30 mg, 60 mg
For the use of a Registered Medical Practitioner or a Hospital or a Institution only.
PYRIDO (Pyridostigmine Bromide) is an orally active cholinesterase inhibitor. Chemically, Pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. The molecular formula is C9H13BrN2O2 and molecular weight is 261.12.
STRUCTURAL FORMULA :
Its structural formula is :
Orange coloured, round film coated tablets.
Each film coated tablet contains :
Pyridostigmine Bromide USP 60 mg
Colours : Titanium Dioxide B.P., Sunset Yellow, Tartrazine.
PYRIDO inhibits the destruction of acetylcholine by cholinesterase and thereby permits free transmission of nerve impulses across the neuromuscular junction. Pyridostigmine is an analog of neostigmine but differs from it in certain clinically significant respects for example, Pyridostigmine is characterized by a longer duration of action and fewer gastrointestinal side effects.
PYRIDO is poorly absorbed from the gastrointestinal tract. It undergoes hydrolysis by cholinesterases and is also metabolised in the liver. PYRIDO is excreted mainly in the urine as unchanged drug and metabolites. PYRIDO crosses the placenta and very small amounts are distributed into breast milk. Penetration into the CNS is poor.
PYRIDO is useful in the treatment of myasthenia gravis, paralytic ileus; post operative urinary retention.
PYRIDO has a gradual onset of action (generally 30-60 minutes).
Myasthenia Gravis :
Doses of 30 to 120 mg are given at intervals throughout the day when maximum strength is needed (for example, on rising and before meal times). The usual duration of action of a dose is three to four hours in the daytime but a longer effect (six hours) is often obtained with a dose taken on retiring for bed. The total daily dose is usually 5-20 tablets but higher than these may be needed by some patients. Newborn Infants : Neostigmine has generally been preferred in the treatment of neonatal myasthenia. However, PYRIDO can be given, particularly if neostigmine proves unsuitable on account of pronounced cholinergic effects. The dosage requirements of PYRIDO range from 5-10 mg every four hours, given 30-60 minutes before feeding. Treatment is not usually required beyond eight weeks of age except in the rare conditions of congenital and familial infantile myasthenia.
Older children :
Children under 6 years should receive an initial dose of half a tablet (30 mg) of PYRIDO; children 6-12 years should receive one tablet (60 mg). Dosage should be increased gradually as increments of 15-30 mg daily, until the maximum improvement is obtained. Total daily requirements are usually in the range of 30-360 mg. The requirement for PYRIDO is usually markedly decreased after thymectomy or when additional therapy (steroids, immunosuppressant drugs) is given. When relatively large doses of PYRIDO are taken by myasthenia patients it may be necessary to give atropine or other anticholinergic drugs to counteract the muscarinic effects. It should be noted that the slower gastrointestinal motility caused by these drugs may affect the absorption of oral PYRIDO. In all patients the possibility of ‘cholinergic crisis’ due to overdose of PYRIDO, 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 1-4 tablets.
Children : 15-60 mg. The frequency of these doses may be varied according to the needs of the patient.
Elderly : There are no specific dosage recommendations for PYRIDO in elderly patients.
PYRIDO tablets are for oral administration.
PYRIDO is contraindicated in mechanical gastrointestinal or urinary obstruction, and particular caution should be used in its administration to patients with bronchial asthma. Care should be observed in the use of atropine. PYRIDO is contraindicated in patients with known hypersensitivity to the drug and bromides. PYRIDO should not be used in conjunction with depolarizing muscle relaxants such as suxamethonium as neuromuscular blockage may be potentiated and prolonged apnoea may result.
Although failure of patients to show clinical improvement may reflect underdosage, it can also be indicative of overdosage. As is true of all cholinergic drugs, overdosage of PYRIDO may result in cholinergic crisis, a state characterized by increasing muscle weakness which, through involvement of the muscles of respiration, may lead to death. Myasthenic crisis due to an increase in the severity of the disease is also accompanied by extreme muscle weakness, and thus may be difficult to distinguish from cholinergic crisis on a
Usage in Pregnancy :
The safety of PYRIDO during pregnancy or lactation in humans has not been established. Therefore, use of PYRIDO in women who may become pregnant requires weighing the drugs potential benefits against its possible hazards to mother and child. 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 may indicate that only negligible amounts of PYRIDO are excreted in breast milk, nevertheless, due regard should be paid to possible effects on the breast feeding infant. The tablet contains “tartrazine” colour which may cause reactions, including bronchial asthma.
PYRIDO 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. Paediatric Use : Safety and effectiveness in paediatric patients have not been established. Extreme caution is required when administering PYRIDO to patients with bronchial asthma. Care should also be taken in patients with bradycardia, recent coronary occlusion, hypotension, vagotonia, epilepsy or Parkinsonism. There is no evidence to suggest that PYRIDO has any special effects in the elderly. However, elderly patients may be more susceptible to dysrhythmias than the younger adult. PYRIDO should not be given during cyclopropane or halothane anaesthesia, however it may be after withdrawal of these agents.
SIDE EFFECTS :
These may include nausea and vomiting, increased salivation, diarrhoea and abdominal cramps. The side effects of PYRIDO are most commonly related to overdosage and generally are of two varieties, muscarinic and nicotinic. Among those in the former group are nausea, vomiting, diarrhoea, abdominal cramps, increased peristalsis, increased salivation, increased bronchial secretions, miosis and diaphoresis. Nicotinic side effects are comprised chiefly of muscle cramps, fasciculation and weakness. Muscarinic side effects can usually be counteracted by atropine. As with any compound containing the bromide radical, a skin rash may be seen in an occasional patient. Such reactions usually subside promptly upon discontinuance of the medication.
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 hypotension may occur.
TREATMENT OF OVERDOSAGE :
Artificial ventilation should be instituted if respiratory depression is severe. Atropine sulphate 1 to 2 mg intravenously is an antidote to the muscarinic effects.
Store below 30°C (86°F), protected from moisture and light. PYRIDO is very hygroscopic means it readily picks up and retains moisture. Do not store these tablets in bathroom or kitchen where there is higher incidence of moisture in the air.
Note : Do not remove dessicants (small canisters containing drying agent) from the pack. Dessicants are provided to protect the drug from moisture and they are not to be consumed.
PYRIDO tablets contain Pyridostigmine Bromide USP 60 mg.
PYRIDO (Pyridostigmine Bromide Tablets USP) is available as film coated tablets containing Pyridostigmine Bromide USP 60 mg per tablet, in a box containing 3 strips of 10 tablets.
Expiration date : 24 months from the date of manufacture.
Disclaimer : For the use of a Registered Medical Practitioner or a Hospital or a Institution only. Also it is not intended to be used by healthcare professionals or patients for the purpose of prescribing or administering these products. Questions regarding the complete and current content of product labeling / specification / presentation should be directed to SGPharma.