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Fentanyl Citrate Injection is an opioid agonist. Fentanyl Citrate Injection, is a sterile, nonpyrogenic solution of fentanyl citrate in water for injection, available as 50 mcg (0.05 mg) per mL which is administered only by the intravenous or intramuscular routes of injection. The chemical name is N-(1- phenethyl-4-piperidyl) propionanilide citrate (1:1). The molecular weight is 528.60. Its molecular formula is C22H28N2O•C6H8O7,
Fentanyl citrate, a white powder which is sparingly soluble in water. 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.
- 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.
DOSAGE AND ADMINISTRATION
Important Dosage And Administration Instructions
Fentanyl Citrate Injection should be administered only by persons specifically trained in the use of intravenous anesthetics and management of the respiratory effects of potent opioids.
- Ensure that an opioid antagonist, resuscitative and intubation equipment, and oxygen are readily available.
- Individualize dosage based on factors such as age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used, and the surgical procedure involved.
- Monitor vital signs routinely.
As with other potent opioids, the respiratory depressant effect of fentanyl may persist longer than the measured analgesic effect. The total dose of all opioid agonists administered should be considered by the practitioner before ordering opioid analgesics during recovery from anesthesia.
If Fentanyl Citrate Injection is administered with a CNS depressant, become familiar with the properties of each drug, particularly each product’s duration of action. In addition, when such a combination is used, fluids and other countermeasures to manage hypotension should be available [see WARNINGS AND PRECAUTIONS].
Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
50 mcg = 0.05 mg = 1 mL
Premedication In Adults
50 to 100 mcg (0.05 to 0.1 mg) (1 to 2 mL) may be administered intramuscularly 30 to 60 minutes prior to surgery.
Adjunct To General Anesthesia
See Dosage Range Charts below.
Table 1: Dosage Range Chart
|Low Dose – 2 mcg/kg (0.002 mg/kg) (0.04 mL/kg). For use in minor, but painful, surgical procedures. May also provide some pain relief in the immediate postoperative period.||Moderate Dose – 2-20 mcg/kg (0.002-0.02 mg/kg) (0.04-0.4 mL/kg). For use in major surgical procedures, in addition to adequate analgesia, may abolish some of the stress response. Expect respiratory depression requiring artificial ventilation during anesthesia and careful observation of ventilation postoperatively is essential.||High Dose – 20-50 mcg/kg (0.02-0.05 mg/kg) (0.4-1 mL/kg). For open heart surgery and certain more complicated neurosurgical and orthopedic procedures where surgery is more prolonged, and the stress response to surgery would be detrimental to the wellbeing of the patient. In conjunction with nitrous oxide/oxygen has been shown to attenuate the stress response as defined by increased levels of circulating growth hormone, catecholamine, ADH and prolactin. Expect the need for postoperative ventilation and observation are essential due to extended postoperative respiratory depression.|
|MAINTENANCE DOSE (expressed as fentanyl base)|
|Low Dose – 2 mcg/kg (0.002 mg/kg) (0.04 mL/kg). Additional dosages are infrequently needed in these minor procedures.||Moderate Dose – 2-20 mcg/kg (0.002-0.02 mg/kg) (0.04-0.4 mL/kg). 25 to 100 mcg (0.025 to 0.1 mg) (0.5 to 2 mL) Administer intravenously or intramuscularly as needed when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia.||High Dose – 20-50 mcg/kg (0.02-0.05 mg/kg) (0.4-1 mL/kg). Maintenance dosage [ranging from 25 mcg (0.025 mg) (0.5 mL) to one half the initial loading dose] as needed based on vital signs changes indicative of stress and lightening of analgesia. Individualize dosage especially if the anticipated remaining operative time is short.|
Adjunct To Regional Anesthesia
50 to 100 mcg (0.05 to 0.1 mg) (1 to 2 mL) may be administered intramuscularly or slowly intravenously, over one to two minutes, when additional analgesia is required.
Postoperatively (recovery room)
For Induction And Maintenance In Children 2 To 12 Years Of Age
A reduced dose as low as 2 to 3 mcg/kg is recommended.
As A General Anesthetic
As a technique to attenuate the responses to surgical stress without the use of additional anesthetic agents, doses of 50 to 100 mcg/kg (0.05 to 0.1 mg/kg) (1 to 2 mL/kg) may be administered with oxygen and a muscle relaxant. In certain cases, doses up to 150 mcg/kg (0.15 mg/kg) (3 mL/kg) may be necessary to produce this anesthetic effect. It has been used for open heart surgery and certain other major surgical procedures in patients for whom protection of the myocardium from excess oxygen demand is particularly indicated, and for certain complicated neurological and orthopedic procedures.