Myasthenia Gravis Treatments
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Generic Name
Pyridostigmine
Brand Names
Mestinon, Pryidostigmine, Regonol
FDA approval date: April 06, 1955
Classification: Cholinesterase Inhibitor
Form: Injection, Tablet, Solution
What is Mestinon (Pyridostigmine)?
INDICATION: MESTINON is useful in the treatment of myasthenia gravis.
Approved To Treat
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Brand Information
Mestinon (pyridostigmine bromide)
1DESCRIPTION:
MESTINON (pyridostigmine bromide) is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is:
MESTINON is available in the following forms:
2ACTIONS:
MESTINON 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.
3INDICATION:
MESTINON is useful in the treatment of myasthenia gravis.
4CONTRAINDICATIONS:
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.
5WARNINGS:
Although failure of patients to show clinical improvement may reflect underdosage, it can also be indicative of overdosage. As is true of all cholinergic drugs, overdosage of MESTINON may result in cholinergic crisis, a state characterized by increasing muscle weakness which, through involvement of the muscles of respiration, may lead to death. Myasthenic crisis due to an increase in the severity of the disease is also accompanied by extreme muscle weakness, and thus may be difficult to distinguish from cholinergic crisis on a symptomatic basis. Such differentiation is extremely important, since increases in doses of MESTINON or other drugs of this class in the presence of cholinergic crisis or of a refractory or “insensitive” state could have grave consequences. Osserman and Genkins
Atropine may also be used to abolish or obtund gastrointestinal side effects or other muscarinic reactions; but such use, by masking signs of overdosage, can lead to inadvertent induction of cholinergic crisis.
For detailed information on the management of patients with myasthenia gravis, the physician is referred to one of the excellent reviews such as those by Osserman and Genkins
5.1Usage in Pregnancy:
The safety of MESTINON during pregnancy or lactation in humans has not been established. Therefore, use of MESTINON in women who may become pregnant requires weighing the drug’s potential benefits against its possible hazards to mother and child.
6PRECAUTION:
Pyridostigmine is mainly excreted unchanged by the kidney.
6.1Pediatric Use:
Safety and effectiveness in pediatric patients have not been established.
7ADVERSE 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 Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
8DOSAGE AND ADMINISTRATION:
MESTINON is available in three dosage forms:
8.1Oral Solution -
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.
8.2Conventional tablets -
each containing 60 mg pyridostigmine bromide.
8.3TIMESPAN 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.
8.4Dosage:
The size and frequency of the dosage must be adjusted to the needs of the individual patient.
8.4.1Oral Solution 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.
8.4.2TIMESPAN 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 oral solution 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).
9HOW SUPPLIED:
Oral Solution, 60 mg pyridostigmine bromide per teaspoonful (5 mL) and 5% alcohol - bottles of 1 pint (473 mL) (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). Each tablet is engraved “MESTINON 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.
10REFERENCES:
- Osserman KE, Genkins G. Studies in myasthenia gravis: Reduction in mortality rate after crisis.
- Osserman KE, Genkins G. Studies in myasthenia gravis.
- Grob D. Myasthenia gravis. A review of pathogenesis and treatment.
- Schwab RS. Management of myasthenia gravis.
- Schwab RS. Management of myasthenia gravis.
- Cronnelly R, Stanski DR, Miller RD, Sheiner LB. Pyridostigmine kinetics with and without renal function.
- Miller RD. Pharmacodynamics and pharmacokinetics of anticholinesterase. In: Ruegheimer E, Zindler M, ed.
- Breyer-Pfaff U, Maier U, Brinkmann AM, Schumm F. Pyridostigmine kinetics in healthy subjects and patients with myasthenia gravis.
11PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
NDC 0187-3012-20
Rx Only
Rx Only
MESTINON®
(pyridostigmine
bromide).
Oral Solution,
USP
(pyridostigmine
bromide).
Oral Solution,
USP
1 Pint (473 mL)
5 mL =
60 mg
5 mL =
60 mg
5 mL (1 teaspoonful) contains
pyridostigmine bromide.
pyridostigmine bromide.
Alcohol 5%
BAUSCH Health
12PRINCIPAL DISPLAY PANEL - 60 mg Tablets Bottle Label
NDC 0187-3010-30
Rx Only
Rx Only
Mestinon®
(pyridostigmine bromide)
Tablets, USP
(pyridostigmine bromide)
Tablets, USP
60 mg
100 Tablets
Each tablet
BAUSCH Health
Dispense in tight containers as defined in USP/NF.
IMPORTANT: These tablets are hygrosciopic. Keep in dry place with the silica gel enclosed.
Usual Dosage: See accompanying package insert.
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Usual Dosage: See accompanying package insert.
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
13PRINCIPAL DISPLAY PANEL - 180 mg Bottle Label
NDC 0187-3013-30
Rx Only
MESTINON®
(pyridostigmine
bromide)
TIMESPAN
Tablets
Rx Only
MESTINON®
(pyridostigmine
bromide)
TIMESPAN
Tablets
180 mg
30 Tablets
Each tablet contains180 mg pyridostigmine bromide
in a specially constructed tablet for sustained release
BAUSCH Health9549902
50104061C
in a specially constructed tablet for sustained release
BAUSCH Health9549902
50104061C
