neostigmine methylsulfate
Pharmaranks rates Neostigmine Methylsulfate 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Neostigmine Methylsulfate is a cholinesterase inhibitor used to treat Drug-Induced Abnormalities, Urinary Bladder Diseases, Myasthenia Gravis, Urinary Retention.
Cholinesterase Inhibitor · by Meitheal
Generic of Bloxiverz
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
- Neostigmine Methylsulfate
- Drug class
- Cholinesterase Inhibitor
- Form
- Injectable
- Strength
- Neostigmine Methylsulfate 10MG/10ML (1MG/ML) · Neostigmine Methylsulfate 5MG/10ML (0.5MG/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Meitheal
- FDA application
- ANDA212804
What is Neostigmine Methylsulfate?
From the FDA label:Neostigmine methylsulfate, a cholinesterase inhibitor, is ( m -hydroxyphenyl) trimethylammonium methylsulfate dimethylcarbamate. The structural formula is: Neostigmine methylsulfate is a white crystalline powder and is very soluble in water and soluble in alcohol. Neostigmine Methylsulfate Injection, USP is a sterile, nonpyrogenic solution intended for intravenous use. Each mL of the 0.5 mg per mL strength contains Neostigmine Methylsulfate, USP 0.51 mg, phenol 4.5 mg (used as preservative), and sodium acetate trihydrate 0.2 mg, in water for injection. The pH is adjusted, when necessary, with glacial acetic acid and/or sodium hydroxide to achieve a value of 5.5. Each mL of the 1 mg per mL strength contains Neostigmine Methylsulfate, USP 1.02 mg, phenol 4.5 mg (used as preservative), and sodium acetate trihydrate 0.2 mg, in water for injection. The pH is adjusted, when necessary, with glacial acetic acid and/or sodium hydroxide to achieve a value of 5.5. Figure
How to use
Should be administered by trained healthcare providers. ( 2.1 ) Peripheral nerve stimulator and monitoring for twitch responses should be used to determine when neostigmine methylsulfate injection should be initiated and if additional doses are needed. ( 2.2 ) For reversal of NMBAs with shorter half-lives, when first twitch response is substantially greater than 10% of baseline, or when a second twitch is present: 0.03 mg/kg by intravenous route ( 2.2 ) For reversal of NMBAs with longer half-lives or when first twitch response is close to 10% of baseline: 0.07 mg/kg by intravenous route ( 2.2 ) Maximum total dosage is 0.07 mg/kg or up to a total of 5 mg (whichever is less). ( 2.2 ) An anticholinergic agent, e.g., atropine sulfate or glycopyrrolate, should be administered prior to or concomitantly with neostigmine methylsulfate injection. ( 2.4 ) 2.1 Important Dosage Information Neostigmine methylsulfate injection should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents. Doses of neostigmine methylsulfate injection should be individualized, and a peripheral nerve stimulator should be used to determine the time of initiation of neostigmine methylsulfate injection and should be used to determine the need for additional doses. Neostigmine…
Side effects
Most common adverse reactions during treatment: bradycardia, nausea and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions to neostigmine methylsulfate are most often attributable to exaggerated pharmacological effects, in particular, at muscarinic receptor sites. The use of an anticholinergic agent, e.g., atropine sulfate or glycopyrrolate, may prevent or mitigate these reactions. Quantitative adverse event data are available from trials of neostigmine methylsulfate in which 200 adult patients were exposed to the product. The following table lists the adverse reactions that occurred with an overall frequency of 1% or greater. System Organ Class Adverse Reaction Cardiovascular Disorders bradycardia, hypotension, tachycardia/heart rate increase Gastrointestinal Disorders dry mouth, nausea, post-procedural nausea, vomiting General Disorders and Administration Site Conditions incision site complication, pharyngolaryngeal pain, procedural complication, procedural…
Warnings
Important safety information
Bradycardia: Atropine or glycopyrrolate should be administered prior to neostigmine methylsulfate to lessen risk of bradycardia. ( 5.1 ) Serious Reactions with Coexisting Conditions: Use with caution in patients with coronary artery disease, cardiac arrhythmias, recent acute coronary syndrome or myasthenia gravis. ( 5.2 ) Neuromuscular Dysfunction: Can occur if large doses of neostigmine methylsulfate are administered when neuromuscular blockade is minimal; reduce dose if recovery from neuromuscular blockade is nearly complete. ( 5.4 ) 5.1 Bradycardia Neostigmine has been associated with bradycardia. Atropine sulfate or glycopyrrolate should be administered prior to neostigmine methylsulfate to lessen the risk of bradycardia [see Dosage and Administration ( 2.4 )]. 5.2 Serious Adverse Reactions in Patients with Certain Coexisting Conditions Neostigmine methylsulfate should be used with caution in patients with coronary artery disease, cardiac arrhythmias, recent acute coronary syndrome or myasthenia gravis. Because of the known pharmacology of neostigmine methylsulfate as an acetylcholinesterase inhibitor, cardiovascular effects such as bradycardia, hypotension or dysrhythmia would be anticipated. In patients with certain cardiovascular conditions such as coronary artery disease, cardiac arrhythmias or recent acute coronary syndrome, the risk of blood pressure and heart rate complications may be increased. Risk of these complications may also be increased in patients with myasthenia gravis. Standard antagonism with anticholinergics (e.g., atropine) is generally successful to mitigate the risk of cardiovascular complications. 5.3 Hypersensitivity Because of the possibility of hypersensitivity, atropine and medications to treat anaphylaxis should be readily available. 5.4 Neuromuscular Dysfunction Large doses of neostigmine methylsulfate administered when neuromuscular blockade is minimal can produce neuromuscular dysfunction. The dose of neostigmine methylsulfate should be reduced if recovery from neuromuscular blockade is nearly complete. 5.5 Cholinergic Crisis It is important to differentiate between myasthenic crisis and cholinergic crisis caused by overdosage of neostigmine methylsulfate. Both conditions result in extreme muscle weakness but require radically different treatment [see Overdosage ( 10 )].
Who should not take Neostigmine Methylsulfate
Neostigmine methylsulfate is contraindicated in patients with: known hypersensitivity to neostigmine methylsulfate (known hypersensitivity reactions have included urticaria, angioedema, erythema multiforme, generalized rash, facial swelling, peripheral edema, pyrexia, flushing, hypotension, bronchospasm, bradycardia and anaphylaxis). peritonitis or mechanical obstruction of the intestinal or urinary tract. Hypersensitivity to neostigmine ( 4 ) Peritonitis or mechanical obstruction of the intestinal or urinary tract ( 4 )
Overdose — what happens if you take too much
Muscarinic symptoms (nausea, vomiting, diarrhea, sweating, increased bronchial and salivary secretions, and bradycardia) may appear with overdosage of neostigmine methylsulfate (cholinergic crisis), but may be managed by the use of additional atropine or glycopyrrolate. The possibility of iatrogenic overdose can be lessened by carefully monitoring the muscle twitch response to peripheral nerve stimulation. Should overdosage occur, ventilation should be supported by artificial means until the adequacy of spontaneous respiration is assured, and cardiac function should be monitored. Overdosage of neostigmine methylsulfate can cause cholinergic crisis, which is characterized by increasing muscle weakness, and through involvement of the muscles of respiration, may result in death. Myasthenic crisis, due to an increase in the severity of the disease, is also accompanied by extreme muscle weakness and may be difficult to distinguish from cholinergic crisis on a symptomatic basis. However, such differentiation is extremely important because increases in the dose of neostigmine methylsulfate or other drugs in this class, in the presence of cholinergic crisis or of a refractory or “insensitive” state, could have grave consequences. The two types of crises may be differentiated by the use of edrophonium chloride as well as by clinical judgment. Treatment of the two conditions differs…
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
The pharmacokinetic interaction between neostigmine methylsulfate and other drugs has not been studied. Neostigmine methylsulfate is metabolized by microsomal enzymes in the liver. Use with caution when using neostigmine methylsulfate with other drugs which may alter the activity of metabolizing enzymes or transporters.
Drug class
How this class works, per Cholinesterase Inhibitors - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Neostigmine Methylsulfate ranks — best-rated cholinesterase inhibitor for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Neostigmine Methylsulfate treat?
- Neostigmine Methylsulfate (Neostigmine Methylsulfate) may be used to treat drug-induced abnormalities, urinary bladder diseases, myasthenia gravis, urinary retention, 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 Neostigmine Methylsulfate work?
- Neostigmine Methylsulfate 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 Neostigmine Methylsulfate rated?
- pharmaranks gives Neostigmine Methylsulfate 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.
- Is there a coupon or discount for Neostigmine Methylsulfate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Neostigmine Methylsulfate. To pay less, Neostigmine Methylsulfate 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 Neostigmine Methylsulfate?
- Neostigmine Methylsulfate is marketed by Meitheal. You can see Meitheal's full profile, rating, and other products on pharmaranks.
- Is Neostigmine Methylsulfate a brand-name or generic drug?
- Neostigmine Methylsulfate is a generic medication; its active ingredient is Neostigmine Methylsulfate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Neostigmine Methylsulfate available over the counter?
- No. Neostigmine Methylsulfate 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 Neostigmine Methylsulfate come in?
- Neostigmine Methylsulfate is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Neostigmine Methylsulfate?
- Neostigmine Methylsulfate is classified as cholinesterase inhibitor, per the FDA's Established Pharmacologic Class.
- Is Neostigmine Methylsulfate FDA-registered?
- Neostigmine Methylsulfate is on record with the U.S. FDA under application number ANDA212804. You can verify this on its official FDA label.
- Has Neostigmine Methylsulfate been recalled by the FDA?
- Neostigmine Methylsulfate 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 Neostigmine Methylsulfate safe?
- There's no single safe-or-not verdict. pharmaranks gives Neostigmine Methylsulfate 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 Neostigmine Methylsulfate?
- Neostigmine Methylsulfate's side effects are taken directly from its FDA label. From the label: Most common adverse reactions during treatment: bradycardia, nausea and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .… 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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