PYRIDOSTIGMINE BROMIDE tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

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下载 产品特点 (SPC)
05-04-2023

有效成分:

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

可用日期:

American Health Packaging

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Pyridostigmine bromide tablets are useful in the treatment of myasthenia gravis. Pyridostigmine bromide 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.

產品總結:

Tablets, are available as white, flat-faced tablets containing 60 mg pyridostigmine bromide in Unit dose packages of 100 (10 x 10) NDC 60687-502-01. Each tablet is white to off-white, round, flat-faced tablet debossed with "C 60" on one side and quadrisect scored on the other side. Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. Keep pyridostigmine bromide tablets, USP in a dry place.

授权状态:

Abbreviated New Drug Application

产品特点

                                PYRIDOSTIGMINE BROMIDE- PYRIDOSTIGMINE BROMIDE TABLET
AMERICAN HEALTH PACKAGING
----------
PYRIDOSTIGMINE BROMIDE TABLETS, USP
8450201/0621
RX ONLY
DESCRIPTION
Pyridostigmine bromide tablets, USP (pyridostigmine bromide) are an
orally active
cholinesterase inhibitor. Chemically, pyridostigmine bromide is
3-hydroxy-1-
methylpyridinium bromide dimethylcarbamate. Its structural formula is:
Pyridostigmine bromide tablets, USP are available in the following
form:
Tablets containing 60 mg pyridostigmine bromide; each tablet also
contains anhydrous
lactose, colloidal silicon dioxide and stearic acid.
CLINICAL PHARMACOLOGY
Pyridostigmine bromide tablets inhibit 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 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.
TM
WARNINGS
Although failure of patients to show clinical improvement may reflect
under dosage, 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 diffe
                                
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