Skip to Content



View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the patient


Ketamine 50 mg/ml Injection
Ketamine hydrochloride

Important information about your medicine
► Your doctor or nurse will give you the injection.
► If this injection causes you any problems talk to your doctor, nurse or pharmacist.
► Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to
any of the ingredients of this medicine.
► Please tell your doctor or pharmacist, if you are taking any other medicines.
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 or nurse.
• If you have been given Ketamine in an emergency you will not have had a chance to read this
leaflet. Your doctor or anaesthetist will have considered the important safety information in this
leaflet, but your urgent need for treatment may have been more important than some of the usual
• If you are discharged on the same day as the operation, you should be accompanied by another
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not
listed in this leaflet.
The name of your medicine is Ketamine 50 mg/ml Injection, which will be referred to as Ketamine
throughout this leaflet.
What is in this leaflet
1. What Ketamine is and what it is used for
2. What you need to know before you are given Ketamine
3. How Ketamine is given
4. Possible side effects
5. How to store Ketamine
6. Contents of the pack and other information

1. What Ketamine is and what it is used

an emergency, this is not possible, Ketamine may
still be used.

This medicine contains ketamine hydrochloride
which belongs to a group of medicines called
anaesthetic agents, which are used to put you
to sleep during an operation. Ketamine may be
used in both routine and emergency surgery.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor for advice before being given this

Ketamine is used in adults, the elderly and
children. Ketamine can be given alone or in
combination with other anaesthetic agents.

2. What you need to know before you are
given Ketamine
Do not use Ketamine:
• if you are allergic to ketamine hydrochloride or
any of the other ingredients of this medicine
(listed in section 6).
• if you are suffering from any condition in which
an increase in blood pressure may be harmful
to you or have suffered in the past from a
medical condition which may have been
caused/made worse by an increase in blood
• if you have been pregnant and during your
pregnancy you have suffered from a condition
called eclampsia or pre-eclampsia which
causes an increase in your blood pressure
• if you have recently suffered a stroke or
serious head or brain injury
• if you have severe heart disease
• if you are pregnant, trying to become pregnant
or breast-feeding. However, Ketamine may
safely be used in caesarean section surgery
or vaginal delivery.
Warnings and precautions
Talk to your doctor or nurse before using Ketamine
if you:
• drink large amounts of alcohol
• have a history of drug abuse or addiction
• have a history of or have current mental health
• have a chest infection or problems breathing
• have problems with your liver
• have increased pressure in the eye (glaucoma)
• have an inherited disease that affects the
blood (porphyria)
• have ever had seizures
• are receiving treatment for your thyroid gland
• have had any injury to your head or abnormal
growth in the brain

Driving and using machines
Caution should be taken when driving or operating
machines following treatment with Ketamine. You
should not drive or operate machines in the first
24 hours after your operation.
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
Talk to your doctor or pharmacist if you are not
sure whether it is safe for you to drive while taking
this medicine.

3. How Ketamine is given

Except in an emergency, Ketamine should
only be used in hospitals by experienced
anaesthetists with resuscitation equipment

Before your operation you will usually be given
a medicine such as atropine or hyoscine to
dry up your secretions (body fluids like saliva
and tears) and another medicine called a
benzodiazepine. The benzodiazepine will
help you to relax and help to prevent a side
effect known as "emergence reaction".

The dose of Ketamine depends on its use and
varies from person to person. When injected
directly into a vein at a dose of 2 mg for every
kg of your bodyweight, Ketamine produces
unconsciousness within 30 seconds and this
lasts for 5 to 10 minutes. Because it works
so quickly, it is important to be lying down, or
supported in some other way when the drug
is given. When Ketamine is injected into a
muscle, at a dose of 10 mg for every kg of
bodyweight, it takes longer to work (3 to 4
minutes) but lasts 12 to 25 minutes.

Your anaesthetist will then keep you
anaesthetised with either:

another anaesthetic

more Ketamine given by injection into a
muscle or vein, or in a drip (infusion)

When it is injected directly into a vein, Ketamine
is given over at least a minute so that it does
not slow your breathing too much. If breathing
is slowed, it can be helped mechanically.

If before your operation the pressure in your
spinal cord is raised, your anaesthetist will pay
special attention to this during the operation.
Other medicines and Ketamine
Tell your doctor if you are taking, have recently
taken or might take any other medicines.
Ketamine is usually given together with other
medicines during surgery.
• When used for an operation on the chest
or abdominal organs, Ketamine is usually
combined with a pain-killer.
• Tell your doctor if you are taking barbiturates
(e.g. thiopental) and narcotics (morphine-like
drugs) since use with Ketamine may slow
your recovery from anaesthesia. Otherwise,
Ketamine may be used with all other general
and local anaesthetics.

Ketamine with food and drink
It is normal not to eat or drink for at least six
hours before an operation; therefore Ketamine is
usually given when your stomach is empty. If in

While you are anaesthetised, your anaesthetist
will watch over you constantly, paying
particular attention to your breathing, airways,
reflexes, the degree of anaesthesia and the
condition of your heart.


The following information is intended for healthcare professionals only:


Ketamine 50 mg/ml Injection
Please refer to the Summary of Product
Characteristics for full prescribing and other
Therapeutic indications
Ketamine is recommended:
• As an anaesthetic agent for diagnostic
and surgical procedures. When used by
intravenous or intramuscular injection,
Ketamine is best suited for short procedures.
With additional doses, or by intravenous
infusion, Ketamine can be used for longer
procedures. If skeletal muscle relaxation is
desired, a muscle relaxant should be used and
respiration should be supported.
• For the induction of anaesthesia prior to the
administration of other general anaesthetic
• To supplement other anaesthetic agents.
Specific areas of application or types of
• When the intramuscular route of administration
is preferred.
• Debridement, painful dressings, and skin
grafting in burned patients, as well as other

superficial surgical procedures.
myelograms, and lumbar punctures.
Diagnostic and operative procedures of the
eye, ear, nose, and mouth, including dental
Note: Eye movements may persist during
ophthalmological procedures.
Anaesthesia in poor-risk patients with
depression of vital functions or where
depression of vital functions must be avoided,
if at all possible.
Orthopaedic procedures such as closed
reductions, manipulations, femoral pinning,
amputations, and biopsies.
Sigmoidoscopy and minor surgery of the anus
and rectum, circumcision and pilonidal sinus.
Cardiac catheterization procedures.
Caesarian section; as an induction agent in
the absence of elevated blood pressure.

You should not be released from hospital until you
have completely recovered from the anaesthetic.
If you are discharged on the same day as the
operation, you should be accompanied by another
adult (see also the section on ‘Driving and Using
If you are given more Ketamine than you
should you may experience breathing difficulties.
Your doctor or nurse may provide you with
equipment to help you breathe.

6. Contents of the pack and other
What Ketamine contains
The active substance is ketamine hydrochloride.
Each 10 ml of solution contains 577mg of
ketamine hydrochloride, equivalent to 500mg of
ketamine base.
The other ingredients are:

If you have any further questions on the use of
this medicine, ask your doctor or nurse.

water for injections

4. Possible side effects

What Ketamine looks like and contents of the
Ketamine is a clear solution for injection or

Like all medicines, Ketamine can cause side
effects although not everyone gets them.
Tell your doctor immediately if you notice pain,
inflammation of the skin or rash at the injection
site. Ketamine can sometimes cause allergic
symptoms (‘anaphylaxis’) such as breathing
problems, swelling and rash. Some people have
hallucinations, vivid dreams, nightmares, feel ill
at ease, confused, anxious or behave irrationally
while recovering from anaesthesia with Ketamine.
These side effects are collectively known as an
‘emergence reaction’. You will be allowed to
recover from the anaesthetic in a quiet place and
this helps to prevent the reaction (see Section 3
under ‘How to use Ketamine’).
The following side effects have been reported:
Common side effects may affect up to 1 in 10
• the following, while recovering from
anaesthesia (these are collectively known
as an ‘emergence reaction’): hallucinations
(which may include flashbacks or floating
sensation), vivid dreams, nightmares, feeling
ill at ease, confused, anxious and irrational

unusual eye movements, increased muscle
tone and muscle twitches (which may
resemble ‘fits’ or convulsions).

double vision.

increased blood pressure and increased pulse

breathing more quickly.

nausea, vomiting.

skin inflammation/rash.

benzethonium chloride (a preservative).

Carton pack containing 1 or 10 clear glass vials
of 10ml.
Not all pack sizes may be marketed
Marketing Authorisation Holder:
hameln pharmaceuticals ltd
United Kingdom
hameln pharmaceuticals gmbh
Langes Feld 13
31789 Hameln, Germany
hameln rds a.s.
Horná 36
900 01 Modra
Slovak Republic
This leaflet was last revised in October 2016


Uncommon side effects may affect up to 1 in 100

loss of appetite, feeling anxious.

slowing of heart rate, changes in heart rhythm.

lowering of blood pressure.

breathing more slowly, narrowing of the voicebox leading to difficulty in breathing.

pain, inflammation of the skin or rash at the
injection site.

Rare side effects may affect up to 1 in 1000 people

allergic symptoms (‘anaphylaxis’) such as
breathing problems, swelling and rash.

drifting in and out of consciousness (with
feeling of confusion and hallucinations),
flashbacks, feeling ill at ease, sleeplessness,
feeling disorientated.

affect on the reflexes which keep your airways
clear, resulting in temporary inability to

increase in salivation.

inflammation of the bladder and/or pain when
urinating (‘cystitis’). The appearance of blood
in the urine may also occur.

Side effects where the occurrence is not known

raised pressure in the eyes.

abnormal results to liver function tests.

• drug-induced liver injury (when taken for more
than 3 days).
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse: This includes any possible
side effects not listed in this leaflet.
You can also report side effects directly via the
Yellow Card Scheme at:
yellowcard. By reporting side effects you can
help provide more information on the safety of
this medicine.

5. How to store Ketamine
Keep out of the sight and reach of children.
Your doctor and pharmacist are responsible for
the correct storage, use and disposal of Ketamine.
Do not use Ketamine after the expiry date which
is stated on the carton and label after “EXP.”. The
expiry date refers to the last day of that month.
Do not freeze. This medicinal product does
not require any special temperature storage
conditions. Store in the original container in order
to protect from light.

The following information is intended for healthcare professionals only:
(Continued from overleaf)


Ketamine 50 mg/ml Injection

Anaesthesia in the asthmatic patient,
either to minimise the risks of an attack of
bronchospasm developing, or in the presence
of bronchospasm where anaesthesia cannot
be delayed.

For intravenous infusion, intravenous injection or
intramuscular injection.

Shelf life
3 years.
For single use only. Discard any unused product.
Special precautions for storage
This medicinal product does not require any
special temperature storage conditions. Do not
freeze. Store in the original container.

A solution containing 1 mg/ml of ketamine in
dextrose 5% or sodium chloride 0.9% is suitable
for administration by infusion.
After dilution the solutions should be used
Ketamine is chemically incompatible with
barbiturates and diazepam because of precipitate
formation. Therefore, these should not be mixed
in the same syringe or infusion fluid.


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.