Trade Name: Neostigmine methylsulfate

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Amneal Biosciences LLC

Presentation: INJECTION, HUMAN PRESCRIPTION DRUG

Strength: 0.5 mg/mL

Storage and handling

NEOSTIGMINE METHYLSULFATE Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Neostigmine methylsulfate (Neostigmine methylsulfate) which is also known as Neostigmine methylsulfate and Manufactured by Amneal Biosciences LLC. It is available in strength of 0.5 mg/mL.

Neostigmine methylsulfate (Neostigmine methylsulfate) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

  • No data
  • Neostigmine methylsulfate injection is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.
  • Neostigmine methylsulfate injection, a cholinesterase inhibitor, is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery. ()
  • u2212u00a0 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:()
  • u2212u00a0 For reversal of NMBAs with longer half-lives or when first twitch response is close to 10% of baseline: . ()
  • Neostigmine methylsulfate injection, USP is a clear, colorless, sterile, nonpyrogenic solution intended for intravenous use.
  • Neostigmine methylsulfate injection, USP is available as
  • Injection: 0.5 mg/mL and 1 mg/mL in 10 mL multiple-dose vials. ()
  • Neostigmine methylsulfate is contraindicated in patients with:
  • Hypersensitivity to neostigmine. ()
  • Peritonitis or mechanical obstruction of the intestinal or urinary tract. ()
  • No data
  • Bradycardia: Atropine or glycopyrrolate should be administered prior to neostigmine methylsulfate to lessen risk of bradycardia. ()
  • Serious Reactions with Coexisting Conditions: Use with caution in patients with, coronary artery disease, cardiac arrhythmias, recent acute coronary syndrome or myasthenia gravis. ()
  • Neuromuscular Dysfunction: Can occur if large doses of neostigmine methylsulfate injection are administered when neuromuscular blockade is minimal; reduce dose if recovery from neuromuscular blockade is nearly complete. ()
  • Most common adverse reactions during treatment: bradycardia, nausea and vomiting. ()
  • 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.u00a0
  • No data
  • Pregnancy: No human data and limited animal data exist. Use only if clearly needed.
  • 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 u201cinsensitiveu201d 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 radically. Whereas the presence of myasthenic crisis requires more intensive anticholinesterase therapy, cholinergic crisis 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 lessen gastrointestinal side effects or other muscarinic reactions; but such use, by masking signs of overdosage, can lead to inadvertent induction of cholinergic crisis.
  • Neostigmine methylsulfate, a cholinesterase inhibitor, is (-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 clear, colorless, sterile, nonpyrogenic solution intended for intravenous use.
  • Each mL of the 0.5 mg/mL strength contains neostigmine methylsulfate 0.5 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 acetic acid/sodium hydroxide to a value of 5.5.
  • Each mL of the 1 mg/mL strength contains neostigmine methylsulfate 1 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 acetic acid/sodium hydroxide to achieve a value of 5.5.
  • No data
  • Carcinogenesis:
  • Genotoxicity:
  • in vitro
  • in vitro
  • in vivo
  • Impairment of Fertility:
  • The evidence for the efficacy of neostigmine methylsulfate for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery is derived from the published literature. Randomized, spontaneous-recovery or placebo-controlled studies using similar efficacy endpoints evaluated a total of 404 adult and 80 pediatric patients undergoing various surgical procedures. Patients had reductions in their recovery time from neuromuscular blockade with neostigmine methylsulfate treatment compared to spontaneous recovery.
  • Neostigmine methylsulfate injection, USP is a clear, colorless, sterile, nonpyrogenic solution intended for intravenous use. It is available as follows:
  • Arrayn- 0.5 mg/mL:
  • 10 mL, Multiple-Dose Vial: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1478-1
  • 10 Vials in a Carton:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1478-7
  • Arrayn- 1 mg/mL:
  • 10 mL, Multiple-Dose Vial:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1479-1
  • 10 Vials in a Carton:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1479-7
  • The vial stopper is not made with natural rubber latex.
  • Neostigmine methylsulfate injection, USP should be stored at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature]. Protect from light. Store in carton until time of use.
  • Manufactured by:
  • Amneal Pharmaceuticals Pvt. Ltd.
  • Parenteral Unit
  • Ahmedabad 382213, INDIA
  • Distributed by:
  • Amneal Pharmaceuticalsu00a0LLC
  • Bridgewater, NJ 08807
  • Rev. 09-2020-02
  • NDC: 70121-1478-1
  • Name: Neostigmine methylsulfate injection, USPn
  • Strength: 5 mg/10 mL (0.5 mg/mL)n
  • Rx Only
  • Vial Labeln
  • Amneal Pharmaceuticalsu00a0LLCn
  • Arrayn- Array
  • u00a0 n
  • NDC: 70121-1478-7
  • Name: Neostigmine methylsulfate injection, USPn
  • Strength: 5 mg/10 mL (0.5 mg/mL)n
  • Rx Only
  • Carton Labeln
  • Amneal Pharmaceuticalsu00a0LLCn
  • NDC: 70121-1479-1
  • Name: Neostigmine methylsulfate injection, USPn
  • Strength: 10 mg/10 mL (1 mg/mL)n
  • Rx Only
  • Vial Labeln
  • Amneal Pharmaceuticalsu00a0LLCn
  • u00a0u00a0
  • NDC: 70121-1479-7
  • Name: Neostigmine methylsulfate injection, USPn
  • Strength: 10 mg/10 mL (1 mg/mL)n
  • Rx Only
  • Carton Labeln
  • Amneal Pharmaceuticalsu00a0LLC
  • u00a0

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