neostigmine methylsulfate and glycopyrrolate

FDA Drug Profile — PREVDUO

Drug Details

Generic Name
neostigmine methylsulfate and glycopyrrolate
Brand Names
PREVDUO
Application Number
NDA216903
Sponsor
Endo USA
NDC Codes
1
Dosage Forms
INJECTION
Routes
INTRAVENOUS
Active Ingredients
GLYCOPYRROLATE, NEOSTIGMINE METHYLSULFATE

Indications and 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 ).