DOBUTAMINE INJECTION USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DOBUTAMINE (DOBUTAMINE HYDROCHLORIDE)

Available from:

HIKMA CANADA LIMITED

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:

15G/50G

Prescription type:

Prescription

Therapeutic area:

SELECTIVE BETA 1-ADRENERGIC AGONISTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2022-06-02

Summary of Product characteristics

_Dobutamine Injection USP_
_Page 1 of 14_
PRODUCT MONOGRAPH
PR
DOBUTAMINE INJECTION USP
Sterile Solution for Injection
12.5 mg/mL (as dobutamine hydrochloride)
Intravenous Solution
Sympathomimetic
Hikma Canada Limited
5995 Avebury Road, Suite 804
Mississauga, Ontario
L5R 3P9
Submission Control No.: 264076
Date of
Preparation:
June 1, 2022
_Dobutamine Injection USP_
_Page 2 of 12_
PR
DOBUTAMINE INJECTION USP
12.5 mg/mL
(as dobutamine hydrochloride)
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
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