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:

Oceanside Pharmaceuticals

INN (International Name):

PYRIDOSTIGMINE BROMIDE

Composition:

PYRIDOSTIGMINE BROMIDE 180 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pyridostigmine Bromide Extended-release Tablets 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 Extended-release Tablets are available as light straw-colored, capsule-shaped tablets containing 180 mg pyridostigmine bromide in bottles of 30 (NDC 68682-301-30). Each tablet is engraved “MES V 180” on one side and is single-scored on the other. Note: Because of the hygroscopic nature of the Extended-release Tablets, mottling may occur. This does not affect their efficacy. Store Pyridostigmine Extended-release Tablets at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Keep Pyridostigmine Bromide Extended-release Tablets in a dry place with the silica gel enclosed.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

PYRIDOSTIGMINE BROMIDE- PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED
RELEASE
OCEANSIDE PHARMACEUTICALS
----------
PYRIDOSTIGMINE BROMIDE
EXTENDED-RELEASE TABLETS,
180 MG
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 contain 180 mg
pyridostigmine bromide; each tablet
also contains carnauba wax, corn-derived proteins, isopropyl alcohol,
magnesium stearate, silica gel,
tribasic calcium phosphate and water.
ACTIONS
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.
INDICATION
Pyridostigmine Bromide Extended-release Tablets are useful in the
treatment of myasthenia gravis.
CONTRAINDICATIONS
Pyridostigmine Bromide Extended-release Tablets 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
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 distinguish from cholinergic
crisis on a sy