Suxamethonium Chloride Injection Bp 50mg/Ml
PACKAGE LEAFLET: INFORMATION FOR THE USER D00249
Suxamethonium Chloride
Read all of this leaflet carefully before you use Suxamethonium Chloride Injection. It contains important information.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
In this leaflet:
1. What Suxamethonium Chloride Injection is and what it is used for
2. Before having Suxamethonium Chloride Injection
3. How Suxamethonium Chloride Injection is given
4. Possible side effects
5. Storing Suxamethonium Chloride Injection
6. Further information
1. What Suxamethonium Chloride Injection is and what it is used for
The active ingredient Suxamethonium Chloride is a medicine that relaxes the muscles of the body.
Suxamethonium Chloride Injection is used:
• to relax muscles during operations on adults and children
• to help insert a tube into the windpipe (endotracheal intubation), if a person needs help to breathe
• to reduce how strongly your muscles contract if you are having a fit (convulsions)
2. Before having Suxamethonium Chloride Injection
You should not be given Suxamethonium Chloride Injection if you:
• are allergic to Suxamethonium Chloride or any of the other ingredients listed in section 6 of this leaflet
• have been told by your doctor that you suffer from abnormal cholinesterase activity
• or any of your family has reacted badly to an anaesthetic before which has caused a very high body temperature (malignant hyperthermia)
• have had a major accident, operation or severe burns within the last three months
• have not been able to move for a long time such as to allow a broken bone to mend or a long period of bed rest
• have high levels of potassium in your blood (hyperkalaemia).
• have recently had an eye injury
• suffer from a problem caused by too much pressure in your eye called 'glaucoma'
• or any of your family have a disease of the muscles or nerves, such as a muscle wasting disease, paralysis, motor neurone disease, muscular dystrophy or cerebral palsy.
Take special care with Suxamethonium Chloride Injection. Tell your doctor if you:
• are suffering from tetanus, an infection which occurs through wound contamination.
• are suffering from tuberculosis or other severe or long standing infection
• have suffered from any long standing illness which has left you weak
• are suffering from cancer
• are suffering from anaemia.
• suffer from malnutrition
• suffer from liver or kidney problems
• suffer from any auto-immune diseases, for example, multiple sclerosis
• have an underactive thyroid gland, a condition known as myxoedema
• suffer from any muscle disease, for example, myasthenia gravis
• have recently had a blood transfusion or a heart-lung by pass
• have been in contact with insecticides
• have ever had an allergic reaction to any muscle relaxant which was given as part of an operation.
Special care will be taken when this medicine is being given to children and the elderly.
If any of the above apply to you or your child, please consult your doctor.
Taking other medicines
Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including herbal medicines or those obtained without prescription, including:
• anaesthetics, or other medicines used during surgery such as pain killers
• medicines for raised pressure in the eye (glaucoma) such as ecothiophate eye drops
• medicines for coughs, cold, sleeping or tablets for allergies
• medicines used to treat malaria containing chloroquine or quinine.
• oral contraceptives (birth control)
• medicines for treating asthma and other breathing conditions
• medicines containing metoclopramide, used to treat and prevent feeling or being sick.
• medicines for treating cancer (cytotoxic drugs)
• medicines used to treat mental problems
• medicines containing magnesium
• medicines containing oestrogens
• medicines containing steroids
• antibiotics (medicines used to treat bacterial infections)
• medicines used to treat disturbances in heartbeat rhythm (antiarrhythmic drugs)
• medicines used to treat a muscle disorder known as myasthenia gravis
• medicines used to control your heart
• medicines used to control your blood pressure during surgery
• medicines that can affect the way your body fights disease (immunosuppressants) such as azathioprine. These can be used to stop your body rejecting a transplanted organ or for 'autoimmune' diseases such as rheumatoid arthritis.
If you have any doubts about whether this medicine should be administered to you, consult your doctor or nurse.
Pregnancy & breast-feeding
Talk to your doctor before having Suxamethonium Chloride Injection if you are pregnant, trying to become pregnant, breast-feeding or have given birth in the last six weeks. Continued overleaf
3. How Suxamethonium Chloride Injection is given
Suxamethonium Chloride Injection will be given to you as an injection into your vein (intravenously) and/or into muscle (intramuscularly). The dose depends on your individual needs, body weight, the amount of muscular relaxation required and how the drug is given.
Adults and the elderly and children over 12 years:
By intravenous injection:
1mg per kilogram of bodyweight.
Supplementary doses of around 50 to 100% of the initial dose given at 5 to 10 minute intervals will maintain muscle relaxation.
A maximum of 500mg/hour will be given.
By slow intravenous infusion (drip):
0.1-0.2% solution, 2.5-4mg per minute up to a maximum of 500mg per hour.
Children aged 12 years and under:
By intravenous injection:
(Children 1-12 years of age): 1 mg per kilogram of bodyweight up to a maximum of 150mg
Infants (under 1 year): 2mg per kilogram of bodyweight
up to a maximum of 150mg
By intramuscular injection:
(Children 1-12 years of age): up to 4mg per kilogram of
bodyweight up to a maximum of 150mg
Infants (under 1 year): up to 4-5mg per kilogram of
bodyweight up to a maximum of 150mg
If you are given too much Suxamethonium Chloride Injection
As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too little or too much, however, tell your doctor or nurse if you have any concerns.
4. Possible side effects
Like all medicines, Suxamethonium Chloride Injection can cause side effects, although not everybody gets them.
Allergic reactions are very rare (they affect less than 1 in 10,000 people)
If you have an allergic reaction, tell your doctor or nurse straight away. The signs may include:
• sudden wheeziness, chest pain or chest tightness
• swelling of your eyelids, face, lips, mouth or tongue
• a lumpy skin rash or 'hives' anywhere on your body
• a collapse.
Very common (affects more than 1 in 10 people)
• abdominal cramps or pain and a feeling of nausea or "fullness”.
• visible twitching of muscle under the skin
• excessive production of saliva
• muscle pain after the operation - your doctor will monitor you for this
Common (affects less than 1 in 10 people)
• raised pressure of fluid in the eye which may cause headache or blurred vision
• speeding up or slowing down of your heart rate
• skin flushing
• skin rash
• high level of potassium in your blood
• high/low blood pressure
• protein in the blood or urine due to muscle damage
• muscle damage which may make your muscles ache or feel tender, stiff and weak. Your urine may also look dark or be red or cola coloured.
Rare (affects less than 1 in 1,000 people)
• abnormal heart rhythm
• heart problems including changes in the way in which your heart beats or your heart stopping beating
• difficulty in breathing or temporary loss of breath
• difficulty in opening your mouth
Very rare (affects less than 1 in 10,000 people)
• high body temperature
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.
5. Storing Suxamethonium Chloride Injection
Keep out of the reach and sight of children.
You should not be given Suxamethonium Chloride Injection after the expiry date which is printed on the carton and syringe label. The doctor or nurse will check that the expiry date on the label has not been passed before administering the injection to you. The expiry date refers to the last day of that month.
Store at 2°C-8°C. Do not freeze. Keep container in the outer box.
Suxamethonium Chloride Injection 50 mg/ml BP should be stored in the fridge. Once first removed from the fridge, it should be used within 28 days but can be stored for short periods at not more than 25°C before being returned to the fridge during those 28 days.
6. Further Information
What Suxamethonium Chloride Injection contains
The active substance is suxamethonium chloride 50mg/ml The other ingredients are hydrochloric acid and water for injections
What Suxamethonium Chloride Injection looks like and contents of the pack
Suxamethonium Chloride Injection is a clear, colourless solution supplied in a clear glass 2ml prefilled syringe. Each prefilled syringe contains 100mg of suxamethonium chloride.
Product Licence Holder: Manufacturer:
Aurum Pharmaceuticals Ltd., Martindale Pharmaceuticals Ltd. Bampton Road, Bampton Road
Harold Hill, Romford, RM3 8UG
Romford, Essex. United Kingdom.
RM3 8UG, UK.
If this leaflet is difficult for you to see or read or if you would like any more information, please contact Medical Information at the above address.
Product licence numbers: PL 12064/0065 ^
Leaflet approved: 09/2009
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