Data from FDA - Curated by Toby Galbraith - Last updated 02 September 2017

Licensing authority

FDA (Food and Drug Administration, USA)

Indication(s)

INDICATION: Mestinon is useful in the treatment of myasthenia gravis.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Allergic Rhinitis

Allergic rhinitis causes great strain on the workforce. Help to reduce sick days and improve productivity with appropriate treatment options.

Visit Allergic Rhinitis

Type 2 Diabetes

View the latest epidemiology data, patient perspectives, ADA and EASD recommendations, treatment options and more.

Visit Type 2 Diabetes

Related Content

Advisory information

contraindications
CONTRAINDICATIONS: Mestinon 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.
Special warnings and precautions
PRECAUTION: Pyridostigmine is mainly excreted unchanged by the kidney.6,7,8 Therefore, lower doses may be required in patients with renal disease, and treatment should be based on titration of drug dosage to effect.6,7 Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Adverse reactions
ADVERSE REACTIONS: The side effects of Mestinon 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 Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION: Mestinon 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).

More information

Category Value
Authorisation number NDA009829
Agency product number KVI301NA53
Orphan designation No
Product NDC 0187-3010,0187-3012,0187-3013
Date Last Revised 06-06-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 903859
Storage and handling Store Mestinon Syrup, Tablets, and Timespan Tablets at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).
Marketing authorisation holder Valeant Pharmaceuticals North America LLC