Label: PYRIDOSTIGMINE BROMIDE tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 6, 2021

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  • DESCRIPTION

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

    Structural Formula

    Pyridostigmine bromide tablets, USP are available in the following form:

    Tablets containing 60 mg pyridostigmine bromide; each tablet also contains anhydrous lactose, colloidal silicon dioxide and stearic acid.

  • CLINICAL PHARMACOLOGY

    Pyridostigmine bromide tablets inhibit 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 TM), 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.

  • INDICATIONS AND USAGE

    Pyridostigmine bromide tablets are useful in the treatment of myasthenia gravis.

  • CONTRAINDICATIONS

    Pyridostigmine bromide tablets are 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 under dosage, it can also be indicative of overdosage. As is true of all cholinergic drugs, overdosage of pyridostigmine bromide 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 pyridostigmine bromide 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 TM (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, Grob 3 or Schwab 4,5

    Usage in Pregnancy
    The safety of pyridostigmine bromide tablets during pregnancy or lactation in humans has not been established. Therefore, use of pyridostigmine bromide tablets in women who may become pregnant requires weighing the drug's potential benefits against its possible hazards to mother and child.

  • PRECAUTIONS

    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 pyridostigmine bromide tablets 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 FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  • DOSAGE AND ADMINISTRATION

    Pyridostigmine bromide tablets are available in following dosage form:

    Conventional Tablets
    each containing 60 mg pyridostigmine bromide.

    Dosage
    The size and frequency of the dosage must be adjusted to the needs of the individual patient.

    Conventional Tablets
    The average dose is ten 60 mg tablets, spaced to provide maximum relief when maximum strength is needed. In severe cases as many as 25 tablets a day may be required, while in mild cases one to six tablets a day may suffice.

    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

    Tablets, are available as white, flat-faced tablets containing 60 mg pyridostigmine bromide in Unit dose packages of 100 (10 x 10) NDC 60687-502-01. Each tablet is white to off-white, round, flat-faced tablet debossed with "C 60" on one side and quadrisect scored on the other side.

    Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].

    FOR YOUR PROTECTION: Do not use if blister is torn or broken.

    Keep pyridostigmine bromide tablets, USP in a dry place.

  • 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. Anaesthesiology. (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.

    All Product/Brand names are the trademarks of their respective owners.

  • PACKAGING INFORMATION

    American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Eywa Pharma Inc as follows:
    (60 mg / 100 UD) NDC 60687-502-01 packaged from NDC 71930-028

    Distributed by:
    American Health Packaging
    Columbus, OH 43217

    8450201/0621

  • Package/Label Display Panel – Carton – 60 mg

    60 mg Pyridostigmine Bromide Tablets Carton

    NDC 60687- 502-01

    Pyridostigmine
    Bromide\

    Tablets, USP

    60 mg

    100 Tablets (10 x 10)               Rx Only

    CAUTION: EXTREMELY MOISTURE SENSITIVE

    Each Tablet Contains:
    Pyridostigmine bromide............................................................60 mg

    Usual Dosage: See package insert for full prescribing information.

    Store at 20° to 25°C (68° to 77°F); excursions permitted between
    15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
    IMPORTANT: These tablets are hygroscopic. Keep in a dry place.

    Keep this and all drugs out of reach of children.

    FOR YOUR PROTECTION: Do not use if blister is torn or broken.

    The drug product contained in this package is from
    NDC # 71930-028, Eywa Pharma Inc.

    Packaged and Distributed by:
    American Health Packaging
    Columbus, Ohio 43217

    750202
    0450201/0719

  • Package/Label Display Panel – Blister – 60 mg

    60 mg Pyridostigmine Bromide Tablet Blister

    Pyridostigmine Bromide
    Tablet, USP

    60 mg

  • INGREDIENTS AND APPEARANCE
    PYRIDOSTIGMINE BROMIDE 
    pyridostigmine bromide tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60687-502(NDC:71930-028)
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (white to off-white) Score4 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code C;60
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60687-502-01100 in 1 BOX, UNIT-DOSE03/18/2021
    1NDC:60687-502-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21118103/18/2021
    Labeler - American Health Packaging (929561009)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Health Packaging929561009repack(60687-502)