pharmacopeia
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/api/v1/drug/pyridostigmine

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Cholinesterase Inhibitors.

Cholinesterase

Indications

Sourced from openFDA
  • Pyridostigmine Bromide Tablets USP are useful in the treatment of myasthenia gravis.

Contraindications

Sourced from openFDA
  • 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.contraindicated

Dosage & administration

Sourced from openFDA

Each Pyridostigmine Bromide Tablet contains 60 mg pyridostigmine bromide. Dosage The size and frequency of the dosage must be adjusted to the needs of the individual patient. The average dose is ten 60 mg tablets daily, spaced to provide maximum relief when maximum strength is needed. In severe cases as many as twenty-five 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).

Warnings & precautions

Sourced from openFDA

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 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.

Adverse reactions

Sourced from openFDA

The side effects of pyridostigmine bromide 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 ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use in specific populations

Sourced from openFDA

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

Approval history

Sourced from openFDA
  • Apr 6, 1955NDANDA009829Bausch
  • Jan 12, 1959NDANDA011665Bausch
  • Jan 25, 1965NDANDA015193Bausch
  • Aug 14, 1973NDANDA017398Sandoz
  • Feb 5, 2003NDANDA020414Us Army
  • Apr 24, 2003ANDAANDA040502Impax Labs
  • Oct 8, 2003ANDAANDA040512Ani Pharms
  • Oct 4, 2024NDANDA217604Amneal

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
10,330 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Myasthenia Gravis1,17211%
  2. 2Off Label Use9959.6%
  3. 3Drug Ineffective9609.3%
  4. 4Fatigue8808.5%
  5. 5Asthenia7166.9%
  6. 6Diarrhoea6666.4%
  7. 7Dyspnoea6145.9%
  8. 8Headache5975.8%
  9. 9Nausea5695.5%
  10. 10Muscular Weakness4654.5%
  11. 11Fall4494.3%
  12. 12Dizziness4043.9%
  13. 13Condition Aggravated3973.8%
  14. 14Pain3473.4%
  15. 15Malaise3443.3%

Literature

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Recent PubMed references pinned to Pyridostigmine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 53 ClinicalTrials.gov registrations naming Pyridostigmine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Pyridostigmine work?
Mechanism-of-action class: Cholinesterase Inhibitors.
What is Pyridostigmine used for?
According to FDA labeling, Pyridostigmine carries indications including: Pyridostigmine Bromide Tablets USP are useful in the treatment of myasthenia gravis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Pyridostigmine?
Pyridostigmine is classified as Anticholinesterases, Cholinesterase Inhibitor, Cholinesterase Inhibitors, Genitourinary Arterial Vasoconstriction, Increased GI Smooth Muscle Tone, Increased Striated Muscle Contraction, Pupillary Constriction, Salivation Stimulation.
What are the brand names for Pyridostigmine?
Pyridostigmine is marketed under brand names including Mestinon, Regonol.
What are the contraindications for Pyridostigmine?
Pyridostigmine labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.
Note. Data for pyridostigmine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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