OXYTOCIN INJECTION, USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OXYTOCIN

Available from:

FRESENIUS KABI CANADA LTD

ATC code:

H01BB02

INN (International Name):

OXYTOCIN

Dosage:

10UNIT

Pharmaceutical form:

SOLUTION

Composition:

OXYTOCIN 10UNIT

Administration route:

INTRAMUSCULAR

Units in package:

1ML/10ML

Prescription type:

Prescription

Therapeutic area:

OXYTOCICS

Product summary:

Active ingredient group (AIG) number: 0106478002; AHFS:

Authorization status:

APPROVED

Authorization date:

1998-07-02

Summary of Product characteristics

Oxytocin Injection, USP – Prescribing Information
Page 1 of 8
PRESCRIBING INFORMATION
PR
OXYTOCIN INJECTION, USP
SYNTHETIC
10 USP OXYTOCIN UNITS PER ML
STERILE SOLUTION
FOR INTRAVENOUS INFUSIONS OR INTRAMUSCULAR USE
OXYTOCIC
FRESENIUS KABI CANADA LTD.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
DATE OF PREPARATION:
May 22, 2020
SUBMISSION CONTROL NUMBER: 225475
Oxytocin Injection, USP – Prescribing Information
Page 2 of 8
PR
OXYTOCIN INJECTION, USP
10 USP UNITS/ML
Sterile Solution
OXYTOCIC
ACTIONS AND CLINICAL PHARMACOLOGY
Oxytocin Injection, USP, synthetic, acts on the smooth muscle of the
uterus to stimulate
contractions; response depends on the uterine threshold of
excitability. It exerts a selective
action on the smooth musculature of the uterus, particularly towards
the end of pregnancy,
during
labour
and
immediately
following
delivery.
Oxytocin
stimulates
rhythmic
contractions of the uterus, increases the frequency of existing
contractions and raises the
tone of the uterine musculature. Synthetic oxytocin
elicits only
slight pressor
and
antidiuretic activity due to the absence of vasopressin. (Hypertension
has been observed
resulting from concomitant use of oxytocics and continuous caudal
block anesthesia).
INDICATIONS AND CLINICAL USE
IMPORTANT NOTICE
Oxytocin Injection, USP is NOT indicated for the ELECTIVE induction of
labour. Elective
induction of labour is defined as the initiation of labour for
convenience in an individual
with a term pregnancy, who is free of medical indications for the
initiation of labour.
Oxytocin Injection, USP is indicated in the following:
ANTEPARTUM

For induction of labour in patients with a medical indication for the
initiation of
labour, such as Rh problems, maternal diabetes, mild pre-eclampsia at
or near term,
when delivery is in the best interest of mother and fetus, or when
membranes are
prematurely ruptured and delivery indicated.

For stimulation or reinforcement of labour as in selected cases of
uterine inertia.

As adjunctive therapy in the managemen