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:

Alvogen, Inc.

INN (International Name):

PYRIDOSTIGMINE BROMIDE

Composition:

PYRIDOSTIGMINE BROMIDE 180 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pyridostigmine Bromide Extended release Tablets 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 supplied in bottles of 30 tablets, NDC 47781-335-30. Pyridostigmine Bromide Extended release Tablets are available as a cream to yellow, capsule-shaped tablet, containing 180 mg pyridostigmine bromide, debossed “335” on one side and has functional scoring on the other side. Store Pyridostigmine Bromide Extended release Tablets at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Keep Pyridostigmine Bromide Extended release Tablets in a dry place with the silica gel (desiccant) enclosed. Note: Because of the hygroscopic nature of the Pyridostigmine Bromide Extended release Tablets, mottling may occur. This does not affect their efficacy.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PYRIDOSTIGMINE BROMIDE- PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED
RELEASE
ALVOGEN, INC.
----------
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 chemical formula is C H
BrN O , molecular weight 261.12. Its structural formula is:
Pyridostigmine Bromide Extended release Tablets contain 180 mg
pyridostigmine
bromide. Inactive Ingredients: carnuba wax, zein, calcium phosphate,
colloidal silicon
dioxide, and magnesium stearate.
ACTIONS
Pyridostigmine Bromide Extended release Tablets 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.
INDICATION
Pyridostigmine Bromide Extended release Tablets is useful in the
treatment of
myasthenia gravis.
CONTRAINDICATIONS
Pyridostigmine Bromide Extended release Tablets is contraindicated in
mechanical
9
13
2
2
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 Extended release Tablets 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 distingu