PYRIDOSTIGMINE BROMIDE solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

即購入

ダウンロード 製品の特徴 (SPC)
14-09-2023

有効成分:

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

から入手可能:

Novadoz Pharmaceuticals LLC

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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.

製品概要:

Pyridostigmine Bromide Oral Solution USP, 60 mg pyridostigmine bromide per teaspoonful (5 mL) is available as a clear, raspberry flavored solution and 0.23% w/w alcohol. It is supplied as follows: Bottles of 16 fluid ounces, (1 pint, 473 mL)                NDC 72205-098-72 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59°to 86°F). [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers as defined by the USP.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

                                PYRIDOSTIGMINE BROMIDE - PYRIDOSTIGMINE BROMIDE SOLUTION
NOVADOZ PHARMACEUTICALS LLC
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PYRIDOSTIGMINE BROMIDE ORAL SOLUTION, USP
DESCRIPTION:
Pyridostigmine bromide oral solution, USP is an orally active
cholinesterase inhibitor.
Chemically, pyridostigmine bromide, USP is
3-hydroxy-1-methylpyridinium bromide
dimethylcarbamate. Its structural formula is:
The molecular formula of pyridostigmine bromide, USP is C H
BrN O having a
molecular weight of 261.12.
Pyridostigmine bromide oral solution, USP contains 60 mg
pyridostigmine bromide per
teaspoonful in a vehicle containing 0.23% w/w alcohol, glycerin,
lactic acid, sodium
benzoate, sorbitol, sucrose, raspberry-flavor (propylene glycol, Nat &
Art flavor) and
water.
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.
INDICATION:
Pyridostigmine bromide oral solution is useful in the treatment of
myasthenia gravis.
CONTRAINDICATIONS:
9
13
2
2
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 acco
                                
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