Fentanyl Citrate

FENTANYL CITRATE- fentanyl citrate injection, solution
Fresenius Kabi USA, LLC

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Fentanyl Citrate Injection. Monitor for respiratory depression, especially during initiation of Fentanyl Citrate Injection or following a dose increase [see Warnings and Precautions (5.2)].

Cytochrome P450 3A4 Interaction

The concomitant use of Fentanyl Citrate Injection with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of

a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving Fentanyl Citrate Injection and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.3), Drug Interactions (7), Clinical Pharmacology (12.3)]

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions (5.4), Drug Interactions (7)].

• Reserve concomitant prescribing of Fentanyl Citrate Injection and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
• Limit dosages and durations to the minimum required.
• Follow patients for signs and symptoms of respiratory depression and sedation.

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 a narcotic 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.

2 DOSAGE AND ADMINISTRATION

2.1 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 (5.4)].

Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

2.2 Dosage

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

Total Dosage (expressed as fentanyl base)

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 to 20 mcg/kg (0.002 to 0.02 mg/kg) (0.04 to 0.4 mL/kg).For use in more 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 to 50 mcg/kg (0.02 to 0.05 mg/kg) (0.4 to 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 well-being 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 of postoperative ventilation and observation due to extended post-operative respiratory depression.

Maintenance Dose (expressed as fentanyl base)

Low Dose —2 mcg/kg (0.002 mg/kg) (0.04 mL/kg).Additional dosages infrequently needed in these minor procedures.

Moderate Dose —2 to 20 mcg/kg (0.002 to 0.02 mg/kg) (0.04 to 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 to 50 mcg/kg (0.02 to 0.05 mg/kg) (0.4 to 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 indicative of stress and lightening of analgesia.Individualize the 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)

50 to 100 mcg (0.05 to 0.1 mg) (1 to 2 mL) may be administered intramuscularly for the control of pain, tachypnea and emergence delirium. The dose may be repeated in one to two hours as needed.

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.