pyridostigmine bromide
Pharmaranks rates Pyridostigmine Bromide 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Pyridostigmine Bromide is a cholinesterase inhibitor used to treat Drug-Induced Abnormalities, Myasthenia Gravis.
Cholinesterase Inhibitor · by Ani Pharms
Generic of Regonol
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Pyridostigmine Bromide
- Drug class
- Cholinesterase Inhibitor
- Form
- Solution, Tablet, Tablet, extended release
- Strength
- Pyridostigmine Bromide 30MG · Pyridostigmine Bromide 60MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- drug-induced abnormalities, myasthenia gravis
- Manufacturer
- Ani Pharms
- What the pharmacy pays
- ~$0.60 per ml — not your price
- FDA application
- ANDA040512
What is Pyridostigmine Bromide?
From the FDA label:Pyridostigmine bromide is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is: Each Pyridostigmine Bromide Tablet USP intended for oral administration contains 60 mg of pyridostigmine bromide USP. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide and stearic acid. structure
How to use
Pyridostigmine Bromide is sold in more than one form (Solution, Tablet and Tablet, extended release), and each is dosed differently. The instructions below come from the FDA label for application ANDA040512 — follow the label that came with the product you were actually prescribed.
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).
Side effects
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.
Warnings
Important safety information
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. 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 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.
Who should not take Pyridostigmine Bromide
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.
Drug class
How this class works, per Cholinesterase Inhibitors - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Pyridostigmine Bromide ranks — best-rated cholinesterase inhibitor for:
Dosage forms
Solution, Tablet and Tablet, extended release
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Pyridostigmine Bromide treat?
- Pyridostigmine Bromide (Pyridostigmine Bromide) may be used to treat drug-induced abnormalities, myasthenia gravis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Pyridostigmine Bromide work?
- Pyridostigmine Bromide is a cholinesterase inhibitor. Cholinesterase inhibitors block the enzyme that breaks down acetylcholine, a chemical messenger nerves use to communicate. By letting acetylcholine build up and act longer, they can help preserve memory and thinking in Alzheimer's disease, where this messenger runs low.
- How is Pyridostigmine Bromide rated?
- pharmaranks gives Pyridostigmine Bromide a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Pyridostigmine Bromide cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.60 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Pyridostigmine Bromide?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Pyridostigmine Bromide. To pay less, Pyridostigmine Bromide is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Pyridostigmine Bromide?
- Pyridostigmine Bromide is marketed by Ani Pharms. You can see Ani Pharms's full profile, rating, and other products on pharmaranks.
- Is Pyridostigmine Bromide a brand-name or generic drug?
- Pyridostigmine Bromide is a generic medication; its active ingredient is Pyridostigmine Bromide. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Pyridostigmine Bromide available over the counter?
- No. Pyridostigmine Bromide is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Pyridostigmine Bromide come in?
- Pyridostigmine Bromide is currently marketed as solution, tablet and tablet, extended release, per the FDA's National Drug Code Directory.
- What class of drug is Pyridostigmine Bromide?
- Pyridostigmine Bromide is classified as cholinesterase inhibitor, per the FDA's Established Pharmacologic Class.
- Is Pyridostigmine Bromide FDA-registered?
- Pyridostigmine Bromide is on record with the U.S. FDA under application number ANDA040512. You can verify this on its official FDA label.
- Has Pyridostigmine Bromide been recalled by the FDA?
- Pyridostigmine Bromide has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Pyridostigmine Bromide safe?
- There's no single safe-or-not verdict. pharmaranks gives Pyridostigmine Bromide a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Pyridostigmine Bromide?
- Pyridostigmine Bromide's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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pyridostigmine bromide
70/100