PHENYLEPHRINE HYDROCHLORIDE INJECTION USP 1% SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PHENYLEPHRINE HYDROCHLORIDE

Available from:

OMEGA LABORATORIES LIMITED

ATC code:

C01CA06

INN (International Name):

PHENYLEPHRINE

Dosage:

10MG

Pharmaceutical form:

SOLUTION

Composition:

PHENYLEPHRINE HYDROCHLORIDE 10MG

Administration route:

INTRAMUSCULAR

Units in package:

1 ML

Prescription type:

Ethical

Therapeutic area:

ALPHA-ADRENERGIC AGONISTS

Product summary:

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

Authorization status:

MARKETED

Authorization date:

2001-07-30

Summary of Product characteristics

PHENYLEPHRINE
HYDROCHLORIDE
INJECTION USP 1%
10 mg / mL
VASOPRESSOR
S.C. / I.M. / I.V.
WARNING:
PHYSICIANS
SHOULD
COM PLETELY
FAMlLIARlZE
THEM­
SELVES WlTH THE COMPLETE CON­
TENTS
OF
THIS
LEAFLET
BEFORE
PRESCRIBING THIS DRUG.
DESCRIPTION
Phenylephrine
Hydrochloride
Injection
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 contrasts 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 injec­
tions produce comparable effects.
INDICATIONS
For the maintenance of blood pressure
during spinal and inhalation anesthesia,
and also for overcoming peripheral vas­
cular
failure
in
shock
and
shock­like
states,
drug­induced
hypotension
or
hypersensitivity. Employed to overcome
paroxysmal
supraventricular
tachy­
cardia, to prolong spinal anesthesia and
as a vasoconstrictor in regional anes­
thesia.
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 caution in
elderly
patients
or
those
with
hyper­
thyroidism,
bradycardia,
partial
heart
block,
myocardial
disease
or
severe
arteriosclerosis.
Vasopressors may cause serious car­
diac
arrhythmias
during
halothane
anesthesia
and
therefore
should
be
used only with great caution or not at all.
Contains sodium metabisulfite, a sulfite
that may cause allergic­type reactions
including
anaphylactic
symptoms
and
life­threatening or less severe asthmatic
episodes in certain susceptible people.
The overall prevalence of sulfite sensi­
tivity
in
the
general
population
is
un