제일제약네오스티그민메틸황산염주

Neostigmine methylsulfate injection USP, a cholinesterase inhibitor, is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery ( 1 ). Neostigmine methylsulfate injection USP is a cholinesterase inhibitor indicated for the reversal of the effects of non depolarizing neuromuscular blocking agents after surgery.

Hypersensitivity to neostigmine (4) Peritonitis or mechanical obstruction of the intestinal or urinary tract (4) Neostigmine methylsulfate injection is contraindicated in patients with: known hypersensitivity to neostigmine methylsulfate (known hypersensitivity reactions have included urticaria, angioedema, erythema multiforme, generalized rash, facial swelling, peripheral edema, pyrexia, flushing, hypotension, bronchospasm, bradycardia and anaphylaxis). peritonitis or mechanical obstruction of the intestinal or urinary tract.

Bradycardia: Atropine or glycopyrrolate should be administered prior to neostigmine methylsulfate injection to lessen risk of bradycardia. (5.1) Serious Reactions with Coexisting Conditions: Use with caution in patients with coronary artery disease, cardiac arrhythmias, recent acute coronary syndrome or myasthenia gravis. (5.2) 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. (5.4) 5.1 Bradycardia Neostigmine has been associated with bradycardia. Atropine sulfate or glycopyrrolate should be administered prior to neostigmine methylsulfate injection to lessen the risk of bradycardia [see Dosage and Administration (2.4)]. 5.2 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. Because of the known pharmacology of neostigmine methylsulfate as an acetylcholinesterase inhibitor, cardiovascular effects such as bradycardia, hypotension or dysrhythmia would be anticipated. 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 …

8.1 Pregnancy Risk Summary There are no adequate or well-controlled studies of neostigmine methylsulfate injection in pregnant women. It is not known whether neostigmine methylsulfate can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. The incidence of malformations in human pregnancies has not been established for neostigmine as the data are limited. All pregnancies, regardless of drug exposure, have a background risk of 2 to 4% for major birth defects, and 15 to 20% for pregnancy loss. No adverse effects were noted in rats or rabbits treated with human equivalent doses of neostigmine methylsulfate doses up to 8.1 and 13 mcg/kg/day, respectively, …