NEOSTIGMINE METHYLSULFATE
Generic: NEOSTIGMINE METHYLSULFATE
Basic Information
Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
c4be8467-7b7e-551d-e053-2995a90a3045
Indications & Usage
1 INDICATIONS & USAGE Neostigmine Methylsulfate Injection, USP, is a cholinesterase inhibitor indicated for the reversal of the effects of nondepolarizing neuromuscular blocking agents after surgery.
Adverse Reactions
6 ADVERSE REACTIONS 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.
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.
ADVERSE 1 ADVERSE 2
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.
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.
ADVERSE 1 ADVERSE 2