"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Mestinon (pyridostigmine) is useful in the treatment of myasthenia gravis.
DOSAGE AND ADMINISTRATION
Mestinon (pyridostigmine) is available in three dosage forms:
Syrup - raspberry-flavored, containing 60 mg pyridostigmine bromide per teaspoonful (5 mL). This form permits accurate dosage adjustment for children and "brittle" myasthenic patients who require fractions of 60 mg doses. It is more easily swallowed, especially in the morning, by patients with bulbar involvement.
Conventional Tablets - each containing 60 mg pyridostigmine bromide.
Timespan 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 Timespan Tablet is about equal to that of a 60 mg Conventional Tablet; however, its duration of effectiveness, although varying in individual patients, averages 2½ 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.
Syrup and Conventional Tablets - The average dose is ten 60 mg tablets or ten 5 mL teaspoonfuls daily, spaced to provide maximum relief when maximum strength is needed. In severe cases as many as 25 tablets or teaspoonfuls a day may be required, while in mild cases one to six tablets or teaspoonfuls a day may suffice.
Timespan 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 Timespan 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).
Syrup, 60 mg pyridostigmine bromide per teaspoonful (5 mL) and 5% alcohol - bottles of 16 fluid ounces (1 pint) (NDC 0187-3012-20).
Tablets, are available as white, flat-faced tablets containing 60 mg pyridostigmine bromide in bottles of 100 (NDC 0187-3010-30) and 500 (NDC 0187-3010-40). Each tablet is engraved MESTINON (pyridostigmine) 60 V" on one side and is quadrisect scored on the other.
Timespan Tablets are available as light straw-colored, capsule-shaped tablets containing 180 mg pyridostigmine bromide in bottles of 30 (NDC 0187-3013-30). Each tablet is engraved "MES V 180" on one side and is single-scored on the other.
Note: Because of the hygroscopic nature of the Timespan Tablets, mottling may occur. This does not affect their efficacy.
Store Mestinon (pyridostigmine) Tablets, Timespan Tablets, and Syrup at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). Keep Mestinon (pyridostigmine) Tablets and Timespan Tablets in a dry place with the silica gel enclosed.
Valeant Pharmaceuticals North America, One Enterprise, Aliso Viejo, CA 92656 U.S.A. Rev.04.07. FDA Rev date: 07/26/01
Last reviewed on RxList: 8/15/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Mestinon Information
Mestinon - User Reviews
Mestinon User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.