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EDROPHONIUM INJECTION BP 10MG/1ML

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PATIENT INFORMATION LEAFLET

Edrophonium Injection
Edrophonium Chloride
Read all of this leaflet carefully because it contains important information for you.
Edrophonium injection is administered by a doctor or nurse as part of the test you are about to have.
• Keep this leaflet. You may need to read it again.
• Ask your doctor or nurse if you need more information or advice.
• If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell
your doctor or nurse.
The information in this leaflet has been divided into the following sections:
1. What Edrophonium is and what it is used for
2. Before you use Edrophonium
3. How to use Edrophonium
4. Possible side effects
5. How to store Edrophonium
6. Further information
1. What Edrophonium is and what it is used for
Edrophonium is a diagnostic agent, which means that it is used in tests rather than as a treatment for a
disease. The active ingredient of Edrophonium is a drug which prevents the action of one of the body's
enzymes. The enzyme (known as cholinesterase) destroys a substance (acetylcholine) which is involved with
many bodily functions, including the contraction of muscle. By preventing the destruction of acetylcholine,
Edrophonium helps the muscles to respond to nerve impulses which tell them to contract.
Edrophonium is mainly used in a diagnostic test for the disease known as myasthenia gravis. This is a chronic
disease in which the muscles are weak and tire easily because the nerve impulses are not transmitted properly
to them.
2. Before you use Edrophonium
Do not use Edrophonium if you:
• are allergic (hypersensitive) to Edrophonium Chloride or any of the other ingredients of Edrophonium
• have, or think you have, a blockage in your gut or urinary tract
If any of the above apply to you, or if you are not sure, speak to your doctor or nurse before you are given
Edrophonium.
Take special care with Edrophonium if you suffer from any of the following:
• Asthma
• Heart problems
• Low blood pressure
• Epilepsy
• Parkinson’s disease
• Stomach ulcers
If any of the above apply to you, or if you are not sure, speak to your doctor or nurse before you are given
Edrophonium.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any medicines, including medicines
obtained without a prescription.
Having an anaesthetic
Edrophonium may interact with some anaesthetics and drugs used to produce muscle relaxation during
surgery. If you are about to have an operation your anaesthetist will be aware of this and will treat you
accordingly. If you are not sure, speak to your doctor or nurse before you are given Edrophonium.
Pregnancy and breast-feeding
Tell your doctor if you are breast-feeding, pregnant or think you may become pregnant. Although no harmful
effects on the unborn child are known, the doctor may prefer to put off the test until after the baby has been
born.
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Summary of Product Characteristics
1.

NAME OF THE MEDICINAL PRODUCT
Edrophonium Injection BP 10mg/1ml.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains 10mg Edrophonium Chloride BP in 1ml of solution.
3.
PHARMACEUTICAL FORM
Ampoules
4.
CLINICAL PARTICULARS
4.1 Therapeutic indications
Myasthenia gravis, as a diagnostic test; to distinguish between overdosage and underdosage of cholinergic drugs in
myasthenic patients; diagnosis of suspected ‘dual block’; antagonist to non-depolarising neuromuscular blockade.
4.2 Posology and method of administration
Edrophonium Injection BP is for intramuscular or intravenous injection. In view of the possibility of provoking a
cholinergic crisis it is recommended that facilities for resuscitation should be available whenever Edrophonium Injection
BP is administered.
Adults - Test for myasthenia gravis:
A syringe is filled with the contents of 1 ampoule (10mg) and 2mg is given intravenously, the needle and syringe being
left in situ. If no response occurs within 30 seconds, the remaining 8mg is injected. In adults with unsuitable veins, 10mg
is given by intramuscular injection.
To differentiate between 'myasthenic' and 'cholinergic' crises:
In a myasthenic patient who is suffering from marked muscle weakness, in spite of taking large doses of Mestinon or
Prostigmin, a test dose of 2mg Edrophonium Injection BP is given intravenously one hour after the last dose of the
cholinergic compound. If therapy has been inadequate, there is a rapid, transient increase in muscle strength; if the
patient has been overtreated, Edrophonium Injection BP causes a transient increase of muscle weakness.
Diagnosis of suspected 'dual block':
Edrophonium Injection BP 10mg intravenously. If the block is due to depolarisation, it is briefly potentiated, whereas in a
'dual block', it is reversed.
Children: Diagnostic tests:
A total dose of 100micrograms/kg body-weight may be given intravenously. One fifth of this dose should be injected
initially; if no reaction occurs, the remainder of the dose is administered 30 seconds later.
Antagonist to non-depolarising neuromuscular blockade:
Generally, reversal of neuromuscular block with Edrophonium Injection BP should not be attempted until there is evidence
of spontaneous recovery from paralysis. It is recommended that the patient be well ventilated and a patent airway
maintained until complete recovery of normal respiration is assured.
Adults and children:
Edrophonium Injection BP 500 - 700micrograms/kg body-weight and atropine 7micrograms/kg body-weight, by slow
intravenous injection over several minutes, is usually adequate for reversal of non-depolarising muscle relaxants within 5
- 15 minutes. The two drugs are usually given simultaneously, but in patients who show bradycardia the pulse rate should
be increased to about 80/minute with atropine before administering Edrophonium Injection BP.
The speed of recovery from neuromuscular blockade is primarily determined by the intensity of the block at the time of
antagonism but it is also subject to other factors, including the presence of drugs (eg. anaesthetic agents, antibiotics,
antiarrhythmic drugs) and physiological changes (electrolyte and acid-base imbalance, renal impairment). These factors
may prevent successful reversal with Edrophonium Injection BP or lead to recurarisation after apparently successful
reversal. Therefore it is imperative that patients should not be left unattended until these possibilities have been excluded.
Elderly:
There are no specific dosage recommendations for Edrophonium Injection BP in elderly patients.
4.3 Contraindications
Edrophonium Injection BP should not be given to patients with mechanical intestinal or urinary obstruction.
Edrophonium Injection BP is contra-indicated in patients with known hypersensitivity to the drug.
4.4 Special warnings and precautions for use
Extreme caution is required when administering Edrophonium Injection BP to patients with bronchial asthma.
Care should also be taken in patients with bradycardia, recent coronary occlusion, vagotonia, hypotension, peptic ulcer,
epilepsy or Parkinsonism.
In diagnostic uses of Edrophonium Injection BP, a syringe containing 1mg of atropine should be kept at hand to
counteract severe cholinergic reactions, should they occur. In view of the possibility of provoking a cholinergic crisis it is
recommended that facilities for resuscitation should always be available.
When Edrophonium Injection BP is used as an antagonist to neuromuscular blockade bradycardia may occur, to a
possibly dangerous level, unless atropine is given simultaneously. In this indication, Edrophonium Injection BP should not
be given during cyclopropane or halothane anaesthesia; however, it may be used after withdrawal of these agents.
There is no evidence to suggest that Edrophonium Injection BP has any special effects in the elderly. However, elderly
patients may be more susceptible to dysrhythmias than younger adults.

3. How to use Edrophonium
A doctor or nurse will give you Edrophonium. The medicine will be injected into either a vein or muscle.
Sometimes part of the dose is given first and the remainder 30 seconds later. The effect of the injection on
muscular strength depends upon the exact purpose of the test.
Dosage
As a test for myasthenia gravis:
2mg will be injected into a vein. If there has been no response within 30 seconds the remaining 8mg will then
also be given. Alternatively your doctor may decide to inject the whole 10mg into a muscle.
To tell whether your existing treatment is too weak or too strong:
2mg given one hour after the last dose of a medicine for myasthenia gravis.
For diagnosis of prolonged breathing difficulties after certain muscle relaxant drugs:
10mg injected into a vein.
To reverse the effects of muscle relaxant drugs:
0.5 - 0.7mg for each kilogram of bodyweight is usually given slowly into a vein, together with another drug
called atropine.
Children’s doses
For diagnostic tests the dose is usually 0.1mg for each kilogram of bodyweight, with one-fifth of the dose
being given first and the remainder 30 seconds later if there has been no response. Children are given the
same dose as adults for reversal of the effects of muscle relaxant drugs.
If you have been given too much Edrophonium
If you think you have been given too much medicine, tell your doctor or nurse. The likely signs of an overdose
are a slow or irregular heartbeat, feeling faint, difficulty in breathing, perspiration, upset stomach and visual
disturbances.
4. Possible side effects
Like all medicines, Edrophonium can cause side effects, although not everybody gets them.
The most likely side effects are:
• nausea and vomiting
• increased salivation
• diarrhoea
• abdominal pains.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor
or nurse.
5. How to store Edrophonium
• Keep out of the reach and sight of children
• Do not use Edrophonium after the expiry date which is stated on the carton. The expiry date refers to the
last day of that month
• Protect from light.
6. Further information
What is in Edrophonium?
• The active ingredient in this medicine is Edrophonium Chloride. Each ampoule contains 10 milligrams.
• The other ingredients are Sodium Citrate, Sodium Sulphite, Citric Acid and Water for Injections.
What Edrophonium looks like and the contents of each pack
Edrophonium is supplied in packs of 10 ampoules, each ampoule is coded with orange and emerald green
colour rings and contains 1ml of solution.
Marketing Authorisation Holder and Manufacturer
The product licence holder is: Alliance Pharmaceuticals Ltd, Avonbridge House, Bath Road, Chippenham, Wiltshire,
SN15 2BB, UK
Edrophonium is made by: BCM Limited, 1 Thane Road, Nottingham, NG2 3AA
The information in this leaflet applies only to Edrophonium Injection BP. If you have any questions or you are not sure
about anything, ask your doctor or a pharmacist.
This leaflet was last amended in: May 2010
© Alliance Pharmaceuticals Ltd 2010

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6.2
6.3
6.4
6.5

6.6

7.
8.
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4.5

Interaction with other medicinal products and other forms of interaction
With doses above 10mg, especially the higher dosage employed to antagonise neuromuscular blockade, Edrophonium
Injection BP should not be used in conjunction with depolarising muscle relaxants such as suxamethonium as
neuromuscular blockade may be potentiated and prolonged apnoea may result.
Fertility, pregnancy and lactation
The safety of Edrophonium Injection BP during pregnancy or lactation has not been established. Although the possible
hazards to mother and child must be weighed against the potential benefits in every case, experience with Edrophonium
Injection BP in pregnant patients with myasthenia gravis has revealed no untoward effect of the drug on the course of
pregnancy.
There is no information on the excretion of Edrophonium Injection BP into breast milk. Although only negligible amounts
would be expected to be present, due regard should be paid to possible effects on the breast-feeding infant.
Effects on ability to drive and use machines
None.
Undesirable effects
These may include nausea and vomiting, increased salivation, diarrhoea and abdominal cramps.
Overdose
Edrophonium Injection BP overdosage may give rise to bradycardia, arrhythmias, hypotension and bronchiolar spasm.
Perspiration, gastro-intestinal hypermotility and visual disturbances may also occur.
Artificial ventilation should be instituted if respiration is severely depressed. Atropine sulphate 1 - 2mg intravenously is an
antidote to the muscarinic effects.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Edrophonium Injection BP is an antagonist to cholinesterase, the enzyme which normally destroys acetylcholine. The
action of Edrophonium Injection BP can briefly be described, therefore, as the potentiation of naturally occurring
acetylcholine. It differs from Prostigmin (neostigmine) and Mestinon (pyridostigmine) in the rapidity and brevity of its
action.
Pharmacokinetic properties
Following intravenous injection of Edrophonium Injection BP an initial rapid phase of elimination (0.5 - 2 minutes)
precedes a much slower decline (24 - 45 minutes). It is suggested that the rapid fall in plasma concentration of
edrophonium is not primarily due to metabolism and excretion but to the rapid uptake of the drug by other tissues.
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections
of the SPC.
PHARMACEUTICAL PARTICULARS
List of excipients
Sodium Sulphite anhydrous
Sodium Citrate BP
Citric Acid BP
Water for Injections BP
Incompatibilities
None known.
Shelf life
Five years.
Special precautions for storage
Protect from light.
Nature and contents of container
Colourless glass ampoules coded with orange and emerald green colour rings, each containing 1ml of solution, in packs
of 10 ampoules.
The ampoule solution is almost colourless.
Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product
and other handling of the product (use “Instructions for use, handling and disposal” on eMC/IPHA)
None.
MARKETING AUTHORISATION HOLDER
Alliance Pharmaceuticals Ltd. Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, UK
MARKETING AUTHORISATION NUMBER
PL 16853/0118
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24th April 1992
DATE OF REVISION OF THE TEXT
22nd July 2010

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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