Suxamethonium Chloride 50mg/Ml Solution For Injection
MercuryPharma
PATIENT INFORMATION LEAFLET
Suxamethonium Chloride 50mg/ml Solution for Injection
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.
However, please be aware that this may not always be possible because of your medical condition.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
The name of your medicine is Suxamethonium Chloride 50mg/ml solution for injection. It will be referred to as Suxamethonium Chloride Injection for ease hereafter.
In this leaflet:
1. What Suxamethonium Chloride Injection is and what it is used for
2. Before you are given Suxamethonium Chloride Injection
3. How Suxamethonium Chloride Injection is given to you
4. Possible side effects
5. How to store Suxamethonium Chloride Injection
6. Further information
1. WHAT SUXAMETHONIUM CHLORIDE INJECTION IS AND WHAT IT IS USED FOR
Suxamethonium Chloride Injection belongs to a group of medicines called muscle relaxants. Their effect is to block the connection between the nerves and certain muscles, which relaxes these muscles by temporarily paralysing them. This effect helps surgeons when performing operations.
This medicine can also be used when a patient is put on a ventilator to control breathing. During this procedure, it is necessary for the muscles used for breathing to be paralysed. Suxamethonium Chloride Injection can also reduce the intensity of muscle contractions associated with drug-induced convulsions or with electroconvulsive therapy (ECT).
2. BEFORE YOU ARE GIVEN SUXAMETHONIUM CHLORIDE INJECTION
You should not be given Suxamethonium Chloride Injection if:
• you know that you are allergic to Suxamethonium Chloride or to any of the other ingredients (see Section 6 of this leaflet)
• you or a member of your family has malignant hyperthermia (hereditary condition in which certain anesthetics such as halothane cause high body temperatures and muscle rigidity)
• you have a deficiency of an enzyme, pseudocholinesterase which breaks down suxamethonium in the body
• you suffer from cerebral palsy (brain activity disorder)
• you have had a major accident, operation or severe burns within the last three months
• you 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
• you or anyone in your family have a disease of the muscles or nerves, such as a muscle wasting disease, paralysis and weakness of the muscles
• you are a conscious patient
• you have high levels of potassium in your blood (hyperkalaemia).
Make sure your doctor knows if this applies to you.
Your doctor will take special care if any of the following situations apply to you:
• you suffer from a condition called myasthenia gravis (which causes severe weakness of the muscles) or from any other disease of nerves or muscles
• you are pregnant or have given birth in the last six weeks
• you suffer from liver or kidney disease
• you have tetanus, an infection which occurs through wound contamination
• you have tuberculosis or other severe long standing infection
• you have any long standing illness which had left you weak
• you suffer from cancer
• you are undernourished
• you have a disease of the thyroid gland
• you have recently had a blood transfusion or a heart-lung by pass
• you ever had an allergic reaction to any muscle relaxant which was given as a part of an operation
• you suffer from a severe bacterial infection
• you have recently had an eye injury
• you suffer from connective tissue disorder such as rheumatoid arthritis which causes pain in the joints
• care should be taken before administering it to children.
Make sure your doctor is aware of these situations before you are given this injection. Taking other medicines
Please tell your doctor if you are taking, or have recently taken, any other medicines. This includes medicines obtained without a prescription. This is extremely important because some medicines can strengthen or weaken the effects of others.
In particular, tell your doctor if you are taking any of the following:
• ecothiopate (eye drops for glaucoma),
• tetrahydroaminoacridine (also called tacrine), donepezil, galantamine which are used for Alzheimer's disease,
• acetylcholine inhibitors including trimetaphan (to lower blood pressure),
• propanidid (an anaesthetic drug), digoxin, procaine (for an irregular heart beat),
• lidocaine, chlorprocaine, cocaine (local anaesthetic drugs),
• oxytocin (to contract the womb),
• some non-penicillin antibiotics (for infection) e.g. clindamycin polymyxins, and aminoglycosides, vancomycin, piperacillin,
• beta-blockers (for example for angina, high blood pressure or irregular heart beat),
• aprotinin (to reduce bleeding),
• magnesium salts (such as some laxatives or antacids),
• the anti-malarial drugs quinine (which is sometimes used for night cramps) morphine or pethidine (to relieve pain) or drugs to reverse their effects (called morphine antagonists),
• the antidepressant drugs phenelzine, lithium, chlorpromazine or promazine,
• anti-cancer drugs (e.g. cyclophosphamide, chlorethamine, tretamine and thiotepa),
• azathioprine (to suppress the immune response),
• oestrogens (e.g. for hormone replacement),
• oral contraceptives,
• steroids (used for inflammatory conditions e.g. rheumatism etc),
• anticholinesterase drugs such as neostigmine, pyridostigmine, rivastigmine and edrophonium (e.g. for glaucoma or myasthenia gravis),
• diphenhydramine or promethazine (for allergic reactions),
• medicines for treating asthma or other breathing conditions (e.g. terbutaline, bambuterol),
• medicines containing metoclopramide, used to treat and prevent feeling or being sick,
• anaesthetic agents like halothane, enflurane, desflurane, isoflurane, ketamine, insecticides, metriphonate (used to treat schistosomiasis - a parasitic disease),
• propofol (used for induction and maintenance of anesthesia).
Pregnancy and breast feeding
Suxamethonium Chloride should only be used during pregnancy when your doctor decides the benefits to you are greater than any possible risk to the unborn baby.
There is insufficient information to say whether this medicine passes in to breast milk. It is recommended not to breast feed for at least 24 hours following administration of Suxamethonium Chloride.
Ask your doctor for advice before taking any medicine.
Driving and using machines:
It can be dangerous to drive or operate machinery too soon after having had an operation. Your doctor will tell you how long to wait before you can drive or use machinery.
3. HOW SUXAMETHONIUM CHLORIDE INJECTION IS GIVEN TO YOU
The anaesthetist will decide on the most appropriate dose.
It may be administered as an injection. The anaesthetist will make sure that you are asleep before this muscle relaxant is administered.
If you are given more Suxamethonium Chloride Injection than you should
As the injection will be administered by an anaesthetist, it is unlikely that you will be given more than is necessary. In case of an overdose, the muscle will stay relaxed for longer than required. If you have any further questions on the use of this product ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines Suxamethonium Chloride Injection can sometimes cause side-effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are very rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.
The following side effects have also been reported:
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
• laboratory tests revealing high level of potassium in your blood
• high/low blood pressure
• laboratory tests revealing 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 stops 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.
When you wake up after the anaesthetic, if you notice any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE SUXAMETHONIUM CHLORIDE INJECTION
Your doctor or nurse will know how to store this medicine properly.
The ampoules containing the injection solution are stored in their original packaging at a temperature between 2 and 8°C. The expiry date (EXP) is printed on the label and the carton. The first 2 digits indicate the month and the remaining digits indicate the year of expiry. The drug should not be used after this date. Once opened, any unused liquid should be discarded.
6. FURTHER INFORMATION
The active substance is Suxamethonium Chloride. There is 100mg of Suxamethonium Chloride in 2ml of the injection.
Other ingredients of the solution are sodium acetate and water for injections.
What Suxamethonium Chloride Injection looks Iike and contents of pack
Suxamethonium Chloride Injection BP 100mg/2ml is a clear, colourless sterile solution. Each glass ampoule (small bottle) contains 2ml with 100mg respectively of the active ingredient, Suxamethonium Chloride. These ampoules are then packed in to cardboard boxes. Each box contains 10 ampoules.
Marketing authorisation holder
Mercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park,
Co Dublin, Ireland.
Manufacturer
B. Braun Melsungen AG, Mistelweg 2/6, Berlin 47, D12357 Germany.
This leaflet was last revised in: May 2012
100527/LF/1
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