Generic Name: fentanyl citrate (oral transmucosal) (FEN ta nil SIT rayt)
Brand Names: Actiq
What is fentanyl citrate?
Fentanyl citrate is a narcotic pain medicine.
Fentanyl citrate treats "breakthrough" cancer pain that is not controlled by other medicines. This medication is not for short-term pain relief.
Fentanyl citrate may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about fentanyl citrate?
You should not use this medication unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.
Seek emergency medical attention if you think you have used too much of this medicine or if anyone else has accidentally swallowed it. An overdose of this medicine can be fatal. Overdose symptoms may include weak pulse, fainting, shallow breathing, or breathing that stops. Do not use more than four Actiq units per day.
What should I discuss with my health care provider before taking fentanyl citrate?
You should not use this medication unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Opioid medicines include fentanyl (Actiq, Duragesic), hydrocodone (Lortab, Vicodin), hydromorphone (Dilaudid, Palladone), morphine (Kadian, MS Contin, Oramorph, and others), oxycodone (Oxycontin), oxymorphone (Numorphan, Opana), and others. Talk with your doctor if you are not sure you are opioid-tolerant.
Do not use fentanyl citrate if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you use fentanyl before the MAO inhibitor has cleared from your body.
You should not use fentanyl citrate if you have had an allergic reaction or severe side effects when using any narcotic pain medicine.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:
a breathing disorder such as asthma or chronic obstructive pulmonary disease (COPD);
a seizure disorder;
a history of head injury or brain tumor;
liver or kidney disease;
low blood pressure, heart disease;
a history of depression or other mental illness; or
a history of drug or alcohol addiction.
FDA pregnancy category C. It is not known whether fentanyl citrate is harmful to an unborn baby. It could cause addiction or withdrawal symptoms in a newborn if the mother uses fentanyl citrate during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Fentanyl citrate can pass into breast milk and may cause sleepiness or breathing problems in a nursing baby. Fentanyl citrate may also cause addiction and withdrawal symptoms in a nursing infant. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more sensitive to the effects of this medicine.
If you are diabetic, you should know that each fentanyl citrate lozenge contains 2 grams (one-half teaspoon) of sugar.
How should I take fentanyl citrate?
Actiq (fentanyl citrate oral transmucosal) comes with a kit and instructions for storing and disposing of the Actiq units. Keep both the used and the unused Actiq units out of the reach of children. The amount of fentanyl citrate in the Actiq unit can be fatal to a child who accidentally sucks on or swallows the unit.
You will also receive instructions for using the medicine. Follow these instructions carefully. Do not use the medication in larger amounts or for longer than prescribed by your doctor. Your doctor may occasionally change your dose to make sure you get the best results.
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.
Do not use more than four Actiq units per day.
If you feel dizzy or sick to your stomach before the medicine has completely dissolved, stop using the unit and call your doctor.
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. Do not stop using any other pain medicines your doctor has prescribed for you. Call your doctor if fentanyl citrate does not relieve your pain. Do not stop using fentanyl citrate suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using fentanyl citrate. 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.
Pay special attention to your dental hygiene. Fentanyl citrate can cause dry mouth leading to tooth decay.
What happens if I miss a dose?
Do not use more than four (4) Actiq units per day.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. The amount of fentanyl citrate in the Actiq unit can be fatal to a child who accidentally sucks on or swallows the unit.
Overdose symptoms may include weak pulse, fainting, shallow breathing, or breathing that stops.
What should I avoid while taking fentanyl citrate?
Grapefruit and grapefruit juice may interact with fentanyl and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.
Fentanyl citrate side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using fentanyl citrate and call your doctor at once if you have any of these serious side effects:
shallow breathing, slow heart rate;
extreme sleepiness; or
feeling light-headed, fainting.
Less serious side effects may include:
dry mouth;
headache, dizziness, weakness, anxiety; or
nausea, vomiting, or constipation.
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.
Fentanyl citrate Dosing Information
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 Adult Dose for Pain:
Transdermal patch - Initial dose: 25 mcg/hour patch (unless opioid tolerance) every 72 hours.
Transmucosal - Initial dose: 200 mcg, place in mouth (between cheek and lower gum) and suck over 15 minutes (do not chew or swallow).
Fentanyl iontophoretic transdermal system - Patients should be titrated to comfort before initiating the fentanyl iontophoretic transdermal system. Fentanyl iontophoretic transdermal system should be applied to intact, nonirritated, nonirradiated skin on the chest or upper outer arm.
Patients must have access to supplemental analgesia during treatment with the fentanyl iontophoretic transdermal system. Fentanyl iontophoretic transdermal system provides a 40 mcg dose of fentanyl per activation on-demand. It is important to instruct patients how to operate fentanyl iontophoretic transdermal system to self-administer doses of fentanyl as needed to manage their acute, short-term, postoperative pain. Only the patient should administer doses from fentanyl iontophoretic transdermal system. Each on-demand dose is delivered over a 10-minute period. To initiate administration of a fentanyl dose, the patient must press the button firmly twice within 3 seconds. An audible tone (beep) indicates the start of delivery of each dose; the red light remains on throughout the 10 minute dosing period.
Patients on chronic opioid therapy or with a history of opioid abuse may require higher analgesic doses in the postoperative period than are available from fentanyl iontophoretic transdermal system. Therefore, these patients should be evaluated frequently to ensure they are receiving adequate analgesia.
A maximum of six 40 mcg doses per hour can be administered by fentanyl iontophoretic transdermal system. The maximum amount of fentanyl that can be administered from a single fentanyl iontophoretic transdermal system over 24 hours is 3.2 mg (eighty 40 mcg doses). Each fentanyl iontophoretic transdermal system operates for 24 hours or until eighty doses have been administered, whichever occurs first. Up to three consecutive fentanyl iontophoretic transdermal systems may be used sequentially, each applied to a different skin site for a maximum of 72 hours of therapy for acute, short-term, postoperative pain.
Buccal Tablet
Initial Dose: 100 mcg.
Dose Titration: Patients should be titrated to a dose of fentanyl buccal tablet that provides adequate analgesia with tolerable side effects.
For patients switching from oral transmucosal fentanyl citrate to fentanyl buccal tablet, the starting dose of fentanyl buccal tablet should be as follows. An oral transmucosal fentanyl citrate dose of 200 mcg or 400 mcg converts to an initial fentanyl buccal tablet dose of 100 mcg. An oral transmucosal fentanyl citrate dose of 600 or 800 mcg converts to an initial fentanyl buccal tablet dose of 200 mcg. And, an oral transmucosal fentanyl citrate dose of 1200 mcg or 1600 mcg converts to an initial fentanyl buccal tablet dose of 400 mcg.
Redosing Patients Within a Single Episode: Dosing may be repeated once during a single episode of breakthrough pain if pain is not adequately relieved by one fentanyl buccal tablet dose. Redosing may occur 30 minutes after the start of administration of fentanyl buccal tablet and the same dosage strength should be used.
Buccal soluble film:
For use only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain:
The goal of dose titration is to find the individual patient's effective and tolerable dose. The dose of fentanyl buccal soluble film is not predicted from the daily maintenance dose of opioid used to manage the persistent cancer pain and must be determined by dose titration.
Individually titrate fentanyl buccal soluble film to a dose that provides adequate analgesia with tolerable side effects.
Initial dose: All patients must begin treatment using one 200 mcg fentanyl buccal soluble film. Due to differences in pharmacokinetic properties and individual variability, patients switching from another oral transmucosal fentanyl product must be started on no greater than 200 mcg of fentanyl buccal soluble film. When prescribing, do not switch patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to fentanyl buccal soluble film as fentanyl buccal soluble film is not equivalent on a mcg per mcg basis with any other fentanyl product. Fentanyl buccal soluble film is not a generic version of any other oral transmucosal fentanyl product.
Following the initial dose, closely follow patients and change the dosage level until the patient reaches a dose that provides adequate analgesia. If adequate pain relief is not achieved after one 200 mcg fentanyl buccal soluble film, titrate using multiples of the 200 mcg fentanyl buccal soluble film (for doses of 400, 600, or 800 mcg). Increase the dose by 200 mcg in each subsequent episode until the patient reaches a dose that provides adequate analgesia with tolerable side effects. Do not use more than four of the 200 mcg fentanyl buccal soluble film simultaneously. When multiple 200 mcg fentanyl buccal soluble films are used, they should not be placed on top of each other and may be placed on both sides of the mouth.
If adequate pain relief is not achieved after 800 mcg fentanyl buccal soluble film (i.e., four 200 mcg fentanyl buccal soluble films), and the patient has tolerated the 800 mcg dose, treat the next episode by using one 1200 mcg fentanyl buccal soluble film. Doses above 1200 mcg fentanyl buccal soluble film should not be used.
The patient should then get a prescription for fentanyl buccal soluble film of the dose determined by titration (i.e., 200, 400, 600, 800, or 1200 mcg) to treat subsequent episodes.
Single doses should be separated by at least 2 hours. Fentanyl buccal soluble film should only be used once per breakthrough cancer pain episode, i.e., fentanyl buccal soluble film should not be redosed within an episode.
During any episode of breakthrough cancer pain, if adequate pain relief is not achieved from use of fentanyl buccal soluble film, the patient may use a rescue medication (after 30 minutes) as directed by their healthcare provider.
During maintenance treatment, if the prescribed dose no longer adequately manages the breakthrough cancer pain episode for several consecutive episodes, increase the dose of fentanyl buccal soluble film. Once a successful dose has been found, each episode is treated with a single film. Fentanyl buccal soluble film should be limited to four or fewer doses per day. Consider increasing the dose of the around-the-clock opioid medicine used for persistent cancer pain in patients experiencing more than four breakthrough cancer pain episodes daily.
The tongue should be used to wet the inside of the cheek or rinse the mouth with water to wet the area for placement of fentanyl buccal soluble film. The fentanyl buccal soluble film package should be opened immediately prior to product use. Place the entire fentanyl buccal soluble film near the tip of a dry finger with the pink side facing up and hold in place. Place the pink side of the fentanyl buccal soluble film against the inside of the cheek. Press and hold the fentanyl buccal soluble film in place for five seconds. The fentanyl buccal soluble film should stay in place on its own after this period. Liquids may be consumed after five minutes. Fentanyl buccal soluble film, if chewed and swallowed, might result in lower peak concentrations and lower bioavailability than when used as directed.
The fentanyl buccal soluble film should not be cut or torn prior to use. The fentanyl buccal soluble film will dissolve within 15 to 30 minutes after application. The film should not be manipulated with the tongue or finger(s). Eating food should be avoided until the film has dissolved.
Sublingual tablets:
For use only for the management of breakthrough pain in patients with cancer who are 18 years of age and older and who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking pain relief medication around-the-clock of at least 60 mg of oral morphine daily, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or at least 25 mg oral oxymorphone daily, or an equal dose of another opioid medication daily for 7 days or more.
The goal of dose titration is to find the effective and tolerable dose for the individual patient. The dose of fentanyl sublingual is not predicted from the daily maintenance dose of opioid used to manage the persistent cancer pain and must be determined by dose titration.
Fentanyl sublingual tablets should be placed on the floor of the mouth directly under the tongue immediately after removal from the packaging. The patient should be instructed not to chew, suck, or swallow the sublingual tablet. Patients should not eat or drink anything until the tablet is completely dissolved. Water may be used to moisten the buccal mucosa before taking fentanyl sublingual in patients who have a dry mouth.
Initial dose: All patients must begin treatment with a single 100 mcg sublingual tablet. Due to differences in pharmacokinetic properties and individual variability, patients switching from another fentanyl product must be started on the 100 mcg sublingual dose. Patients should not be switched on a mcg per mcg basis from any other fentanyl product to fentanyl sublingual as fentanyl sublingual is not equivalent on a mcg per mcg basis with any other fentanyl product. Fentanyl sublingual is not a generic version of any other fentanyl product. Following the initial dose, patients should be followed closely and the dosage level adjusted until the patient reaches a dose that provides adequate analgesia. If adequate analgesia is obtained within 30 minutes of administration of the 100 mcg tablet, continue to treat subsequent episodes of breakthrough pain with this dose. If adequate pain relief is not achieved after one 100 mcg tablet, the patient may take a second dose (after 30 minutes). No more than 2 doses may be used to treat one episode of breakthrough pain. Patients must wait at least 2 hours after the last dose to treat another episode of breakthrough pain.
Titration: If adequate pain relief is not achieved after the first 100 mcg dose, the dose should be increased in a stepwise manner over consecutive breakthrough pain episodes until adequate analgesia with tolerable side effects is achieved. The dose should be increased by 100 mcg multiples up to 400 mcg if needed. If adequate analgesia is not obtained with a 400 mcg dose, increase to 600 mcg. If adequate analgesia is not obtained with a 600 mcg dose, increase to 800 mcg. During titration, patients can be instructed to use multiples of 100 mcg tablets and/or 200 mcg tablets for any single dose. Patients should not use more than 4 tablets at one time. If adequate analgesia is not obtained 30 minutes after use, the patient may repeat the same dose. No more than two doses of may be used to treat an episode of breakthrough pain. Rescue medication as directed by the healthcare provider may be used if adequate analgesia is not achieved.
The efficacy and safety of doses higher than 800 mcg have not been evaluated in clinical studies.
Maintenance: Once an appropriate dose for pain management has been established, patients should be instructed to use only one tablet of the appropriate strength per dose. Patients should be maintained on this dose. If adequate analgesia is not obtained, the patient may use a second dose (after 30 minutes) as directed by their health care provider. No more than two doses may be used to treat an episode of breakthrough pain. Patients must wait at least 2 hours before treating another episode of breakthrough pain.
Dose readjustment: If the response (analgesia or adverse reactions) to the titrated dose markedly changes, an adjustment of dose may be necessary to ensure that an appropriate dose is maintained.
If more than four episodes of breakthrough pain are experienced daily, the dose of the long-acting opioid used for persistent underlying cancer pain should be reevaluated. If the long-acting opioid or dose of long-acting opioid is changed, the fentanyl sublingual dose should be retitrated as necessary to ensure the patient is on an appropriate dose.
The use of fentanyl sublingual should be limited to treat four or fewer episodes of breakthrough pain per day.
It is important that any dose retitration is monitored carefully by a healthcare professional.
Discontinuation: Patients no longer requiring opioid therapy may discontinue fentanyl sublingual along with a gradual downward titration of other opioids to minimize possible withdrawal effects. Patients who continue to take chronic opioid therapy for chronic pain but no longer need treatment for breakthrough pain may discontinue fentanyl sublingual immediately.
Fentanyl nasal spray:
For use only for the management of breakthrough pain in patients with cancer who are 18 years of age and older and who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain.
Fentanyl nasal spray should be titrated to a dose that provides adequate analgesia with tolerable side effects.
Initial dose: Treatment of all patients (including those switching from another fentanyl product) should be initiated with 1 spray into 1 nostril.
Maintenance dose: If adequate analgesia is achieved within 30 minutes of administration of 1 spray in 1 nostril, subsequent episodes of breakthrough pain may be treated with this dose. If adequate analgesia is not achieved with the first dose, the dose should be escalated in a step wise manner over consecutive episodes of breakthrough pain until adequate analgesia with tolerable side effects is achieved.
Titration: Patients must wait at least 2 hours between doses:
Step 1: 1 spray (100 mcg per spray) into 1 nostril (100 mcg)
Step 2: 1 spray (100 mcg per spray) into each nostril (200 mcg)
Step 3: 1 spray (400 mcg per spray) into 1 nostril (400 mcg)
Step 4: 1 spray (400 mcg per spray) into each nostril (800 mcg)
Maximum dose: 800 mcg per episode of breakthrough pain no more often than every 2 hours and no more than 4 doses per day.
During any episode of breakthrough cancer pain, if there is inadequate pain relief after 30 minutes following fentanyl nasal spray dosing or if a separate episode of breakthrough cancer pain occurs before the next dose is permitted (i.e., within 2 hours), the healthcare provider should be prepared to offer the patient another medication for rescue.
There are no clinical data to support the use of a combination of dose strengths to treat an episode.
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.
Adolescents greater than or equal to 16 years to adult: Breakthrough cancer pain: Transmucosal lozenge: Opioid-tolerant patients: Titrate dose to provide adequate analgesia: Initial: 200 mcg; may repeat dose only once, 15 minutes after completion of first dose if needed. Do not exceed a maximum of 2 doses per each breakthrough cancer pain episode; patient must wait at least 4 hours before treating another episode. Titrate dose up to next higher strength if treatment of several consecutive breakthrough episodes requires more than 1 lozenge per episode; evaluate each new dose over several breakthrough cancer pain episodes (generally 1 to 2 days) to determine proper dose of analgesia with acceptable side effects. Once the dose has been determined, consumption should be limited to less than or equal to 4 units/day. Reevaluate maintenance (around-the-clock) opioid dose if patient requires more than 4 units/day. If signs of excessive opioid effects occur before a dose is complete, the unit should be removed from the mouth immediately, and subsequent doses decreased.
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.
Adolescents greater than or equal to 16 years to adult: Breakthrough cancer pain: Transmucosal lozenge: Opioid-tolerant patients: Titrate dose to provide adequate analgesia: Initial: 200 mcg; may repeat dose only once, 15 minutes after completion of first dose if needed. Do not exceed a maximum of 2 doses per each breakthrough cancer pain episode; patient must wait at least 4 hours before treating another episode. Titrate dose up to next higher strength if treatment of several consecutive breakthrough episodes requires more than 1 lozenge per episode; evaluate each new dose over several breakthrough cancer pain episodes (generally 1 to 2 days) to determine proper dose of analgesia with acceptable side effects. Once the dose has been determined, consumption should be limited to less than or equal to 4 units/day. Reevaluate maintenance (around-the-clock) opioid dose if patient requires more than 4 units/day. If signs of excessive opioid effects occur before a dose is complete, the unit should be removed from the mouth immediately, and subsequent doses decreased.
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.
Adolescents greater than or equal to 16 years to adult: Breakthrough cancer pain: Transmucosal lozenge: Opioid-tolerant patients: Titrate dose to provide adequate analgesia: Initial: 200 mcg; may repeat dose only once, 15 minutes after completion of first dose if needed. Do n
