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Ketamine 50mg/ml Solution for Injection/Infusion

Active Ingredient:
ketamine hydrochloride
Company:  
Flynn Pharma Ltd See contact details
ATC code: 
N01AX03
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL)
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 06 May 2025
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 13621/0086.

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Ketamine 50mg/ml Solution for Injection/Infusion

Package leaflet: Information for the user

Ketamine 50 mg/ml Solution for Injection/Infusion

ketamine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
  • 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 precautions.
  • If you are discharged on the same day as the operation, you should be accompanied by another adult.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or nurse.
  • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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 for

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. 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 take 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 pressure
  • 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 if any of the following apply to you, to help them decide if Ketamine is suitable for you. If you:

  • drink large amounts of alcohol
  • have a history of drug abuse or addiction
  • have a history of or have current mental health problems
  • 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

If before your operation the pressure in your spinal cord is raised, your anaesthetist will pay special attention to this during the operation.

Long-Term Use

Ketamine is not indicated and not recommended for long-term use.

Bladder infection sometimes accompanied by bleeding, and liver problems have been reported particularly with long-term use (>3 days) or drug abuse (see Section 4 Possible side effects).

Drug Abuse and Addiction

If used on a daily basis for a few weeks, dependence and tolerance may develop, particularly in individuals with a history of drug abuse and dependence. Other adverse effects have also been reported (see “Long-Term Use”).

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.

  • 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.
  • Diazepam can increase the effects of Ketamine so dose adjustments may be needed.
  • Using sympathomimetics (for example adrenaline or noradrenaline) or vasopressin with Ketamine may lead to an increase in blood pressure and heart rate.
  • Using Ketamine with ergometrine may lead to an increase in blood pressure.
  • Using Ketamine with theophylline or aminophylline may lead to an increased likelihood of seizures.
  • Concomitant use of medicines used to treat high blood pressure carries the risk of developing hypotension (low blood pressure).
  • When given to patients already on thyroid hormone tablets, there is an increased risk of developing a fast heart rate and high blood pressure.

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

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 medicine.

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 safely.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Information about sodium content

This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium free’.

3. How Ketamine is given
  • Ketamine is not indicated nor recommended for long-term use.
  • Except in an emergency, Ketamine should only be used in hospitals by experienced anaesthetists with resuscitation equipment available.
  • 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),
    • Ketamine together with another anaesthetic.
  • 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.
  • 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.
    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 Machines’).

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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 Ketamine is given’).

Common: may affect up to 1 in 10 people

  • 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 behaviour,
  • unusual eye movements, increased muscle tone and muscle twitches (which may resemble ‘fits’ or convulsions),
  • double vision,
  • increased blood pressure and increased pulse rate,
  • breathing more quickly,
  • nausea, vomiting,
  • skin inflammation/rash.

Uncommon: may affect up to 1 in 100 people

  • loss of appetite, feeling anxious,
  • slowing of heart rate, changes in heart rhythm,
  • lowering of blood pressure,
  • breathing more slowly, narrowing of the voice-box leading to difficulty in breathing,
  • pain, inflammation of the skin or rash at the injection site.

Rare: 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 breathe,
  • increase in salivation,
  • inflammation of the bladder and/or pain when urinating (‘cystitis’). The appearance of blood in the urine may also occur.

Not known: frequency cannot be estimated from the available data

  • 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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 Ketamine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle label and on the carton. The expiry date refers to the last day of that month.

Store in the original container in order to protect from light. This medicine requires no special temperature storage conditions.

6. Contents of the pack and other information
What Ketamine contains
  • the active substance is ketamine hydrochloride. Each 10 ml vial contains 500 mg of ketamine base (50 mg/ml),
  • the other ingredients are water for injection, sodium hydroxide and hydrochloric acid.

What Ketamine looks like and contents of the pack

Ketamine is a clear solution for injection/infusion available in a pack of 5 or 10 glass vials with a grey stopper covered with a blue aluminium cap.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Flynn Pharma Limited
5th Floor
40 Mespil Road
Dublin 4
D04 C2N4
IRELAND

Manufacturer
Inresa Arzneimittel GmbH
Obere Hardtstr. 18
79114 Freiburg
Germany

This leaflet was last revised in July 2024

Flynn Pharma Ltd
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Address
Hertlands House, Primett Road, Stevenage, Hertfordshire, SG1 3EE, UK
Telephone
+44 (0)1438 727822
Medical Information e-mail
[email protected]
WWW
http://www.flynnpharma.com
Medical Information Direct Line
+44 (0)1438 727822