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:

Amneal Pharmaceuticals of New York LLC

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 are white to off white, flat-faced, round tablets debossed with "G” and “3511" on one side and double-scored on the other side. They are available as follows: Bottles of 100:                                                NDC 0115-3511-01 Bottles of 500:                                                NDC 0115-3511-02 IMPORTANT: These tablets are hygroscopic. Keep in a dry place with the silica gel enclosed. Dispense in a tightly-closed, light-resistant container as defined in the USP, with a child-resistant closure, as required. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PYRIDOSTIGMINE BROMIDE- PYRIDOSTIGMINE BROMIDE TABLET
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
PYRIDOSTIGMINE BROMIDE TABLETS, USP
(60 MG)
RX ONLY
DESCRIPTION
Pyridostigmine bromide, USP 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