10 mg/ml solution for injection in a pre-filled syringe
anhydrous suxamethonium chloride
What Suxamethonium Aguettant is and what it is used for
Suxamethonium Aguettant belongs to a group of medicines called muscle relaxants.
They work by blocking the connection between nerves and certain muscles, causing the muscles to relax by temporarily paralyzing them.
It is used for adults and children over the age of 12 under anesthesia (sedation) or in emergencies.
Suxamethonium Aguettant is given when a tube is inserted into the trachea (endotracheal intubation ) if a person needs help to breathe. During the procedure, the muscles used for breathing must be paralyzed.
Suxamethonium chloride contained in Suxamethonium Aguettant may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Suxamethonium Aguettant
You must not be given Suxamethonium Aguettant:
- if you are allergic to suxamethonium or any of the other ingredients of this medicine (listed in section 6);
- if you as a patient are conscious;
- if you or someone in your family has had an adverse reaction to anesthesia in the past, such as a very high body temperature ( malignant hyperthermia );
- if you have a deficiency of an enzyme called pseudocholinesterase which breaks down suxamethonium in the body;
- if you have high levels of potassium in your blood ( hyperkalemia );
- if you have had a serious accident, surgery, or severe burns;
- if you have had a spinal cord injury, nerve damage, or sudden muscle wasting;
- if you have not been able to move for a long time, for example, to allow a broken leg to heal or if you have been bedridden for a long period;
- if you have muscle weakness or wasting (such as Duchenne muscular dystrophy);
- if you or someone in your family has a disease that causes muscle weakness ( myotonia congenita, myotonic dystrophy);
- if you recently had an eye injury;
- if you suffer from complications caused by excessive pressure in the eye ( glaucoma ) unless the possible benefits outweigh the possible risks to the eye.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given Suxamethonium Aguettant:
- if you have ever had an allergic reaction to any muscle relaxant given as part of an operation
- if you suffer from myasthenia gravis, a disease that causes severe muscle weakness, or from any other nerve or muscle disease
- if you are pregnant or have given birth within the last six weeks
- if you have tetanus, an infection that can occur when a wound becomes infected
- if you have tuberculosis or any other serious or long-term bacterial infection
- if you have a long-term illness that has made you weak
- if you suffer from a blood disorder called anemia ( lack of blood )
- if you are malnourished or unable to absorb nutrients from food ( malnutrition )
- if you have liver or kidney disorders
- if you suffer from a disease caused by your body attacking itself ( autoimmune disease) such as a disease affecting the thyroid gland ( myxedema )
- if you suffer from a disease that causes joint problems (collagen diseases)
- if you are undergoing or have undergone blood treatment called plasmapheresis treatment
- if you have recently had cardiopulmonary bypass surgery.
Children
This medicine is not recommended for children under 12 years of age because the graduation of the pre-filled syringe does not allow the correct administration of the medicine to this group.
Special care should be taken when this medicine is given to children over 12 years of age.
Other medicines and Suxamethonium Aguettant
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, you should tell your doctor, pharmacist, or nurse if you are taking or being treated with any of the following:
- psychiatric drugs (eg, phenelzine, promazine)
- cancer medicines (eg cyclophosphamide, thiotepa, irinotecan)
- anesthetic (sleeping) drugs (eg, ketamine, halothane, enflurane, desflurane, propofol)
- local anesthetics (eg lidocaine , procaine, procainamide )
- a medicine used to treat or prevent nausea or vomiting (metoclopramide)
- medicines used for Alzheimer’s disease or myasthenia gravis (anticholinesterases such as donepezil, edrophonium, galantamine, neostigmine, pyridostigmine, rivastigmine, and tacrine)
- medicines to treat asthma or other breathing problems (eg bambuterol, terbutaline;
- organic substances containing phosphorus
- a medicine used to reduce bleeding (aprotinin)
- estrogens and birth control pills that contain estrogen
- a medicine for uterine contraction ( oxytocin )
- medicines for inflammatory conditions (e.g. steroids for rheumatism, etc.)
- medicines used to treat heart rhythm disorders ( antiarrhythmics such as e.g. quinidine, verapamil)
- certain antibiotics used to treat bacterial infections (eg lincosamides, polymyxins, and aminoglycosides )
- antiepileptic drugs used to prevent epileptic seizures (eg carbamazepine, phenytoin )
- a beta-blocker medicine used to slow the heart rate (esmolol)
- a medicine to suppress the immune system (azathioprine)
- a medicine to counteract mania and/or depression (lithium)
- magnesium salts
- medicines that increase heart muscle contraction (cardiac glycosides such as digoxin )
- medicine to treat high pressure in the eye, i.e. glaucoma (ecothiopath).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before being given this medicine.
Suxamethonium Aguettant should only be used during pregnancy when your doctor considers that the benefits to you outweigh any potential risks to the baby.
Caution should be exercised after suxamethonium is administered to patients who are pregnant or have recently given birth.
It is not known whether suxamethonium is excreted in breast milk. However, since suxamethonium is quickly broken down into an inactive residual product ( metabolite ), no effects on the nursing child are anticipated.
Driving ability and use of machinery
It may be dangerous to drive or operate machinery too soon after receiving this medicine. Your doctor will inform you how long you should wait before driving or using machinery.
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.
Suxamethonium Aguettant contains sodium.
This medicine contains 27.9 mg of sodium (the main component of table salt). This corresponds to 1.4% of the recommended daily intake of sodium for an adult.
How Suxamethonium Aguettant is given
You are never expected to give the medicine to yourself. It will always be given by trained healthcare professionals.
Your doctor will decide what dose you will receive. Does one depend on your individual needs, body weight, and how strong muscle relaxation is required?
Suxamethonium Aguettant is given as an injection into a vein ( intravenous use). The pre-filled syringe is not suitable for use in a syringe pump.
If you have been given too much Suxamethonium Aguettant
As this medicine is always administered under carefully controlled conditions, it is unlikely that you will receive a larger dose than necessary. If an overdose has been given, your muscles will be relaxed longer than necessary.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people)
- visible twitching of the muscles under the skin
- muscle pain after surgery – your doctor will monitor if this happens.
Common (may affect up to 1 in 10 people)
- allergic reactions: itching, rash, collapse
- increased fluid pressure in the eye which can cause headaches or blurred vision
- increased pressure in the stomach
- increase or decrease in heart rate
- low blood pressure
- protein in blood or urine due to muscle damage
- high potassium levels in the blood
- skin redness
- rash
Rare (may affect up to 1 in 1,000 people)
- breathing difficulties
- high body temperature
- difficulty opening the mouth
Frequency not known (cannot be estimated from available data)
- swelling ( Quincke’s edema, angioedema )
- cardiac arrest
- high or low blood pressure
- greatly increased saliva production
- greatly increased mucus production
- temporary shortness of breath
- muscle injuries
How to store Suxamethonium Aguettant
Keep this medicine out of the sight and reach of children.
You should not be given this medicine after the expiry date which is stated on the pre-filled syringe label, blister, and carton. The expiration date is the last day of the specified month.
Store in a refrigerator (2°C–8 ºC).
Do not freeze.
Keep the pre-filled syringe in its unopened blister until ready to use.
Once the package has been opened, the medicine must be used immediately.
For short periods, this medicine can be stored at temperatures not exceeding 25 °C. Once the medicine has been removed from refrigerated storage, it must in any case be discarded after 30 days.
Do not use this medicine if you notice visible signs of deterioration.
All pre-filled syringes, even if only partially used, should be disposed of appropriately after use. Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is suxamethonium chloride. Each ml solution for injection contains 10 mg of anhydrous suxamethonium chloride (in the form of 11 mg of suxamethonium chloride dihydrate). Each 10 ml pre-filled syringe contains 100 mg anhydrous suxamethonium chloride (as 110 mg suxamethonium chloride dihydrate).
- Other ingredients are sodium chloride, succinic acid, sodium hydroxide, hydrochloric acid (for pH adjustment), and water for injections.
Appearance and package sizes of the medicine
Suxamethonium Aguettant is a clear colorless solution for injection, in a 10 ml pre-filled polypropylene syringe, individually packaged in a transparent blister pack. Boxes of 1 or 10 pre-filled syringes. Not all pack sizes may be marketed.
Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France