PREVDUO .2 mg/mL
neostigmine methylsulfate and glycopyrrolate · INJECTION · Endo USA
PREVDUO is a injection containing neostigmine methylsulfate and glycopyrrolate at .2 mg/mL, taken intravenous. Manufactured by Endo USA.
Key Facts
- Brand Name
- PREVDUO
- Generic Name
- neostigmine methylsulfate and glycopyrrolate
- NDC Code (Product)
42023-269- Manufacturer
- Endo USA
- Strength
- .2 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA216903
- Marketing Start
- 05/15/2023
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE PREVDUO ® , a fixed dose combination of cholinesterase inhibitor and antimuscarinic agent, is indicated in patients age two years and above for the reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery, while decreasing the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) associated with cholinesterase inhibition following NMBA reversal administration. PREVDUO ® , a fixed dose combination of a cholinesterase inhibitor and antimuscarinic agent, is indicated in patients age two years and above for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery, while decreasing the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) associated with cholinesterase inhibition following NMBA reversal administration ( 1 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Should be administered by trained healthcare providers ( 2.1 ) • Peripheral nerve stimulator and monitoring for twitch responses should be used to determine when PREVDUO ® should be initiated and if additional doses are needed ( 2.2 ) • For reversal of NMBAs with shorter half-lives in patients age 2 years and up, when first twitch response is substantially greater than 10% of baseline, or when a second twitch is present: 0.03 mg/kg of neostigmine methylsulfate (0.006 mg/kg of glycopyrrolate) by intravenous route ( 2.2 ) • For reversal of NMBAs with longer half-lives or when first twitch response is close to 10% of baseline in patients age 2 years and up: 0.07 mg/kg of neostigmine methylsulfate (0.014 mg/kg of glycopyrrolate) by intravenous route ( 2.2 ) • Maximum total dosage is 0.07 mg/kg of neostigmine methylsulfate or up to a total of 5 mg neostigmine methylsulfate (whichever is less) ( 2.2 ) 2.1 Important Dosage and Administration Information • PREVDUO ® should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal ag…
Contraindications
4 CONTRAINDICATIONS PREVDUO ® 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) and glycopyrrolate or any inactive ingredients [ see Warnings and Precautions ( 5.3 ) ]. • peritonitis or mechanical obstruction of the intestinal or urinary tract. • 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. • Hypersensitivity to neostigmine, glycopyrrolate, or nonactive ingredients ( 4 ) • Peritonitis or mechanical obstruction of the intestinal or urinary tract ( 4 ) • Patients with glaucoma; obstructive uropathy; obstructive disease of the gastrointestinal tract; paralytic…
Drug Interactions
7 DRUG INTERACTIONS Neostigmine Methylsulfate The pharmacokinetic interaction between neostigmine methylsulfate and other drugs has not been studied. Neostigmine methylsulfate is metabolized by microsomal enzymes in the liver. Use with caution when using neostigmine methylsulfate with other drugs which may alter the activity of metabolizing enzymes or transporters. Glycopyrrolate The concurrent use of glycopyrrolate with other anticholinergics or medications with anticholinergic activity, such as phenothiazines, antiparkinson drugs, or tricyclic antidepressants, may intensify the antimuscarinic effects and may result in an increase in anticholinergic side effects. The concurrent use of glycopyrrolate with other anticholinergics or medications with anticholinergic activity may intensify the antimuscarinic effects and may result in an increase in anticholinergic side effects. ( 7 )
Adverse Reactions
6 ADVERSE REACTIONS • Most common adverse reactions to neostigmine during treatment: bradycardia, nausea, vomiting, blurred vision and photophobia. ( 6 ) • Most common adverse reactions to glycopyrrolate are related to anticholinergic pharmacology and may include xerostomia (dry mouth); urinary hesitancy and retention; blurred vision and photophobia due to mydriasis (dilation of the pupil); cycloplegia; increased ocular tension; tachycardia; bradycardia; palpitation; and decreased sweating. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Endo at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Neostigmine Methylsulfate Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions to neostigmine methylsulfate are most often attributable to exaggerated pharmacological effects, in particular, at muscarinic receptor sites. The addition of glycopyrrolate to the neostigmine-glycopyrrolate prefilled syringe may prevent or…
Frequently Asked Questions
What is PREVDUO used for?
PREVDUO contains neostigmine methylsulfate and glycopyrrolate. It is a injection taken intravenous. Consult your doctor for specific uses.
Is PREVDUO a controlled substance?
PREVDUO is not classified as a controlled substance by the DEA.
What is the generic name for PREVDUO?
The generic name for PREVDUO is neostigmine methylsulfate and glycopyrrolate. There are no other listed brand versions of neostigmine methylsulfate and glycopyrrolate.
What is the NDC code for PREVDUO .2 mg/mL?
The NDC (National Drug Code) for PREVDUO .2 mg/mL is 42023-269, listed by Endo USA.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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