PRYIDOSTIGMINE BROMIDE- pyridostigmine bromide solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PYRIDOSTIGMINE BROMIDE (UNII: KVI301NA53) (PYRIDOSTIGMINE - UNII:19QM69HH21)

Available from:

Trigen Laboratories LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pyridostigmine bromide oral solution is contraindicated in mechanical intestinal 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 for counteracting side effects, as discussed below.

Product summary:

Oral Solution, 60 mg pyridostigmine bromide per teaspoonful (5 mL) and 5% alcohol — bottles of 16 fluid ounces (1 pint) (NDC 13811-716-16). Store pyridostigmine bromide oral solution USP at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Brands mentioned are trademarks of their respective owners.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PRYIDOSTIGMINE BROMIDE- PYRIDOSTIGMINE BROMIDE SOLUTION
TRIGEN LABORATORIES LLC
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PYRIDOSTIGMINE BROMIDE ORAL SOLUTION USP
DES CRIPTION
Pyridostigmine bromide oral solution USP is an orally active
cholinesterase inhibitor. Chemically,
pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide
dimethylcarbamate. Its structural
formula is:
Pyridostigmine bromide syrup is available in the following form: Syrup
containing 60 mg
pyridostigmine bromide per teaspoonful in a vehicle containing 5%
alcohol, glycerin, lactic acid,
sodium benzoate, sorbitol, sucrose, FD&C Red No. 40, FD&C Blue No. 1,
raspberry flavor and water.
CLINICAL PHARMACOLOGY
Pyridostigmine bromide oral solution inhibits the destruction of
acetylcholine by cholinesterase and
thereby permits freer transmission of nerve impulses across the
neuromuscular junction. Pyridostigmine
is an analog of neostigmine (Prostigmin®), 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.
INDICATION
Pyridostigmine bromide oral solution USP is useful in the treatment of
myasthenia gravis.
CONTRAINDICATIONS
Pyridostigmine bromide oral solution is contraindicated in mechanical
intestinal 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 for counteracting side effects, as
discussed below.
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
oral solution 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 f