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PETHIDINE INJECTION BP

Active substance(s): PETHIDINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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

D03942

Read all of this leaflet carefully before you are given this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse
or midwife.
• If you get any side effects, talk to your doctor or pharmacist .
This includes any possible side effects not listed in this leaflet.
See section 4.

What is 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
Contents of the pack and other 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)
Patients in a coma should not be given this medicine
Warnings and precautions
Talk to your doctor or pharmacist before being given Pethidine
Injection if:
• 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
• you have weak muscular movement
• you have lung problems

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) (eg.
benzodiazepines such as diazepam)
• 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.
• phenytoin, a medicine used to treat fits
• medicines used to treat serious mental disorders
(phenothiazines)
• citalopram, a medicine used to treat depression
• medicines for depression (eg. tricyclic antidepressants such as
amitriptyline)
• sedatives, sleeping tablets or barbiturates (eg. phenobarbitone
for epilepsy)
• domperidone and metoclopramide (used for disorders of the
gastrointestinal tract)
• pain relievers and other opioid medicines
• pain relievers and other opioid medicines
• ciprofloxac in, an antibiotic used to treat a number of bacterial
infections
• mexiletine, a medicine used to treat seriously irregular
heartbeats
If you are in any doubt please tell your doctor of any medication
you are taking.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before using this medicine.
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, drink and alcohol
You are advised not to drink alcohol during your treatment with
this medicine.

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.
Other medicines and Pethidine Injection
Tell your doctor, nurse or midwife if you are taking, have recently
taken or might take any other medicines including medicines
obtained without a prescription.

TECHNICAL PRESCRIBING INFORMATION

Product Name: Pethidine 50mg/ml
& 100mg/2ml Solution for Injection)
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.
Method of administration
Intramuscular, intravenous or subcutaneous injection.

Contra-indications:
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
Severe Respiratory depression, severe 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 ( including moclobemide, and the
monoamine B inhibitors selegiline and rasagiline) 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 phaechromocytoma may result
in hypertensive crisis.
Use of pethidine should be avoided in patients with diabetic
acidosis where there is danger of coma.
In comatose patients
In patients with a risk of paralytic ileus
In patients with head injuries.

Warnings :
Continued overleaf

Repeated use may result in dependence of the morphine type.
Pethidine should be used with caution in patients with acute or

chronic airflow obstruction including asthma.
Pethidine should be used with caution or in reduced doses in
patients with myasthenia gravis.
The use of pethidine should be avoided in patients with head
injuries where administration may affect both the respiratory
function and 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.
Renal impairment may result in accumulation of the potentially
toxic metabolite norpethidine, particularly with repeat dosing All
of these patient groups may experience increased or prolonged
effects of the product.
Pethidine should be used with caution in patients with shock,
hypothyrodism,adreno-corticol 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
The concurrent use of MAOIs (including moclobemide) is contraindicated (see section 4.3) as they may result in CNS excitation or
depression.
CNS depressants
CNS depressants such as alcohol, hypnotics, anxiolytics and
sedatives, barbiturates and tricyclic antidepressants may increase
the general depressant effects of pethidine and should therefore
be used with caution.
Opioid agonists
Additive effects on CNS depression, respiratory depression and
hypotension can occur with concomitant use of opioid agonist
analgesics.
MAO-B inhibitors
Concomitant use of MAO-B inhibitors such as selegiline or
rasagiline is contraindicated (see section 4.3) as this may lead to
hyperpyrexia and CNS toxicity.
Anticonvulsants
Administration of phenytoin may cause an increase in hepatic
metabolism of pethidine and subsequently increased levels of
norpethidine (a toxic metabolite).
Antipsychotics
Concomitant use of phenothiazines and pethidine can induce
severe hypotension.
Anti-virals
Plasma concentrations of pethidine may be decreased by
concomitant administration of ritonavir, however levels of
norpethidine (a toxic metabolite) may rise. Concomitant
administration of ritanovir and pethidine should be avoided (see
section 4.3).
Histamine H2 antagonists
Cimetidine can reduce the metabolism of pethidine resulting in
increased plasma concentration.
Effects of pethidine on other drugs
Pethidine may have an effect on the activities of other drugs, for
example domperidone, as a consequence of reduced gastrointestinal motility.
The plasma levels of ciprofloxacin may be reduced in the presence
of opiate premedicants.
Plasma levels of mexiletine may also be reduced in the presence of
opioid analgesics.
Continued overleaf

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Possible increased serotonergic effects when pethidine is given
with SSRI’s.

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. Patients should be advised to discontinue
breast-feeding during treatment with pethidine.

Side Effects:
The undesirable effects listed below include class effects for
opioid analgesics and effects related to the pharmacologically
active metabolite, norpethidine.
Immune system disorders:
General hypersensitivity reactions occur rarely.
Psychiatric disorders:
Dependence, confusion, mood altered, mild euphoria,
hallucinations, Dysphoria
Nervous system disorders:
Drowsiness, dizziness, tremor, convulsions, headache, fainting
Eye disorders:
Dry eye, miosis, corneal reflex decreased
Ear and labyrinth disorders:
Vertigo General hypersensitivity reactions occur rarely.
Cardiac disorders:
Tachycardia, bradycardia, palpitations
Vascular disorders:
Orthostatic hypotension, flushing, hypotension, hypertension
Respiratory, thoracic and mediastinal disorders:
Respiratory depression
Gastrointestinal disorders:
Nausea, vomiting, dry mouth, constipation
Hepatobiliary disorders:
Biliary spasm
Skin & subcutaneous tissue disorders:
Sweating, rash, urticaria, pruritus
Musculoskeletal and connective tissue disorders:
Muscle twitching
Renal & urinary disorders:
Difficulty in micturition, renal colic
Reproductive system and breast disorders:
Sexual dysfunction
General disorders & administration site conditions:
Hypothermia, weakness, injection site reactions including
induration and irritation

Overdose:
Symptoms:
Respiratory depression, CNS depression with extreme somnolence
progressing to incoordination, stupor or coma, convulsions, CNS
stimulation, cyanosis, miosis, skeletal muscle flaccidity or tremors,
cold, clammy skin, hypothermia, bradycardia and hypotension.
In severe overdosage, apnoea, circulatory collapse, pulmonary
oedema, mydriasis, cardiac arrest and death may occur.
Treatment:
Treatment is supportive. A patent airway must be established
with assisted or controlled ventilation. If signs of CNS toxicity are
exhibited the use of pethidine should be discontinued. Narcotic
antagonists may be required if there is evidence of significant
respiratory or cardiovascular depression.
Naloxone should be given intravenously as soon as possible
and repeated every 2-3 minutes if necessary (refer to naloxone
product literature for details).
Anti-convulsive therapy, oxygen, intravenous fluids, vasopressors
and other supportive measures should be employed as indicated.

Incompatibilities:
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.
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 rapidly absorbed following intramuscular or
subcutaneous injection, however, there are wide interindividual variations. It is widely distributed in the tissues
with a volume of distribution of 200-300 litres and is
extensively protein bound (60-80%).
Pethidine is metabolised in the liver and excreted via
the urine (70% in 24 hours). One of the metabolites,
norpethidine, is pharmacologically active and its
accumulation can result in toxicity. Urinary excretion is
pH-dependent, the lower the pH the greater the clearance.
At normal urinary pH only a small amount of pethidine is
excreted unchanged.
Pethidine has a plasma elimination half-life of about 3
to 6 hours. The metabolite norpethidine is eliminated
more slowly with a half-life of up to 20 hours and may
accumulate with chronic use, especially in the presence of
renal impairment.
Pethidine crosses the placenta and is excreted in breast
milk.
Both pethidine and norpethidine cross the blood/brain
barrier and are found in the cerebrospinal fluid.

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 01883/6150R
Last revised: November 2017

3. How Pethidine Injection will be given
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.
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:
The symptoms and signs of taking too much of this medicine
include shallow breathing, drowsiness, incoordination, coma,
seizures, blue skin and lips, eye closure (miosis), shaking, cold,
clammy skin, drop in body temperature, slow heartbeat and low
blood pressure.
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 this medicine 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.
Not known (frequency cannot be estimated from the
available data):
• 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:
Not known (frequency cannot be estimated from the
available data):
• 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
• addiction
• confusion
• tremor or involuntary shaking
• convulsions
• dry eye
• dizziness
• muscle twitching
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via Yellow Card
Scheme. Website: www.mhra.gov.uk/yellowcard or search for
MHRA Yellow Card in the Google Play or Apple App Store. By
reporting side effects you can help provide more information on
the safety of this medicine.

5. How to Store Pethidine Injection
Keep this medicine out of the sight and reach 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.
Store in airtight container. Protect from light.

6. Contents of the pack and other 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 Pharma, Bampton Road, Harold Hill,
Romford, RM3 8UG, United Kingdom.
Manufacturers:
Macarthys Laboratories Limited, T/A Martindale Pharma,
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: November 2017

D03942

3942-D

100mm Measurement Verification Bar

DEVELOPMENT ARTWORK
D03942
Pethidine 50mg/ml & 100mg/2ml
PIL UK PL 01883/6150R Solution
for Injection
340 x 260mm

24/08/17

NF

01/0917

NF

10/11/17

NF

11/01/18

NF

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pethidine 50mg/ml & 100mg/2ml
Solution for Injection
Pethidine Hydrochloride
D03933

Read all of this leaflet carefully before you are given this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse
or midwife.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. See section 4.

What is 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
Contents of the pack and other 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)
Patients in a coma should not be given this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before being given Pethidine
Injection if:
• 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
• you have weak muscular movement
• you have lung problems
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.

TECHNICAL PRESCRIBING INFORMATION

Pethidine 50mg/ml & 100mg/2ml
(Solution for Injection)
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:
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
Severe rRespiratory depression, severe 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 ( including moclobemide, and the monoamine
B inhibitors selegiline and rasagiline) 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 phaechromocytoma may result in
hypertensive crisis.
Use of pethidine should be avoided in patients with diabetic acidosis
where there is danger of coma.
In comatose patients
In patients with a risk of paralytic ileus
In patients with head injuries.

Other medicines and Pethidine Injection
Tell your doctor, nurse or midwife if you are taking, have
recently taken or might take any other medicines including
medicines obtained without a 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) (eg.
benzodiazepines such as diazepam)
• 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, antihistamines (medicines used to treat allergies) that make you
drowsy, medicines used to treat certain mental disorders.
• phenytoin, a medicine used to treat fits
• medicines used to treat serious mental disorders
(phenothiazines)
• citalopram, a medicine used to treat depression
• medicines for depression (eg. tricyclic antidepressants such
as amitriptyline)
• sedatives, sleeping tablets or barbiturates (eg.
phenobarbitone for epilepsy)
• domperidone and metoclopramide (used for disorders of the
gastrointestinal tract)
• pain relievers and other opioid medicines
• pain relievers and other opioid medicines
• ciprofloxac in, an antibiotic used to treat a number of
bacterial infections
• mexiletine, a medicine used to treat seriously irregular
heartbeats
If you are in any doubt please tell your doctor of any
medication you are taking.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before using this medicine.
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.
The medicine can affect your ability to drive 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, drink and alcohol
You are advised not to drink alcohol during your treatment
with this medicine.
Continued overleaf

3.How Pethidine Injection will be given

Like all medicines this medicine 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.
Not known (frequency cannot be estimated from the
available data):
• 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:
Not known (frequency cannot be estimated from the
available data):
• restlessness
• drowsiness
• constipation
• dry mouth
• feeling sick (nausea)
• being sick (vomiting)
• facial flushing
• sweating
• a fast or slow heartbeat

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 Pharma, Bampton Road, Harold Hill,
Romford, Essex, RM3 8UG, UK
Manufacturers:
Macarthys Laboratories Limited T/A Martindale Pharma,
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: November 2017

Warnings :

Plasma levels of mexiletine may also be reduced in the presence of
opioid analgesics.
Possible increased serotonergic effects when pethidine is given with
SSRI’s.

Incompatibilities:

Pethidine should be used with caution in patients with acute or
chronic airflow obstruction including asthma.
Pethidine should be used with caution or in reduced doses in patients
with myasthenia gravis.
The use of pethidine should be avoided in patients with head injuries
where administration may affect both the respiratory function and
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. Renal impairment
may result in accumulation of the potentially toxic metabolite
norpethidine, particularly with repeat dosing All of these patient
groups may experience increased or prolonged effects of the product.
Pethidine should be used with caution in patients with shock,
hypothyrodism,adreno-corticol 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 :
Monoamine Oxidase Inhibitors
The concurrent use of MAOIs (including moclobemide) is contraindicated (see section 4.3) as they may result in CNS excitation or
depression.
CNS depressants
CNS depressants such as alcohol, hypnotics, anxiolytics and sedatives,
barbiturates and tricyclic antidepressants may increase the general
depressant effects of pethidine and should therefore be used with
caution.
Opioid agonists
Additive effects on CNS depression, respiratory depression and
hypotension can occur with concomitant use of opioid agonist
analgesics.
MAO-B inhibitors
Concomitant use of MAO-B inhibitors such as selegiline or rasagiline is
contraindicated (see section 4.3) as this may lead to hyperpyrexia and
CNS toxicity.
Anticonvulsants
Administration of phenytoin may cause an increase in hepatic
metabolism of pethidine and subsequently increased levels of
norpethidine (a toxic metabolite).
Antipsychotics
Concomitant use of phenothiazines and pethidine can induce severe
hypotension.
Anti-virals
Plasma concentrations of pethidine may be decreased by concomitant
administration of ritonavir, however levels of norpethidine (a toxic
metabolite) may rise. Concomitant administration of ritanovir and
pethidine should be avoided (see section 4.3).
Histamine H2 antagonists
Cimetidine can reduce the metabolism of pethidine resulting in
increased plasma
concentration.
Effects of pethidine on other drugs
Pethidine may have an effect on the activities of other drugs, for
example domperidone, as a consequence of reduced gastro-intestinal
motility.
The plasma levels of ciprofloxacin may be reduced in the presence of
opiate premedicants.

Continued overleaf

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.
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:
The symptoms and signs of taking too much of this medicine
include shallow breathing, drowsiness, incoordination, coma,
seizures, blue skin and lips, eye closure (miosis), shaking, cold,
clammy skin, drop in body temperature, slow heartbeat and
low blood pressure.
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

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. Patients should be advised to discontinue breast-feeding
during treatment with pethidine

Side Effects:
The undesirable effects listed below include class effects for opioid
analgesics and effects related to the pharmacologically active
metabolite, norpethidine.
Immune system disorders:
General hypersensitivity reactions occur rarely.
Psychiatric disorders:
Dependence, confusion, mood altered, mild euphoria, hallucinations,
Dysphoria
Nervous system disorders:
Drowsiness, dizziness, tremor, convulsions, headache, fainting
Eye disorders:
Dry eye, miosis, corneal reflex decreased
Ear and labyrinth disorders:
Vertigo General hypersensitivity reactions occur rarely.
Cardiac disorders:
Tachycardia, bradycardia, palpitations
Vascular disorders:
Orthostatic hypotension, flushing, hypotension, hypertension
Respiratory, thoracic and mediastinal disorders:
Respiratory depression
Gastrointestinal disorders:
Nausea, vomiting, dry mouth, constipation
Hepatobiliary disorders:
Biliary spasm
Skin & subcutaneous tissue disorders:
Sweating, rash, urticaria, pruritus
Musculoskeletal and connective tissue disorders:
Muscle twitching
Renal & urinary disorders:
Difficulty in micturition, renal colic
Reproductive system and breast disorders:
Sexual dysfunction
General disorders & administration site conditions:
Hypothermia, weakness, injection site reactions including induration
and irritation

• 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 (symptoms include feeling tense and restless)
• 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
• addiction
• confusion
• tremor or involuntary shaking
• convulsions
• dry eye
• dizziness
• muscle twitching
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via Yellow Card
Scheme. Website: www.mhra.gov.uk/yellowcard or search for
MHRA Yellow Card in the Google Play or Apple App Store. By
reporting side effects you can help provide more information
on the safety of this medicine.

5.How to Store Pethidine Injection
Keep this medicine out of the sight and reach 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.
Store in airtight container. Protect from light.

6. Contents of the pack and other information

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.
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 synthetic opioid analgesic similar to morphine although
less potent and shorter acting. Its analgesic effect usually lasts for 2 to
4 hours. The analgesic effect occurs after about 10 minutes following
parenteral administration. It acts on the CNS system and smooth
muscles via the peripheral nervous system. However, it has a weaker
action on smooth muscle than morphine and therefore has less
effect on cough, bowel motility, biliary tone and secretion of pituitary
hormones. Pethidine also causes the release of histamine from mast
cells resulting in a number of allergic-type reactions.

Pharmacokinetics:
Pethidine is rapidly absorbed following intramuscular or subcutaneous
injection, however, there are wide inter-individual variations. It is
widely distributed in the tissues with a volume of distribution of 200300 litres and is extensively protein bound (60-80%).
Pethidine is metabolised in the liver and excreted via the urine (70% in
24 hours). One of the metabolites, norpethidine, is pharmacologically
active and its accumulation can result in toxicity. Urinary excretion is
pH-dependent, the lower the pH the greater the clearance. At normal
urinary pH only a small
amount of pethidine is excreted unchanged.
Pethidine has a plasma elimination half-life of about 3 to 6 hours. The
metabolite norpethidine is eliminated more slowly with a half-life of
up to 20 hours and may accumulate with chronic use, especially in the
presence of renal impairment.
Pethidine crosses the placenta and is excreted in breast milk.
Both pethidine and norpethidine cross the blood/brain barrier and are
found in the cerebrospinal fluid.
Shelf Life: 36 months.
Storage:
Store below 25°C.
Store in airtight container. Protect from light.
Product licence numbers: PL 01883/6150R
Last revised: November 2017

Overdose:
Symptoms:
Respiratory depression, CNS depression with extreme somnolence
progressing to incoordination, stupor or coma, convulsions, CNS
stimulation, cyanosis, miosis, skeletal muscle flaccidity or tremors,
cold, clammy skin,hypothermia,bradycardia and hypotension.
In severe overdosage, apnoea, circulatory collapse, pulmonary
oedema, mydriasis, cardiac arrest and death may occur.
Treatment:
Treatment is supportive. A patent airway must be established with
assisted or controlled ventilation. If signs of CNS toxicity are exhibited
the use of pethidine should be discontinued. Narcotic antagonists
may be required if there is evidence of significant respiratory or
cardiovascular depression.
Naloxone should be given intravenously as soon as possible and
repeated every 2-3 minutes if necessary (refer to naloxone product
literature for details).
Anti-convulsive therapy, oxygen, intravenous fluids, vasopressors and
other supportive measures should be employed as indicated.
D03933

3933-D

100mm Measurement Verification Bar

DEVELOPMENT ARTWORK
D03933
Pethidine 50mg/ml & 100mg/2ml
PIL UK PL 01883/6150R Solution
for Injection Rotex
210 x 594mm

23/08/17

NF

01/09/17

NF

10/11/17

NF

10/01/18

NF

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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