NOREPINEPHRINE BITARTRATE INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

NOREPINEPHRINE (NOREPINEPHRINE BITARTRATE MONOHYDRATE)

Available from:

ACALA PHARMACEUTICALS INC. (A DIVISION OF FERNBANK MANAGEMENT CORPORATION)

ATC code:

C01CA03

INN (International Name):

NOREPINEPHRINE

Dosage:

1MG

Pharmaceutical form:

SOLUTION

Composition:

NOREPINEPHRINE (NOREPINEPHRINE BITARTRATE MONOHYDRATE) 1MG

Administration route:

INTRAVENOUS

Units in package:

100

Prescription type:

Ethical

Therapeutic area:

ALPHA-AND BETA-ADRENERGIC AGONISTS

Product summary:

Active ingredient group (AIG) number: 0131301001; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-10-14

Summary of Product characteristics

_Norepinephrine Bitartrate Injection _
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PRESCRIBING INFORMATION
NOREPINEPHRINE BITARTRATE INJECTION
1 mg / mL norepinephrine
(as norepinephrine bitartrate monohydrate)
Sterile Solution for Intravenous Infusion
Manufacturer’s Standard
Sympathomimetic Amine for Use in Hypotensive Emergencies
Preservative Free
Acala Pharmaceuticals Inc.
(a division of
Fernbank Management Corporation)
224 King Street W, Suite 1702
Toronto, ON M5H 0A6
Canada
Submission Control No: 241796
Date of Revision: October 13, 2021
_Norepinephrine Bitartrate Injection _
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DESCRIPTION
Norepinephrine (sometimes referred to as
l-arterenol/Levarterenol or l-norepinephrine)
is a
sympathomimetic amine which differs from epinephrine by the absence of
a methyl group on the
nitrogen atom.
ACTION AND CLINICAL PHARMACOLOGY
Norepinephrine functions as a powerful peripheral vasoconstrictor
(alpha-adrenergic action) and as
a potent inotropic stimulator of the heart and dilator of coronary
arteries (beta-adrenergic action).
Both of these actions result in an increase in systemic blood pressure
and coronary artery blood
flow. Cardiac output will vary reflexly in response to systemic
hypertension but is usually increased
in the hypotensive person when the blood pressure is raised to an
optimal level. In myocardial
infarction accompanied by hypotension, norepinephrine usually
increases aortic blood pressure,
coronary artery blood flow, and myocardial oxygenation, thereby
helping to limit the area of
myocardial ischemia and infarction. Venous return is increased and the
heart tends to resume a
more normal rate and rhythm than in the hypotensive state.
In hypotension that persists after correction of blood volume
deficits, norepinephrine helps raise the
blood pressure to an optimal level and establish a more adequate
circulation.
In myocardial infarction norepinephrine has been shown to increase
greatly the patient survival rate.
Norepinephrine not only corrects systemic shock (through cardiotonic
and peripheral
vasoconstrictor action), but also