fentanyl transdermal

Pronunciation

Generic Name: fentanyl transdermal (skin patch) (FEN ta nil trans DERM al)
Brand Name: Duragesic, Duragesic-100, Duragesic-12, Duragesic-25, Duragesic-50, Duragesic-75

What is fentanyl transdermal skin patch?

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

The fentanyl skin patch is used to treat moderate to severe chronic pain around the clock. Fentanyl transdermal is not for treating mild or occasional pain or pain from surgery.

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

What is the most important information I should know about a this medicine?

Fentanyl can slow or stop your breathing. MISUSE OF FENTANYL TRANSDERMAL CAN CAUSE DEATH, especially in a child who gets a hold of the skin patch and places it in the mouth or on the skin.

Fentanyl may be habit-forming, and the transdermal skin patch contains a high concentration of this medicine. 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.

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Do not use a fentanyl skin patch if you have a breathing problem, a blockage in your stomach or intestines, or 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 transdermal 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.

Avoid sources of heat while you are wearing a fentanyl skin patch. Heat can increase the amount of drug your skin absorbs.

What should I discuss with my healthcare provider before using a fentanyl transdermal skin patch?

Fentanyl may be habit-forming, and the transdermal skin patch contains a high concentration of this medicine. 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 fentanyl is against the law.

Do not use a fentanyl skin patch if you are allergic to fentanyl, or if you have:

  • a severe breathing problem such as asthma attacks;

  • a blockage in your digestive tract (stomach or intestines); 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 transdermal. 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 transdermal 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 fever;

  • urination problems;

  • liver or kidney disease; or

  • problems with your gallbladder, pancreas, or thyroid.

Fentanyl transdermal should not be used on a child younger than 2 years old. Do not put a fentanyl skin patch on any child who does not have a personal prescription for this medicine.

FDA pregnancy category C. It is not known whether fentanyl transdermal will harm an unborn baby. Fentanyl may cause breathing problems, behavior changes, or addiction and withdrawal symptoms in your newborn if you use the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant.

Fentanyl can pass into breast milk and may also cause addiction and withdrawal symptoms in a nursing infant. Do not breast-feed while using fentanyl transdermal.

The fentanyl skin patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

How should I use fentanyl transdermal skin patches?

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.

MISUSE OF FENTANYL TRANSDERMAL CAN CAUSE HARMFUL SIDE EFFECTS OR DEATH, especially in a child who gets a hold of the skin patch and places it in the mouth or on the skin. Read all patient instructions carefully before using a fentanyl skin patch.

Do not use this medicine on a child who does not have a prescription to use fentanyl transdermal. When placing a skin patch on a young child, choose a wearing area where the child cannot easily remove the patch unsupervised.

Do not use a skin patch if it has been cut or damaged, or you could receive a fatal overdose of fentanyl.

A fentanyl skin patch is for use only on the skin. Avoid touching the sticky side of a skin patch. Wash your hands after applying a skin patch. Do not allow the medicine to come into contact with your eyes, nose, mouth, or lips.

Apply the patch to a flat area of the chest, back, side, or outer side of your upper arm. Trim body hair with scissors but do not shave patch-wearing areas. Clean the skin only with clear water, and dry completely. Press the patch firmly with the palm of your hand for 30 seconds. Check the patch often, to make sure it is firmly on your skin at all times.

Avoid sources of heat while you are wearing the patch. Do not use a heating pad or electric blanket, a waterbed heater, tanning bed or sauna. Do not sit in hot water, sunbathe, or raise your body temperature with vigorous activity. Heat can increase the amount of drug you absorb through your skin and may cause an overdose or death.

Remove and replace the patch every 72 hours. Apply the new patch to a different skin area on the chest, back, side, or upper arm. After removing a skin patch: fold it in half firmly with the sticky side in, and flush the patch down the toilet right away. Do not place a used skin patch into a trash can. Also flush any unused skin patches in the same folded manner when you no longer need this medicine. Do not flush the foil pouch or patch liners; place them in a trash container out of the reach of children and pets.

Keep both used and unused fentanyl skin patches out of the reach of children or pets. The amount of fentanyl in a used skin patch could be fatal to a child or pet who accidentally chews, sucks on, or swallows the patch. Seek emergency medical attention if this happens.

Store the skin patches at room temperature. Keep each patch in its foil pouch until you are ready to use it. Keep track of how many skin patches have been used from each new package. Fentanyl is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

If you are using the skin patches on a schedule, apply the missed patch as soon as you remember. Continue wearing the patch for up to 72 hours and then apply a new one if needed for pain. Do not wear extra patches to make up a 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 using a fentanyl transdermal patch?

This medication may impair your thinking or reactions. Do not drive or operate machinery until you know how fentanyl will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Do not drink alcohol or dangerous side effects and death could occur. Check your food and medicine labels to be sure these products do not contain alcohol.

Avoid wearing a skin patch on a part of your body where a child could reach or remove the patch from your skin. Avoid allowing children to watch you put on a skin patch. Never tell a child that the fentanyl skin patch is a "bandage."

A fentanyl transdermal skin patch 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 skin patch and call your doctor at once if you have:

  • slow heart rate, sighing, weak or shallow breathing (can occur up to 3 days or longer after removing the skin patch);

  • chest pain, fast or pounding heartbeats; or

  • extreme drowsiness, feeling like you might pass out.

Common side effects may include:

  • nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation;

  • drowsiness, dizziness, tired feeling;

  • increased sweating, or cold feeling;

  • sleep problems (insomnia); or

  • itching, redness, or mild rash where the patch was worn.

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 transdermal dosing information

Usual Adult Dose for Pain:

TRANSDERMAL PATCH:
Initial dose: The initial dose should be calculated based on the dose conversion guidelines in the product package insert, local protocol, or another reliable reference. The initial calculated dose may be increased 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.
Comments:
-For patients already treated with strong opioids (i.e., opioid tolerant), the initial dose should be calculated based on the previous 24 hour opioid use.
-It may take up to 6 days for drug levels to reach equilibrium on a new dose. Patients should be evaluated for further titration after no less than two 3-day applications before any further increase in dosage is made.
-The dose should be titrated individually until a balance between analgesic efficacy and tolerability is achieved.
-For delivery rates in excess of 100 mcg/hour, multiple systems may be used.
-Once therapy is initiated, pain intensity and opioid adverse reactions should be assessed frequently, especially respiratory depression.
Uses: 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.
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.
-Most patients are adequately maintained with one patch applied every 72 hours. Some patients may not receive adequate analgesia using the 72 hour dosing interval and may require a 48 hour interval. An increase in the dose should be considered before changing dosing intervals in order to maintain patients on a 72 hour regimen. Dosing intervals less than every 72 hours are not recommended in children and adolescents.

TRANSMUCOSAL LOZENGE:
Initial dose: 200 mcg placed in mouth (in between cheek and gum) and consumed over 15 minutes no sooner than every 4 hours. Dose titration should occur based on individual requirements necessary to provide adequate pain relief using a single dosage unit per episode of breakthrough pain.
Comments:
-For management of breakthrough pain in patients already receiving maintenance opioid therapy for chronic cancer pain.
-If signs of excessive opioid effects appear before the unit is consumed, the dosage unit should be removed from the patient's mouth immediately, disposed of properly, and subsequent doses should be decreased.
-In cases where the breakthrough pain episode is not relieved 15 minutes after completion of the unit (30 minutes after the start of the unit), patients should only take one additional dose of the same strength for that episode. Patients should take a maximum of 2 doses for any breakthrough pain episode.
-During titration, patients should be prescribed an initial titration supply of 6 units, thus limiting the number of units in the home during titration.
Use: For the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.

NASAL SPRAY:
Initial dose: 100 mcg in one nostril once. The dose should be individually titrated to a dose that provides adequate analgesia with tolerable side effects.
Comments:
-For the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
-Titrate through range of available strengths until adequate pain relief obtained. The same strength dosage form can be used again after 10 minutes at the earliest. Strength can be increased if more than one dose per breakthrough pain episode is required for consecutive episodes.
Comments:
-The dose should be titrated according to response. A maximum of 2 sprays should be used per breakthrough pain episode. A minimum 4 hour interval should be maintained between each dosage.
Use: For the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

SUBLINGUAL TABLETS:
Initial dose: 100 mcg sublingually once
-If adequate analgesia is obtained within 30 minutes subsequent episodes of breakthrough pain should be treated with this dose.
-If adequate analgesia is not obtained after 30 minutes, the patient may use a second dose (after 30 minutes) as directed by their health care provider.
-No more than 2 doses should be used to treat an episode of breakthrough pain.
-Patients should wait at least 2 hours before treating another episode of breakthrough pain.
Titration:
-If adequate analgesia was not obtained with the first 100 mcg dose, continue dose escalation in a stepwise manner over consecutive breakthrough episodes until adequate analgesia with tolerable side effects is achieved.
-Increase the dose by 100 mcg multiples up to 400 mcg as needed. If adequate analgesia is not obtained with a 400 mcg dose, the next titration step is 600 mcg.
-If adequate analgesia is not obtained with a 600 mcg dose, the next titration step is 800 mcg.
-During titration, multiples of 100 mcg tablets and/or 200 mcg tablets may be used for any single dose. Patients should not use more than 4 tablets at one time.
-Rescue medication as directed by the health care provider can 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 in patients.
Comments:
-For the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
-Due to differences in the pharmacokinetic properties and individual variability, even patients switching from other fentanyl containing products to the sublingual tablets should start with the 100 mcg dose.
Use: For the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

SUBLINGUAL SPRAY:
Initial dose: 100 mcg sublingually once
-If adequate analgesia is obtained within 30 minutes subsequent episodes of breakthrough pain should be treated with this dose.
-If adequate analgesia is not obtained after 30 minutes, the patient may use a second dose (after 30 minutes) as directed by their health care provider.
-No more than 2 doses should be used to treat an episode of breakthrough pain.
-Patients should wait at least 4 hours before treating another episode of breakthrough pain.
-Once a maintenance dose is achieved, the patient should consume 4 or fewer does per day.
Titration:
-If adequate analgesia was not obtained with the first 100 mcg dose, change the dosage level until the patient reaches a dose that provides adequate analgesia using a single dose per breakthrough cancer pain episode with tolerable side effects.
-For each breakthrough pain episode treated, if pain is not relieved after 30 minutes, patients should only take one additional dose of the same strength for that episode for a maximum of 2 doses for any breakthrough pain episode.
-Patients should wait at least 4 hours before treating another episode of breakthrough pain.
Comments:
-This product is not bioequivalent with other fentanyl products. Patients should not be converted on a mcg per mcg basis from other fentanyl products. There are no conversion directions available for patients on any other fentanyl products other than Actiq (R). (Note: This includes oral, transdermal, or parenteral formulations.)
Uses: For the management of breakthrough pain in adult cancer patients who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.

BUCCAL TABLETS:
Initial dose: 100 mcg. From an initial dose, patients should be closely followed and the dosage strength changed until the patient reaches a dose that provides adequate analgesia with tolerable side effects.
Titration:
-Patients whose initial dose is 100 mcg and who need to titrate to a higher dose, should be instructed to use two 100 mcg tablets (one on each side of the mouth in the buccal cavity) with their next breakthrough pain episode.
-If 2 tablets are not successful, the patient should be instructed to place two 100 mcg tablets on each side of the mouth in the buccal cavity (total of four 100 mcg tablets).
-For doses above 400 mcg titrate using multiples 200 mcg (600 mcg and 800 mcg). Note: Should not use more than 4 tablets simultaneously.
-In cases where the breakthrough pain episode is not relieved after 30 minutes, patients should only take one additional dose of the same strength for that episode.
-Patients should take a maximum of 2 doses for any breakthrough pain episode.
-During titration, one dose may include administration of 1 to 4 tablets of the same dosage strength (100 mcg or 200 mcg).
-Patients should wait at least 4 hours before treating another episode of breakthrough pain.
-To reduce the risk of overdosing during titration, patients should have only one strength available at any time.
Comments:
-For the treatment of breakthrough pain in patients with cancer who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.
Comments:
-For patients being converted from Actiq (R) refer to the manufacturer product information or local protocol.
-Patients should use all of their tablets of one strength prior to being prescribed the next strength. If this is not practical, unused fentanyl buccal tablets should be disposed of safely.
Use: For the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.

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.

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 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.

What other drugs will affect fentanyl transdermal?

Using 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 using fentanyl transdermal 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 transdermal 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 transdermal, 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 transdermal.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about fentanyl transdermal.
  • 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: 10.03. Revision Date: 2013-12-10, 11:46:51 AM.

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