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

Therapeutic indications

Myasthenia gravis; paralytic ileus; post-operative urinary retention.

Posology and method of administration

Neostigmine bromide has a slower onset of effect when given orally than when given parenterally, but the duration of action is longer and the intensity of action more uniform.

To facilitate change of treatment from one route of administration to another, the following doses are approximately equivalent in effect:

0.5 mg intravenously = 1-1.5 mg intramuscularly or subcutaneously = 15 mg orally.

Myasthenia gravis

Adults: Doses of 1-2 tablets by mouth are given at intervals throughout the day when maximum strength is needed (for example, on rising and before mealtimes). The usual duration of action of a dose is two to four hours.

The total daily dose is usually in the range of 5-20 tablets but doses higher than these may be needed by some patients.

Newborn infants: Neostigmine bromide ampoules are recommended.

Older children: Children under 6 years old should receive an initial dose of half a tablet (7.5 mg) of Neostigmine Bromide; children 6-12 years old should receive one tablet (15 mg). Dosage requirements should be adjusted according to the response but are usually in the range of 15-90 mg orally per day.

The requirement for Neostigmine Bromide is usually markedly decreased after thymectomy, or when additional therapy (steroids, immunosuppressant drugs) is given.

When relatively large doses of neostigmine bromide are taken by myasthenic patients, it may be necessary to give atropine or other anticholinergic drugs to counteract the muscarinic effects. It should be noted that the slower gastro-intestinal motility caused by these drugs may affect the absorption of oral neostigmine bromide.

In all patients the possibility of ‘cholinergic crisis’, due to overdosage of neostigmine bromide, and its differentiation from ‘myasthenic crisis’, due to increased severity of disease, must be borne in mind. Both types of crisis are manifested by increased muscle weakness, but whereas myasthenic crisis may require more intensive anticholinesterase treatment, cholinergic crisis calls for immediate discontinuation of this treatment and institution of appropriate supportive measures, including respiratory assistance.

Other indications

Adults: The usual dose is 1 to 2 tablets orally.

Children: 2.5-15 mg orally.

The frequency of these doses may be varied according to the needs of the patient.

The elderly

There are no specific dosage recommendations for neostigmine bromide in elderly patients.

Overdose

Signs of overdose due to muscarinic effects may include abdominal cramps, increased peristalsis, diarrhoea, nausea and vomiting, increased bronchial secretions, salivation, diaphoresis and miosis. Nicotinic effects consist of muscular cramps, fasciculations and general weakness. Bradycardia and hypotension may also occur.

Artificial ventilation should be instituted if respiration is severely depressed. Atropine sulphate 1 to 2 mg intravenously is an antidote to the muscarinic effects.

Shelf life

Five years.

Special precautions for storage

The recommended maximum storage temperature is 30°C. The tablets should be protected from light.

Nature and contents of container

Polypropylene tracer pots with HDPE caps, each containing 140 tablets.

Special precautions for disposal and other handling

None.

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