PYRIDOSTIGMINE BROMIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

INN (International Name):

PYRIDOSTIGMINE BROMIDE

Composition:

PYRIDOSTIGMINE BROMIDE 60 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pyridostigmine bromide tablets are useful in the treatment of myasthenia gravis. Pyridostigmine bromide 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:

Pyridostigmine Bromide Tablets USP, 60 mg - Each white to off white, round, flat-faced tablet is debossed with "G3511" on one side and quadrisect on the other side. Unit dose packages of 100 (10 x 10) NDC 68084-494-01 IMPORTANT: These tablets are hygroscopic. Keep in a dry place. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PYRIDOSTIGMINE BROMIDE- PYRIDOSTIGMINE BROMIDE TABLET
AMERICAN HEALTH PACKAGING
----------
PYRIDOSTIGMINE BROMIDE TABLETS, USP
8249401/0420
RX ONLY
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 tablets USP is available as a 60 mg tablet for
oral administration. The tablet contains
the following inactive ingredients: colloidal silicon dioxide, lactose
anhydrous, magnesium stearate and stearic
acid.
CLINICAL PHARMACOLOGY
Pyridostigmine bromide 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.
INDICATIONS AND USAGE
Pyridostigmine bromide tablets are useful in the treatment of
myasthenia gravis.
CONTRAINDICATIONS
Pyridostigmine bromide 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 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