PYRIDOSTIGMINE BROMIDE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals of New York LLC

INN (International Name):

PYRIDOSTIGMINE BROMIDE

Composition:

PYRIDOSTIGMINE BROMIDE 180 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pyridostigmine bromide is 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 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PYRIDOSTIGMINE BROMIDE- PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED
RELEASE
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
PYRIDOSTIGMINE BROMIDE EXTENDED-RELEASE TABLETS
(180 MG)
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 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.
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, 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 is 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 extreme