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Mestinon 60mg TabletsPyridostigmine Bromide
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Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
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Each Tablet contains 60.0mg Pyridostigmine (as bromide).
Each Tablet contains 60.75mg lactose monohydrate.
For excipient, see section 6.1.
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Tablet
White to off-white, round, biplanar, bevel-edged tablets imprinted with " V " M60 across one face and with two break marks forming a cross on the other.
The tablet can be divided into equal halves.
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Myasthenia gravis, paralytic ileus and post-operative urinary retention.
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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.
Children
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 of 30 - 360mg.
The requirement for Mestinon is usually markedly decreased after thymectomy or when additional therapy (steroids, immunosuppressant drugs) is given.
When relatively large doses of Mestinon 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 Mestinon.
In all patients the possibility of “cholinergic crisis", due to overdosage of Mestinon, and its differentiation from "myasthenic crisis", due to increased severity of the 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 4 tablets (60 to 240mg) per day.
Children
15 to 60mg per day.
The frequency of these doses may be varied according to the needs of the patient.
Elderly
There are no specific dosage recommendation for Mestinon in elderly patients.
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Mestinon should not be given to patients with mechanical gastro-intestinal or urinary obstruction. Mestinon is contra-indicated in patients with known hypersensitivity to the drug and to bromides.
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Extreme caution is required when administering Mestinon to patients with bronchial asthma.
Care should also be taken in patients with bradycardia, recent coronary occlusion, hypotension, vagotonia, peptic ulcer, epilepsy or Parkinsonism.
There is no evidence to suggest that Mestinon has any special effects on the elderly. However, elderly patients may be more susceptible to dysrhythmias than the young adult.
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.
Lactose intolerance: Mestinon tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency of glucose-galactose malabsorption should not take this medicine.
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Antimuscarinics:
Atropine and Hyoscine antagonise the muscarinic effects of Pyridostigmine bromide.
Muscle Relaxants:
Pyridostigmine antagonises the effect of non-depolarising muscle relaxants (e.g. pancuronium and vecuronium). Pyridostigmine may prolong the effect of depolarising muscle relaxants (e.g. suxarnethonium)
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The safety of Mestinon 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 Mestinon 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 Mestinon are excreted in breast milk; nevertheless, due regard should be paid to possible effects on the breast-feeding infant.
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These may include nausea and vomiting, increased salivation, diarrhoea and abdominal cramps.
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Signs of overdosage 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 2mg intravenously is an antidote to the muscarinic effects.
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Pharmacotherapeutic group: Anticholinesterases,
ATC code: N07AA02
Mestinon is an antagonist to cholinesterase, the enzyme which normally destroys acetylcholine. The action of Mestinon can briefly be described, therefore, as the potentiation of naturally occurring acetylcholine. Mestinon has a more prolonged action that Prostigmin (neostigmine) although it is somewhat slower to take effect (generally taking 30-60 Minutes). Because it has a weaker "muscarinic" action than Prostigmin, it is usually much better tolerated by myasthenic patients in whom the longer action is also an advantage.
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Oral Pyridostigmine is poorly absorbed. Maximum plasma concentrations occur at 1 to 2 hours and it is eliminated by the kidney largely unchanged with a half-life of 3 to 4 hours.
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Each tablet contains: Lactose
Monohydrate
Maize Starch
Colloidal Hydrated Silica
Talc
Magnesium stearate
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Do not store above 25°C. Store in the original package. Keep the bottle tightly closed.
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Amber glass bottles with aluminium screw or low density polyethylene caps and desiccant containing 200 tablets.
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Meda Health Sales Ireland Limited,
Unit 34.35, Block A,
Dunboyne Business Park,
Dunboyne,
Co. Meath
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Date of first authorisation: 01 April 1979
Date of last renewal: 01 April 2009
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