cisatracurium besylate

FDA Drug Profile — cisatracurium besylate

Drug Details

Generic Name
cisatracurium besylate
Brand Names
cisatracurium besylate
Application Number
ANDA212171
Sponsor
Zydus Pharmaceuticals USA Inc.
NDC Codes
8
Dosage Forms
INJECTION, POWDER
Routes
INTRAVENOUS
Active Ingredients
CISATRACURIUM BESYLATE

Indications and Usage

1 INDICATIONS AND USAGE Cisatracurium besylate injection is indicated: • as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age • to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU • to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older. Limitations of Use Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action. Cisatracurium besylate is a nondepolarizing neuromuscular blocker indicated: • as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age ( 1 ) • to provide skeletal muscle relaxation during surgery in adults and in pediatric patients 2 to 12 years of age as a bolus or infusion maintenance ( 1 ) • for mechanical ventilation in the ICU in adults ( 1 ) Limitations of Use Cisatracurium besylate is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action (1)