fentanyl citrate

FDA Drug Profile — FENTANYL CITRATE

Drug Details

Generic Name
fentanyl citrate
Brand Names
FENTANYL CITRATE
Application Number
NDA019115
Sponsor
Bond Pharmacy INC
NDC Codes
2
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAMUSCULAR, INTRAVENOUS
Active Ingredients
FENTANYL CITRATE

Indications and Usage

1 INDICATIONS AND USAGE Fentanyl Citrate Injection is indicated for: • analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. • use as an opioid analgesic supplement in general or regional anesthesia. • administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia. • use as an anesthetic agent with oxygen in selected high-risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures. Fentanyl Citrate Injection is an opioid agonist indicated for: ( 1 ) • analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. • use as an opioid analgesic supplement in general or regional anesthesia. • administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia. • use as an anesthetic agent with oxygen in selected high risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures.