Duratocin

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Carbetocin

Available from:

Ferring Pharmaceuticals Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

DURATOCIN
®
 INJECTION

_Carbetocin_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Duratocin.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having Duratocin
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT DURATOCIN IS
USED FOR
Duratocin contains carbetocin, a
substance which is an oxytocic agent
and causes the womb (uterus) to
contract.
Duratocin is used to minimise post
delivery bleeding in women who
have delivered their baby by elective
caesarean section under local
anaesthetic around the spinal cord
(epidural).
_HOW IT WORKS_
In some women, following delivery
by caesarean section, the womb fails
to contract quickly enough which
increases the risk of bleeding. Drugs
that act directly on the womb to
make it contract are used to minimise
post delivery bleeding and are
sometimes called oxytocic agents
because they act in a similar manner
to oxytocin.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Duratocin is available only with a
doctor's prescription. It is not
addictive.
BEFORE YOU ARE GIVEN
DURATOCIN
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DURATOCIN MUST NOT BE GIVEN IF YOU
HAVE AN ALLERGY TO:
•
carbetocin, the active ingredient,
or to any of the ingredients listed
at the end of this leaflet
•
any medicines containing
oxytocin.
Symptoms of an allergic reaction
may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
YOU MUST NOT BE GIVEN DURATOCIN
DURING PREGNANCY OR ANY TIME
BEFORE DELIVERY OF THE BABY.
YOU MUST NOT BE GIVEN DURATOCIN IF

Summary of Product characteristics

PRODUCT INFORMATION 

#15449-v8A 

DURATOCIN


(CARBETOCIN INJECTION) 

NAME OF THE DRUG 
Carbetocin  

SYNONYMS:  
2,1-Desamino-4, 1-desthio-O4, 2-Methyl
1 [1-homocysteine] oxytocin 
1-desamino-1-monocarba-2-(0-methyl)-tyrosine-oxytocin 
(2-0-methyltyrosine)-1-deaminocarba-1-oxytocin 
(6,1-

 deaminocystathionine, 2-0-methyl-tyrosine)-oxytocin 
[Tyr(Me)
2
]-desamino-1-carba-oxytocin 

CAS: 37025-55-1 

STRUCTURE: 
O
C
Tyr
Ile
Glu
Asp
Cys
Pro
Leu
Gly
NH
2
Me
NH
2
NH
2
CH
2
CH
2
CH
2

MOLECULAR FORMULA:  C
45
H
69
N
11
O
12
S 
MOLECULAR WEIGHT: 988.1  

DESCRIPTION 
Carbetocin  is  a  white,  fluffy  lyophilized  powder,  soluble  in  water,  ethanol,  methanol  and  acetic  acid.  
Carbetocin is insoluble in ether and petroleum ether.  
Each ampoule contains 100μg of carbetocin, 9 mg sodium chloride, acetic acid  – glacial to pH 3.8 and 
water for injections to 1 mL.   

PHARMACOLOGY 
DURATOCIN  (carbetocin  injection)  is  a  long-acting  synthetic  octapeptide  analogue  of  oxytocin  with 
agonist properties. It can be administered intravenously as a single dose immediately following delivery 
by  caesarean  section  under  epidural  or  spinal  anaesthesia,  to  prevent  uterine  atony  and  postpartum 
haemorrhage. 
The  clinical  and  pharmacological  properties  of  carbetocin  are  similar  to  those  of  naturally  occurring 
oxytocin,  another  posterior  pituitary  hormone.    In  in  vitro  studies,  carbetocin  was  shown  to  bind  to  the 
oxytocin  receptor  with  similar  affinity  as  the  natural  peptide.    Carbetocin  elicited  similar  uteronic  and 
galactogogic effects to oxytocin in animals and in vitro. Carbetocin was less potent than oxytocin, but its 
action was more prolonged.