MESTINON Tablet Ref.[8205] Active ingredients: Pyridostigmine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Therapeutic indications

Myasthenia gravis, paralytic ileus and post-operative urinary retention.

Posology and method of administration

Posology

Myasthenia gravis

Adults

Doses of 30 to 120mg 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 3 to 4 hours in the daytime but a longer effect (6 hours) is often obtained with a dose taken on retiring for bed.

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

Paediatric population

Children under 6 years old should receive an initial dose of half a tablet (30mg) of Mestinon; children 6–12 years old should receive one tablet (60mg). Dosage should be increased gradually, in increments of 15–30mg daily, until maximum improvement is obtained. Total daily requirements are usually in the range to 30–360mg.

Other Indications (paralytic ileus, post-operative urinary retention)

Adults

The usual dose is 1 to 4 tablets (60–240mg) per day.

Paediatric population

The usual dose is 15–60mg per day.

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

Special populations

Elderly

There are no specific dosage recommendations for Mestinon in elderly patients.

Renal impairment

Mestinon is mainly excreted unchanged by the kidney, therefore lower doses may be required in patients with renal disease and treatment should be based on titration of drug dosage to effect.

Hepatic impairment

There are no specific dosage recommendations for Mestinon in patients with hepatic impairment.

Method of administration

For oral use.

Overdose

Overdosage may lead to “cholinergic crisis” characterised by severe muscarinic and nicotinic symptoms of marked muscle weakness. Cardiovascular and respiratory failure may occur.

Signs of overdosage due to muscarinic effects may include abdominal cramps, increased peristalsis, diarrhoea, nausea and vomiting, increased bronchial secretions, salivation, hyperhydrosis and miosis. Nicotinic effects consist of muscular cramps, fasciculations and general weakness up to paralysis.

Hypotension up to cardiovascular collapse, bradyarrhythmia, up to cardiac arrest may also occur.

Central nervous system effects may include agitation, confusion, slurred speech, nervousness, irritation, visual hallucinations.

Artificial ventilation should be instituted if respiration is severely depressed.

Atropine sulphate 1 to 2mg intravenously is an antidote to the muscarinic effects. Doses may be repeated every 5 to 30 minutes as needed.

Shelf life

3 years.

Special precautions for storage

Store below 25°C. Store in the original package in order to protect from light and moisture.

Nature and contents of container

Amber glass bottles with aluminium screw or low density polyethylene caps and desiccant containing 200 tablets.

Special precautions for disposal and other handling

No special requirements for disposal.

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