Fentanyl Injection BP

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Fentanyl citrate

Available from:

Sandoz Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

FENTANYL INJECTION BP
1
FENTANYL INJECTION
BP
_Fentanyl citrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
Fentanyl. It does not contain all the
information that is known about
Fentanyl.
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 being given Fentanyl
against the benefits they expect it
will have for you. 
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. YOU MAY NEED TO
READ IT AGAIN.
WHAT FENTANYL IS FOR
Fentanyl is a powerful drug used to
relieve pain and produce sleepiness. 
It can be used as a premedication
before an operation, or with a general
anaesthetic during an operation. It
can also be used after painful
operations to reduce the pain that you
feel. 
Fentanyl belongs to a group of
medicines called opioid (narcotic)
analgesics. 
Fentanyl works by changing the
messages that are sent to the brain
about pain.
Your doctor will have explained why
you are being treated with Fentanyl
and told you what dose you will be
given.  Follow all directions given to
you by your doctor carefully. They
may differ from the information
contained in this leaflet. 
Your doctor may prescribe this
medicine for another use. Ask your
doctor if you want more information.
Fentanyl can be addictive, but when
it is used only to relieve or prevent
pain it is unlikely to become habit
forming.
BEFORE YOU ARE GIVEN
FENTANYL
_WHEN YOU MUST NOT USE IT_
YOU SHOULD NOT BE GIVEN FENTANYL
IF YOU ARE PREGNANT OR
BREASTFEEDING UNLESS YOUR DOCTOR
SAYS IT IS SAFE.  ASK YOUR DOCTOR
ABOUT THE RISKS AND BENEFITS
INVOLVED.
We do not know if it is safe for you
to be given Fentanyl while you are
pregnant. 
It may affect your baby if it is given
early in pregnancy or�

Summary of Product characteristics

Fentanyl Injection Product Information 
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FENTANYL INJECTION 

PRODUCT INFORMATION 

NAME OF THE MEDICINE 

Fentanyl citrate is chemically identified
as N-(1-phenethyl-4-piperidyl) propionanilide 
citrate, MW 528.61.  The chemical formula is C
22
H
28
N
2
O, C
6
H
8
O
7.
 The Australian 
Approved name is fentanyl citrate.  The CAS number is 990-73-8.

The structural formula is: 

N
N
O
CH
3
, HO
C
CH
2
COOH
COOH
CH
2
COOH

DESCRIPTION 

Fentanyl injection contains fentanyl citrate 50 
µg/mL in citric acid anhydrous, sodium 
citrate, sodium chloride in
Water for Injections BP in glass vials or polyethylene
sterile 
ampoules.  Fentanyl injection contains no antimicrobial agent. 
It should be used only 
once and any residue discarded.  The
pH is adjusted with sodium hydroxide and ranges 
from 4.0 to 7.5. 

PHARMACOLOGY 

Fentanyl is a opioid analgesic.  A dose of  100 
µg (0.1 mg or 2.0 mL) is approximately 
equivalent in analgesic activity to 10 mg of morphine
or 75 mg of pethidine.  The principal 
actions of therapeutic value are analgesia and sedation. 
Alterations in respiratory rate 
and alveolar ventilation associated with opioid
analgesics may last longer than the 
analgesic effect.  As the dose of opioid is increased, the
decrease in pulmonary 
exchange becomes greater.  Large
doses may produce apnoea.  Fentanyl appears to 
have less emetic activity than either morphine or pethidine. 
Histamine assays and skin 
wheal testing in man indicate
that clinically significant histamine release rarely occurs 
with fentanyl.  Recent assays in man show no
clinically significant histamine release at 
doses up to 50 
µg/kg (0.05 mg/kg or 1 mL/kg). 
Fentanyl preserves cardiac stability and 
blunts stress-related hormonal changes at higher doses. 
Fentanyl Injection Product Information 
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Fenta