Suxamethonium Chloride 50 mg/ml, solution for injection / infusion – patient leaflet, side effects, dosage

1. What Suxamethonium Chloride is and what it is used for

Suxamethonium Chloride contains the active substance suxamethonium chloride. This belongs to a group of medicines called muscle relaxants. Suxamethonium chloride 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.

2. What you need to know before you are given Suxamethonium Chloride

You should not be given Suxamethonium Chloride:

• if you are allergic to suxamethonium, or any of the other ingredients of this

  medicine (listed in section 6)

• if you or your family have reacted badly to an anaesthetic before such as a

  very high body temperature (malignant hyperthermia)

• if your doctor has told you that you suffer from abnormal cholinesterase

  activity (cholinesterase is an enzyme that breaks down acetylcholine) - if you have abnormally high levels of potassium in your blood (hyperkalaemia) - if you have muscle weakness and wasting of muscle tissue (Duchenne

  muscular dystrophy)

• if you or any of your family have a disease causing weakness of the muscles

  (myotonia congenita or dystrophia myotonica)

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Suxamethonium Chloride :

• if you ever had an allergic reaction to any muscle relaxant which was given

  as part of an operation

• if you are suffering from an infection that causes muscle stiffness (tetanus)
• if you are suffering from tuberculosis
• if you feel unwell
• if you have a fever
• if you have cancer
• if you suffer from a blood disease known as anaemia

• if you suffer from a lack of proper nutrition or an inability to absorb nutrients

  from food (malnutrition)

• if you have serious liver or kidney problems

• if you suffer from a disease caused by the body attacking itself (autoimmune

  disease) such as a disease of the thyroid gland (myxoedema)

• if you suffer from diseases that cause problems with the joints (collagen

  disease)

• if you suffer from heart problems (including heart attacks, heart disease or

  an irregular heart beat)

• if you are having or have had in the past treatment to your blood known as

  plasmapheresis therapy

• if you have had any head injuries
• if you are recovering from major trauma or severe burns
• if you have suffered a spinal cord injury, nerve injury or sudden muscle wasting
• if you have a muscle disease, for example, myasthenia gravis

• if you recently had an eye injury

  • if you have glaucoma (increased pressure in the eye)
  • if you have not been able to walk for a long period of time
  • if you have severe blood poisoning (sepsis)
  • if you have recently had a blood transfusion

Children

Extra care or monitoring must be carried out on infants and children given Su-xamethonium Chloride.

Other medicines and Suxamethonium Chloride

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

• anti-arrhythmics (medicines used to alter the rhythm of the heart) such as lidocaine, procaine and cocaine.
• antibacterials (medicines able to kill bacteria) such as neomycin, vancomycin and polymyxin B
• anticholinesterases (medicines used to treat muscle problems) such as neostigmine
• ecothiopate, a medicine used to treat raised pressure in the eye (glaucoma)
• metoclopramide, a medicine used to stop you feeling or being sick
• phenelzine, a medicine used to treat depression (monoamine oxidase inhibitor)
• promazine, a medicine used to treat restlessness and agitation
• medicines used to treat malaria such as quinine and chloroquine
• tacrine, a medicine used to treat Alzheimers disease
• ACE inhibitors
• antiepileptics (medicines used to stop fits) like carbamazepine and phenytoin
• antineoplastics (medicines used to treat cancer) such as cyclophosphamide and tretamine
• benzodiazepines (medicines which help you to relax) like diazepam and midazolam
• calcium-channel blockers (medicines which reduce the strength of the heart) such as nifedipine, verapamil or dantrolene.

• cardiac glycosides (medicines which increase heart muscle contraction)

  such as. digoxin

• cytotoxics (a type of medicine used to treat cancer) like. cyclophosphamide and thiotepa

• general anaesthetics (medicines used to put you to sleep for surgery) like.

  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, bambuterol.

Tell your doctor if you have recently been exposed to pesticides e.g. sheep dip. Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before this medicine is given to you. This medicine 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 into breast milk. Since Suxamethonium Chloride is rapidly degraded to an inactive metaboli-te, no effects on the breast-feeding baby are expected

Driving and using machines

Do not drive or operate machinery immediately after you have received this me-dicine because it can be dangerous. Your doctor will tell you how long you should wait before you can drive and use machinery.

Suxamethonium Chloride contains sodium

This medicine contains less than 1 mmol sodium (23 mg per ampoule), that is to say essentially ‘sodium- free’.

The following information is intended for healthcare professionals only Suxamethonium chloride 50 mg/ml solution for injection / infusion

Suxamethonium Chloride is indicated for short term muscle relaxation during general anaesthesia and to facilitate endotracheal intubation during induction of general anaesthesia or emergency situations.

Posology and method of administration

Suxamethonium Chloride should be administered only by or under close supervision of an anaesthetist familiar with its action, characteristics and hazards, who is skilled in the management of artificial respiration and only where there are adequate facilities for immediate endotracheal intubation with administration of oxygen by intermittent positive pressure ventilation.

Use by intravenous injection

Adults

The dose is dependent on body weight, the degree of muscular relaxation required, the route of administration, and the response of individual patients. To achieve endotracheal intubation Suxamethonium chloride is usually administered intravenously in a dose of 1mg/kg. This dose will usually produce muscular relaxation in about 30 to 60 seconds and has a duration of action of about 2 to 6 minutes. Larger doses will produce more prolonged muscular relaxation but doubling the dose does not necessarily double the duration of relaxation. Supplementary doses of Suxamethonium chloride of 50% to 100% of the initial dose administered at 5 to 10 minute intervals will maintain muscle relaxation during short surgical procedures performed under general anaesthesia.

The total dose of suxamethonium chloride given by repeated intravenous injection or continuous infusion should not exceed 500 mg per hour.

Use by intravenous infusion

Suxamethonium chloride may be given by intravenous infusion as a 0.1% to 0.2% solution, diluted in glucose 50 mg/ml (5%) or sodium chloride 9 mg/ml (0,9%) solution for infusion , at a rate of 2.5 to 4mg per minute. The infusion rate should be adjusted according to the response of individual patients.

Special populations

Elderly

As for adults. The elderly may be more susceptible to cardiac arrhythmias, especially if digitalis-like medicinal products are also being taken. Renal impairment:

A normal single dose of suxamethonium injection may be administered to patients with renal insufficiency in the absence of hyperkalaemia. Multiples or larger doses may cause clinically significant rises in serum potassium and should not be used. Hepatic impairment:

Termination of the action of suxamethonium is dependent on plasma cholinesterase, which is synthesised in the liver. Although plasma cholinesterase levels often fall in patients with liver disease, with the exception of severe hepatic failure, levels are seldom low enough to significantly prolong suxamethonium-induced apnoea. Patients with reduced plasma cholinesterase:

Patients with reduced plasma cholinesterase activity may experience prolonged and intensified neuromuscular blockade following administration of suxamethonium. In these patients it may be advisable to administer reduced doses of suxamethonium injection.

Paediatric population

Use by intravenous injection

Adolescents over 12 years: posology is the same as for adults. Package leaflet: Information for the user

suxamethonium chloride dihydrate Suxamethonium Chloride 50 mg/ml, solution for injection/infusion

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3. How Suxamethonium Chloride is given

This medicine will be given to you by a qualified anaesthetist under carefully controlled conditions, along with other medicines to help you sleep. Ventilation equipment will be used to help you breathe.

Your doctor will decide the dose and duration of treatment appropriate to your intervention. It will depend on:

• your body weight
• the amount of muscle relaxation you require
• your expected response to the medicine.

Suxamethonium Chloride will be given to you as an injection into your vein (in-travenously).

If you are given more Suxamethonium Chloride than you should

As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too much, however, tell your doctor or nurse if you have any concerns. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Very rarely, a sudden and severe allergic reaction to suxamethonium can occur. If you get any of the following symptoms tell your doctor or nurse immediately:

• shortness of breath, wheezing or trouble breathing
• swelling of your eyelids, face, lips, tongue or other parts of the body
• rash, itching or hives on the skin
• a collapse.

There are other serious side effects that you and your doctor must look out for. You must tell your doctor or nurse straight away if you have any of the following:

Very common: (may affect more than 1 in 10 people)

• abdominal cramps or pain and a feeling of nausea or “fullness”
• visible twitching of muscle under the skin
• muscle pain after the operation - your doctor will monitor you for this. Common: (may affect up to 1 in 10 people)

• raised pressure of fluid in the eye which may cause headache or blurred

  vision

• skin flushing
• skin rash
• high level of potassium in your blood
• speeding up or slowing down of your heart rate
• 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: (may affect up to 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: (may affect up to 1 in 10,000 people)

• high body temperature.

Other side effects include:

Not known: frequency cannot be estimated from the available data

• excessive production of saliva
• high/low blood pressure

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Suxamethonium Chloride

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 carton and ampoule label after ‘EXP’. The expiry date refers to the last day of that month.

The doctor or nurse will check that the expiry date on the label has not been passed before administering the injection to you.

Store in a refrigerator (2°C - 8°C).

This medicine should be used immediately after first opening. Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C when diluted with the infusion fluids listed under “The following information is intended for medical or healthcare professionals only ».

From a microbiological point of view, the product should be used immediately. If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C.

Do not use this medicine if you notice any discoloration or there are particles in it. Do not throw away any medicines via wastewater <or household waste>. Your doctor or nurse will throw away any medicine that is no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Suxamethonium Chloride contains

• The active substance is suxamethonium chloride dihydrate. Each ml of solution for injection / infusion contains 50 mg of suxamethonium chloride dihydrate (equivalent to 36.55 mg of suxamethonium). Each 2 ml ampoule contains 100 mg of suxamethonium chloride dihydrate (equivalent to 73.1 mg of suxamethonium).

• The other ingredients are hydrochlorid acid 10%, and/or sodium hydroxide

  (for pH adjustment), water for injections.

What Suxamethonium Chloride looks like and contents of the pack

Suxamethonium Chloride is a clear, colourless to almost colourless solution for injection/infusion supplied in a clear glass 2ml ampoule.

Packs of 5, 10 or 100 ampoules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

PANPHARMA

ZI du Clairay

35133 Luitré

France

Manufacturer

Panpharma GmbH

Bunsenstrasse 4

22946 Trittau

Germany

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.

Date of last revision : July 2024

Infants and young children are more resistant to suxamethonium compared with adults.

Children 1 to 12 years

1-2 mg/kg by intravenous injection.

Infants, under 1 year

2 mg/kg by intravenous injection.

Method of administration:

Intravenous use

Overdose

Symptoms:

Profound, prolonged muscle paralysis with respiratory depression are manifestations of a suxamethonium overdose. Ventilatory support is required. Management:

The use of neostigmine and other cholinesterase inhibitors should be avoided, as these prolong the depolarising effect of suxamethonium chloride. The decision to use neostigmine to reverse a Phase II suxamethonium-induced block depends on the judgement of the clinician in the individual case. Valuable information in regard to this decision will be gained by monitoring neuromuscular function. If neostigmine is used, its administration should be accompanied by appropriate doses of an anticholinergic medicinal product such as atropine.

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned under “Special precautions for disposal and other handling”. Suxamethonium chloride is acidic and should not be mixed with highly alkaline solutions, e.g. barbiturates.

Shelf life

Before opening 2 years.

After first opening: the product must be used immediately.

Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C when diluted with the infusion fluids listed under “Special precautions for disposal and other handling”.

From a microbiological point of view, the product should be used immediately. If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C. Special precautions for storage

Store in a refrigerator, (2°C - 8°C).

Special precautions for disposal and other handling

Suxamethonium chloride may be given by intravenous infusion as a 0.1% to 0.2% solution, diluted in glucose 50 mg/ml (5%) or sodium chloride 9 mg/ml (0,9%) solution for infusion.

For single use only.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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11.07.2024

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