Indications and Usage
Pyridostigmine Bromide Tablets USP are useful in the treatment of myasthenia gravis.
Dosage and Administration
Each Pyridostigmine Bromide Tablet contains 60 mg pyridostigmine bromide.
Dosage
The size and frequency of the dosage must be adjusted to the needs of the individual patient.
The average dose is ten 60 mg tablets daily, spaced to provide maximum relief when maximum strength is needed. In severe cases as many as twenty-five tablets a day may be required, while in mild cases one to six tablets a day may suffice.
NOTE: For information on a diagnostic test for myasthenia gravis, and for the evaluation and stabilization of therapy, please see product literature on Tensilon (edrophonium chloride).
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.
Adverse Reactions
The side effects of pyridostigmine bromide are most commonly related to overdosage and generally are of two varieties, muscarinic and nicotinic. Among those in the former group are nausea, vomiting, diarrhea, abdominal cramps, increased peristalsis, increased salivation, increased bronchial secretions, miosis and diaphoresis. Nicotinic side effects are comprised chiefly of muscle cramps, fasciculation and weakness. Muscarinic side effects can usually be counteracted by atropine, but for reasons shown in the preceding section the expedient is not without danger. As with any compound containing the bromide radical, a skin rash may be seen in an occasional patient. Such reactions usually subside promptly upon discontinuance of the medication.
To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Description
Pyridostigmine bromide is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is:
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 and stearic acid.
structureClinical 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 (ProstigminTM), 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.
How Supplied / Storage and Handling
Pyridostigmine Bromide Tablets USP, 60 mg are white, round, flat-faced, beveled edge tablets with a quadrisect functional score on one side and debossed with ‘ANI’ over ‘470’ on the other and are supplied in bottles of 100 (NDC 62559-470-01).
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in original container. Keep Pyridostigmine Bromide Tablets USP in a dry place with the silica gel enclosed.