Warn patients not to participate in activities requiring mental alertness, such as operate a motor vehicle or other machinery or perform hazardous work until these issues resolve. Drowsiness and Blurred Vision: Glycopyrrolate, a component of PREVDUO ™, may cause drowsiness or blurred vision. Advise patients with glaucoma to promptly seek medical care in the event that they experience symptoms of acute angle closure glaucoma (pain and reddening of the eyes, accompanied by dilated pupils). Precipitation of Acute Glaucoma: Glycopyrrolate, a component of PREVDUO ™, is contraindicated in patients with glaucoma because it may cause mydriasis and increase intraocular pressure. Both conditions result in extreme muscle weakness but require radically different treatment. Cholinergic Crisis: It is important to differentiate between myasthenic crisis and cholinergic crisis caused by overdosage of neostigmine. The dose of PREVDUO™ should be reduced if recovery from neuromuscular blockade is nearly complete. Neuromuscular Dysfunction: Large doses of PREVDUO ™ administered when neuromuscular blockade is minimal can produce neuromuscular dysfunction. Hypersensitivity: Because of the possibility of hypersensitivity, medications to treat anaphylaxis should be readily available. Risk of these complications may also be increased in patients with myasthenia gravis. In patients with acute 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. Because of the known pharmacology of neostigmine methylsulfate as an acetylcholinesterase inhibitor, cardiovascular effects such as bradycardia, hypotension or dysrhythmia would be anticipated. Serious Adverse Reactions in Patients with Certain Coexisting Conditions: PREVDUO ™ should be used with caution in patients with coronary artery disease, congestive heart failure, cardiac arrhythmias, recent acute coronary syndrome, hypertension, myasthenia gravis and hyperthyroidism. Consideration should be given to administration of glycopyrrolate prior to neostigmine (i.e., as separate products) in patients with bradycardia or in patients in whom bradycardia, a known risk of neostigmine methysulfate, may cause hemodynamic instability. WARNINGS AND PRECAUTIONS Bradycardia: Neostigmine, a component of PREVDUO ™, is associated with bradycardia.
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