regonol
Pharmaranks rates Regonol 3.4/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Regonol (Pyridostigmine Bromide) is a cholinesterase inhibitor used to treat Drug-Induced Abnormalities, Myasthenia Gravis.
Pyridostigmine Bromide · by Sandoz
Available as a generic: Pyridostigmine Bromide
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
- Injectable
- Strength
- Pyridostigmine Bromide 5MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- drug-induced abnormalities, myasthenia gravis
- Manufacturer
- Sandoz
- What the pharmacy pays
- ~$0.60 per ml — not your price
- FDA application
- NDA017398
What is Regonol?
From the FDA label:REGONOL ® (pyridostigmine bromide injection, USP) is an active cholinesterase inhibitor chemically designated as 3-hydroxy-1-methylpyridinium bromide dimethyl-carbamate. Its structural formula is: REGONOL ® is supplied as a sterile, isotonic, nonpyrogenic solution for injection. Each mL contains 5 mg of pyridostigmine bromide USP as active, 10 mg BENZYL ALCOHOL NF as preservative WHICH IS NOT INTENDED FOR USE IN NEWBORNS, 0.23 mg sodium citrate dihydrate USP and 0.1 mg anhydrous citric acid USP as buffering agent, pH adjusted with sodium hydroxide NF and anhydrous citric acid USP if necessary and water for injection USP. chemical-structure
How to use
REGONOL ® (pyridostigmine bromide injection, USP) 2 mL single-dose ampule is for intravenous use only. This drug should be administered by or under the supervision of experienced clinicians familiar with the use of agents which reverse or antagonize the effects of neuromuscular blocking agents. Dosage must be individualized in each case. The dosage information which follows is derived from studies based upon units of drug per unit of body weight and is intended to serve as a guide only. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. NOTE: CONTAINS BENZYL ALCOHOL (see PRECAUTIONS ) Reversal doses of REGONOL ® range from 0.1 to 0.25 mg/kg. 5,10,11,12,13 The onset time to peak effect is dose-dependent; return of twitch height to 90% of control occurs within approximately 6 minutes following administration of a 0.25 mg/kg dose of REGONOL ® . 5,12 At lower doses, full recovery usually occurs within 15 minutes in most patients, although others may require a half-hour or more. When REGONOL ® is given intravenously to reverse the action of muscle relaxant drugs, it is recommended that atropine sulfate (0.6 to 1.2 mg) or an equipotent dose of glycopyrrolate be given immediately prior to or simultaneously with the administration of REGONOL ® . Side effects, notably excessive…
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. 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. Thrombophlebitis has been reported subsequent to intravenous administration.
Warnings
Important safety information
NOT FOR USE IN NEONATES REGONOL ® (pyridostigmine bromide injection, USP) should be used with particular caution in patients with bronchial asthma or cardiac dysrhythmias. Transient bradycardia may occur and be relieved by atropine sulfate. Atropine sulfate should also be used with caution in patients with cardiac dysrhythmias. When large doses of pyridostigmine bromide are administered, as during reversal of muscle relaxants, prior or simultaneous injection of atropine sulfate or an equipotent dose of glycopyrrolate is advisable. Because of the possibility of hypersensitivity in an occasional patient, atropine and antishock medication should always be readily available. When used as an antagonist to nondepolarizing muscle relaxants, adequate recovery of voluntary respiration and neuromuscular transmission must be obtained prior to discontinuation of respiratory assistance, and there should be continuous patient observation. Satisfactory recovery may be judged by adequacy of skeletal muscle tone, respiratory measurements, and by observation of the response to peripheral nerve stimulation. A patent airway should be maintained and manual or mechanical ventilation should be continued until complete recovery of normal respiration is assured. Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. The amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol. Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. The amount of benzyl alcohol at which toxicity may occur is not known. If the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources (see PRECAUTIONS: Pediatric Use ).
Who should not take Regonol
Known hypersensitivity to anticholinesterase agents; intestinal and urinary obstructions of mechanical type.
Overdose — what happens if you take too much
Should overdosage occur, ventilation should be supported by artificial means until the adequacy of spontaneous respiration is assured, and cardiac function should be monitored. Respiratory depression following administration of nondepolarizing neuromuscular blocking agents may be due either wholly or in part to other drugs used during the conduct of general anesthesia, such as narcotics, thiobarbiturates and other central nervous system depressants. A peripheral nerve stimulator may be used to assess the degree of residual neuromuscular blockade and to help differentiate residual neuromuscular blockade from other causes of decreased respiratory reserve.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Concomitant administration of REGONOL ® (pyridostigmine bromide injection, USP) and 4-aminopyridine has been reported to delay the onset of action of REGONOL ® . 9 Antibiotics Parenteral administration of high doses of certain antibiotics may intensify or produce neuromuscular block through their own pharmacologic actions. The following antibiotics have been associated with various degrees of paralysis: aminoglycosides (such as neomycin, streptomycin, kanamycin, gentamicin, and dihydrostreptomycin); tetracyclines; bacitracin; polymyxin B; colistin; and sodium colistimethate. If these or other newly introduced antibiotics are used in conjunction with nondepolarizing neuromuscular blocking drugs during surgery, unexpected prolongation of neuromuscular block or resistance to its reversal should be considered a possibility. Other Experience concerning injection of quinidine during recovery from use of nondepolarizing muscle relaxants suggest that recurrent paralysis may occur. This possibility must be considered when administering anticholinesterase agents to antagonize neuromuscular blockade induced by nondepolarizing muscle relaxants. Electrolyte imbalance and diseases which lead to electrolyte imbalance, such as adrenal cortical insufficiency, have been shown to alter neuromuscular blockade. Depending on the nature of the imbalance, either enhancement or inhibition may be expected. Magnesium salts, administered for the management of toxemia of pregnancy, may enhance the neuromuscular blockade. The possibility that such circumstances may interfere with the restoration of neuromuscular function should be considered when administering REGONOL ® .
Drug class
How this class works, per Cholinesterase Inhibitors - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Regonol ranks — best-rated cholinesterase inhibitor for:
Dosage forms
Injectable
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 Regonol treat?
- Regonol (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 Regonol work?
- Regonol 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 Regonol rated?
- pharmaranks gives Regonol a composite score of 3.4 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 Regonol 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 Regonol?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Regonol. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Regonol?
- Regonol is marketed by Sandoz. You can see Sandoz's full profile, rating, and other products on pharmaranks.
- Is Regonol a brand-name or generic drug?
- Regonol is a brand-name product with the active ingredient Pyridostigmine Bromide. Lower-cost generic equivalents containing Pyridostigmine Bromide are available — ask your pharmacist.
- Is Regonol available over the counter?
- No. Regonol 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 Regonol come in?
- Regonol is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Regonol?
- Regonol is classified as cholinesterase inhibitor, per the FDA's Established Pharmacologic Class.
- Is Regonol FDA-registered?
- Regonol is on record with the U.S. FDA under application number NDA017398. You can verify this on its official FDA label.
- Has Regonol been recalled by the FDA?
- Regonol 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 Regonol safe?
- There's no single safe-or-not verdict. pharmaranks gives Regonol a recall-safety score of 68/100, 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 Regonol?
- Regonol'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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regonol
68/100