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fentanyl citrate

Pronunciation

Generic Name: fentanyl citrate (oral transmucosal) (FEN ta nil SIT rayt)
Brand Name: Actiq

What is fentanyl citrate?

Fentanyl citrate is an opioid pain medication. An opioid is sometimes called a narcotic.

Fentanyl citrate treats "breakthrough" cancer pain that is not controlled by other medicines. This medication is not for treating pain that is not cancer-related, such as migraine headaches or pain after surgery.

Fentanyl citrate is available only from a certified pharmacy under a special program called Actiq REMS Program.

Fentanyl citrate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about fentanyl citrate?

Fentanyl can slow or stop your breathing. MISUSE OF ACTIQ CAN CAUSE DEATH, especially in a child who gets a hold of an Actiq unit and places it in the mouth. Keep both the used and the unused Actiq units out of the reach of children.

Do not use fentanyl citrate if you are NOT already being treated with a similar opioid (narcotic) pain medicine and are tolerant to it. You may not be able to use fentanyl citrate if you also use certain antibiotics, antifungal medications, heart or blood pressure medications, or medicines to treat HIV or AIDS. Tell your doctor about all medicines you use.

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If you switch from using Actiq to using other forms of fentanyl, you will not use the same dose.

Fentanyl may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction.

What should I discuss with my health care provider before taking fentanyl citrate?

Do not use this medicine if you are allergic to fentanyl, or:

  • if you are NOT already being treated with a similar opioid (narcotic) pain medicine and are tolerant to it.

Some medicines can cause unwanted or dangerous effects when used with fentanyl citrate. You may not be able to use this medicine if you also use certain antibiotics, antifungal medications, heart or blood pressure medications, or medicines to treat HIV or AIDS. Tell your doctor about all medicines you use.

To make sure fentanyl citrate is safe for you, tell your doctor if you have:

  • any type of breathing problem or lung disease;

  • a history of head injury, brain tumor, or mental illness;

  • a history of alcoholism or drug addiction;

  • a seizure disorder;

  • liver or kidney disease; or

  • low blood pressure, heart disease, slow heartbeats.

Fentanyl citrate should not be given to a child younger than 16 years old. Do not give an Actiq unit to any person who does not have a personal prescription for this medicine.

It is not known whether this medicine will harm an unborn baby. If you use fentanyl while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Fentanyl can pass into breast milk and may cause sleepiness or breathing problems in a nursing baby. Fentanyl may also cause withdrawal symptoms in a nursing infant. Do not breast-feed while using fentanyl citrate.

If you are diabetic, you should know that each Actiq unit contains 2 grams (one-half teaspoon) of sugar.

How should I take fentanyl citrate?

Follow all directions on your prescription label. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Fentanyl may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Fentanyl can slow or stop your breathing. MISUSE OF ACTIQ CAN CAUSE DEATH, especially in a child who gets a hold of an Actiq unit and places it in the mouth. Read all patient instructions carefully before using fentanyl citrate.

The Actiq transmucosal unit is a fentanyl citrate lozenge attached to a plastic handle. Each unit is wrapped in a child-proof blister pack. Cut the blister pack open with scissors when you are ready to use the unit.

Place the medicine in your mouth between your cheek and gum, and hold the handle with your fingers. Twirl the handle to move the medicine around in your mouth while sucking on it.

Allow the medicine to dissolve in your mouth for 15 minutes. Swallow when needed. Do not bite or chew the lozenge. Do not eat or drink anything while the unit is in your mouth. If you need to use a second unit, wait at least 15 minutes after you have finished the first unit. Use only 1 Actiq unit at a time.

If you feel dizzy or sick to your stomach before the medicine has completely dissolved, stop using the unit and call your doctor.

Do not stop using any other pain medicines your doctor has prescribed for you.

If you switch from using Actiq to using other forms of fentanyl, you will not use the same dose. Many forms of fentanyl are given at lower doses than Actiq. If you use the same dose of each medication, you may have life-threatening overdose symptoms.

Pay special attention to your dental hygiene. Fentanyl citrate can cause dry mouth leading to tooth decay.

Do not stop using fentanyl citrate suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat. Leave each unit in its child-proof blister pack until you are ready to use it.

Keep track of how many Actiq units have been used from each new supply of this medicine. Fentanyl citrate is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Keep both used and unused Actiq units out of the reach of children or pets. The amount of fentanyl citrate in the Actiq unit can be fatal to a child who accidentally sucks on or swallows the unit. Seek emergency medical attention if this happens.

Actiq comes with a kit and instructions for storing and disposing of the Actiq units.

After you have stopped using this medication, use wire-cutting pliers to cut the handles off any unused Actiq lozenges. Do not keep leftover lozenges. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the lozenges down the toilet. Follow the instructions provided with Actiq when disposing of unused medicine.

What happens if I miss a dose?

Since fentanyl citrate is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

What should I avoid while taking fentanyl citrate?

Do not drink alcohol or dangerous side effects and death could occur.

Fentanyl citrate may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Grapefruit and grapefruit juice may interact with fentanyl citrate and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Fentanyl citrate side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Remove the Actiq unit from your mouth and call your doctor at once if you have:

  • weak or shallow breathing;

  • confusion, extreme drowsiness; or

  • a light-headed feeling, like you might pass out.

This medicine is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

Common side effects may include:

  • dizziness, mild drowsiness, depressed mood;

  • sleep problems (insomnia);

  • headache, weakness, anxiety;

  • nausea, vomiting, constipation; or

  • mild rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Fentanyl citrate dosing information

Usual Adult Dose for Chronic Pain:

TRANSDERMAL PATCH:
-Due to the risk of respiratory depression, the transdermal patch is for use in opioid-tolerant patients only; opioid tolerant patients have been taking at least: morphine 60 mg daily, oral oxycodone 30 mg daily, oral hydromorphone 8 mg daily, or an equianalgesic dose of another opioid for 1 week or longer.
-Discontinue all other extended-release opioids when beginning therapy.

Initial doses: The initial dose should be individualized taking into account the patient's prior treatment experience. This dose may be calculated based on the dose conversion guidelines in the product package insert, local protocol, or another reliable reference; when calculating, be aware there is substantial inter-patient variability in the relative potency of different opioid drugs and products and therefore it is preferable to underestimate a 24-hour fentanyl requirement and provide rescue medication than to overestimate which could result in adverse reactions.
Dose titration:
-Initial: May increase dose after 3 days based on the daily dose of supplemental opioid analgesics required by the patient on the second or third day of the initial application.
-Further titration should occur after no less than two 3-day applications as it may take up to 6 days for fentanyl levels to reach equilibrium. Titration should be based on the daily dose of supplementary opioids required and the following ratio may be used: Increase transdermal fentanyl by 12 mcg//hr for use of supplemental oral morphine doses of 45 mg/24 hours.
Maintenance dose: Adjust dose to obtain an appropriate balance between pain management and opioid-related adverse reactions. During chronic therapy, periodically reassess the continued need for opioid analgesics.

Comments:
-Do not begin a patient on a fentanyl transdermal patch as their first opioid..
-A small number of patients may require a 48-hour dosing interval; an increase in dose should be evaluated before changing dosing intervals.
-For delivery rates in excess of 100 mcg/hour, multiple systems may be used.

Use: For the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Usual Adult Dose for Breakthrough Pain:

TRANSMUCOSAL PRODUCTS
-For use in patients who are opioid-tolerant and taking around-the-clock opioids. Opioid tolerant patients have been taking at least: morphine 60 mg daily, oral oxycodone 30 mg daily, oral hydromorphone 8 mg daily, or an equianalgesic dose of another opioid for 1 week or longer.
-All transmucosal products must be individually titrated to an effective and tolerable dose. Once titrated, these products are used to treat up to 4 episodes of breakthrough pain a day; if a patient is experiencing more than 4 breakthrough episodes per day, the around-the-clock opioid dose should be re-evaluated. If the around-the-clock opioid dose is adjusted, re-adjustment of the transmucosal product may be necessary.
-Transmucosal fentanyl products are not bioequivalent; patients should not be interchanged on a mcg per mcg basis from 1 fentanyl product to any other fentanyl product

TRANSMUCOSAL LOZENGE (Actiq(R))
Initial dose: 200 mcg consumed over 15 minutes
Dose titration: If breakthrough pain is not relieved 15 minutes after completion of 1 unit (30 minutes after start), 1 additional unit of the same strength may be taken; Patients must wait at least 4 hours before re-treating. If breakthrough pain had not been relieved with 1 unit, the dose should be increased to the next highest strength with subsequent episodes of pain.
Maintenance dose: An effective dose is achieved when 1 unit is mostly sufficient to treat an episode of breakthrough pain; however, if there is inadequate analgesia a second dose of the same strength may be given 15 minutes after completion (30 minutes after start); no more than 2 doses should be used to treat any episode of breakthrough pain.
Maximum dose: 4 breakthrough episodes per day at intervals of at least 4 hours

Comments: The lozenge should be placed in mouth between cheek and lower gum and sucked; occasionally move from side to side using the handle; do not chew.
-If signs of excessive opioid effects appear before the unit is consumed, the unit should be removed immediately and subsequent doses should be decreased.

NASAL SPRAY (Lazanda(R))
Initial dose: 100 mcg sprayed in 1 nostril
Dose titration: If adequate analgesia is not achieved after 30 minutes, the dose should be escalated in a step-wise manner (100 to 200 to 400 to 800 mcg) over consecutive episodes. Patients must wait at least 2 hours between doses. Patients should confirm the dose that works for them with a second episode of breakthrough pain.
Maintenance dose: Once an effective dose has been established, patients should use that dose for each subsequent breakthrough episode.
Maximum dose: 800 mcg per dose; 4 breakthrough episodes per day at intervals of at least 2 hours

SUBLINGUAL TABLETS (Abstral(R))
Initial dose: 100 mcg sublingually
Dose titration: If adequate analgesia is not obtained after 30 minutes, a second dose of the same strength may be taken. Patients must wait at least 2 hours before re-treating. Dose escalation should proceed in a stepwise manner (200 to 300 to 400 to 600 to 800 mcg) as needed. During titration, multiples of 100 mcg and/or 200 mcg tablets may be used for any single dose. Patients should not use more than 4 tablets at one time.
Maintenance dose: An effective dose is achieved when 1 dose is sufficient to treat most episodes of breakthrough pain; however, if there is inadequate analgesia a second dose of the same strength may be given after 30 minutes; no more than 2 doses should be used to treat any episode of breakthrough pain. Patients should limit treatment to 4 or fewer breakthrough episodes per day.
Maximum dose: 4 episodes per day; 800 mcg per dose at intervals of at least 2 hours

Comments: The sublingual tablet should be placed on the floor of the mouth and allowed to completely dissolve; do not eat or drink until the tablet is completely dissolved.
-The initial dose of the sublingual tablet is always 100 mcg except in patients receiving the transmucosal lozenge - see dose adjustment section for initial dosing recommendations for these patients.

SUBLINGUAL SPRAY:
Initial dose: 100 mcg sprayed sublingually
Dose titration: If adequate analgesia is not obtained after 30 minutes, a second dose of the same strength may be used. Patients must wait at least 4 hours before re-treating. If breakthrough pain is not relieved with the 100 mcg dose, dose escalation should proceed in a stepwise manner (200 to 400 to 600 to 800 to 1200 to 1600 mcg) for subsequent episodes of pain.
Maintenance dose: An effective dose is achieved when 1 dose is sufficient to treat most episodes of breakthrough pain; however, if there is inadequate analgesia a second dose of the same strength may be given after 30 minutes; no more than 2 doses should be used to treat any episode of breakthrough pain. Patients should limit treatment to 4 or fewer breakthrough episodes per day.
Maximum dose: 4 episodes per day at intervals of at least 4 hours

Comments: Spray into mouth underneath the tongue.
-The initial dose of is always 100 mcg except in patients receiving the transmucosal lozenge - see dose adjustment section for initial dosing recommendations for these patients.

BUCCAL TABLETS (Fentora(R))
Initial dose: 100 mcg buccally
Dose titration: If adequate analgesia is not obtained after 30 minutes, a second dose of the same strength may be taken. Patients must wait at least 4 hours before re-treating. If breakthrough pain is not relieved with 100 mcg, the next dose should be two 100 mcg tablets (one on each side of the mouth in the buccal cavity). The patient may be further titrated in a stepwise manner. During titration, multiples of 100 mcg or 200 mcg tablets may be used for any single dose. Patients should not use more than 4 tablets at one time.
Maintenance dose: An effective dose is achieved when 1 dose is sufficient to treat most episodes of breakthrough pain; however, if there is inadequate analgesia a second dose of the same strength may be given after 30 minutes; no more than 2 doses should be used to treat any episode of breakthrough pain. Patients should limit treatment to 4 or fewer breakthrough episodes per day.
Maximum dose: 4 episodes per day; at intervals of at least 4 hours

Comments: Tablet should be placed in the buccal cavity (above the rear molar, between the upper cheek and gum); alternatively, may be placed under the tongue.
-The initial dose of is always 100 mcg except in patients receiving the transmucosal lozenge - see dose adjustment section for initial dosing recommendations for these patients.

Use: For the management of breakthrough pain in patients who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.

Usual Adult Dose for Pain:

IONTOPHORETIC TRANSDERMAL SYSTEM -For Hospital Use Only
-This system is to be used only after patients have been titrated to an acceptable level of analgesia using alternate opioid analgesics.

Initial dose: Apply 1 system transdermally to healthy, unbroken/intact, non-irritated and non-irradiated skin on the chest or upper outer arm
-The patient should be instructed to self-administer doses; to initiate administration, the patient must press and release the button twice within 3 seconds.
-A maximum of six 40 mcg doses can be administered per hour; each on-demand dose is delivered over 10 minutes
-Each unit will operate for up to 24 hours or 80 doses, whichever comes first.
Maximum duration of therapy: 3 days (72 hours)

Comments:
-This system should only be used in patients who are alert enough and have adequate cognitive ability to understand the directions for use; discontinue treatment before patients leave the hospital.
-The system is a for single-use only. After 24 hours or 80 doses have been delivered, the unit will cease functioning; the light and audible beep will no longer function, although the digital display will show the number of doses delivered for an additional 12 hours.
-Only 1 unit should be applied at a time; if analgesia is inadequate, either provide additional analgesic medication or change therapy.
-Gloves should always be warn when handling the system; avoid contact with synthetic materials (such as carpeted floors) during device assembly to reduce the possibility of electrostatic discharge and avoid exposure to electronic security systems as this may damage the system.
-Remove system prior to MRI, cardioversion, defibrillation, or diathermy as the system can be damaged by strong electromagnetic fields; this system contains radio-opaque components that may interfere with an X-ray image or a CT scan.
-TROUBLESHOOTING; In the event the system does not appear to function normally, remove and replace with a new system; consult Product Information for Important Device Instructions including specific electromagnetic compatibility and recommendations to minimize electromagnetic interference.

Use: For the short-term management of acute postoperative pain in adult patients requiring opioid analgesia in the hospital.

Usual Adult Dose for Anesthesia:

Premedication for Anesthesia:
50 to 100 mcg IM, 30 to 60 minutes prior to surgery.
Lozenge: 5 mcg/kg (400 mcg is the maximum dose).
Lower doses should be used for vulnerable patients.

General Anesthesia:
Total Low dose: 2 mcg/kg (minor procedures).
Maintenance low dose: Infrequently needed.
Total Moderate dose: 2 to 20 mcg/kg.
Maintenance moderate dose: 25 to 100 mcg IV/IM.
Total high dose: 20 to 50 mcg/kg (prolonged surgeries).
Maintenance high dose: 25 mcg to half of the initial dose.

Adjunct to Regional Anesthesia:
50 to 100 mcg IM or slow IV over 3 to 5 minutes as required.

Postoperative :
50 to 100 mcg IM. May repeat dose in 1 to 2 hours as needed.

Usual Pediatric Dose for Anesthesia:

Doses should be titrated to appropriate effects; wide range of doses exist, dependent upon desired degree of analgesia/anesthesia, clinical environment, patient's status, and presence of opioid tolerance.

Neonates: Analgesia: International Evidence-Based Group for Neonatal Pain recommendations:
Intermittent doses: Slow IV push: 0.5 to 3 mcg/kg/dose
---Continuous IV infusion: 0.5 to 2 mcg/kg/hour
---Sedation/analgesia: Slow IV push: 1 to 4 mcg/kg/dose; may repeat every 2 to 4 hours
---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg, then 0.5 to 1 mcg/kg/hour; titrate upward
---Mean required dose: Neonates with gestational age less than 34 weeks: 0.64 mcg/kg/hour; neonates with gestational age greater than or equal to 34 weeks: 0.75 mcg/kg/hour
---Continuous sedation/analgesia during extracorporeal membrane oxygenation (ECMO): Initial IV bolus: 5 to 10 mcg/kg slow IV push over 10 minutes, then 1 to 5 mcg/kg/hour; titrate upward; tolerance may develop; higher doses (up to 20 mcg/kg/hour) may be needed by day 6 of ECMO.

Younger infants:
---Sedation/analgesia: Slow IV push: 1 to 4 mcg/kg/dose; may repeat every 2 to 4 hours
---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg, then 0.5 to 1 mcg/kg/hour; titrate upward
---Continuous sedation/analgesia during extracorporeal membrane oxygenation ECMO: Initial IV bolus: 5 to 10 mcg/kg slow IV push over 10 minutes, then 1 to 5 mcg/kg/hour; titrate upward; tolerance may develop; higher doses (up to 20 mcg/kg/hour) may be needed by day 6 of ECMO.

Older Infants and Children 1 to 12 years:
---Sedation for minor procedures/analgesia: IM or IV: 1 to 2 mcg/kg/dose; may repeat at 30 to 60 minute intervals. Note: Children 18 to 36 months of age may require 2 to 3 mcg/kg/dose.
--- Intranasal: Children greater than or equal to 10 kg: 1.5 mcg/kg once (maximum: 100 mcg/dose); reported range: 1 to 2 mcg/kg; some studies allowed for additional incremental doses of 0.5 mcg/kg to be administered every 5 minutes, not to exceed a total dose of 3 mcg/kg depending on pain type and severity.
---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg then 1 mcg/kg/hour; titrate upward; usual: 1 to 3 mcg/kg/hour; some require 5 mcg/kg/hour
---Moderate to severe chronic pain: Transdermal patch: Opioid-tolerant children greater than or equal to 2 years receiving at least 60 mg oral morphine equivalents per day: Initial: 25 mcg/hour system or higher, based on conversion to fentanyl equivalents and administration of equianalgesic dosage (see package insert for further information); use short-acting analgesics for first 24 hours with supplemental PRN doses thereafter (for breakthrough pain); dose may be increased after 3 days, based on the daily dose of supplementary PRN opioids required; use the ratio of 45 mg of oral morphine equivalents per day to a 12.5 mcg/hour increase in transdermal patch dosage; change patch every 72 hours; Note: Dosing intervals less than every 72 hours are not recommended for children and adolescents. Initiation of the transdermal patch in children taking less than 60 mg of oral morphine equivalents per day has not been studied in controlled clinical trials; in open-label trials, children 2 to 18 years of age who were receiving at least 45 mg of oral morphine equivalents per day were started with an initial transdermal dose of 25 mcg/hour (or higher, depending upon equianalgesic dose of opioid received).

Children greater than or equal to 5 years and less than 50 kg:
Patient-controlled analgesia (PCA): IV: Opioid-naive: Note: PCA has been used in children as young as 5 years of age; however, clinicians need to assess children 5 to 8 years of age to determine if they are able to use the PCA device correctly. All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Adjust doses, lockouts, and limits based on required loading dose, age, state of health, and presence of opioid tolerance. Use lower end of dosing range for opioid-naive. Assess patient and pain control at regular intervals and adjust settings if needed.

Usual concentration: Determined by weight; some clinicians use the following:
---Children less than 12 kg: 10 mcg/mL
---Children 12 to 30 kg: 25 mcg/mL
---Children greater than 30 kg: 50 mcg/mL
---Demand dose: Usual initial: 0.5 to 1 mcg/kg/dose; usual range: 0.5 to 1 mcg/kg/dose
---Lockout: Usual initial: 5 doses/hour
---Lockout interval: Range: 6 to 8 minutes
---Usual basal rate: 0 to 0.5 mcg/kg/hour

Children greater than 12 years to adult:
Sedation for minor procedures/analgesia: IV: 0.5 to 1 mcg/kg/dose; may repeat after 30 to 60 minutes; or 25 to 50 mcg, repeat full dose in 5 minutes if needed, may repeat 4 to 5 times with 25 mcg at 5 minute intervals if needed. Note: Higher doses are used for major procedures.

Continuous sedation/analgesia:
---Less than 50 kg: Initial IV bolus: 1 to 2 mcg/kg; continuous infusion rate: 1 to 2 mcg/kg/hour
---Greater than 50 kg: Initial IV bolus: 1 to 2 mcg/kg or 25 to 100 mcg/dose; continuous infusion rate: 1 to 2 mcg/kg/hour or 25 to 200 mcg/hour

Patient-controlled analgesia (PCA): IV: Children greater than 50 kg, Adolescents greater than 50 kg, and Adults: Note: All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Adjust doses, lockouts, and limits based on required loading dose, age, state of health, and presence of opioid tolerance. Use lower end of dosing range for opioid-naive. Assess patient and pain control at regular intervals and adjust settings if needed:

---Usual concentration: 50 mcg/mL
---Demand dose: Usual initial: 20 mcg; usual range: 10 to 50 mcg
---Lockout interval: Usual initial: 6 minutes; usual range: 5 to 8 minutes
---Usual basal rate: less than or equal to 50 mcg/hour

Preoperative sedation, adjunct to regional anesthesia, postoperative pain: IM, IV: 25 to 100 mcg/dose

Adjunct to general anesthesia: Slow IV:
---Low dose: 0.5 to 2 mcg/kg/dose depending on the indication
---Moderate dose: Initial: 2 to 20 mcg/kg/dose; Maintenance (bolus or infusion): 1 to 2 mcg/kg/hour. Discontinuing fentanyl infusion 30 to 60 minutes prior to the end of surgery will usually allow adequate ventilation upon emergence from anesthesia. For "fast-tracking" and early extubation following major surgery, total fentanyl doses are limited to 10 to 15 mcg/kg.
---High dose: 20 to 50 mcg/kg/dose; Note: High dose fentanyl as an adjunct to general anesthesia is rarely used, but is still described in the manufacturer label.

General anesthesia without additional anesthetic agents: IV: 50 to 100 mcg/kg with oxygen and skeletal muscle relaxant

Moderate to severe chronic pain: Transdermal patch: Opioid tolerant patients receiving at least 60 mg oral morphine equivalents per day: Initial: 25 mcg/hour system or higher, based on conversion to fentanyl equivalents and administration of equianalgesic dosage (see package insert for further information); use short-acting analgesics for first 24 hours with supplemental PRN doses thereafter (for breakthrough pain); dose may be increased after 3 days based on the daily dose of supplementary PRN opioids required; use the ratio of 45 mg of oral morphine equivalents per day to a 12.5 mcg/hour increase in transdermal patch dosage; transdermal patch is usually administered every 72 hours but select adult patients may require every 48-hour administration; dosage increase administered every 72 hours should be tried before 48-hour schedule is used.

Usual Pediatric Dose for Pain:

Doses should be titrated to appropriate effects; wide range of doses exist, dependent upon desired degree of analgesia/anesthesia, clinical environment, patient's status, and presence of opioid tolerance.

Neonates: Analgesia: International Evidence-Based Group for Neonatal Pain recommendations:
Intermittent doses: Slow IV push: 0.5 to 3 mcg/kg/dose
---Continuous IV infusion: 0.5 to 2 mcg/kg/hour
---Sedation/analgesia: Slow IV push: 1 to 4 mcg/kg/dose; may repeat every 2 to 4 hours
---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg, then 0.5 to 1 mcg/kg/hour; titrate upward
---Mean required dose: Neonates with gestational age less than 34 weeks: 0.64 mcg/kg/hour; neonates with gestational age greater than or equal to 34 weeks: 0.75 mcg/kg/hour
---Continuous sedation/analgesia during extracorporeal membrane oxygenation (ECMO): Initial IV bolus: 5 to 10 mcg/kg slow IV push over 10 minutes, then 1 to 5 mcg/kg/hour; titrate upward; tolerance may develop; higher doses (up to 20 mcg/kg/hour) may be needed by day 6 of ECMO.

Younger infants:
---Sedation/analgesia: Slow IV push: 1 to 4 mcg/kg/dose; may repeat every 2 to 4 hours
---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg, then 0.5 to 1 mcg/kg/hour; titrate upward
---Continuous sedation/analgesia during extracorporeal membrane oxygenation ECMO: Initial IV bolus: 5 to 10 mcg/kg slow IV push over 10 minutes, then 1 to 5 mcg/kg/hour; titrate upward; tolerance may develop; higher doses (up to 20 mcg/kg/hour) may be needed by day 6 of ECMO.

Older Infants and Children 1 to 12 years:
---Sedation for minor procedures/analgesia: IM or IV: 1 to 2 mcg/kg/dose; may repeat at 30 to 60 minute intervals. Note: Children 18 to 36 months of age may require 2 to 3 mcg/kg/dose.
--- Intranasal: Children greater than or equal to 10 kg: 1.5 mcg/kg once (maximum: 100 mcg/dose); reported range: 1 to 2 mcg/kg; some studies allowed for additional incremental doses of 0.5 mcg/kg to be administered every 5 minutes, not to exceed a total dose of 3 mcg/kg depending on pain type and severity.
---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg then 1 mcg/kg/hour; titrate upward; usual: 1 to 3 mcg/kg/hour; some require 5 mcg/kg/hour
---Moderate to severe chronic pain: Transdermal patch: Opioid-tolerant children greater than or equal to 2 years receiving at least 60 mg oral morphine equivalents per day: Initial: 25 mcg/hour system or higher, based on conversion to fentanyl equivalents and administration of equianalgesic dosage (see package insert for further information); use short-acting analgesics for first 24 hours with supplemental PRN doses thereafter (for breakthrough pain); dose may be increased after 3 days, based on the daily dose of supplementary PRN opioids required; use the ratio of 45 mg of oral morphine equivalents per day to a 12.5 mcg/hour increase in transdermal patch dosage; change patch every 72 hours; Note: Dosing intervals less than every 72 hours are not recommended for children and adolescents. Initiation of the transdermal patch in children taking less than 60 mg of oral morphine equivalents per day has not been studied in controlled clinical trials; in open-label trials, children 2 to 18 years of age who were receiving at least 45 mg of oral morphine equivalents per day were started with an initial transdermal dose of 25 mcg/hour (or higher, depending upon equianalgesic dose of opioid received).

Children greater than or equal to 5 years and less than 50 kg:
Patient-controlled analgesia (PCA): IV: Opioid-naive: Note: PCA has been used in children as young as 5 years of age; however, clinicians need to assess children 5 to 8 years of age to determine if they are able to use the PCA device correctly. All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Adjust doses, lockouts, and limits based on required loading dose, age, state of health, and presence of opioid tolerance. Use lower end of dosing range for opioid-naive. Assess patient and pain control at regular intervals and adjust settings if needed.

Usual concentration: Determined by weight; some clinicians use the following:
---Children less than 12 kg: 10 mcg/mL
---Children 12 to 30 kg: 25 mcg/mL
---Children greater than 30 kg: 50 mcg/mL
---Demand dose: Usual initial: 0.5 to 1 mcg/kg/dose; usual range: 0.5 to 1 mcg/kg/dose
---Lockout: Usual initial: 5 doses/hour
---Lockout interval: Range: 6 to 8 minutes
---Usual basal rate: 0 to 0.5 mcg/kg/hour

Children greater than 12 years to adult:
Sedation for minor procedures/analgesia: IV: 0.5 to 1 mcg/kg/dose; may repeat after 30 to 60 minutes; or 25 to 50 mcg, repeat full dose in 5 minutes if needed, may repeat 4 to 5 times with 25 mcg at 5 minute intervals if needed. Note: Higher doses are used for major procedures.

Continuous sedation/analgesia:
---Less than 50 kg: Initial IV bolus: 1 to 2 mcg/kg; continuous infusion rate: 1 to 2 mcg/kg/hour
---Greater than 50 kg: Initial IV bolus: 1 to 2 mcg/kg or 25 to 100 mcg/dose; continuous infusion rate: 1 to 2 mcg/kg/hour or 25 to 200 mcg/hour

Patient-controlled analgesia (PCA): IV: Children greater than 50 kg, Adolescents greater than 50 kg, and Adults: Note: All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Adjust doses, lockouts, and limits based on required loading dose, age, state of health, and presence of opioid tolerance. Use lower end of dosing range for opioid-naive. Assess patient and pain control at regular intervals and adjust settings if needed:

---Usual concentration: 50 mcg/mL
---Demand dose: Usual initial: 20 mcg; usual range: 10 to 50 mcg
---Lockout interval: Usual initial: 6 minutes; usual range: 5 to 8 minutes
---Usual basal rate: less than or equal to 50 mcg/hour

Preoperative sedation, adjunct to regional anesthesia, postoperative pain: IM, IV: 25 to 100 mcg/dose

Adjunct to general anesthesia: Slow IV:
---Low dose: 0.5 to 2 mcg/kg/dose depending on the indication
---Moderate dose: Initial: 2 to 20 mcg/kg/dose; Maintenance (bolus or infusion): 1 to 2 mcg/kg/hour. Discontinuing fentanyl infusion 30 to 60 minutes prior to the end of surgery will usually allow adequate ventilation upon emergence from anesthesia. For "fast-tracking" and early extubation following major surgery, total fentanyl doses are limited to 10 to 15 mcg/kg.
---High dose: 20 to 50 mcg/kg/dose; Note: High dose fentanyl as an adjunct to general anesthesia is rarely used, but is still described in the manufacturer label.

General anesthesia without additional anesthetic agents: IV: 50 to 100 mcg/kg with oxygen and skeletal muscle relaxant

Moderate to severe chronic pain: Transdermal patch: Opioid tolerant patients receiving at least 60 mg oral morphine equivalents per day: Initial: 25 mcg/hour system or higher, based on conversion to fentanyl equivalents and administration of equianalgesic dosage (see package insert for further information); use short-acting analgesics for first 24 hours with supplemental PRN doses thereafter (for breakthrough pain); dose may be increased after 3 days based on the daily dose of supplementary PRN opioids required; use the ratio of 45 mg of oral morphine equivalents per day to a 12.5 mcg/hour increase in transdermal patch dosage; transdermal patch is usually administered every 72 hours but select adult patients may require every 48-hour administration; dosage increase administered every 72 hours should be tried before 48-hour schedule is used.

Usual Pediatric Dose for Sedation:

Doses should be titrated to appropriate effects; wide range of doses exist, dependent upon desired degree of analgesia/anesthesia, clinical environment, patient's status, and presence of opioid tolerance.

Neonates: Analgesia: International Evidence-Based Group for Neonatal Pain recommendations:
Intermittent doses: Slow IV push: 0.5 to 3 mcg/kg/dose
---Continuous IV infusion: 0.5 to 2 mcg/kg/hour
---Sedation/analgesia: Slow IV push: 1 to 4 mcg/kg/dose; may repeat every 2 to 4 hours
---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg, then 0.5 to 1 mcg/kg/hour; titrate upward
---Mean required dose: Neonates with gestational age less than 34 weeks: 0.64 mcg/kg/hour; neonates with gestational age greater than or equal to 34 weeks: 0.75 mcg/kg/hour
---Continuous sedation/analgesia during extracorporeal membrane oxygenation (ECMO): Initial IV bolus: 5 to 10 mcg/kg slow IV push over 10 minutes, then 1 to 5 mcg/kg/hour; titrate upward; tolerance may develop; higher doses (up to 20 mcg/kg/hour) may be needed by day 6 of ECMO.

Younger infants:
---Sedation/analgesia: Slow IV push: 1 to 4 mcg/kg/dose; may repeat every 2 to 4 hours
---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg, then 0.5 to 1 mcg/kg/hour; titrate upward
---Continuous sedation/analgesia during extracorporeal membrane oxygenation ECMO: Initial IV bolus: 5 to 10 mcg/kg slow IV push over 10 minutes, then 1 to 5 mcg/kg/hour; titrate upward; tolerance may develop; higher doses (up to 20 mcg/kg/hour) may be needed by day 6 of ECMO.

Older Infants and Children 1 to 12 years:
---Sedation for minor procedures/analgesia: IM or IV: 1 to 2 mcg/kg/dose; may repeat at 30 to 60 minute intervals. Note: Children 18 to 36 months of age may require 2 to 3 mcg/kg/dose.
--- Intranasal: Children greater than or equal to 10 kg: 1.5 mcg/kg once (maximum: 100 mcg/dose); reported range: 1 to 2 mcg/kg; some studies allowed for additional incremental doses of 0.5 mcg/kg to be administered every 5 minutes, not to exceed a total dose of 3 mcg/kg depending on pain type and severity.
---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg then 1 mcg/kg/hour; titrate upward; usual: 1 to 3 mcg/kg/hour; some require 5 mcg/kg/hour
---Moderate to severe chronic pain: Transdermal patch: Opioid-tolerant children greater than or equal to 2 years receiving at least 60 mg oral morphine equivalents per day: Initial: 25 mcg/hour system or higher, based on conversion to fentanyl equivalents and administration of equianalgesic dosage (see package insert for further information); use short-acting analgesics for first 24 hours with supplemental PRN doses thereafter (for breakthrough pain); dose may be increased after 3 days, based on the daily dose of supplementary PRN opioids required; use the ratio of 45 mg of oral morphine equivalents per day to a 12.5 mcg/hour increase in transdermal patch dosage; change patch every 72 hours; Note: Dosing intervals less than every 72 hours are not recommended for children and adolescents. Initiation of the transdermal patch in children taking less than 60 mg of oral morphine equivalents per day has not been studied in controlled clinical trials; in open-label trials, children 2 to 18 years of age who were receiving at least 45 mg of oral morphine equivalents per day were started with an initial transdermal dose of 25 mcg/hour (or higher, depending upon equianalgesic dose of opioid received).

Children greater than or equal to 5 years and less than 50 kg:
Patient-controlled analgesia (PCA): IV: Opioid-naive: Note: PCA has been used in children as young as 5 years of age; however, clinicians need to assess children 5 to 8 years of age to determine if they are able to use the PCA device correctly. All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Adjust doses, lockouts, and limits based on required loading dose, age, state of health, and presence of opioid tolerance. Use lower end of dosing range for opioid-naive. Assess patient and pain control at regular intervals and adjust settings if needed.

Usual concentration: Determined by weight; some clinicians use the following:
---Children less than 12 kg: 10 mcg/mL
---Children 12 to 30 kg: 25 mcg/mL
---Children greater than 30 kg: 50 mcg/mL
---Demand dose: Usual initial: 0.5 to 1 mcg/kg/dose; usual range: 0.5 to 1 mcg/kg/dose
---Lockout: Usual initial: 5 doses/hour
---Lockout interval: Range: 6 to 8 minutes
---Usual basal rate: 0 to 0.5 mcg/kg/hour

Children greater than 12 years to adult:
Sedation for minor procedures/analgesia: IV: 0.5 to 1 mcg/kg/dose; may repeat after 30 to 60 minutes; or 25 to 50 mcg, repeat full dose in 5 minutes if needed, may repeat 4 to 5 times with 25 mcg at 5 minute intervals if needed. Note: Higher doses are used for major procedures.

Continuous sedation/analgesia:
---Less than 50 kg: Initial IV bolus: 1 to 2 mcg/kg; continuous infusion rate: 1 to 2 mcg/kg/hour
---Greater than 50 kg: Initial IV bolus: 1 to 2 mcg/kg or 25 to 100 mcg/dose; continuous infusion rate: 1 to 2 mcg/kg/hour or 25 to 200 mcg/hour

Patient-controlled analgesia (PCA): IV: Children greater than 50 kg, Adolescents greater than 50 kg, and Adults: Note: All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Adjust doses, lockouts, and limits based on required loading dose, age, state of health, and presence of opioid tolerance. Use lower end of dosing range for opioid-naive. Assess patient and pain control at regular intervals and adjust settings if needed:

---Usual concentration: 50 mcg/mL
---Demand dose: Usual initial: 20 mcg; usual range: 10 to 50 mcg
---Lockout interval: Usual initial: 6 minutes; usual range: 5 to 8 minutes
---Usual basal rate: less than or equal to 50 mcg/hour

Preoperative sedation, adjunct to regional anesthesia, postoperative pain: IM, IV: 25 to 100 mcg/dose

Adjunct to general anesthesia: Slow IV:
---Low dose: 0.5 to 2 mcg/kg/dose depending on the indication
---Moderate dose: Initial: 2 to 20 mcg/kg/dose; Maintenance (bolus or infusion): 1 to 2 mcg/kg/hour. Discontinuing fentanyl infusion 30 to 60 minutes prior to the end of surgery will usually allow adequate ventilation upon emergence from anesthesia. For "fast-tracking" and early extubation following major surgery, total fentanyl doses are limited to 10 to 15 mcg/kg.
---High dose: 20 to 50 mcg/kg/dose; Note: High dose fentanyl as an adjunct to general anesthesia is rarely used, but is still described in the manufacturer label.

General anesthesia without additional anesthetic agents: IV: 50 to 100 mcg/kg with oxygen and skeletal muscle relaxant

Moderate to severe chronic pain: Transdermal patch: Opioid tolerant patients receiving at least 60 mg oral morphine equivalents per day: Initial: 25 mcg/hour system or higher, based on conversion to fentanyl equivalents and administration of equianalgesic dosage (see package insert for further information); use short-acting analgesics for first 24 hours with supplemental PRN doses thereafter (for breakthrough pain); dose may be increased after 3 days based on the daily dose of supplementary PRN opioids required; use the ratio of 45 mg of oral morphine equivalents per day to a 12.5 mcg/hour increase in transdermal patch dosage; transdermal patch is usually administered every 72 hours but select adult patients may require every 48-hour administration; dosage increase administered every 72 hours should be tried before 48-hour schedule is used.

Usual Pediatric Dose for Breakthrough Pain:

TRANSMUCOSAL LOZENGE (Actiq(R))
Age 16 years or older:
-For use in patients who are opioid-tolerant and taking around-the-clock opioids. Opioid tolerant patients have been taking at least: morphine 60 mg daily, oral oxycodone 30 mg daily, oral hydromorphone 8 mg daily, or an equianalgesic dose of another opioid for 1 week or longer.
-Must be individually titrated to an effective and tolerable dose. Once titrated, treat up to 4 episodes of breakthrough pain a day; if a patient is experiencing more than 4 breakthrough episodes per day, the around-the-clock opioid dose should be re-evaluated. If the around-the-clock opioid dose is adjusted, re-adjustment of the transmucosal product may be necessary.
-Transmucosal fentanyl products are not bioequivalent; patients should not be interchanged on a mcg per mcg basis from 1 fentanyl product to any other fentanyl product

Initial dose: 200 mcg consumed over 15 minutes
Dose titration: If breakthrough pain is not relieved 15 minutes after completion of 1 unit (30 minutes after start), 1 additional unit of the same strength may be taken; Patients must wait at least 4 hours before re-treating. If breakthrough pain had not been relieved with 1 unit, the dose should be increased to the next highest strength with subsequent episodes of pain.
Maintenance dose: An effective dose is achieved when 1 unit is mostly sufficient to treat an episode of breakthrough pain; however, if there is inadequate analgesia a second dose of the same strength may be given 15 minutes after completion (30 minutes after start); no more than 2 doses should be used to treat any episode of breakthrough pain.
Maximum dose: 4 breakthrough episodes per day at intervals of at least 4 hours

Comments: The lozenge should be placed in mouth between cheek and lower gum and sucked; occasionally move from side to side using the handle; do not chew.
-If signs of excessive opioid effects appear before the unit is consumed, the unit should be removed immediately and subsequent doses should be decreased.

Use: For the management of breakthrough pain in adolescents 16 years or older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.

What other drugs will affect fentanyl citrate?

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking fentanyl citrate with a sleeping pill, a sedative or tranquilizer, other narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

You should not use fentanyl citrate if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Other drugs may interact with fentanyl citrate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your medications and any you start or stop using during treatment with fentanyl citrate.

Where can I get more information?

  • Your pharmacist can provide more information about fentanyl citrate.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 5.02. Revision Date: 2015-06-08, 2:53:04 PM.

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