The first FDA-Approved neostigmine methylsulfate injection products offering proven efficacy.
Important Safety Information
INDICATIONS AND USAGE
BLOXIVERZ® (Neostigmine Methylsulfate Injection), a cholinesterase inhibitor, is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery.
DOSAGE AND ADMINISTRATION
- Should be administered by trained healthcare providers
- Peripheral nerve stimulator and monitoring for twitch responses should be used to determine when BLOXIVERZ should be initiated and if additional doses are needed
- For reversal of NMBAs with shorter half-lives, when first twitch response is substantially greater than 10% of baseline, or when a second twitch is present: 0.03 mg/kg by intravenous route
- For reversal of NMBAs with longer half-lives or when first twitch response is close to 10% of baseline: 0.07 mg/kg by intravenous route
- Maximum total dosage is 0.07 mg/kg or up to a total of 5 mg (whichever is less)
- An anticholinergic agent, e.g., atropine sulfate or glycopyrrolate, should be administered prior to or concomitantly with BLOXIVERZ
- Hypersensitivity to neostigmine
- Peritonitis or mechanical obstruction of the intestinal or urinary tract
WARNINGS AND PRECAUTIONS
- Bradycardia: Atropine or glycopyrrolate should be administered prior to BLOXIVERZ to lessen risk of bradycardia.
- Serious Reactions with Coexisting Conditions: Use with caution in patients with, coronary artery disease, cardiac arrhythmias, recent acute coronary syndrome or myasthenia gravis.
- Neuromuscular Dysfunction: Can occur if large doses of BLOXIVERZ are administered when neuromuscular blockade is minimal; reduce dose if recovery from neuromuscular blockade is nearly complete.
Most common adverse reactions during treatment: bradycardia, nausea, and vomiting.
To report SUSPECTED ADVERSE REACTIONS, contact Avadel at 1-877-638-4579 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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