PYRIDOSTIGMINE BROMIDE tablet, extended release

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

NuCare Pharmaceuticals,Inc.

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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.

Обзор продуктов:

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. NDC 68071-5032-3 BOTTLES OF 30 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°C) [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.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

PYRIDOSTIGMINE BROMIDE- PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED
RELEASE
NUCARE PHARMACEUTICALS,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 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 extremely
importan