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)
Novadoz 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) 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.
Abbreviated New Drug Application
PYRIDOSTIGMINE BROMIDE - PYRIDOSTIGMINE BROMIDE SOLUTION NOVADOZ PHARMACEUTICALS LLC ---------- 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 完全なドキュメントを読む