50 mg/ml, solution for injection/infusion,
suxamethonium chloride dihydrate
What Suxamethonium Ethypharm is and what it is used for
Suxamethonium Ethypharm contains a medicine called suxamethonium chloride. It belongs to a group of medicines called muscle relaxants.
Suxamethonium Ethypharm is used:
• for the muscles to be relaxed during surgery on adults and children
Ask your doctor if you want more information about this medicine
Suxamethonium chloride contained in Suxamethonium Ethypharm may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Suxamethonium Ethypharm
Do not use Suxamethonium Ethypharm
if
- you are allergic to suxamethonium chloride or any of the other ingredients of this medicine (listed in section 6).
- your doctor has said that you have abnormal cholinesterase activity ( cholinesterase is an enzyme that breaks down acetylcholine )
- you or someone in your family has ever had an abnormally high body temperature ( hyperthermia )
- you have abnormally high levels of potassium in your blood ( hyperkalemia )
- you or someone in your family has a disease that causes muscle weakness ( myotonia congenita or dystrophia myotonica)
- you have muscle weakness and loss of muscle tissue (Duchenne muscular dystrophy)
Warnings and precautions
This medicine will be given to you by an experienced anesthesiologist, along with other medicines to help you sleep. Respiratory equipment will be used to help you breathe. Talk to your doctor, nurse, or operating room staff before using this medicine if you:
- have an infection that causes muscle stiffness ( tetanus )
- have tuberculosis
- feel that you are unwell
- have fever
- have cancer
- have a blood disorder called anemia
- have difficulty getting proper nutrition or have an inability to absorb nutrients from food ( malnutrition )
- have serious liver or kidney problems
- have a disease caused by the body attacking itself ( autoimmune disease), for example, a disease of the thyroid gland ( myxedema )
- have a disease that causes discomfort in the joints (connective tissue disease)
- have heart problems (eg heart attack, heart disease, or irregular heartbeat)
- have or have had a treatment for the blood called plasmapheresis
- have had any kind of head injury
- recovering from major trauma or severe burns
- have an injury to the spinal cord, nerve damage, or muscle wasting
- have a muscle disease, for example, myasthenia gravis
- recently injured the eye
- have glaucoma
- have ever had an allergic reaction to any muscle relaxant given during surgery
- you haven’t been able to walk for a long time
- have blood poisoning ( sepsis )
Children and young people
Extra caution or monitoring is needed when suxamethonium is given to infants or children. Therefore, consult a doctor if any of the above apply to you or your child.
Other medicines and Suxamethonium Ethypharm
Tell the doctor, nurse, or other appropriate staff at the hospital if you are taking, have recently taken, or might take any other medicines.
- antiarrhythmics (medicines taken to change the heart rhythm) such as lidocaine, procaine, and cocaine.
- antibacterial agents (medicines that kill bacteria), such as neomycin, vancomycin, and polymyxin B
- anticholinesterases (medicines used to treat muscle problems) such as neostigmine
- ecothiopath, a medicine used to treat high pressure in the eye ( glaucoma )
- metoclopramide, a medicine used for nausea or vomiting
- phenelzine, a medicine used to treat depression ( MAOIs )
- promazine, a medicine used to treat restlessness and anxiety
- medicines used to treat malaria such as quinine and chloroquine
- tacrine, a medicine used to treat Alzheimer’s disease
- ACE inhibitors (medicines that lower blood pressure etc.)
- antiepileptics (medicines used to prevent seizures), such as carbamazepine and phenytoin
- antineoplastics (medicines used in the treatment of cancer) such as cyclophosphamide and tretamine
- benzodiazepines (medicines that have a relaxing effect) such as diazepam and midazolam
- calcium antagonists (medicines that reduce the strength of the heart) such as nifedipine, verapamil, or dantrolene
- cardiac glycosides (medicines that increase the contraction of the heart) eg digoxin
- cytotoxics (a type of medicine used to treat cancer) such as cyclophosphamide and thiotepa.
- medicines used in general anesthesia (medicines that make you sleep during an operation) such as propofol, fentanyl citrate droperidol (Innovar), and ether
- magnesium salts (a dietary supplement)
- medicines that affect the nervous system (parasympathomimetics and sympathomimetics ) such as demecarium, neostigmine, donepezil, and bambuterol
Tell your doctor if you have recently been exposed to insecticides such as sheep wash.
Tell your doctor if you have recently had a blood transfusion
If you are in any doubt about whether you should be given this medicine, talk to your doctor or nurse.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Driving ability and use of machinery
Do not drive or use machinery immediately after you have been operated on as this can be dangerous. Your doctor will tell you how long you should wait before driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
How to use Suxamethonium Ethypharm
Suxamethonium Ethypharm will be given as an injection into a vein ( intravenously ). The doctor determines the dose and treatment time that is suitable for your procedure. Does one will depend on:
- your body weight
- how much muscle relaxation do you need
- how you are expected to react to the medicine
Suxamethonium Ethypharm will always be given in controlled forms. If you have any more questions about how to use the medicine, ask your doctor.
Use for children and adolescents
Adults, the elderly, and young people over the age of 12:
For intravenous injection:
1 mg per kilogram of body weight
Additional doses of approximately 50% to 100% of the initial dose given at 5 to 10-minute intervals will maintain muscle relaxation.
For intravenous infusion:
0.1-0.2% solution, 2.5 to 4 mg per minute.
The maximum total dose is 500 mg.
Children 1 to 12 years
For intravenous injection:
1-2 mg per kilogram of body weight.
Infants (under 1 year): 2 mg per kilogram of body weight.
If you have used too much Suxamethonium Ethypharm
As this medicine will be given to you while you are in hospital, it is unlikely that you will get too much or too little, but ask your doctor or nurse if you are concerned.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get side effects, talk to a doctor, nurse, or other staff at the hospital. This also applies to any side effects that are not mentioned in this information.
In very rare cases, a sudden, severe allergic reaction to suxamethonium chloride may occur. If you experience any of the following symptoms, contact a doctor or nurse immediately:
- shortness of breath, wheezing, or trouble breathing
- swelling of your eyelids, face, lips, tongue, or other parts of your body
- rash, itching, hives on the skin
- fainting
There are other serious side effects that you and your doctor need to be aware of. You must contact your doctor or nurse immediately if you get any of the following:
Very common (may affect more than 1 in 10 users)
- stomach cramps and pain, feeling sick or “full”
- visible twitching of muscles under the skin
- muscle pain after surgery – your doctor will monitor you for this.
Common (may affect up to 1 in 10 users)
- increased fluid pressure in the eye which can cause headaches or “blurry” vision
- skin redness
- rash
- increased levels of potassium in the blood
- fast or slow heartbeat
- protein in the blood or urine due to muscle damage
- muscle damage that can cause pain or tenderness, stiffness, and weakness. The urine may also become dark, red, or cola-colored.
Rare (may affect up to 1 in 1,000 users)
- abnormal heart rhythm
- heart problems, change in the way your heart beats, or cardiac arrest
- difficulty breathing or temporary shortness of breath
- difficulty opening your mouth
Very rare (may affect up to 1 in 10,000 people)
- elevated body temperature
Other side effects include:
Has been reported (occurring in an unknown number of users):
- overproduction of saliva
- high/low blood pressure
How to store Suxamethonium Ethypharm
Keep this medicine out of the sight and reach of children.
You should not be treated with Suxamethonium Ethypharm after the expiry date which is stated on the carton and ampoule one after “EXP”. The doctor or nurse will check that the expiry date on the label has not passed before the injection is given to you. The expiration date is counted as the last day of the month.
Store in a refrigerator, between 2 and 8 °C. Do not freeze. Store in the original packaging. Light sensitive. This medicine should be used immediately after opening. Do not use this medicine if it is discolored or contains particles.
Medicines must not be thrown into the drain or among the household waste. The doctor or nurse will throw away medicine that is no longer needed. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is suxamethonium chloride dihydrate 50 mg/ml.
- Other ingredients are hydrochloric acid (for pH adjustment) and water for injections.
Appearance and package sizes of the medicine
Suxamethonium Ethypharm solution for injection/infusion is a clear, colorless solution supplied in a clear glass ampoule. Each 2 ml ampoule contains 100 mg of suxamethonium chloride dihydrate ( equivalent to 73.1 mg of suxamethonium). There are 10 ampoules in each carton.
Ethypharm
194 Bureaux de la Colline, Bâtiment D
92213,Saint-Cloud CEDEX
France
Manufacturer :
Macarthy’s Laboratories Limited,
Bampton Road, Harold Hill,
Romford, Essex,
RM38UG,
UK
ETHYPHARM,
Chemin de la Poudriere,
GRAND QUEVILLY,
76120, France
ETHYPHARM,
Zone Industrielle de Saint-Arnoult,
CHATEAUNEUF A THYMERAIS,
28170, France