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

4.3. 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 anaesthesiaอพ 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.

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.

4.6. 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.

4.7. Effects on ability to drive and use machines

None.

4.8. Undesirable effects

These may include nausea and vomiting, increased salivation, diarrhoea and abdominal cramps.

6.2. Incompatibilities

None known.

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