EDROPHONIUM Ampoules Ref.[27578] Active ingredients: Edrophonium

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2010  Publisher: Alliance Pharmaceuticals Ltd, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, UK

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.

4.9. 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.

6.3. Shelf life

Five years.

6.4. Special precautions for storage

Protect from light.

6.5. 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.

6.6. Special precautions for disposal and other handling

None.

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