Label: MESTINON- pyridostigmine bromide solution
MESTINON- pyridostigmine bromide tablet
MESTINON- pyridostigmine bromide tablet, extended release

  • NDC Code(s): 0187-3010-30, 0187-3012-20, 0187-3013-30
  • Packager: Bausch Health US, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 1, 2019

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  • DESCRIPTION:

    Mestinon (pyridostigmine bromide) Oral Solution, USP is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is:

    mestinon-01.jpg

    Mestinon is available in the following forms: Oral Solution containing 60 mg pyridostigmine bromide per teaspoonful in a vehicle containing 5% alcohol, glycerin, lactic acid, sodium benzoate, sorbitol, sucrose, FD&C Red No. 40, FD&C Blue No. 1, flavors and water. Tablets containing 60 mg pyridostigmine bromide; each tablet also contains lactose, silicon dioxide and stearic acid. Timespan Tablets containing 180 mg pyridostigmine bromide; each tablet also contains carnauba wax, corn-derived proteins, magnesium stearate, silica gel and tribasic calcium phosphate.

  • ACTIONS:

    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.

  • INDICATION:

    Mestinon is useful in the treatment of myasthenia gravis.

  • 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.

  • 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 Genkins1 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 Genkins,1 calls for the prompt withdrawal of all drugs of this type. The immediate use of atropine in cholinergic crisis is also recommended.

    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,2 Grob3 or Schwab.4,5

    Usage 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.

  • 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:

    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.

  • 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. 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 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).

  • HOW SUPPLIED

    Oral Solution, 60 mg pyridostigmine bromide per teaspoonful (5 mL) and 5% alcohol - bottles of 16 fluid ounces (1 pint) (NDC 0187-3012-20).

    Tablets, 60 mg pyridostigmine bromide each - bottles of 100 (NDC 0187-3010-30).

    Timespan Tablets, 180 mg pyridostigmine bromide each - bottles of 30 (NDC 0187-3013-30).
    Note: Because of the hygroscopic nature of the Timespan Tablets, mottling may occur. This does not affect their efficacy.

    Store Mestinon (pyridostigmine bromide) Oral Solution, USP, Tablets, and Timespan Tablets at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).

  • REFERENCES:

    1.
    Osserman KE, Genkins G. Studies in myasthenia gravis: Reduction in mortality rate after crisis. JAMA. Jan 1963; 183:97-101.
    2.
    Osserman KE, Genkins G. Studies in myasthenia gravis. NY State J Med. June 1961; 61:2076-2085.
    3.
    Grob D. Myasthenia gravis. A review of pathogenesis and treatment. Arch Intern Med. Oct 1961; 108:615-638.
    4.
    Schwab RS. Management of myasthenia gravis. New Eng J Med. Mar 1963; 268:596-597.
    5.
    Schwab RS. Management of myasthenia gravis. New Eng J Med. Mar 1963; 268:717-719.
    6.
    Cronnelly R, Stanski DR, Miller RD, Sheiner LB. Pyridostigmine kinetics with and without renal function. Clin Pharmacol Ther. 1980; 28:No. 1, 78-81.
    7.
    Miller RD. Pharmacodynamics and pharmacokinetics of anticholinesterase. In: Ruegheimer E, Zindler M, ed. Anaesthesialagy. (Hamburg, Germany: Congress; Sep 14-21, 1980; 222-223.) (Int Congr. No. 538), Amsterdam, Netherlands: Excerpta Medica; 1981.
    8.
    Breyer-Pfaff U, Maier U, Brinkmann AM, Schumm F. Pyridostigmine kinetics in healthy subjects and patients with myasthenia gravis. Clin Pharmacol Ther. 1985;5:495-501.
  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Bausch Health US, LLC
    Bridgewater, NJ 08807 USA

    Manufactured by: Bausch Health Companies Inc. (formerly as Valeant Pharmaceuticals International Inc.)

    2150 St-Elzear Boulevard West,

    Laval, Quebec H7L 4A8, Canada (CAN)

    Product of Canada

     
    © 2019 Bausch Health US, LLC®/™ are trademarks of Bausch Health Companies, Inc. or its affiliates.
     

    9600200 50102987C Rev. 10/2019
     
  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC 0187-3012-20
    Rx Only

    Mestinon®
    (pyridostigmine
    bromide)
    Oral Solution, USP

    5 mL = 60 mg
    1 Pint (473 mL)

    5 mL
    (1 teaspoonful)
    contains 60 mg
    pyridostigmine
    bromide.

    Alcohol 5%

    BAUSCH Health

    Mestinon Oral Solution
  • PRINCIPAL DISPLAY PANEL - 60 mg Tablets Bottle Label

    NDC 0187-3010-30
    Rx Only
    Pull here

    Mestinon®
    (pyridostigmine bromide
    tablets, USP)

    60 mg

    Each tablet
    contains 60 mg
    pyridostigmine
    bromide

    100
    Tablets
    Valeant

    VALEANT
    Pharmaceuticals North America LLC

    mestinon60label.jpg
  • PRINCIPAL DISPLAY PANEL - 180 mg Bottle Label

    mestinon180label.jpg

    NDC 0187-3013-30
    Rx OnlyPull here

    Mestinon®
    (pyridostigmine bromide)
    TIMESPAN®

    180 mg

    Each tablet
    contains180 mg
    pyridostigmine
    bromide
    n a specially
    constructed tablet for
    sustained release

    30
    Tablets

    VALEANT

  • INGREDIENTS AND APPEARANCE
    MESTINON 
    pyridostigmine bromide solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0187-3012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    pyridostigmine bromide (UNII: KVI301NA53) (pyridostigmine - UNII:19QM69HH21) pyridostigmine bromide60 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    alcohol (UNII: 3K9958V90M)  
    glycerin (UNII: PDC6A3C0OX)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    sucrose (UNII: C151H8M554)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    water (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0187-3012-20473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/25/1965
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01519301/25/1965
    MESTINON 
    pyridostigmine bromide tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0187-3010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    pyridostigmine bromide (UNII: KVI301NA53) (pyridostigmine - UNII:19QM69HH21) pyridostigmine bromide60 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    stearic acid (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScore4 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code Mestinon;V;60
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0187-3010-30100 in 1 BOTTLE; Type 0: Not a Combination Product04/06/1995
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA00982904/06/1955
    MESTINON 
    pyridostigmine bromide tablet, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0187-3013
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    pyridostigmine bromide (UNII: KVI301NA53) (pyridostigmine - UNII:19QM69HH21) pyridostigmine bromide180 mg
    Inactive Ingredients
    Ingredient NameStrength
    carnauba wax (UNII: R12CBM0EIZ)  
    magnesium stearate (UNII: 70097M6I30)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    tribasic calcium phosphate (UNII: 91D9GV0Z28)  
    Product Characteristics
    ColorYELLOW (light straw) Scoreno score
    ShapeOVAL (capsule-shaped) Size19mm
    FlavorImprint Code MES;V;180
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0187-3013-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/12/1959
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01166501/12/1959
    Labeler - Bausch Health US, LLC (042230623)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch Health Companies Inc.245141858MANUFACTURE(0187-3012, 0187-3010, 0187-3013) , LABEL(0187-3012, 0187-3010, 0187-3013) , PACK(0187-3012, 0187-3010, 0187-3013)