHLORIDE)
12.5 MG/ML
STERILE SOLUTION FOR INJECTION
THERAPEUTIC CLASSIFICATION
SYMPATHOMIMETIC
ACTION AND CLINICAL PHARMACOLOGY
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. Dobutamine, unlike dopamine,
does
not cause the
release of endogenous norepinephrine. No specific effect on the renal
vasculature has been
observed. Dobutamine produces less increase
in heart rate and
less decrease in peripheral
vascular resistance for a given inotropic effect than does
isoproterenol as demonstrated in both
animal and human studies.
The onset of action is within 1 to 2 minutes, although the peak effect
of a particular infusion may
not be reached for 10 minutes. The plasma half-life in humans is 2
minutes.
INDICATIONS AND CLINICAL USE
Dobutamine
Injection
USP
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 dobutamine is short-term -- up to
several hours in duration. In the
3
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 baseline values.
CONTRAINDICATIONS
Dobutamine Injection USP is contraindicated in patients with
pheochromocytoma, idiopathic
hypertrophic subaortic stenosis, and in those patients with
hypersensitivity to dobutamine.
WARNINGS
Dobutamine Injection USP may caus