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. 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).ĭrowsiness and Blurred Vision: Glycopyrrolate, a component of PREVDUO ™, may cause drowsiness or blurred vision. 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. The dose of PREVDUO™ should be reduced if recovery from neuromuscular blockade is nearly complete.Ĭholinergic Crisis: It is important to differentiate between myasthenic crisis and cholinergic crisis caused by overdosage of neostigmine. 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. Glaucoma obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy) obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.) paralytic ileus, intestinal atony of the elderly or debilitated patient unstable cardiovascular status in acute hemorrhage severe ulcerative colitis toxic megacolon complicating ulcerative colitis myasthenia gravis.īradycardia: Neostigmine, a component of PREVDUO ™, is associated with bradycardia. Peritonitis or mechanical obstruction of the intestinal or urinary tract. 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) and glycopyrrolate or any inactive ingredients. PREVDUO ™ is contraindicated in patients with: This may reduce waste and costs, optimize convenience and workflow and reduce the chance for preparation error-all of which support quality patient care. Ready-to-use, or RTU, products streamline operations for hospitals by eliminating the need to prepare or transfer the product before patient administration. "Following the development and FDA approval of Prevduo ™, we're pleased to partner with Endo and tap into Endo's proven capabilities in commercializing injectable solutions, including ready-to-use products," said Ajay Singh, Founder and CEO of Slayback Pharma. "We're proud to partner with Slayback to bring this critical care product to market and help hospitals deliver quality patient care." "Prevduo ™ further strengthens our commitment to supporting healthcare providers and their patients through ready-to-use products that streamline operations," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. Neostigmine is always administered in conjunction with glycopyrrolate, and currently, its administration requires two syringes. as single, active ingredient drug products. Both neostigmine methylsulfate and glycopyrrolate have been approved in the U.S. When launched, Prevduo ™ will be the first and only FDA-approved neostigmine–glycopyrrolate combination product in the U.S. Endo will commercialize Prevduo ™ through its Par Sterile Products business and expects to launch the product in June 2023.
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