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:

Major Pharmaceuticals

INN (International Name):

PYRIDOSTIGMINE BROMIDE

Composition:

PYRIDOSTIGMINE BROMIDE 60 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pyridostigmine bromide tablets, USP are useful in the treatment of myasthenia gravis. Pyridostigmine bromide tablets, USP are 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 having functional scoring. Pyridostigmine Bromide Tablets USP, 60 mg are white to off-white, round, flat, uncoated tablets with quadrisect breakline on one side and debossed with '659' on the other side and are supplied as follows: Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6622-61 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in original container. IMPORTANT:  These  tablets  are  hygroscopic.  Keep  in  a  dry  place  with  the  silica  gel  enclosed.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PYRIDOSTIGMINE BROMIDE- PYRIDOSTIGMINE BROMIDE TABLET
MAJOR PHARMACEUTICALS
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PYRIDOSTIGMINE BROMIDE TABLETS, USP
RX ONLY
DESCRIPTION
Pyridostigmine bromide tablets, USP are an orally active
cholinesterase inhibitor.
Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium
bromide
dimethylcarbamate. Its structural formula is:
Pyridostigmine bromide, USP is a white or almost white crystalline,
deliquescent powder.
It is very soluble in water and in alcohol, slightly soluble in
hexane, practically insoluble in
ether.
Each pyridostigmine bromide tablet, USP intended for oral
administration contains 60 mg
of pyridostigmine bromide, USP. In addition, each tablet contains the
following inactive
ingredients: anhydrous lactose, colloidal silicon dioxide, low
substituted hydroxypropyl
cellulose, silicon dioxide 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, USP are useful in the treatment of
myasthenia gravis.
CONTRAINDICATIONS
Pyridostigmine bromide tablets, USP are 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 muscl