PYRIDOSTIGMINE BROMIDE solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

pyridostigmine bromide (UNII: KVI301NA53) (pyridostigmine - UNII:19QM69HH21)

Mevcut itibaren:

Oceanside Pharmaceuticals

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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.

Ürün özeti:

Oral Solution , 60 mg pyridostigmine bromide per teaspoonful (5 mL) and 5% alcohol - bottles of 1 pint (473 mL) (NDC 68682-307-05). Tablets , are available as white, flat-faced tablets containing 60 mg pyridostigmine bromide in bottles of 100 (NDC 68682-302-10). Each tablet is engraved “OCEANSIDE 302” on one side and is quadrisect scored on the other. TIMESPAN 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 TIMESPAN tablets, mottling may occur. This does not affect their efficacy. Store Pyridostigmine Bromide Oral Solution, USP, tablets, and TIMESPAN tablets at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Keep Conventional tablets and TIMESPAN tablets in a dry place with the silica gel enclosed.

Yetkilendirme durumu:

New Drug Application Authorized Generic

Ürün özellikleri

PYRIDOSTIGMINE BROMIDE- PYRIDOSTIGMINE BROMIDE SOLUTION
OCEANSIDE PHARMACEUTICALS
----------
PYRIDOSTIGMINE BROMIDE
ORAL SOLUTION, USP
ORAL SOLUTION
TABLETS
AND
TIMESPAN TABLETS
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 is available in the following forms: _Oral
Solution_ containing 60 mg
pyridostigmine bromide per teaspoonful in a vehicle containing 5%
alcohol, glycerin, lactic acid,
sodium benzoate, sorbitol, sucrose, FD&C Red No. 40, FD&C Blue No. 1,
flavors and water. _Tablets_
containing 60 mg pyridostigmine bromide; each tablet also contains
lactose, silicon dioxide and stearic
acid. _TIMESPAN tablets_ containing 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 Oral Solution, USP 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
Oral Solution