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  • Mestinon Dragees 60 mg
    / Megapharm


    Active Ingredient
    Pyridostigmine (Bromide) 60 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Coated Tablets

    20 X 60 mg

    partial basket chart 1312 13097,13706

    Related information


    Dosage

    Adults:
    Oral dosage forms: Multiple doses of 30 to 120 mg are given at intervals throughout the day. Mestinon 60mg must not be divided.
    If available, use a tablet containing 30mg pyridostigmine bromide for 30mg dose.
    The total daily dose is usually in the range of 120 – 1200 mg but doses higher than these may be needed by some patients according to dose titration.
    Children:
    Children under 6 years old should receive an initial dose of 30 mg of pyridostigmine bromide.
    Mestinon 60mg must not be divided. If available, use a tablet containing 30mg pyridostigmine bromide for 30mg dose.
    Children 6 – 12 years old should receive 60 mg. Dosage should be increased gradually, in increments of 30 mg daily, until maximum improvement is obtained. Total daily requirements are usually in the range to 30 – 360 mg.
    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.


    Indications

    Treatment of myasthenia gravis.


    Contra-Indications

    Hypersensitivity to the active substance, bromides or to any of the excipients.
    Mechanical gastro-intestinal or urinary obstructionn.


    Special Precautions

    Extreme caution is required when administering Mestinon to patients with obstructive respiratory diseases like bronchial asthma and chronic obstructive pulmonary disease (COPD).
    Care should also be taken in patients with:
    – Arrhythmias such as bradycardia and AV block(elderly patients may be more susceptible to dysrhythmias than the young adult)
    – Recent coronary occlusion
    – Hypotension
    – Vagotonia
    – Peptic ulcer
    – Patients who have undergone gastrointestinal surgery
    – Epilepsy or Parkinsonism
    – Hyperthyroidism
    See prescribing information for full details.


    Side Effects

    As with all cholinergic products, Mestinon may have unwanted functional effects on the autonomic nervous system. Muscarine-like adverse effects may be exhibited as nausea, vomiting, diarrhoea, abdominal cramps, increased peristaltic and increased bronchial secretion, salivation, bradycardia and miosis.
    The primary nicotinic effects are muscle spasms, fasciculation and muscular weakness.
    For full details see prescribing information.


    Drug interactions

    Immunosuppressant drugs: The requirement for pyridostigmine bromide could be decreased when additional therapy (steroids, immunosuppressant drugs) is given although peak plasma concentration and AUC of pyridostigmine may be
    decreased by high doses of corticosteroids.
    Methylcellulose: Methylcellulose and medicine containing methylcellulose as excipients can completely inhibit absorption of pyridostigmine bromide.
    Antimuscarinics: Atropine and Hyoscine antagonise the muscarinic effects of pyridostigmine bromide.It should be noted that the slower gastro-intestinal motility caused by these drugs may affect the absorption 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. suxamethonium).
    Others: Aminoglycoside antibiotics, local and some general anesthetics, antiarrhythmic agents, and other drugs that interfere with neuromuscular transmission may interact with pyridostigmine bromide.


    Pregnancy and Lactation

    Pregnancy: 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. Pyridostigmine bromide crosses the placenta barrier. Excessive doses of pyridostigmine bromide should be avoided; the newborn child should be monitored for possible effects.
    Intravenous application of pyridostigmine bromide can induce contraction of the uterus (especially in the last period 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 nonpregnant patients.
    Breastfeeding: 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.


    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.


    Manufacturer
    ICN Pharmaceuticals
    Licence holder
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