Please be aware that the wording of leaflets is updated regularly.
This electronic version is the most up-to-date version and so may differ from the leaflet in the pack. If you are unsure about anything, or would like to know more, please ask your pharmacist or doctor.
THIOPENTAL INJECTION BP
The active ingredient in thiopental injection, thiopental sodium, is also known as thiopentone sodium.
Please read this leaflet carefully before you receive your medicine. Do not throw it away as you may want to read it again. This leaflet provides a summary of the information available on your medicine. If you have any questions, or are not sure about anything, ask your doctor, nurse or pharmacist.
What Is In My Medicine?
Each vial of this product contains 500 milligrams of thiopental sodium as a powder for solution for injection, and is presented in packs of 25 vials. It is a dry powder which needs to be dissolved in Water for Injections.
What Is Thiopental?
Thiopental sodium is an anaesthetic agent which is usually given by intravenous injection.
Marketing Authorisation Holder And Manufacturer
The Marketing Authorisation Holder is
Thiopental injection is manufactured by
What Is Thiopental Used For?
Thiopental may be used for any of the following reasons:
- i) as a general anaesthetic, or to make you sleepy before using another anaesthetic agent, or before using agents to prevent pain or to relax muscles.
- ii) to control fits.
Is Thiopental Safe For Everybody?
You should not normally receive thiopental if any of the following apply to you:
- You have an obstruction in your lungs or in the tubes leading to them.
- You are having an acute asthma attack.
- You are in severe shock.
- You have the condition known as myotonic dystrophy.
- You have the condition known as porphyria.
People with these last two conditions will know if they have them.
You should tell your doctor, nurse or pharmacist if any of these apply to you. They will usually decide to use another medicine instead.
Precautions
Although you can still receive thiopental, your doctor may decide to use another medicine in the following circumstances:
- If you have diseases of the heart or circulation as these can suddenly be made more severe by thiopental injection.
- If you have cranial hypertension (high pressure inside your head) or adrenocortical insufficiency, low blood pressure, severe bleeding, burns, muscle weakness or degeneration (associated with conditions such as myasthenia gravis or muscular dystrophies), malnutrition or wasting. Your doctor will need to take extra precautions while treating you with thiopental injection.
- If thiopental is accidentally injected into an artery instead of a vein, it can cause damage to your tissues but your doctors may be able to treat these effects (a similar problem can occur if thiopental leaks from the vein into surrounding tissue). If you feel severe pain near where the drug was injected say so immediately so that treatment can be started quickly.
- Thiopental injection has been used safely during pregnancy but if you are pregnant, or think you could be, you should make sure that your doctors know about this. They can then discuss any possible risks with you before treatment starts. If you intend breast-feeding a baby after having thiopental injection you should discuss the safety of doing so with your doctor.
- You may not be fit to drive (or operate other machinery) after receiving thiopental injection. Although this effect will wear off quite quickly, you must be certain that you are able to drive safely before you try. During this time, even a small amount of alcohol can have a very strong effect on you, making driving very dangerous. Other medicines that cause drowsiness can have a similar effect. Make sure you read the label of any medicines carefully.
- Other medicines which can interact with thiopental injection include medicines called beta-blockers or calcium antagonists which are used to decrease your blood pressure, or any medicines prescribed to you for anxiety, or which are used to alter your mood (called antipsychotics).
If you are in doubt about the kind of medicine you are taking please contact your doctor or pharmacist.
Reduced doses may be needed if you have any of the following:
- Liver disease (including jaundice), shock, dehydration, severe anaemia, high blood level of potassium, infection in your blood. Elderly patients and people who suffer from metabolic disorders may also need smaller doses. An example of this type of disease is myxoedema (a condition caused by an underactive thyroid gland).
- People who have received morphine or similar medicines before they are given thiopental injection often need lower doses. If you have received a medicine called sulfafurazole please tell your doctor. He or she may need to give you smaller doses of thiopental and give these more frequently than usual.
Increased doses: if you are a heavy and frequent drinker of alcohol, or if you regularly take non-prescribed drugs, the dose of thiopental may need to be increased or given with another medicine to increase its effect.
You should tell your doctor, nurse or pharmacist if any of these apply to you.
How Is Thiopental Given?
Thiopental injection is first made into a solution usually containing 25mg in 1ml. Sometimes a higher strength may be used.
A needle will have been placed into a vein in advance. Thiopental injection can be injected directly through this needle or it may be put into a drip which runs through it.
Dosages used for convulsions (fitting) are 75mg to 125mg given as soon as possible after the convulsion begins. Further doses may be required and your doctor will decide the best dose to give you.
The normal anaesthetic dose for adults is 100mg to 150mg, injected over 10 to 15 seconds, although smaller doses may be used for elderly patients. The dose for a child depends on their weight (usually between 2mg to 7mg for every kg of body-weight). You will normally feel the effects within 30 seconds and be asleep within one minute. Further small doses will be given to you as necessary (you will normally be asleep during this process).
Thiopental injection Side Effects
The effects which have been seen with thiopental injection are listed below.
Thiopental injection can cause coughing, sneezing or spasm of the airways in your throat when it is injected. It can cause skin rashes and other allergic reactions, such as itching.
Your body’s automatic breathing control may be affected causing spasm of the airways and difficulty breathing, and the pumping action of the heart can be reduced or irregular heartbeats may occur.
Thiopental injection can cause headaches.
When injected thiopental can cause severe pain at the site of injection. If this happens inform your doctor immediately.
If you experience any of the above side effects or any other side effects please tell your doctor, nurse or pharmacist.
More Information About Thiopental Injection
Do not use thiopental after the expiry date printed on the pack and on each vial. The vials should not be stored above 25°C and should be kept in the outer carton.
The injection solution is quite strongly alkaline, to stop the thiopental from “going off”. Because of this it cannot be mixed with other injections that are acidic. The solution should be kept cool (between 2°C and 8°C) after making it up and normally should be used within seven hours. If the solution is discoloured it should not be used.
This leaflet was written in September 2003.
PIL0304
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