Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
PYRIDOSTIGMINE BROMIDE (UNII: KVI301NA53) (PYRIDOSTIGMINE - UNII:19QM69HH21)
Zydus Lifesciences Limited
PYRIDOSTIGMINE BROMIDE
PYRIDOSTIGMINE BROMIDE 60 mg
ORAL
PRESCRIPTION DRUG
Pyridostigmine bromide tablets, USP are useful in the treatment of myasthenia gravis. Pyridostigmine bromide tablets, USP 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.
Pyridostigmine Bromide Tablets USP, 60 mg having functional scoring. Pyridostigmine Bromide Tablets USP, 60 mg are white to off-white, round, flat, uncoated tablets with quadrisect breakline on one side and debossed with '659' on the other side and are supplied as follows: NDC 65841-819-06 in bottles of 30 tablets with child-resistant closure NDC 65841-819-16 in bottles of 90 tablets with child-resistant closure NDC 65841-819-01 in bottles of 100 tablets with child-resistant closure NDC 65841-819-05 in bottles of 500 tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in original container. IMPORTANT: These tablets are hygroscopic. Keep in a dry place with the silica gel enclosed.
Abbreviated New Drug Application
PYRIDOSTIGMINE BROMIDE- PYRIDOSTIGMINE BROMIDE TABLET ZYDUS LIFESCIENCES LIMITED ---------- PYRIDOSTIGMINE BROMIDE TABLETS, USP RX ONLY DESCRIPTION Pyridostigmine bromide tablets, USP are an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is: Pyridostigmine bromide, USP is a white or almost white crystalline, deliquescent powder. It is very soluble in water and in alcohol, slightly soluble in hexane, practically insoluble in ether. Each pyridostigmine bromide tablet, USP intended for oral administration contains 60 mg of pyridostigmine bromide, USP. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, low substituted hydroxypropyl cellulose, silicon dioxide and stearic acid. 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. INDICATIONS AND USAGE Pyridostigmine bromide tablets, USP are useful in the treatment of myasthenia gravis. CONTRAINDICATIONS Pyridostigmine bromide tablets, USP 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 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 Pročitajte cijeli dokument