PHENYLEPHRINE HYDROCHLORIDE INJECTION USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PHENYLEPHRINE HYDROCHLORIDE

Available from:

STERIMAX INC

ATC code:

C01CA06

INN (International Name):

PHENYLEPHRINE

Dosage:

10MG

Pharmaceutical form:

SOLUTION

Composition:

PHENYLEPHRINE HYDROCHLORIDE 10MG

Administration route:

INTRAMUSCULAR

Units in package:

15G/50G

Prescription type:

Ethical

Therapeutic area:

VASOCONSTRICTORS

Product summary:

Active ingredient group (AIG) number: 0100662004; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-09-01

Summary of Product characteristics

_Product Monograph – Phenylephrine Hydrochloride Injection USP _
_Page 1 of 7 _
PRESCRIBING INFORMATION
PHENYLEPHRINE HYDROCHLORIDE INJECTION USP
10 mg/ml
For subcutaneous, intramuscular or intravenous injection only
VASOPRESSOR
SteriMax Inc.
2770 Portland Drive
Oakville, Ontario
L6H 6R4
Date of Preparation:
August 31, 2020
CONTROL NO.: 232497
_Product Monograph – Phenylephrine Hydrochloride Injection USP _
_Page 2 of 7 _
PRESCRIBING INFORMATION
PHENYLEPHRINE HYDROCHLORIDE INJECTION USP
10 mg/ml
For subcutaneous, intramuscular or intravenous injection only
VASOPRESSOR
WARNING: PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH
THE COMPLETE CONTENTS OF THIS PRESCRIBING INFORMATION BEFORE
PRESCRIBING THIS DRUG.
DESCRIPTION
Phenylephrine Hydrochloride Injection USP is a vasoconstrictor and
pressor drug chemically
related to epinephrine and ephedrine.
PHARMACOLOGY
When applied topically or infiltrated into the tissues, phenylephrine
produces vasoconstriction
that lasts longer than that of epinephrine and ephedrine. Its action
on the heart contrast sharply
with that of epinephrine and ephedrine, in that it slows the heart
rate and increases the stroke
output, inducing no disturbance in the rhythm of the pulse.
In therapeutic doses, it produces little if any stimulation of either
the spinal cord or cerebrum. A
singular advantage of this drug is the fact that repeated injections
produce comparable effects.
INDICATIONS
For the maintenance of blood pressure during spinal and inhalation
anesthesia, and also for
overcoming peripheral vascular failure in shock and shock-like states,
drug-induced hypotension
or hypersensitivity. Employed to overcome paroxysmal supraventricular
tachycardia, to prolong
spinal anesthesia and as a vasoconstrictor in regional anesthesia.
_Product Monograph – Phenylephrine Hydrochloride Injection USP _
_Page 3 of 7 _
PRECAUTIONS
May be contraindicated in patients with hypertension or ventricular
tachycardia or in patients
who are hypersensitive to the drug.
Should be used with extreme c