MESTINON® Product Information

MESTINON®(pyridostigmine bromide, USP)

WHAT IS MESTINON® (pyridostigmine bromide,USP) AND HOW DOES IT WORK?

MESTINON® is an orally active cholinesterase inhibitor. MESTINON® prevents the breakdown of acetylcholine (pronounced "a cee til coline") by allowing more acetylcholine to accumulate. Acetylcholine is the chemical that sends nerve impulses to the muscle. With more acetylcholine, there is more control of voluntary functions such as eye movements, limited strength, swallowing and breathing.1,3,4

WHAT DISEASE DOES MESTINON® TREAT?

MESTINON® is useful in the treatment of myasthenia gravis. After nearly 50 years of use, MESTINON® continues to be used as the first line of therapy in the treatment of myasthenia gravis. 1,2

WHAT IS THE RIGHT DOSE OF MESTINON® FOR ME?

The size and frequency of the dosage must be adjusted to the needs of the individual patient. Follow the prescribed dose regimen carefully. Record the response after each dose for the initial period of taking MESTINON®, or in times of instability of your myasthenia gravis weakness, to help your physician adjust the dose. Take care to discuss dosage changes with your physician since too much MESTINON® can result in extreme muscle weakness.1

WHAT ARE THE POSSIBLE ADVERSE REACTIONS and PRECAUTIONS?

MESTINON® is contraindicated in mechanical intestinal or urinary obstruction, and particular caution should be used in its administration to patients with bronchial asthma. The most common side effects of MESTINON® include nausea, vomiting, diarrhea, abdominal cramps, increased salivation,tearing and increased bronchial secretions. Additional side effects of MESTINON® are muscle twitching, muscle cramps and weakness. MESTINON® is mainly eliminated unchanged by the kidney. Therefore, lower doses may be required in patients with renal (kidney) disease. The safety of MESTINON® during pregnancy or lactation in humans has not been established nor has the safety and effectiveness in pediatric patients. Although failure of patients to show improvement with MESTINON® may reflect underdosage, it can also be caused by overdosage.1

THREE DOSAGE FORMS OF MESTINON®

Conventional MESTINON® Tablets each contain 60 mg pyridostigmine bromide; each tablet also contains: lactose, silicon dioxide and stearic acid.1

MESTINON® Syrup: One teaspoon of raspberry flavored syrup contains 60 mg of pyridostigmine bromide. In addition to pyridostigmine bromide, each teaspoon of MESTINON® Syrup contains 5% alcohol, glycerin, lactic acid, sodium benzoate, sorbitol, sucrose, FD&C Red #40, FD&C Blue #1, flavors and water. MESTINON® Syrup permits accurate dosage adjustment for children and "brittle" (fragile) myasthenic patients who require fractions of 60 mg doses. It is more easily swallowed, especially in the morning by patients with swallowing difficulties.1

MESTINON® Timespan® Tablets contain 180 mg pyridostigmine bromide. Timespan® Tablets are a slow release dosage form. In addition to pyridostigmine bromide, each Mestinon® Timespan® Tablet contains carnauba wax, corn-derived proteins, magnesium stearate, silica gel and tribasic calcium phosphate. As with most timed release dosage forms, MESTINON® Timespan® should not be crushed or broken into pieces. A broken Timespan® Tablet may disturb the timed release mechanism and could result in immediate release instead of slow release of the pyridostigmine bromide.

STORAGE OF MESTINON® TABLETS AND TIMESPAN®

MESTINON® Tablets and Timespan® are very hygroscopic (pronounced "hi gro ska pic") which means they readily pick up and retain moisture. Moist MESTINON® Tablets may become mottled or discolored or crumble easily. Moisture affects the appearance of MESTINON® but it does not alter the effectiveness of the drug.

Do not store MESTINON® Tablets or TIMESPAN® Tablets in bathrooms or kitchens where there is a higher incidence of moisture in the air.

MESTINON® Tablets are packaged in a bottle of 100 or 500 tablets. MESTINON® Timespan® is packaged in a bottle of 30 tablets. Do not remove the desiccant(s) (a small canister containing a drying agent) from any MESTINON® prescription bottle.