FENTANYL SUMMARY
FENTANYL CITRATE INJECTION, USP
Fentanyl Citrate Injection, USP is a sterile, nonpyrogenic solution of fentanyl citrate in water for injection. Fentanyl Citrate is a potent narcotic analgesic which is administered only by the intravenous or intramuscular routes of injection. Each milliliter contains fentanyl (as the citrate) 50 mcg (0.05 mg). May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH 4.7 (4.0 to 7.5). The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. When smaller doses are required, the unused portion should be discarded in an appropriate manner.
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.
− for use as a narcotic analgesic supplement in general or regional anesthesia.
− for administration with a neuroleptic such as droperidol injection as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia.
− for 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.
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