Fentanyl Citrate
Loading...Fentanyl Citrate Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
FENTANYL CITRATE SHOULD BE ADMINISTERED ONLY BY PERSONS SPECIFICALLY TRAINED IN THE USE OF INTRAVENOUS ANESTHETICS AND MANAGEMENT OF THE RESPIRATORY EFFECTS OF POTENT OPIOIDS.
AN OPIOID ANTAGONIST, RESUSCITATIVE AND INTUBATION EQUIPMENT, AND OXYGEN SHOULD BE READILY AVAILABLE.
See also discussion of opioid antagonists in PRECAUTIONS and OVERDOSAGE.
If fentanyl is administered with a tranquilizer, the user should become familiar with the special properties of each drug, particularly the widely differing duration of action. In addition, when such a combination is used, fluids and other countermeasures to manage hypotension should be available.
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. It is recommended that opioids, when required, should be used in reduced doses initially, as low as 1/4 to 1/3 those usually recommended.
Fentanyl may cause muscle rigidity, particularly involving the muscles of respiration. This rigidity has been reported to occur or recur infrequently in the extended postoperative period usually following high dose administration. In addition, skeletal muscle movements of various groups in the extremities, neck, and external eye have been reported during induction of anesthesia with fentanyl; these reported movements have, on rare occasions, been strong enough to pose patient management problems. This effect is related to the dose and speed of injection and its incidence can be reduced by: 1) administration of up to 1/4 of the full paralyzing dose of a nondepolarizing neuromuscular blocking agent just prior to administration of fentanyl citrate; 2) administration of a full paralyzing dose of a neuromuscular blocking agent following loss of eyelash reflex when fentanyl is used in anesthetic doses titrated by slow intravenous infusion; or, 3) simultaneous administration of fentanyl citrate and a full paralyzing dose of a neuromuscular blocking agent when fentanyl citrate is used in rapidly administered anesthetic dosages. The neuromuscular blocking agent used should be compatible with the patient’s cardiovascular status.
Adequate facilities should be available for postoperative monitoring and ventilation of patients administered anesthetic doses of fentanyl. Where moderate or high doses are used (above 10 mcg/kg), there must be adequate facilities for postoperative observation, and ventilation if necessary, of patients who have received fentanyl. It is essential that these facilities be fully equipped to handle all degrees of respiratory depression.
Fentanyl may also produce other signs and symptoms characteristic of opioid agonists including euphoria, miosis, bradycardia, and bronchoconstriction.
Severe and unpredictable potentiation by MAO inhibitors has been reported for other opioid agonists. Although this has not been reported for fentanyl, there are insufficient data to establish that this does not occur with fentanyl. Therefore, when fentanyl is administered to patients who have received MAO inhibitors within 14 days, appropriate monitoring and ready availability of vasodilators and beta-blockers for the treatment of hypertension is indicated.
Head Injuries and Increased Intracranial Pressure — Fentanyl should be used with caution in patients who may be particularly susceptible to respiratory depression, such as comatose patients who may have a head injury or brain tumor. In addition, fentanyl may obscure the clinical course of patients with head injury.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Fentanyl Citrate Injection, USP 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 an opioid analgesic supplement in general or regional anesthesia.
- •
- for 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.
- •
- 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.
History
There is currently no drug history available for this drug.
Other Information
Fentanyl Citrate Injection, USP is a potent opioid agonist. Each milliliter of solution contains fentanyl (as the citrate) 50 mcg (0.05 mg), adjusted to pH 4.0 to 7.5 with sodium hydroxide. Fentanyl citrate is chemically identified as N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1) with a molecular weight of 528.61. The structural formula of fentanyl citrate is:
Fentanyl Citrate Injection, USP is a sterile, nonpyrogenic, preservative free aqueous solution for intravenous or intramuscular injection.
Sources
Fentanyl Citrate Manufacturers
-
Hospira, Inc.
![Fentanyl Citrate Injection, Solution [Hospira, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Fentanyl Citrate | Hospira, Inc.
50 mcg = 0.05 mg = 1 mL
Dosage should be individualized. Some of the factors to be considered in determining the dose are age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used and the surgical procedure involved. Dosage should be reduced in elderly or debilitated patients (see PRECAUTIONS).
Vital signs should be monitored routinely.
I. Premedication — Premedication (to be appropriately modified in the elderly, debilitated, and those who have received other depressant drugs)—50 mcg to 100 mcg (0.05 mg to 0.1 mg) (1 mL to 2 mL) may be administered intramuscularly 30 to 60 minutes prior to surgery. II. Adjunct to General Anesthesia — See Dosage Range Chart III. Adjunct to Regional Anesthesia — 50 mcg to 100 mcg (0.05 mg to 0.1 mg) (1 mL to 2 mL) may be administered intramuscularly or slowly intravenously, over one to two minutes, when additional analgesia is required. IV. Postoperatively (recovery room) — 50 mcg to 100 mcg (0.05 mg to 0.1 mg) (1 mL 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.Usage in Children: For induction and maintenance in children 2 to 12 years of age, a reduced dose as low as 2 mcg/kg to 3 mcg/kg is recommended.
DOSAGE RANGE CHARTTOTAL DOSAGE (expressed as fentanyl base)
Low Dose -
Moderate Dose -
High Dose -
2 mcg/kg (0.002 mg/kg) (0.04 mL/kg) Fentanyl, in small doses is most useful for minor, but painful, surgical procedures. In addition to the analgesia during surgery, Fentanyl may also provide some pain relief in the immediate postoperative period.
2-20 mcg/kg (0.002‑0.02 mg/kg) (0.04‑0.4 mL/kg) Where surgery becomes more major, a larger dose is required. With this dose, in addition to adequate analgesia, one would expect to see some abolition of the stress response. However, respiratory depression will be such that artificial ventilation during anesthesia is necessary and careful observation of ventilation postoperatively is essential.
20-50 mcg/kg (0.02-0.05 mg/kg) (0.4‑1 mL/kg) During open heart surgery and certain more complicated neurosurgical and orthopedic procedures where surgery is more prolonged, and in the opinion of the anesthesiologist, the stress response to surgery would be detrimental to the well being of the patient, dosages of 20‑50 mcg/kg (0.02-0.05 mg/kg) (0.4‑1 mL/kg) of fentanyl with nitrous oxide/oxygen have been shown to attenuate the stress response as defined by increased levels of circulating growth hormone, catecholamine, ADH, and prolactin. When dosages in this range have been used during surgery, postoperative ventilation and observation are essential due to extended postoperative respiratory depression. The main objective of this technique would be to produce “stress-free” anesthesia.
DOSAGE RANGE CHARTMAINTENANCE DOSAGE (expressed as fentanyl base)
Low Dose -
Moderate Dose -
High Dose -
2 mcg/kg (0.002 mg/kg) (0.04 mL/kg) Additional dosages of fentanyl are infrequently needed in these minor procedures.
2-20 mcg/kg (0.002-0.02 mg/kg) (0.04‑0.4 mL/kg) 25-100 mcg (0.025 to 0.1 mg) (0.5 to 2 mL) may be administered intravenously or intramuscularly when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia.
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) will be dictated by the changes in vital signs which indicate stress and lightening of analgesia. However, the additional dosage selected must be individualized especially if the anticipated remaining operative time is short.
As a General Anesthetic:
When attenuation of the responses to surgical stress is especially important, doses of 50 mcg/kg to 100 mcg/kg (0.05 mg/kg to 0.1 mg/kg) (1 mL/kg to 2 mL/kg) may be administered with oxygen and a muscle relaxant. This technique has been reported to provide anesthesia without the use of additional anesthetic agents. 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.
As noted above, it is essential that qualified personnel and adequate facilities be available for the management of respiratory depression.
See WARNINGS and PRECAUTIONS for use of fentanyl with other CNS depressants, and in patients with altered response.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
Hospira, Inc.
Fentanyl Citrate | Hospira, Inc.
50 mcg = 0.05 mg = 1 mL
Dosage should be individualized. Some of the factors to be considered in determining the dose are age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used and the surgical procedure involved. Dosage should be reduced in elderly or debilitated patients (see PRECAUTIONS).
Vital signs should be monitored routinely.
I. Premedication − Premedication (to be appropriately modified in the elderly, debilitated and those who have received other depressant drugs) − 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. II. Adjunct to General Anesthesia − See Dosage Range Chart. III. 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. IV. 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.Usage in Children: 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: When attenuation of the responses to surgical stress is especially important, 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. This technique has been reported to provide anesthesia without the use of additional anesthetic agents. 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.
As noted above, it is essential that qualified personnel and adequate facilities be available for the management of respiratory depression.
See WARNINGS and PRECAUTIONS for use of fentanyl with other CNS depressants, and in patients with altered response.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Do not administer unless solution is clear and container undamaged. Discard unused portion.
To prevent needle-stick injuries, needles should not be recapped, purposely bent, or broken by hand.
DOSAGE RANGE CHART
TOTAL DOSAGE (expressed as fentanyl base)
Low Dose −
Moderate Dose −
High Dose −
2 mcg/kg (0.002 mg/kg) (0.04 mL/kg). Fentanyl in small doses is most useful for minor, but painful, surgical procedures. In addition to the analgesia during surgery, fentanyl may also provide some pain relief in the immediate postoperative period.
2–20 mcg/kg (0.002–0.02 mg/kg) (0.04–0.4 mL/kg).Where surgery becomes more major, a larger dose is required.With this dose, in addition to adequate analgesia, one would expect to see some abolition of the stress response. However, respiratory depression will be such that artificial ventilation during anesthesia is necessary and careful observation of ventilation postoperatively is essential.
20–50 mcg/kg (0.02‑0.05 mg/kg) (0.4–1 mL/kg). During open heart surgery and certain more complicated neurosurgical and orthopedic procedures where surgery is more prolonged, and in the opinion of the anesthesiologist, the stress response to surgery would be detrimental to the well being of the patient, dosages of 20‑50 mcg/kg (0.02–0.05 mg/kg) (0.4‑1 mL/kg) of fentanyl with nitrous oxide/oxygen have been shown to attenuate the stress response as defined by increased levels of circulating growth hormone, catecholamine, ADH and prolactin. When dosages in this range have been used during surgery, postoperative ventilation and observation are essential due to extended postoperative respiratory depression. The main objective of this technique would be to produce “stress free” anesthesia.
DOSAGE RANGE CHART
MAINTENANCE DOSE (expressed as fentanyl base)
Low Dose −
Moderate Dose −
High Dose −
2 mcg/kg (0.002 mg/kg) (0.04 mL/kg). Additional dosages of fentanyl are infrequently needed in these minor procedures.
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) may be administered intravenously or intramuscularly when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia.
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) will be dictated by the changes in vital signs which indicate stress and lightening of analgesia. However, the additional dosage selected must be individualized especially if the anticipated remaining operative time is short.
-
Baxter Healthcare Corporation
Fentanyl Citrate | Baxter Healthcare Corporation
The 2 mL Fentanyl Citrate Injection vial includes a cautionary label that extends above the main label and highlights the drug name, fentanyl. The purpose of the extended label is to prevent selection error with other drugs, such as Sufentanil. Read the label and confirm you have selected the correct medication. Then locate the “Tear Here” point on the label, and remove this cautionary label prior to removing the flip-off cap.
Single Dose - Destroy unused contents.
50 mcg = 0.05 mg = 1 mL
Dosage should be individualized. Some of the factors to be considered in determining the dose are age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used and the surgical procedure involved. Dosage should be reduced in elderly or debilitated patients (see PRECAUTIONS).
Vital signs should be monitored routinely.
I. PremedicationPremedication (to be appropriately modified in the elderly, debilitated and those who have received other depressant drugs)—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.
II. Adjunct to General AnesthesiaSee Dosage Range Charts.
III. Adjunct to Regional Anesthesia50 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.
IV. 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.
Usage in ChildrenFor induction and maintenance in children 2 to 12 years of age, a reduced dose as low as 2 to 3 mcg/kg is recommended.
Dosage Range Chart
Total Dosage (expressed as fentanyl base)
Low dose—2 mcg/kg (0.002 mg/kg) (0.04 mL/kg).
Fentanyl in small doses is most useful for minor, but painful, surgical procedures. In addition to the analgesia during surgery, fentanyl 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).
Where surgery becomes more major, a larger dose is required. With this dose, in addition to adequate analgesia, one would expect to see some abolition of the stress response. However, respiratory depression will be such that artificial ventilation during anesthesia is necessary, 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).
During open heart surgery and certain more complicated neurosurgical and orthopedic procedures where surgery is more prolonged, and in the opinion of the anesthesiologist, the stress response to surgery would be detrimental to the well being of the patient, dosages of 20 to 50 mcg/kg (0.02 to 0.05 mg/kg) (0.4 to 1 mL/kg) of fentanyl with nitrous oxide/oxygen have been shown to attenuate the stress response as defined by increased levels of circulating growth hormone, catecholamine, ADH and prolactin. When dosages in this range have been used during surgery, postoperative ventilation and observation are essential due to extended post-operative respiratory depression. The main objective of this technique would be to produce “stress free” anesthesia.Dosage Range Chart
Maintenance Dose (expressed as fentanyl base)
Low dose—2 mcg/kg (0.002 mg/kg) (0.04 mL/kg).
Additional dosages of fentanyl are 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) may be administered intravenously or intramuscularly 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).
As a General Anesthetic
Maintenance dosage (ranging from 25 mcg [0.025 mg] [0.5 mL] to one half the initial loading dose) will be dictated by the changes in vital signs which indicate stress and lightening of analgesia. However, the additional dosage selected must be individualized especially if the anticipated remaining operative time is short.When attenuation of the responses to surgical stress is especially important, 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. This technique has been reported to provide anesthesia without the use of additional anesthetic agents. 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.
As noted above, it is essential that qualified personnel and adequate facilities be available for the management of respiratory depression.
See WARNINGS and PRECAUTIONS for use of fentanyl with other CNS depressants, and in patients with altered response.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
Mallinckrodt Inc.
Fentanyl Citrate | Mallinckrodt Inc.
Healthcare professionals who prescribe oral transmucosal fentanyl citrate on an outpatient basis must enroll in the TIRF REMS Access program and comply with the requirements of the REMS to ensure safe use of oral transmucosal fentanyl citrate [see Warnings and Precautions (5.10)].
As with all opioids, the safety of patients using such products is dependent on health care professionals prescribing them in strict conformity with their approved labeling with respect to patient selection, dosing, and proper conditions for use.
2.1 Initial DoseIndividually titrate oral transmucosal fentanyl citrate to a dose that provides adequate analgesia and minimizes side effects. The initial dose of oral transmucosal fentanyl citrate to treat episodes of breakthrough cancer pain is always 200 mcg. The oral transmucosal fentanyl citrate unit should be consumed over 15 minutes. Patients should be prescribed an initial titration supply of six 200 mcg oral transmucosal fentanyl citrate units, thus limiting the number of units in the home during titration. Patients should use up all units before increasing to a higher dose to prevent confusion and possible overdose.
2.2 Dose TitrationFrom this initial dose, closely follow patients and change the dosage level until the patient reaches a dose that provides adequate analgesia using a single oral transmucosal fentanyl citrate dosage unit per breakthrough cancer pain episode. If signs of excessive opioid effects appear before the unit is consumed, the dosage unit should be removed from the patient’s mouth immediately, disposed of properly, and subsequent doses should be decreased. Patients should record their use of oral transmucosal fentanyl citrate over several episodes of breakthrough cancer pain and review their experience with their physicians to determine if a dosage adjustment is warranted.
In cases where the breakthrough pain episode is not relieved 15 minutes after completion of the oral transmucosal fentanyl citrate unit (30 minutes after the start of the unit), patients may take ONLY ONE additional dose of the same strength for that episode. Thus, patients should take a maximum of two doses of oral transmucosal fentanyl citrate for any breakthrough pain episode.
Patients must wait at least 4 hours before treating another episode of breakthrough pain with oral transmucosal fentanyl citrate. To reduce the risk of overdosing during titration, patients should have only one strength of oral transmucosal fentanyl citrate available at any one time.
2.3 Maintenance DosingOnce titrated to an effective dose, patients should generally use ONLY ONE oral transmucosal fentanyl citrate unit of the appropriate strength per breakthrough pain episode.
On those occasions when the breakthrough pain episode is not relieved 15 minutes after completion of the oral transmucosal fentanyl citrate unit, patient may take ONLY ONE additional dose using the same strength for that episode.
Patients MUST wait at least 4 hours before treating another episode of breakthrough pain with oral transmucosal fentanyl citrate. Once a successful dose has been found (i.e., an average episode is treated with a single unit), patients should limit consumption to four or fewer units per day.
Dosage adjustment of oral transmucosal fentanyl citrate may be required in some patients in order to continue to provide adequate relief of breakthrough pain.
Generally, the oral transmucosal fentanyl citrate dose should be increased only when a single administration of the current dose fails to adequately treat the breakthrough pain episode for several consecutive episodes.
If the patient experiences greater than four breakthrough pain episodes per day, the dose of the maintenance (around-the-clock) opioid used for persistent pain should be re-evaluated.
2.4 Administration of Oral Transmucosal Fentanyl CitrateOpen the blister package with scissors immediately prior to product use. The patient should place the oral transmucosal fentanyl citrate unit in his or her mouth between the cheek and lower gum, occasionally moving the drug matrix from one side to the other using the handle. The oral transmucosal fentanyl citrate unit should be sucked, not chewed. A unit dose of oral transmucosal fentanyl citrate, if chewed and swallowed, might result in lower peak concentrations and lower bioavailability than when consumed as directed [see Clinical Pharmacology (12.3)].
The oral transmucosal fentanyl citrate unit should be consumed over a 15-minute period. Longer or shorter consumption times may produce less efficacy than reported in oral transmucosal fentanyl citrate clinical trials. If signs of excessive opioid effects appear before the unit is consumed, remove the drug matrix from the patient’s mouth immediately and decrease future doses.
2.5 Discontinuation of Oral Transmucosal Fentanyl CitrateFor patients requiring discontinuation of opioids, a gradual downward titration is recommended because it is not known at what dose level the opioid may be discontinued without producing the signs and symptoms of abrupt withdrawal.
-
West-ward Pharmaceutical Corp.
Fentanyl Citrate | West-ward Pharmaceutical Corp.
The 2 mL Fentanyl Citrate Injection vial includes a cautionary label that extends above the main label and highlights the drug name, fentanyl. The purpose of the extended label is to prevent selection error with other drugs, such as Sufentanil. Read the label and confirm you have selected the correct medication. Then locate the “Tear Here” point on the label, and remove this cautionary label prior to removing the flip-off cap.
Single Dose - Destroy unused contents.
50 mcg = 0.05 mg = 1 mLDosage should be individualized. Some of the factors to be considered in determining the dose are age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used and the surgical procedure involved. Dosage should be reduced in elderly or debilitated patients (see PRECAUTIONS).
Vital signs should be monitored routinely.
I. PremedicationPremedication (to be appropriately modified in the elderly, debilitated and those who have received other depressant drugs)—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.
II. Adjunct to General AnesthesiaSee Dosage Range Charts.
III. Adjunct to Regional Anesthesia50 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.
IV. 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.
Usage in ChildrenFor induction and maintenance in children 2 to 12 years of age, a reduced dose as low as 2 to 3 mcg/kg is recommended.
Dosage Range Chart
Total Dosage (expressed as fentanyl base) Low dose—2 mcg/kg (0.002 mg/kg) (0.04 mL/kg).
Fentanyl in small doses is most useful for minor, but painful, surgical procedures. In addition to the analgesia during surgery, fentanyl 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).
Where surgery becomes more major, a larger dose is required. With this dose, in addition to adequate analgesia, one would expect to see some abolition of the stress response. However, respiratory depression will be such that artificial ventilation during anesthesia is necessary, 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).
During open heart surgery and certain more complicated neurosurgical and orthopedic procedures where surgery is more prolonged, and in the opinion of the anesthesiologist, the stress response to surgery would be detrimental to the well being of the patient, dosages of 20 to 50 mcg/kg (0.02 to 0.05 mg/kg) (0.4 to 1 mL/kg) of fentanyl with nitrous oxide/oxygen have been shown to attenuate the stress response as defined by increased levels of circulating growth hormone, catecholamine, ADH and prolactin. When dosages in this range have been used during surgery, postoperative ventilation and observation are essential due to extended post-operative respiratory depression. The main objective of this technique would be to produce “stress free” anesthesia.Dosage Range Chart
Maintenance Dose (expressed as fentanyl base) Low dose—2 mcg/kg (0.002 mg/kg) (0.04 mL/kg).
Additional dosages of fentanyl are 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) may be administered intravenously or intramuscularly 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) will be dictated by the changes in vital signs which indicate stress and lightening of analgesia. However, the additional dosage selected must be individualized especially if the anticipated remaining operative time is short. As a General AnestheticWhen attenuation of the responses to surgical stress is especially important, 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. This technique has been reported to provide anesthesia without the use of additional anesthetic agents. 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.
As noted above, it is essential that qualified personnel and adequate facilities be available for the management of respiratory depression.
See WARNINGS and PRECAUTIONS for use of fentanyl with other CNS depressants, and in patients with altered response.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Akorn, Inc.
Fentanyl Citrate | Akorn, Inc.
50 mcg = 0.05 mg = 1 mL
Dosage should be individualized. Some of the factors to be considered in determining the dose are age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used and the surgical procedure involved. Dosage should be reduced in elderly or debilitated patients (see PRECAUTIONS).
Vital signs should be monitored routinely.
Premedication — Premedication (to be appropriately modified in the elderly, debilitated and those who have received other depressant drugs) — 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 Chart 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.Usage in Children: 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.
DOSAGE RANGE CHART TOTAL DOSAGE Low Dose — 2 mcg/kg
(0.002 mg/kg) (0.04 mL/kg) fentanyl. Fentanyl in small doses is most useful for minor, but painful, surgical procedures. In addition to the analgesia during surgery, fentanyl 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). Where surgery becomes more major, a larger dose is required. With this dose, in addition to adequate analgesia, one would expect to see some abolition of the stress response. However, respiratory depression will be such that artificial ventilation during anesthesia is necessary 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). During open heart surgery and certain more complicated neurosurgical and orthopedic procedures where surgery is more prolonged, and in the opinion of the anesthesiologist, the stress response to surgery would be detrimental to the well being of the patient, dosages of 20 to 50 mcg/kg (0.02 to 0.05 mg) (0.4 to 1 mL) of fentanyl with nitrous oxide/oxygen have been shown to attenuate the stress response as defined by increased levels of circulating growth hormone, catecholamine, ADH and prolactin. When dosages in this range have been used during surgery, postoperative ventilation and observation are essential due to extended postoperative respiratory depression. The main objective of this technique would be to produce “stress free” anesthesia. DOSAGE RANGE CHART MAINTENANCE DOSAGE Low Dose — 2 mcg/kg (0.002 mg/kg) (0.04 mL/kg).
Additional dosages of fentanyl are 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 2.0 mL) may be administered intravenously or intramuscularly 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 mcg/kg) (0.4 to 1.0 mL/kg). Maintenance dosage (ranging from 25 mcg (0.025 mg) (0.5 mL) to one half the initial loading dose) will be dictated by the changes in vital signs which indicate stress and lightening of analgesia. However, the additional dosage selected must be individualized especially if the anticipated remaining operative time is short. As a General AnestheticWhen attenuation of the responses to surgical stress is especially important, 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. This technique has been reported to provide anesthesia without the use of additional anesthetic agents. 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.
As noted above, it is essential that qualified personnel and adequate facilities be available for the management of respiratory depression.
See WARNINGS and PRECAUTIONS for use of fentanyl with other CNS depressants, and in patients with altered response.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cantrell Drug Company
Fentanyl Citrate | Cantrell Drug Company
There is currently no dosage information available for this product. We apologize for any inconvenience.
![Fentanyl Citrate Injection, Solution [Hospira, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bfa8018a-4cbc-434b-e09e-782872b0340a&name=fentanyl-citrate1-figure-2-jRL-1132.jpg)
![Fentanyl Citrate Injection, Solution [Baxter Healthcare Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8c630f74-906d-47a5-8e41-3334df191cb0&name=550d42a8-7410-4e89-85f8-30dd1bf26149-02.jpg)
![Fentanyl Citrate (Fentanyl Citrate ) Lozenge [Mallinckrodt Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=552ba162-76ed-4bc9-8c2c-fac7a1804da0&name=920230-cxs030-us0112.jpg)
![Fentanyl Citrate Injection [West-ward Pharmaceutical Corp.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ce5db1c2-feb1-4ad2-847a-d02e865bd47e&name=fentanyl-citrate-injection-usp-10.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bb940c9d-99c0-4a6e-941e-4bc91d9d3628&name=52533-024-71.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a2603cb4-a700-420e-aee5-58f6838567ab&name=52533-024-01.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4ebe41a0-539a-4914-85ff-3971e994785f&name=52533-116-75.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6f57b24b-b0ce-4d6a-b533-26ef4b9a20b1&name=52533-026-10.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=262fde40-115d-4d8a-b044-643128fff56b&name=52533-024-75.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f98ebc12-05ac-4777-9eb5-642fb8124b50&name=52533-025-75.jpg)
![Fentanyl Citrate Injection [Akorn, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c5d40297-b769-48cc-9f84-f98b7a333507&name=fen02-0000-02.jpg)
![Fentanyl Citrate, Bupivacaine Hcl Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2eb63a37-acd7-4b8a-a002-48e5060a703d&name=52533-080-64.jpg)
![Fentanyl Citrate, Bupivacaine Hcl Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7d12ffd8-ae8e-4fe2-9900-769e05fbe4ce&name=52533-174-75.jpg)
![Fentanyl Citrate, Bupivacaine Hcl Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=33c34be1-4871-4f0a-9f52-f9606c87e1df&name=52533-080-75.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=119881aa-f508-455e-9fdb-6444ccce2d56&name=52533-024-43.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=898706aa-203a-497b-9ac2-8a3728d955d8&name=52533-116-10.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=972f6cbc-32e3-4ef1-b644-94f79ff23a95&name=52533-026-04.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=207c3e4b-2cf0-41d8-82c3-caa21553edd4&name=52533-074-39.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1bc95d37-9d10-4c6c-88a3-bb83d937b268&name=52533-116-48.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=73cede3f-aff0-40b8-8a58-f5fc269d1b8d&name=52533-074-16.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=62752ca3-060e-430b-a05c-40c89ee5df1d&name=52533-024-45.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=58c3bcc5-4e6b-4cb9-9912-940a664e9d71&name=52533-074-15.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7b01f652-6ee8-4bf1-b311-6e1c75356284&name=52533-024-61.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=62f80157-f1d7-4d4a-b88a-117fe3285da1&name=52533-024-05.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8f0aa19c-825a-435e-8b72-4e39a5c9e226&name=52533-024-10.jpg)
![Fentanyl Citrate, Bupivacaine Hcl Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0aad9e57-d33f-444f-90b6-67138387e631&name=52533-081-62.jpg)
![Fentanyl Citrate, Bupivacaine Hcl Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cfecc5f4-5ce0-46d5-b1d4-92654246fcb2&name=52533-080-61.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bde24a8c-526d-4246-acfa-ea2b95e8a5fb&name=52533-024-04.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=da928672-4144-4ec4-93ba-e466f2a4a7e4&name=52533-024-18.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a7d7e065-8089-4951-bd39-71e9963672d5&name=52533-024-35.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=dfd161c2-a2e2-437c-abb5-5c33d87da31c&name=52533-026-07.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cef7cd9f-c665-4fba-88aa-325e63ecf384&name=52533-116-05.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5d17e37e-f2dc-4f77-9b9b-d8f6945b6862&name=52533-214-60.jpg)
![Fentanyl Citrate, Bupivacaine Hcl Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e364b224-8fb5-45cd-8e29-adb09afae80f&name=52533-124-11.jpg)
![Fentanyl Citrate, Bupivacaine Hcl Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8461f53f-445c-48df-8f73-07d8a96e057c&name=52533-124-46.jpg)
![Fentanyl Citrate, Bupivacaine Hcl Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=17606e46-f2c4-4821-b67d-a76b41a227e1&name=52533-080-11.jpg)
![Fentanyl Citrate, Bupivacaine Hcl Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f901adfc-82e2-412d-ae29-685263506837&name=52533-124-62.jpg)
![Fentanyl Citrate, Bupivacaine Hcl Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d33ab284-dcda-43d9-8fad-b1fd988a7bc9&name=52533-124-61.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f936818a-b0bd-4811-b9b8-3fa9620a7379&name=52533-025-10.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9622cd81-1387-41c5-a42d-469d2e757629&name=52533-025-05.jpg)
![Fentanyl Citrate Injection, Solution [Cantrell Drug Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2e325659-b551-4fb0-b5fc-302de211596b&name=52533-026-05.jpg)
Login To Your Free Account