Neostigmine Methylsulfate And Glycopyrrolate
Generic Name: neostigmine methylsulfate and glycopyrrolate
Brand Names:
Prevduo
11 DESCRIPTION PREVDUO @ (neostigmine methylsulfate and glycopyrrolate) injection is a clear colorless solution available as a prefilled syringe that contains a fixed dose combination of neostigmine methylsulfate, a cholinesterase inhibitor and glycopyrrolate, an anticholinergic agent, for intravenous administration. PREVDUO @ is available as a sterile solution in 3 mL Prefilled Syringe.
Overview
11 DESCRIPTION PREVDUO @ (neostigmine methylsulfate and glycopyrrolate) injection is a clear colorless solution available as a prefilled syringe that contains a fixed dose combination of neostigmine methylsulfate, a cholinesterase inhibitor and glycopyrrolate, an anticholinergic agent, for intravenous administration. PREVDUO @ is available as a sterile solution in 3 mL Prefilled Syringe.
Uses
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.
Dosage
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 ) • Maxi...
Side Effects
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.
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.
Warnings
5 WARNINGS AND PRECAUTIONS • Bradycardia : 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. ( 5.1 ) • Serious Reactions with Coexisting Conditions : Use with caution in patients with, coronary artery disease, cardiac arrhythmias, recent acute coronary syndrome, hyperthyroidism or myasthenia gravis. ( 5.2 ) • Hypersensitivity : Because of the possibility of hypersensitivity, medications to treat anaphylaxis should be readily available. 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 Warnin...
Pregnancy
8.1 Pregnancy Risk Summary Neostigmine Methylsulfate There are no adequate or well-controlled studies of neostigmine in pregnant women. It is not known whether neostigmine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. The incidence of malformations in human pregnancies has not been established for neostigmine as the data are limited. All pregnancies, regardless of drug exposure, have a background risk of 2 to 4% for major birth defects, and 15 to 20% for pregnancy loss.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING PREVDUO @ (neostigmine methylsulfate and glycopyrrolate) injection is a clear, colorless solution available in the following: NDC No.
Frequently Asked Questions
What is Neostigmine Methylsulfate And Glycopyrrolate used for?▼
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.
What are the side effects of Neostigmine Methylsulfate And Glycopyrrolate?▼
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.
Can I take Neostigmine Methylsulfate And Glycopyrrolate during pregnancy?▼
8.1 Pregnancy Risk Summary Neostigmine Methylsulfate There are no adequate or well-controlled studies of neostigmine in pregnant women. It is not known whether neostigmine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. The incidence of malformations in human pregnancies has not been established for neostigmine as the data are limited. All pregnancies, regardless of drug exposure, have a background risk of 2 to 4% for major birth defects, and 15 to 20% for pregnancy loss.
What are the important warnings for Neostigmine Methylsulfate And Glycopyrrolate?▼
5 WARNINGS AND PRECAUTIONS • Bradycardia : 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. ( 5.1 ) • Serious Reactions with Coexisting Conditions : Use with caution in patients with, coronary artery disease, cardiac arrhythmias, recent acute coronary syndrome, hyperthyroidism or myasthenia gravis. ( 5.2 ) • Hypersensitivity : Because of the possibility of hypersensitivity, medications to treat anaphylaxis should be readily available. 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 Warnin...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.