NEOSTIGMINE BROMIDE Tablet Ref.[8003] Active ingredients: Neostigmine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, United Kingdom

Contraindications

Neostigmine Bromide should not be given to patients with mechanical gastro-intestinal or urinary obstruction.

Neostigmine Bromide is contra-indicated in patients with known hypersensitivity to the drug and to bromides.

Neostigmine Bromide should not be used in conjunction with depolarising muscle relaxants such as suxamethonium as neuromuscular blockade may be potentiated and prolonged apnoea may result.

Special warnings and precautions for use

Extreme caution is required when administering Neostigmine Bromide to patients with bronchial asthma.

Care should also be taken in patients with bradycardia, recent coronary occlusion, hypotension, peptic ulcer, vagotonia, epilepsy or parkinsonism.

Interaction with other medicinal products and other forms of interaction

Neostigmine bromide should not be given during cyclopropane or halothane anaesthesia; however, it may be used after withdrawal of these agents.

Pregnancy and lactation

The safety of neostigmine bromide during pregnancy or lactation has not been established. Although the possible hazards to mother and child must therefore be weighed against the potential benefits in every case, experience with neostigmine bromide in pregnant patients with myasthenia gravis has revealed no untoward effect of the drug on the course of pregnancy.

As the severity of myasthenia gravis often fluctuates considerably, particular care is required to avoid cholinergic crisis, due to overdosage of the drug, but otherwise management is no different from that in non-pregnant patients.

Observations indicate that only negligible amounts of neostigmine bromide are excreted in breast milk; nevertheless, due regard should be paid to possible effects on the breast-feeding infant.

Effects on ability to drive and use machines

Not known.

Undesirable effects

There is no evidence to suggest that neostigmine bromide has any special effects in the elderly; however, elderly patients may be more susceptible to arrhythmias than the younger adult.

Side-effects and adverse reactions may include nausea and vomiting, increased salivation, diarrhoea and abdominal cramps.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Incompatibilities

None known.

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