Generic: NEOSTIGMINE METHYLSULFATE
1 INDICATIONS AND USAGE Neostigmine Methylsulfate Injection, a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery. Neostigmine Methylsulfate, a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery ( 1 ).
5 WARNINGS AND PRECAUTIONS Bradycardia : Atropine or glycopyrrolate should be administered prior to administration of neostigmine methylsulfate injection to lessen risk of bradycardia ( 5.1 ) Coexisting Conditions : patients with known cardiac disease, cardiac arrhythmias, or recent coronary artery occlusion may be particularly sensitive to the hemodynamic effects of neostigmine; their blood pressure and electrocardiogram should be continuously monitored with the initiation of neostigmine treatm...
5 WARNINGS AND PRECAUTIONS Bradycardia : Atropine or glycopyrrolate should be administered prior to administration of neostigmine methylsulfate injection to lessen risk of bradycardia ( 5.1 ) Coexisting Conditions : patients with known cardiac disease, cardiac arrhythmias, or recent coronary artery occlusion may be particularly sensitive to the hemodynamic effects of neostigmine; their blood pressure and electrocardiogram should be continuously monitored with the initiation of neostigmine treatment and for a duration sufficient to assure hemodynamic stability. ( 5.2 ) Neuromuscular Dysfunction : Can occur if large doses of neostigmine methylsulfate are administered when there is minimal neuromuscular blockade; reduce the dose if recovery from neuromuscular blockade is nearly complete. ( 5.4 ) 5.1 Bradycardia Neostigmine has been associated with bradycardia. An anticholinergic agent, (e.g., atropine sulfate or glycopyrrolate) should be administered prior to Neostigmine Methylsulfate Injection administration to lessen the risk of bradycardia [ see Dosage and Administration ( 2.4 ) ]. 5.2 Cardiovascular Complications Cardiac arrhythmias, nonspecific electrocardiogram changes, cardiac arrest, syncope and hypotension have been reported with neostigmine methylsulfate. 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 (Anaphylaxis) Hypersensitivity reactions including anaphylaxis have been reported with neostigmine. Ensure that appropriate medical support measures, including atropine, cardiopulmonary resuscitation equipment, and medications to treat anaphylaxis are readily available. 5.4 Neuromuscular Dysfunction Neuromuscular dysfunction has been associated with administration of large doses of neostigmine when neuromuscular blockade is minimal. To mitigate the risk of neuromuscular dysfunction, consider reducing the dose of neostigmine if recovery from neuromuscular blockade is nearly complete. 5.5 Cholinergic Crisis Overdosage of neostigmine may cause cholinesterase inhibitor toxicity or cholinergic crisis which may be difficult to differentiate from myasthenia crisis since both conditions present with similar symptoms. Both conditions result in extreme muscle weakness but require radically different treatments. Cholinergic crisis requires immediate withdrawal of all anticholinergic medication and immediate use of atropine [ see Overdosage ( 10 ) ].
6 ADVERSE REACTIONS The most common adverse reactions include bradycardia and nausea and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial 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 r...
6 ADVERSE REACTIONS The most common adverse reactions include bradycardia and nausea and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial 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. The following serious adverse reactions are described below and elsewhere in the labeling: Bradycardia [ see Warnings and Precautions ( 5.1 ) ] Cardiovascular Complications [ see Warnings and Precautions ( 5.2 ) ] Hypersensitivity (Anaphylaxis) [ see Warnings and Precautions ( 5.3 ) ] 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. Adverse reactions that occurred with an overall frequency of 1% or greater included the following: Allergic: Allergic reactions and anaphylaxis. Neurological: Dizziness, syncope, weakness, convulsions, loss of consciousness, drowsiness, headache, dysarthria, miosis and visual changes. Cardiovascular: Cardiac arrhythmias including bradycardia, tachycardia, atrioventricular block and nodal rhythm, as well as cardiac arrest, and hypotension. Respiratory: Increased oral, pharyngeal and bronchial secretions, dyspnea, respiratory depression, oxygen desaturation, respiratory arrest and bronchospasm. Dermatologic: Diaphoresis, flushing, rash, pruritus, and urticaria. Gastrointestinal: Dry mouth, nausea, emesis, flatulence and increased peristalsis. Genitourinary: Increased urinary frequency. Musculoskeletal: Muscle cramps and spasm, arthralgia. Psychiatric: Insomnia General: Incision site complication, pharyngolaryngeal pain, procedural complication, procedural pain 6.2 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. 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 diaphoresis, flushing Gastrointestinal Disorders: Bowel cramps, diarrhea, flatulence, increased peristalsis Renal and Urinary Disorders: Urinary frequency Musculoskeletal and Connective Tissue Disorders: Arthralgia, muscle cramps, spasms, weakness
Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare provider before making any decisions about your medications. Data sourced from openFDA.