PETHIDINE INJECTION BP 50MG/ML & 100MG/2ML

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pethidine Injection
50mg/ml & 100mg/2ml
Pethidine Hydrochloride

D02711

Read all of this leaflet carefully before you are given this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor,
nurse or midwife.
• If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
nurse.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Pethidine Injection is and what it is used for
Before you are given Pethidine Injection
How Pethidine Injection will be given
Possible side effects
How to store Pethidine Injection
Further information

1. What Pethidine Injection is and what it is used
for
Pethidine is a drug with powerful pain relieving properties.
Pethidine Injection is used for the relief of moderate to severe
pain and is used for pain relief during labour. It may also be used
to stop you from feeling pain before and during an operation and
to provide continuous pain relief if needed

2. Before you are given Pethidine Injection
You should not be given Pethidine Injection if:
• you are allergic (hypersensitive) to Pethidine Hydrochloride or
to any of the ingredients of this medicine (listed in section 6)
• you suffer from asthma, shallow breathing or other breathing
difficulties
• you are suffering from severe headaches or have suffered a
head injury
• you suffer from alcoholism
• you suffer from a convulsive disorder (fits) such as epilepsy
• you have any liver or kidney problems
• you are suffering from a condition known as delirium tremens,
caused by withdrawal from alcohol
• your heartbeat is faster than usual
• you suffer from a tumour of the adrenal gland known as
phaeochromocytoma
• you suffer from diabetes
• you are taking or have recently taken any drugs used to treat
depression known as Monoamine Oxidase Inhibitors (MAOI’s)
(see ‘Taking other medicines)
Take special care with Pethidine Injection
Tell your doctor if you:
• are in shock, the symptoms of which include sweating, a fast
pulse and cold, clammy skin
• suffer from thyroid problems
• suffer from problems related to your adrenal gland (the organ
responsible for stress levels), including adrenocortical
insufficiency (a lack of the hormones produced by the adrenal
gland)
• suffer from low blood pressure
• suffer from problems with your prostate
• suffer from problems with your gallbladder
• suffer from problems with your bowel
If you are elderly or ill, or your baby or child is being given
Pethidine Injection, special care will be taken.
If any of the above apply to you or your child, please tell your
doctor before being given Pethidine Injection.

Taking other medicines
Please tell your doctor, nurse or midwife if you are taking, or have
recently taken, any other medicine including medicines obtained
without prescription.
Pethidine Injection must not be used with drugs used to treat
severe depression, such as rasagiline or moclobemide, or if you
are within 2 weeks of discontinuing them.
These drugs are known as Monoamine Oxidase Inhibitors
(MAOI’s),
Other medicines which may interact with Pethidine Injection
include:
• selegiline, a medicine used to treat Parkinson’s disease
• ritonavir, a medicine used to treat HIV
• cimetidine, a medicine used to treat stomach ulcers
• medicines used to reduce anxiety (anxiolytics)
• medicines used to help you to sleep (hypnotics)
• CNS depressants (drugs that act on the brain and make you
feel drowsy or faint). These include sleeping pills,
anti-histamines (medicines used to treat allergies) that make
you drowsy, medicines used to treat certain mental disorders,
other pain killers or a general anaesthetic.
• phenytoin, a medicine used to treat fits
• medicines used to treat serious mental disorders
(phenothiazines)
• duloxetine, a medicine used to treat depression
If you are in any doubt please tell your doctor of any medication
you are taking.
Pregnancy and breast-feeding:
If you are pregnant, think you may be pregnant or you are breastfeeding, you should consult your doctor before having Pethidine
Injection.
Pethidine can pass into your baby either through your blood
(during pregnancy and labour) or through your breast milk. This
can cause breathing problems in newborn babies. Your doctor
will be aware of this and will correct the problem and discuss
feeding with you.
Driving and using machines:
This medicine can affect your ability to drive and operate
machinery. Do not drive or operate machinery if you feel drowsy
or cannot think clearly.
This medicine can affect your ability to drive and operate
machinery as it may make you sleepy or dizzy.
• Do not drive while taking this medicine until you know how it
affects you.
• It is an offence to drive if this medicine affects your ability to
drive.
• However, you would not be committing an offence if:
• The medicine has been prescribed to treat a medical or
dental problem and
• You have taken it according to the instructions given by the
prescriber or in the information provided with the medicine
and
• It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is
safe for you to drive while taking this medicine.
Having Pethidine Injection with food and drink
You are advised not to drink alcohol during your treatment with
this medicine.
Continued overleaf

TECHNICAL PRESCRIBING INFORMATION

Product Name: Pethidine Injection BP
50mg/ml and 100mg/2ml
Composition/excipients:
Pethidine injection is a sterile aqueous solution of 5% w/v
Pethidine Hydrochloride BP. It also contains Water for Injections
and may contain Sodium Hydroxide as a pH adjuster.
Indications:
Relief of moderate to severe pain, as a premedication, obstetric
analgesia and enhancement of analgesia.

Dose:
Adults.
For moderate or severe pain.
Normal single dose (usually not to be repeated more often than 4
hourly)
By intramuscular or subcutaneous injection 25 - 100 mg.
By slow intravenous injection
25 - 50 mg.
For obstetric analgesia.
By intramuscular or subcutaneous
injection repeated 1 – 3 hours later.
Maximum of 400mg in 24 hours.
As a premedication.
By intramuscular injection one hour prior
to the operation.

50 - 100 mg.

50 - 100mg

For the enhancement of analgesia.
By slow intravenous injection.
10 -25mg as required.
Elderly or debilitated patients.
Initial doses should not exceed 25mg as this group of patients may
be specially sensitive to the central depressant effect of the drug.
Children
For moderate or severe pain.
By intramuscular injection
0.5 - 2 mg per Kg of body weight.
As a premedication.
By intramuscular injection one
hour prior to the operation
1 - 2 mg per Kg of body weight.

Contra-indications:
Respiratory depression, obstructive airways disease or acute
asthma. It should not be administered to patients with severe
renal impairment or severe hepatic impairment. Should be
avoided in patients with acute alcoholism, delirium tremens,
raised intracranial pressure or in those with convulsive states such
as status epilepticus. It should not be administered to patients
receiving monoamine oxidase inhibitors or moclobemide, or
within two weeks of their withdrawal. Pethidine should not be
administered to patients receiving ritonavir or selegiline. Not to be
given to patients with a history of hypersensitivity or idiosyncratic
response to the drug or its excipients. Use of pethidine should
be avoided in patients with supraventricular tachycardia. Use
of Pethidine in patients with phaeochromocytoma may result in
hypertensive crisis. Use of pethidine should be avoided in patients
with diabetic acidosis where there is a danger of coma.

Warnings :
Repeated use may result in dependence of the morphine type.
The use of pethidine should be avoided in patients with head
injuries, where administration may affect both the respiratory
function and the pupillary responses required for neurological
assessment. Pethidine should be avoided in patients with low
respiratory reserve due to the respiratory effects of the drug.
Pethidine should only be given with caution and in reduced
doses to neonates, premature infants, patients who are elderly or
debilitated or those with impaired hepatic or renal function. All
of these patient groups may experience increased or prolonged
effects of the product. Pethidine should be used with caution in
patients with shock, hypothyroidism, adreno-cortical insufficiency
and a history of convulsive disorders. Although less spasmogenic
than morphine, pethidine may precipitate spasm of the ureter or
Sphincter of Oddi. Subsequently it should be used with caution
in patients with prostatic hypertrophy and biliary tract disorders
including those with pain secondary to gallbladder pathology.

Pethidine should be used with caution in patients with existing
hypotension as it may reduce the blood pressure further. In
addition it should be avoided in patients with severe inflammatory
bowel disease due to its effects on the gastrointestinal tract where
it may precipitate toxic megacolon.

Interactions :
Pethidine should not be administered to patients receiving
monoamine oxidase inhibitors or moclobemide or within two
weeks of their withdrawal. Patients receiving selegiline should
not be given pethidine as hyperpyrexia and CNS toxicity may
result. Plasma concentrations of pethidine may be decreased
by concomitant administration of ritonavir, however levels
of norpethidine (a toxic metabolite) may rise. Concomitant
administration of ritonavir and pethidine should be avoided. (see
Contra-indications). Rasagiline should not be given with Pethidine
as there is a risk of CNS toxicity, its use should be avoided for
two weeks after taking rasagiline. Cimetidine potentiates the
effect of pethidine. Duloxetine when given with pethidine can
increase the serotonergic effects. The effects of pethidine may
also be potentiated by concurrent administration with other CNS
depressants including anaesthetics, anxiolytics, hypnotics, and
alcohol. Administration of Phenytoin may cause an increase in
hepatic metabolism of pethidine and subsequently increased
levels of norpethidine (a toxic metabolite). Concomitant
administration with phenothiazines may induce severe
hypotension.

Pregnancy :
There is inadequate evidence of safety in human pregnancy, but
the drug has been widely used for many years without apparent ill
consequence. Animal studies have not shown any hazard. As with
all drugs during pregnancy care should be taken in assessing the
risk to benefit ratio. Pethidine crosses the placental barrier and is
excreted in breast milk. This should be taken into account when
considering its use in patients during pregnancy or breast feeding.
Administration during labour may cause respiratory depression in
the new-born infant.

Side Effects:
General hypersensitivity reactions occur rarely. Mild euphoria
may occur and CNS excitation has been reported in some
patients. Following administration of pethidine dizziness, fainting,
drowsiness, weakness, hallucinations, dysphoria, mood changes,
vertigo, sweating and headache have been reported. Dependence
may occur as a result of continued use. Pethidine may obtund
or abolish the corneal reflex and cause pupillary constriction.
In addition miosis has been reported. Other undesirable effects
include hypotension, hypertension, dry mouth, facial flushing,
bradycardia, tachycardia, palpitations, vasodilation and postural
hypotension. Administration of pethidine may cause respiratory
depression. Nausea, vomiting and constipation have all been
reported following administration of pethidine. Rashes, urticaria
and pruritus may occur due to histamine release. Ureteric or biliary
spasm may be experienced, as may difficulty with micturition.
There have been reports of decreased libido or potency. Local
reactions at the injection site may be experienced. These include
induration and local irritation. The development of hypothermia
has been reported.

Overdose:
Symptoms:
Incoordination, tremors and convulsions followed by respiratory
depression and coma.
Treatment:
If respiration is dangerously depressed the use of naloxone is
recommended. Artificial respiration may be necessary. If signs
of CNS toxicity are exhibited the use of pethidine should be
discontinued. Respiratory support and, if necessary, anticonvulsive
therapy should be provided.
Continued overleaf

2711-C

100mm Measurement Verification Bar

Incompatibilities:

3. How Pethidine Injection will be given

Pethidine is incompatible with barbiturate salts and with other
drugs including aminophylline, heparin sodium, methicillin
sodium, morphine sulphate, nitrofurantoin sodium, phenytoin
sodium, sulphadiazine sodium, sodium iodide, sulphafurazole
diethanolamine. Incompatibility has also been observed between
pethidine hydrochloride and acyclovir sodium, imipenem,
frusemide and idarubicin.

Your doctor will give Pethidine Injection to you as an injection
into a vein (intravenously), under the skin (subcutaneously) or
into a muscle (intramuscularly). Your doctor will determine how
much you need.
Adults
For the relief of moderate to severe pain:
The usual initial dose is 25-100mg either into a muscle or under
the skin, or 25-50mg if given into a vein. The dose is given at a
minimum of four hourly intervals if needed.

Colour changes or precipitation have been observed on
mixing pethidine with the following drugs, minocycline
hydrochloride, tetracycline hydrochloride, cefoperazone sodium,
mezlocillin sodium, nafcillin sodium and liposomal doxorubicin
hydrochloride.

Pharmacodynamics:
Pethidine is a narcotic analgesic with similar actions to morphine.

Pharmacokinetics:
Pethidine is extensively distributed throughout the body with a
distribution volume of 200-300L. It is 40 - 65% plasma bound and
can cross the placenta. 70% of a dose is excreted in the urine in 24
hours. 5 – 30% is unchanged depending on the pH of the urine.
Shelf Life: 36 months.
Storage: Store below 25°C.
Store in airtight container. Protect from light.
Product licence numbers: PL 1883/6150R
Last revised: August 2012

For pain relief during labour:
The usual dose is 50-100mg either into a muscle or under the skin
every 1-3 hours during labour up to a maximum of 400mg in 24
hours.
For pain relief before and during an operation:
The usual dose is 50-100mg into a muscle one hour before the
operation.
For continuous pain relief:
The usual dose is 10-25mg by slow injection into the vein as
needed.
The elderly and ill
It is recommended that a reduced dose be used. The usual initial
dose is up to a maximum of 25mg.
Children
For the relief of moderate to severe pain:
The usual dose is 0.5-2mg per kilogram of body weight by
intramuscular injection.
For pain relief before and during an operation:
The usual dose is 1-2mg per kilogram of body weight into the
muscle one hour before the operation.
If you are given too much of Pethidine Injection:
This medicine will be given to you in hospital so it is unlikely you
will receive too much. Your doctor has information on how to
recognise and treat an overdose.
If you feel unwell after being given this medicine, or are at all
concerned you have been given too much, tell your doctor or
nurse.
If you have any further questions on the use of this product, ask
your doctor or nurse.

4. Possible Side Effects
Like all medicines Pethidine Injection can cause side effects,
although not everybody gets them.
Repeated use of pethidine can result in tolerance and
addiction
If any of the following symptoms occur contact your doctor or
nearest accident and emergency department immediately.
These are symptoms of a serious allergic reaction.
• sudden wheeziness and tightness of chest
• swelling of eyelids, face or lips
• skin lumps or hives
• skin rash (red spots), itchiness, fever
• collapse

Other side effects that may occur include:
• restlessness
• drowsiness
• constipation
• dry mouth
• feeling sick (nausea)
• being sick (vomiting)
• facial flushing
• sweating
• a fast or slow heartbeat
• palpitations (an irregular heart rhythm or missed beats)
• low blood pressure, the symptoms of which include feeling
dizzy or light-headed, feeling weak and fainting.
• high blood pressure
• pin-point pupils
• a feeling of dizziness or spinning
• fainting
• feeling weak
• hallucinations (seeing or hearing things that aren’t real)
• mood changes
• headache
• feeling faint on standing up from a seated position
• slowed breathing
• a red, itchy rash
• reduced sex drive
• difficulty achieving or maintaining an erection
• pain, redness or itching at the injection site
• hypothermia, the symptoms of which include shivering,
drowsiness and feeling weak
• feeling of intense happiness (euphoria)
• difficulty in passing urine
• spasms in the lower abdomen
If any of these side effects get serious, or you notice any other
side effects not listed in this leaflet, please tell your doctor,
nurse or midwife.

5. How to Store Pethidine Injection
Keep all medicines out of the reach and sight of children.
You should not be given Pethidine Injection after the expiry date
on the ampoule and carton label. The expiry date refers to the
last day of that month. The doctor or nurse will check that the
product has not passed this date.
Do not store above 25°C.

6. Further Information
What Pethidine Injection contains
Active Ingredient: Pethidine Hydrochloride 5%w/v
Other Ingredients: sodium hydroxide and water for injections.
What Pethidine Injection looks like and contents of the pack:
Pethidine Injection is a sterile solution, supplied in clear glass
ampoules. Each ampoule contains 1ml or 2ml of the solution.
Marketing Authorisation Holder:
Martindale Pharmaceuticals, Bampton Road, Harold Hill,
Romford, RM3 8UG, United Kingdom.
Manufacturers:
Martindale Pharmaceuticals, Bampton Road, Harold Hill,
Romford, RM3 8UG, United Kingdom.
Rotexmedica GmbH Arzneimittelwerk
Bunsenstraße 4
D-22946 Trittau
Germany
Product Licence Number:
PL 01883/6150R
This leaflet was last revised in: January 2014

D02711

2711-C

100mm Measurement Verification Bar