Mestinon 60 mg/5mL
pyridostigmine bromide · SOLUTION · Bausch Health US, LLC
Mestinon is a solution containing pyridostigmine bromide at 60 mg/5mL, taken oral. Manufactured by Bausch Health US, LLC.
Key Facts
- Brand Name
- Mestinon
- Generic Name
- pyridostigmine bromide
- NDC Code (Product)
0187-3012- Manufacturer
- Bausch Health US, LLC
- Strength
- 60 mg/5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- NDA015193
- Marketing Start
- 01/25/1965
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATION: MESTINON is useful in the treatment of myasthenia gravis.
Dosage & Administration
DOSAGE AND ADMINISTRATION: MESTINON is available in three dosage forms: Oral 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. 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. Oral 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. I…
Warnings
WARNINGS: 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 1 indicate that the differential diagnosis of the two types of crisis may require the use of Tensilon (edrophonium chloride) as well as clinical judgment. The treatment of the two conditions obviously differs radically. Whereas the presence of myasthenic crisis suggests the need for more intensive anticholinesterase therapy, the diagnosis of cholinergic crisis, according to Osserman and Genki…
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.
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 Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Mestinon used for?
Mestinon contains pyridostigmine bromide. It is a solution taken oral. Consult your doctor for specific uses.
Is Mestinon a controlled substance?
Mestinon is not classified as a controlled substance by the DEA.
What is the generic name for Mestinon?
The generic name for Mestinon is pyridostigmine bromide. There are 12 other brand versions of pyridostigmine bromide.
What is the NDC code for Mestinon 60 mg/5mL?
The NDC (National Drug Code) for Mestinon 60 mg/5mL is 0187-3012, listed by Bausch Health US, LLC.
Other Pyridostigmine Brands
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- Pyridostigmine Bromide180 mg/147781-335
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)