Pethidine Injection BP

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

Pethidine hydrochloride

Patient Information leaflet

                                PETHIDINE INJECTION
BP
 
_Pethidine Hydrochloride_
CONSUMER MEDICINE INFORMATION
   
 
 
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
Pethidine. It does not contain all the
information that is known about
Pethidine.
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 taking Pethidine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. YOU MAY NEED TO
READ IT AGAIN.
WHAT PETHIDINE IS FOR
Pethidine is a powerful drug used to
relieve pain and produce sleepiness.
It can be used simply to relieve pain
or it can be used before painful
operations to reduce the pain that you
feel. It can also be used during
childbirth to ease the pain of
contractions.
Pethidine belongs to a group of
medicines called opioid (narcotic)
analgesics.
Pethidine works by changing the pain
messages that are sent to the brain.
 
Your doctor will have explained why
you are being treated with Pethidine
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.
Pethidine 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
PETHIDINE
_WHEN YOU MUST NOT USE IT_
YOU SHOULD NOT BE GIVEN PETHIDINE
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 Pethidine while you are
pregnant.
It may affect your baby if it is given
early in pregnancy or in the last
weeks before your baby is due.
However, it can be used during
childbirth.
Your baby can take in Pethidine from
breast milk if you are breastfeeding
                                
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Summary of Product characteristics

                                Pethidine Injection BP Product Information 
1 (10) 
 
PETHIDINE INJECTION BP 50 MG/ML 
PRODUCT INFORMATION 
 
NAME OF THE MEDICINE 
 
The active ingredient in Pethidine Injection BP is pethidine
hydrochloride.   
The chemical name for pethidine hydrochloride
is ethyl 1-methyl-4-phenylpiperidine-
4-carboxylate hydrochloride. The CAS number for pethidine
hydrochloride is  
50-13-5. The Australian Approved Name is pethidine
hydrochloride. Empirical 
formula C
15
H
21
NO
2
,HCl,  MW: 283.8. 
 
The chemical structure of pethidine hydrochloride is: 
 
 
 
 
 
 
DESCRIPTION 
 
Pethidine Injection BP contains the hydrochloride
of ethyl 1-methyl-4 
phenylpiperidine-4-carboxylate (pethidine hydrochloride) 50 mg/mL in
Water for 
Injections BP in polyethylene sterile ampoules.  Pethidine
Injection BP contains no 
antimicrobial agent.  It should be used only once and any residue
discarded.  The pH 
ranges from 3.5 to 6. 
 
 
PHARMACOLOGY 
 
Pethidine is a synthetic opioid with analgesic and sedative
properties, its actions 
qualitatively similar to those of morphine.  In addition to
providing analgesia, 
pethidine, in common with other opioids, produces respiratory depression, 
drowsiness, sedation, mood changes, euphoria, dysphoria, mental clouding, nausea, 
vomiting and electroencephalographic changes.  Large
doses of pethidine may 
cause excitation and convulsions. 
 
After parenteral administration, 75 to 100 mg of pethidine
has comparable analgesic, 
euphoric and respiratory depressant effects to 10
mg of morphine.  Pethidine has a 
more rapid onset of action but shorter duration
of analgesic effect than does 
morphine. 
 
The depressant effect of pethidine on the cough reflex may be
less than morphine at 
equianalgesic doses.  Pethidine
has spasmolytic as well as spasmogenic effects and 
may produce less constipation than morphine.  Atropine like
effec
                                
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