fentanyl citrate injection, USP CARPUJECT Dosage and Administration

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.
•
Discard unused portion.

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 (5.3)].

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 for postoperative ventilation and observation due to extended postoperative respiratory depression.

MAINTENANCE DOSAGE

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).


From 25 mcg (0.025 mg) (0.5 mL) to one half the initial loading dose as needed based on vital sign changes 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.

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Dosage and Administration

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.
•
Discard unused portion.

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 (5.3)].

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 for postoperative ventilation and observation due to extended postoperative respiratory depression.

MAINTENANCE DOSAGE

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).


From 25 mcg (0.025 mg) (0.5 mL) to one half the initial loading dose as needed based on vital sign changes 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.
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