Pyridostigmine Bromide 180 MG Extended Release Oral Tablet
Generic Name: PYRIDOSTIGMINE BROMIDE
Brand Name: Pyridostigmine Bromide
- Substance Name(s):
- PYRIDOSTIGMINE BROMIDE
WARNINGS
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 pyridostigmine bromide 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 symptomatic basis.
Such differentiation is extremely important, since increases in doses of pyridostigmine bromide or other drugs of this class in the presence of cholinergic crisis or of a refractory or “insensitive” state could have grave consequences.
Osserman and Genkins 1 indicate that the differential diagnosis of the two types of crisis may require the use of edrophonium chloride as well as clinical judgment.
The treatment of the two conditions obviously differs radically.
Whereas the presence of myasthenic crisis suggests the need for more intensive anticholinesterase therapy, the diagnosis of cholinergic crisis, according to Osserman and Genkins 1 , calls for the prompt withdrawal of all drugs of this type.
The immediate use of atropine in cholinergic crisis is also recommended.
Atropine may also be used to abolish or obtund gastrointestinal side effects or other muscarinic reactions; but such use, by masking signs of overdosage, can lead to inadvertent induction of cholinergic crisis.
For detailed information on the management of patients with myasthenia gravis, the physician is referred to one of the excellent reviews such as those by Osserman and Genkins 2 , Grob 3 or Schwab 4,5 .
Usage in Pregnancy: The safety of pyridostigmine bromide during pregnancy or lactation in humans has not been established.
Therefore, use of pyridostigmine bromide in women who may become pregnant requires weighing the drug’s potential benefits against its possible hazards to mother and child.
DESCRIPTION
Pyridostigmine bromide is an orally active cholinesterase inhibitor.
Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate.
Its structural formula is: Pyridostigmine bromide extended-release tablets are available as extended-release tablets containing 180 mg pyridostigmine bromide; each tablet also contains carnauba wax, copovidone, lactose, magnesium stearate, and silicon dioxide.
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HOW SUPPLIED
Pyridostigmine Bromide Extended-Release Tablets, 180 mg are available as light brown to pale yellow, capsule-shaped tablets, debossed with “W1” on one side and single-scored on the other side.
They are supplied as follows: Bottles of 30: NDC 0115-1404-08 Note: Because of the hygroscopic nature of the extended-release tablets, mottling may occur.
This does not affect their efficacy.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container.
Keep pyridostigmine bromide extended-release tablets in a dry place with the silica gel enclosed.
INDICATIONS AND USAGE
Pyridostigmine bromide is useful in the treatment of myasthenia gravis.
DOSAGE AND ADMINISTRATION
Pyridostigmine bromide is available in extended-release dosage form: Extended-Release Tablets — each containing 180 mg pyridostigmine bromide.
This form provides uniformly slow release, hence prolonged duration of drug action; it facilitates control of myasthenic symptoms with fewer individual doses daily.
The immediate effect of a 180 mg extended-release tablet is about equal to that of a 60 mg immediate-release tablet; however, its duration of effectiveness, although varying in individual patients, averages 2 1/2 times that of a 60 mg dose.
Dosage: The size and frequency of the dosage must be adjusted to the needs of the individual patient.
Extended-Release Tablets — One to three 180 mg tablets, once or twice daily, will usually be sufficient to control symptoms; however, the needs of certain individuals may vary markedly from this average.
The interval between doses should be at least 6 hours.
For optimum control, it may be necessary to use the more rapidly acting regular tablets or syrup in conjunction with extended-release therapy.
Note: For information on a diagnostic test for myasthenia gravis, and for the evaluation and stabilization of therapy, please see product literature on edrophonium chloride.