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Prevduo Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose prefilled syringes (3mL)—1, 5
Manufacturer
Generic Availability
NO
Mechanism of Action
Neostigmine methylsulfate, a competitive cholinesterase inhibitor, reduces the breakdown of acetylcholine by inducing an increase in acetylcholine in the synaptic cleft which competes for the same binding site as nondepolarizing neuromuscular blocking agents and reverses the neuromuscular blockade.
Glycopyrrolate inhibits the action of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. Glycopyrrolate also antagonizes muscarinic symptoms induced by cholinergic drugs.
Prevduo Indications
Indications
To reverse the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery, while decreasing the peripheral muscarinic effects (eg, bradycardia and excessive sedations) associated with cholinesterase inhibition following NMBA reversal administration.
Prevduo Dosage and Administration
Adults and Children
<2yrs: not recommended. Peripheral nerve stimulator and monitoring for twitch responses should be used to determine time of Prevduo initiation and the need for additional doses. Individualize. ≥2yrs: Give by IV inj slowly over a period of at least 1min. Reversal of NMBAs with shorter half-lives (eg, rocuronium), or when first twitch response to the train-of-four (TOF) stimulus is substantially >10% of baseline or when a second twitch is present: 0.03mg/kg of neostigmine methylsulfate (0.006mg/kg of glycopyrrolate). Reversal of NMBAs with longer half-lives (eg, vecuronium, pancuronium) or when first twitch response is not substantially >10% of baseline or if rapid recovery required: 0.07mg/kg of neostigmine methylsulfate (0.014mg/kg of glycopyrrolate). Max total dose: 0.07mg/kg of neostigmine methylsulfate or up to a total of 5mg, whichever is less.
Prevduo Contraindications
Contraindications
Peritonitis. Mechanical obstruction of the intestinal or urinary tract. Glaucoma. Obstructive uropathy (eg, bladder neck obstruction due to prostatic hypertrophy). Obstructive disease of the GI tract (eg, achalasia, pyloroduodenal stenosis). 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.
Prevduo Boxed Warnings
Not Applicable
Prevduo Warnings/Precautions
Warnings/Precautions
Should be administered by trained healthcare providers. Have treatment for anaphylaxis readily available. Increased risk of BP and HR complications with cardiovascular conditions (eg, coronary artery disease, congestive heart failure, cardiac arrhythmias, recent acute coronary syndrome, hypertension, hyperthyroidism) or myasthenia gravis. Neuromuscular dysfunction with large doses; reduce dose if recovery is nearly complete. Differentiate between myasthenic or cholinergic crisis. Precipitation of acute glaucoma. Avoid exertion and high environmental temperatures. Avoid in patients with ileostomy or colostomy. Renal or hepatic impairment; monitor closely. Elderly (monitor for longer periods). Pregnancy. Nursing mothers.
Prevduo Pharmacokinetics
Distribution
-
Volume of distribution: 0.12–1.4 L/kg (neostigmine methylsulfate); 0.42±0.22 L/kg (glycopyrrolate).
-
Protein binding of neostigmine methylsulfate to human serum albumin ranges from 15 to 25%.
Elimination
Adults
-
Half-life: 24 to 113 minutes (neostigmine methylsulfate); 0.83±0.13 hour (glycopyrrolate).
-
Clearance: 1.14 to 16.7 mL/min/kg (neostigmine methylsulfate); 0.54±0.14 L/kg/hr (glycopyrrolate).
Pediatrics
-
Half-life: 48±16 min (neostigmine methylsulfate); 19.2 to 99.2 minutes (glycopyrrolate).
-
Clearance: 11±3 mL/min/kg (neostigmine methylsulfate).
Prevduo Interactions
Interactions
Caution with other drugs that may alter activity of metabolizing enzymes or transporters. May increase antimuscarinic and anticholinergic effects with other anticholinergics or medications with anticholinergic activity (eg, phenothiazines, antiparkinson drugs, or tricyclics).
Prevduo Adverse Reactions
Adverse Reactions
Bradycardia, nausea, vomiting, blurred vision, photophobia, dry mouth, urinary hesitancy and retention, cycloplegia, increased ocular tension, tachycardia, palpitation, decreased sweating.
Prevduo Clinical Trials
See Literature
Prevduo Note
Not Applicable
Prevduo Patient Counseling
See Literature
