Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
PYRIDOSTIGMINE BROMIDE (UNII: KVI301NA53) (PYRIDOSTIGMINE - UNII:19QM69HH21)
Method Pharmaceuticals, LLC
ORAL
PRESCRIPTION DRUG
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.
Tablets, are available as white, flat-faced tablets containing 30 mg pyridostigmine bromide, USP in bottles of 21 (NDC 58657-810-21) and cartons of 30 (3 x 10 blister packs - NDC 58657-810-30) and cartons of 210 tablets (21 blister cards of 10 tablets - NDC 58657-810-10). Each tablet is White to off white, round, flat tablet, debossed IT above bisect and 106 below bisect on one side, other side is plain. Store pyridostigmine bromide tablets, USP at 25°C (77°F); excursions permitted to 15° -30°C (59° -86°F) [See USP Controlled Room Temperature]. Keep pyridostigmine bromide tablets, USP in a dry place with the silica gel enclosed
Abbreviated New Drug Application
PYRIDOSTIGMINE BROMIDE- PYRIDOSTIGMINE BROMIDE TABLET METHOD PHARMACEUTICALS, LLC ---------- PYRIDOSTIGMINE BROMIDE TABLETS PYRIDOSTIGMINE BROMIDE TABLETS Method Pharmaceuticals, LLC ---------- PYRIDOSTIGMINE BROMIDE TABLETS 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 30 mg pyridostigmine bromide; each tablet also contains anhydrous lactose, colloidal silicon dioxide and stearic acid. CLINICAL PHARMACOLOGY Pyridostigmine bromide tablets 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. 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. 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 Прочитать полный документ