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Neostigmine MethylsulfateInjection, USP

  • “AP” Rated and therapeutically equivalent to Bloxiverz®*1
  • Vial closure is not made with natural rubber latex

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*Bloxiverz is a registered trademark of Avadel Pharmaceuticals, LLC
1. US Food and Drug Administration. Neostigmine Methylsulfate Injection, USP. ANDA 209182 Approval Letter. May 2018.

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For Intravenous Use. INDICATIONS AND USAGE Neostigmine methylsulfate injection is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. IMPORTANT SAFETY INFORMATION Important Dosage Information: 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. CONTRAINDICATIONS Neostigmine methylsulfate injection is contraindicated in patients with known hypersensitivity to neostigmine methylsulfate and in patients with peritonitis or mechanical obstruction of the intestinal or urinary tract. WARNINGS AND PRECAUTIONS Bradycardia: Neostigmine has been associated with bradycardia. Serious Adverse Reactions in Patients with Certain Coexisting Conditions: Neostigmine methylsulfate injection should be used with caution in patients with: coronary artery disease, cardiac arrhythmias, recent acute coronary syndrome or myasthenia gravis. Hypersensitivity: Because of the possibility of hypersensitivity, atropine and medications to treat anaphylaxis should be readily available. 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. Cholinergic Crisis: It is important to differentiate between myasthenic crisis and cholinergic crisis caused by overdosage of neostigmine methylsulfate injection. ADVERSE REACTIONS Clinical Trials Experience: 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 pain
Nervous System Disorders dizziness, headache, postoperative shivering, prolonged neuromuscular blockade
Psychiatric Disorders insomnia
Respiratory, Thoracic and Mediastinal Disorders dyspnea, oxygen desaturation <90%
Skin and Subcutaneous Tissue Disorders pruritus
Post-Marketing Experience: The following adverse reactions have been identified during parenteral use of neostigmine methylsulfate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
System Organ Class Adverse Reaction
Allergic Disorders allergic reactions, anaphylaxis
Nervous System Disorders convulsions, drowsiness, dysarthria, fasciculation, loss of consciousness, miosis, visual changes
Cardiovascular Disorders cardiac arrest, cardiac arrhythmias (A-V block, nodal rhythm), hypotension, nonspecific EKG changes, syncope
Respiratory, Thoracic and Mediastinal Disorders bronchospasm; increased oral, pharyngeal and bronchial secretions; respiratory arrest; respiratory depression
Skin and Subcutaneous Tissue Disorders rash, urticaria
Gastrointestinal Disorders bowel cramps, diarrhea, flatulence, increased peristalsis
Renal and Urinary Disorders urinary frequency
Musculoskeletal and Connective Tissue Disorders arthralgia, muscle cramps, spasms, weakness
Miscellaneous diaphoresis, flushing
USE IN SPECIFIC POPULATIONS Pregnancy: There are no adequate or well-controlled studies of neostigmine methylsulfate injection in pregnant women.
Neostigmine methylsulfate injection should be given to a pregnant woman only if clearly needed. Labor and Delivery: The effect of neostigmine methylsulfate injection on the mother and fetus with regard to labor and delivery is not known. Cholinesterase inhibitor drugs may induce premature labor when given intravenously to pregnant women near term. Nursing Mothers: It is not known whether neostigmine methylsulfate is excreted in human milk. Caution should be exercised when neostigmine methylsulfate injection is administered to a nursing woman. Pediatric Use: Recovery of neuromuscular activity occurs more rapidly with smaller doses of cholinesterase inhibitors in infants and children than in adults. However, infants and small children may be at greater risk of complications from incomplete reversal of neuromuscular blockade due to decreased respiratory reserve. The risks associated with incomplete reversal outweigh any risk from giving higher doses of neostigmine methylsulfate injection. Geriatric Use: Neostigmine methylsulfate injection should be used with caution and monitored for a longer period in elderly patients. Renal Impairment: Elimination half-life of neostigmine methylsulfate was prolonged in anephric patients compared to normal subjects. Hepatic Impairment: The pharmacokinetics of neostigmine methylsulfate in patients with hepatic impairment have not been studied. OVERDOSAGE Muscarinic symptoms may appear with overdosage of neostigmine methylsulfate injection (cholinergic crisis), but may be managed by the use of additional atropine or glycopyrrolate. Ventilation should be supported by artificial means until the adequacy of spontaneous respiration is assured, and cardiac function should be monitored. Cholinergic crisis may result in death. Myasthenic crisis may be difficult to distinguish from cholinergic crisis on a symptomatic basis. The presence of myasthenic crisis requires more intensive anticholinesterase therapy; cholinergic crisis calls for the prompt withdrawal of all drugs of this type. For additional Safety Information, please see Full Prescribing Information. You are encouraged to report Adverse Drug Events (ADEs) to American Regent Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/MedWatch or calling 1-800-FDA-1088.
REF-0717 5/2018