Get your patient on Pyridostigmine Bromide - Pyridostigmine Bromide tablet (Pyridostigmine Bromide)

Pyridostigmine bromide is available in one dosage form.
Extended-release Tablets - each containing 180 mg Pyridostigmine bromide. This form provides uniformly slow release, hence prolonged duration of drug action; it facilitates control of myasthenic symptoms with fewer individual doses daily. The immediate effect of a 180 mg Extended-release Tablet is about equal to that of a 60 mg Conventional Tablet, however, its duration of effectiveness, although varying in individual patients, averages 2 ½ times that of a 60 mg dose.

Dosage The size and frequency of the dosage must be adjusted to the needs of the individual patient.

Extended-release Tablets - One to three 180 mg tablets, once or twice daily, will usually be sufficient to control symptoms; however, the needs of certain individuals may vary markedly from this average. The interval between doses should be at least 6 hours. For optimum control, it may be necessary to use the more rapidly acting regular tablets or syrup in conjunction with extended-release therapy.
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).

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.

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 Rising Pharmaceuticals, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch.

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 in the following form: Extended-release tablets containing 180 mg Pyridostigmine bromide, each tablet also contains colloidal silicon dioxide, carnauba wax, tribasic calcium phosphate, zein (corn protein) and magnesium stearate.

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.

Extended-release Tablets are available as light straw colored capsule-shaped tablets containing 180 mg Pyridostigmine bromide in bottles of 30 (NDC 64980-220-03). Each tablet is engraved "NM 180" on one side and is single-scored on the other.

Note : Because of the hygroscopic nature of the Extended-release Tablets, mottling may occur. This does not affect their efficacy.

Store Pyridostigmine Bromide Extended-Release Tablets, 180 mg at 25°C (77°F), excursions permitted to 15°C-30°C (59°F-86°F). Keep Pyridostigmine Bromide Extended-Release Tablets, 180 mg in a dry place with the silica gel enclosed.