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Suxamethonium Chloride Injection Bp 100mg/2ml

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Patient Information Leaflet Suxamethonium Chloride Injection BP 100mg in 2mI

This leaflet will provide you with important information about your medicine. Please read it carefully before your medicine is administered.

WHAT'S IN YOUR MEDICINE

Each glass ampoule contains 2ml of clear, colourless, sterile solution and each 2ml of this solution contains 100mg of Suxamethonium Chloride. There are 10x2ml ampoules in each carton.

Inactive ingredients: sodium acetate and water for injections

Holder of Product Licence:

MercuryPharm Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland. PL15372/0007.

Manufacturer: Antigen Pharmaceuticals Limited, Roscrea, Co. Tipperary, Ireland.

ABOUT YOUR MEDICINE

Suxamethonium Chloride Injection BP belongs to a group of medicines called depolarising neuromuscular blocking agents. It produces relaxation of the body muscles that are under voluntary control, i.e. skeletal muscles. Because neuromuscular blocking drugs affect muscles involved in breathing as well as other skeletal muscles, your breathing will need to be controlled by the anaesthetist until the effects of suxamethonium have worn off, fully.

USES

Suxamethonium is used as an aid to general anaesthesia to facilitate the insertion of a tube

into the windpipe and to relax skeletal muscles during surgery. It is also used to reduce the intensity of

muscle contractions associated with drug-induced convulsions or with electroconvulsive therapy

(ECT).

BEFORE YOU RECEIVE THIS INJECTION

Before receiving this injection, make sure to tell your doctor if

•    you are allergic to any of the ingredients

•    you ever had an allergic reaction to any muscle relaxing drug

•    you are suffering from glaucoma, a detached retina or an eye injury

•    you or a member of your family has a history of malignant hyperthermia

•    you have a deficiency in pseudocholinesterase, the enzyme that breaks down suxamethonium in the body

•    you have too much potassium in your blood or you are suffering from kidney disease, a major injury, severe burns, nerve or muscle damage such as injury to the spinal cord, a stroke, cerebral palsy, myotonic dystrophy or Eaton-Lambert (myasthenic) syndrome

•    you are suffering from myasthenia gravis

•    you are suffering from a liver disease or from cancer

•    you have been vomiting or had diarrhoea recently, or you have not been drinking normal amounts of fluid

•    you are pregnant or if you gave birth within the previous six weeks

•    you are receiving any other medicines. These include medicines that may prolong the action of suxamethonium, such as ecothiopate (eye drops for glaucoma), tetrahydroaminoacridine (also called tacrine and used for Alzheimer's disease), hexaflurenium (sometimes used to prolong the muscle relaxing effects of suxamethonium), acetylcholine inhibitors including trimetaphan (to lower blood pressure) and some drugs used to relax muscles, propanidid (an anaesthetic drug) digoxin, procaine, procainamide or quinidine (for an irregular heart beat), lignocaine (a local anaesthetic drug), oxytocin (to contract the womb), some nonpenicillin antibiotics (for infection), beta-blockers or verapamil (for example for angina, high blood pressure or irregular heart beat), aprotinin (to reduce bleeding), magnesium salts (such as some laxatives or antiacids), the anti-malarial drugs quinine (which is sometimes used for night cramps) or chloroquine, morphine or pethidine (to relieve pain) or drugs to reverse their effects (called morphine antagonists), the psychiatric drugs pheneIzine, lithium,chlorpromazine or promazine, anti-cancer drugs, azathioprine (to suppress the immune response), oestrogens (e.g. for hormone replacement), oral contraceptives, steroids, anticholinesterase drugs such as neostigmine, pyridostigmine, physostigmine and edrophonium (e.g. for glaucoma or myasthenia gravis), or the antihistamine drugs diphenhydramine or promethazine.

HOW THIS MEDICINE IS ADMINISTERED

Suxamethonium Chloride Injection BP is usually given by injection into a vein.

It may also be administered into a vein through a drip. If necessary, it may be given by injection into a muscle.

You must be fully asleep under a general anaesthetic before the injection may be given Dosage in adults:

The dosage may vary but the usual single dose for an adult is in the range of 20 to 100mg by injection into a vein. For administration as a continuous drip into a vein, a 0.1 to 0.2% solution (containing 1mg to 2mg per ml of suxamethonium chloride) may be used and the usual dosage range is 2 to 5mg per minute. If necessary, a dose of up to 2.5mg per kilogram of body weight may be given by injection into a muscle, to a maximum total of 150mg.

Dosage in children:

The dosage may vary but the usual single dose for a child is in the range of 1 to 2mg per kilogram of body weight by injection into a vein. If necessary, a dose of up to 2.5mg per kilogram of body weight may be given by injection into a muscle, to a maximum total of 150mg.

AFTER YOU RECEIVE YOUR MEDICINE

Suxamethonium may sometimes cause unwanted effects in some patients. These include:

•    muscle pain or muscle twitching

•    tummy cramps or discomfort

•    loose or frequent bowel motions

•    too much saliva or coughing up a lot of mucus

•    a very slow or rapid heart beat or irregular heart beats

•    high or low blood pressure

•    heart attack

•    headache, dizziness or faintness

•    difficulty in breathing

•    feeling too hot

•    blurred vision or problems with your eyes

•    presence in the blood of myoglobin (a protein normally found in muscle)

•    any signs of an allergic reaction such as a skin rash or breathlessness

If you notice any unwanted effects including ones that are not mentioned here, tell your doctor STORAGE CONDITIONS

Do not use after the expiry date shown on the ampoule and carton.

Keep the container in the outer carton in order to protect from light.

Store at 2-8°C. Do not freeze.

MercuryPharm Ltd 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland.

Date of revision: March, 2012.