国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
PYRIDOSTIGMINE BROMIDE (UNII: KVI301NA53) (PYRIDOSTIGMINE - UNII:19QM69HH21)
Acella Pharmaceuticals, LLC
ORAL
PRESCRIPTION DRUG
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.
Pyridostigmine Bromide Oral Solution, USP, 60 mg pyridostigmine bromide per teaspoonful (5 mL) and 5% alcohol — bottles of 16 fluid ounces (1 pint) (NDC 42192-626-16) Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Abbreviated New Drug Application
PYRIDOSTIGMINE BROMIDE- PYRIDOSTIGMINE BROMIDE SOLUTION ACELLA PHARMACEUTICALS, LLC ---------- PYRIDOSTIGMINE BROMIDE ORAL SOLUTION USP 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 as an 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. 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 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 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 important, since increases in doses of 完全なドキュメントを読む