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P: 877-845-6371For 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 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
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.