Duragesic 50mcg/hr Patch
WARNING: This is an opioid drug. Opioid drugs can put you at risk for drug use disorder. These can lead to overdose and death. You will be watched closely while taking this drug.Severe breathing problems may happen with this drug. The risk is highest when you first start taking this drug or any time your dose is raised. These breathing problems can be deadly. Call your doctor right away if you have slow, shallow, or trouble breathing. Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.Severe side effects have happened when opioid drugs were used with benzodiazepines, alcohol, marijuana, other forms of cannabis, or street drugs. This includes severe drowsiness, breathing problems, and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. If you have questions, talk with the doctor.Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs.Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.Avoid hot baths, sunbathing, and use of heat sources (including tanning beds, heating pads, and hot tubs). Avoid activities like heavy exercise. Tell your doctor if you get a fever. A rise in body temperature may cause too much drug to pass into your body. This can cause overdose and deadly breathing problems.If you are pregnant or plan to get pregnant, talk with your doctor right away about the benefits and risks of using this drug during pregnancy. Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. Withdrawal in the newborn can be life- threatening if not treated. @ COMMON USES: It is used to manage pain.This drug is not for mild pain or pain that only lasts a short time (like headaches, toothaches, or pain after surgery).This drug is only for use by people who have been taking pain drugs (opioids) and are used to their effects. Talk with the doctor.
Drug Class
Opioid Analgesic
Pharmacologic Class
Opioid Agonist
Pregnancy Category
Category C
FDA Approved
Aug 1990
DEA Schedule
Schedule II
Overview
What is this medicine?
Fentanyl is a very strong pain medicine that comes as a patch you stick on your skin. It's used for severe, ongoing pain in people who are already used to taking strong pain medicines. The patch slowly releases the medicine over 3 days to help control your pain.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Wash your hands before and after handling the patch. It's essential to touch the sticky side of the patch as little as possible, as it contains a significant amount of medication even after use. Carefully follow the guidelines for handling, storing, and disposing of the patch, and consult your doctor if you have any questions.
Applying the Patch
1. Remove the old patch before applying a new one.
2. Place the patch on clean, dry, healthy skin on your chest, back, upper leg, or upper arm.
3. Choose a new area for each patch application.
4. If there is hair where you plan to apply the patch, clip it as close to the skin as possible. Avoid shaving the area.
5. Do not apply the patch to skin that has recently been treated with creams, oils, lotions, or other skin products.
6. Avoid placing the patch on the belt line, bra line, or skin folds.
7. You do not need to apply the patch directly to the area where you are experiencing pain for it to be effective.
Caring for the Patch
You can bathe, shower, or swim for short periods while wearing the patch. To keep it in place, cover it with plastic wrap and tape.
If the patch falls off, replace it with a new one.
If you experience difficulties with the patch sticking, you can use first aid tape on the edges to secure it. Alternatively, you can use a see-through film dressing (such as Bioclusive or Askina Derm) over the patch. Ensure you know what type of dressing is suitable for use.
Do not cover the patch with any other bandage or tape.
Important Safety Precautions
Do not cut or divide patches.
Do not use damaged patches.
Avoid touching the area where the patch was applied to someone else's skin.
If the patch accidentally adheres to someone else's skin, remove it immediately and wash the area with water. Seek medical help right away, as this can cause severe side effects or even death.
Misusing or abusing this medication by placing it in the mouth, chewing, swallowing, injecting, or snorting it can lead to overdose and death.
Storage and Disposal
Store the patch at room temperature in a dry place, avoiding bathrooms.
After removing a used patch, fold the sticky sides together and dispose of it in a location inaccessible to children and pets.
Missed Dose
If you miss a dose, apply a new patch as soon as possible after removing the old one.
* Do not apply a double dose or extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Wash your hands before and after handling the patch. It's essential to touch the sticky side of the patch as little as possible, as it contains a significant amount of medication even after use. Carefully follow the guidelines for handling, storing, and disposing of the patch, and consult your doctor if you have any questions.
Applying the Patch
1. Remove the old patch before applying a new one.
2. Place the patch on clean, dry, healthy skin on your chest, back, upper leg, or upper arm.
3. Choose a new area for each patch application.
4. If there is hair where you plan to apply the patch, clip it as close to the skin as possible. Avoid shaving the area.
5. Do not apply the patch to skin that has recently been treated with creams, oils, lotions, or other skin products.
6. Avoid placing the patch on the belt line, bra line, or skin folds.
7. You do not need to apply the patch directly to the area where you are experiencing pain for it to be effective.
Caring for the Patch
You can bathe, shower, or swim for short periods while wearing the patch. To keep it in place, cover it with plastic wrap and tape.
If the patch falls off, replace it with a new one.
If you experience difficulties with the patch sticking, you can use first aid tape on the edges to secure it. Alternatively, you can use a see-through film dressing (such as Bioclusive or Askina Derm) over the patch. Ensure you know what type of dressing is suitable for use.
Do not cover the patch with any other bandage or tape.
Important Safety Precautions
Do not cut or divide patches.
Do not use damaged patches.
Avoid touching the area where the patch was applied to someone else's skin.
If the patch accidentally adheres to someone else's skin, remove it immediately and wash the area with water. Seek medical help right away, as this can cause severe side effects or even death.
Misusing or abusing this medication by placing it in the mouth, chewing, swallowing, injecting, or snorting it can lead to overdose and death.
Storage and Disposal
Store the patch at room temperature in a dry place, avoiding bathrooms.
After removing a used patch, fold the sticky sides together and dispose of it in a location inaccessible to children and pets.
Missed Dose
If you miss a dose, apply a new patch as soon as possible after removing the old one.
* Do not apply a double dose or extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply the patch to a clean, dry, flat area of skin (e.g., upper torso, upper arm).
- Press firmly for 30 seconds to ensure good adhesion.
- Change the patch every 72 hours (3 days), or as directed by your doctor. Rotate application sites.
- Do NOT cut, chew, or swallow the patch.
- Avoid exposing the patch to direct heat (e.g., heating pads, electric blankets, hot tubs, saunas, prolonged sun exposure) as this can cause too much medicine to be absorbed, leading to overdose.
- Do not drink alcohol or take other sedatives (like sleeping pills or anxiety medications) while using this patch, as it can dangerously slow your breathing.
- Keep all patches, new and used, out of reach of children and pets. Fold used patches in half so the sticky sides stick together, then flush down the toilet or dispose of in a secure, child-proof container as instructed by your pharmacist or local regulations.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
For opioid-tolerant patients, apply one patch transdermally every 72 hours. The 50 mcg/hr patch delivers 50 micrograms of fentanyl per hour.
Dose Range:
12 - 100 mg
Condition-Specific Dosing:
chronic_severe_pain:
Initial dose based on prior opioid use, typically 12 or 25 mcg/hr for conversion. 50 mcg/hr is for patients requiring higher doses.
opioid_tolerance:
Only for patients who are opioid tolerant (e.g., taking at least 60 mg oral morphine/day, 30 mg oral oxycodone/day, or 8 mg oral hydromorphone/day for a week or longer).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for opioid-naive children. For opioid-tolerant children >2 years of age, dosing must be individualized and carefully titrated, typically starting at lower strengths (e.g., 12 mcg/hr).
Adolescent:
Similar considerations as adults for opioid-tolerant adolescents, but with careful monitoring.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor for increased adverse effects.
Moderate:
Use with caution; consider dose reduction and close monitoring due to potential accumulation of fentanyl and its metabolites.
Severe:
Contraindicated or use with extreme caution; significant dose reduction and extended monitoring required. Not recommended for initiation.
Dialysis:
Fentanyl is not dialyzable. Use with extreme caution; monitor closely for respiratory depression.
Hepatic Impairment:
Mild:
Use with caution; monitor for increased adverse effects.
Moderate:
Use with caution; consider dose reduction and close monitoring due to reduced clearance.
Severe:
Contraindicated or use with extreme caution; significant dose reduction and extended monitoring required. Not recommended for initiation.
Pharmacology
Mechanism of Action
Fentanyl is a potent, synthetic opioid analgesic that primarily acts as an agonist at the mu-opioid receptors in the central nervous system (CNS). Its principal therapeutic actions are analgesia and sedation. It also produces respiratory depression, miosis, bradycardia, and physical dependence.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (transdermal absorption is slow and sustained)
Tmax:
24-72 hours (for initial patch application to reach steady-state plasma concentrations)
FoodEffect:
Not applicable (transdermal)
Distribution:
Vd:
4 L/kg (large volume of distribution)
ProteinBinding:
80-85%
CnssPenetration:
Yes
Elimination:
HalfLife:
13-48 hours (terminal half-life after patch removal, due to continued absorption from skin depot)
Clearance:
Not available (highly variable)
ExcretionRoute:
Primarily renal (75% as metabolites, <10% as unchanged drug), fecal (9% as metabolites)
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
12-24 hours (for significant analgesia after initial application)
PeakEffect:
24-72 hours (to reach steady-state analgesic effect)
DurationOfAction:
Up to 72 hours (while patch is applied)
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE: Fentanyl transdermal exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing and monitor all patients regularly for the development of these behaviors and conditions.
LIFE-THREATENING RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase.
ACCIDENTAL EXPOSURE: Accidental exposure to fentanyl transdermal, especially in children, can result in a fatal overdose. Keep out of reach of children and dispose of used patches properly.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.
CYP3A4 INTERACTION: Concomitant use with CYP3A4 inhibitors (e.g., ritonavir, ketoconazole) can increase fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. Avoid the use of CYP3A4 inhibitors in patients receiving fentanyl transdermal. If co-administration is necessary, monitor patients closely for respiratory depression and sedation.
LIFE-THREATENING RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase.
ACCIDENTAL EXPOSURE: Accidental exposure to fentanyl transdermal, especially in children, can result in a fatal overdose. Keep out of reach of children and dispose of used patches properly.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.
CYP3A4 INTERACTION: Concomitant use with CYP3A4 inhibitors (e.g., ritonavir, ketoconazole) can increase fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. Avoid the use of CYP3A4 inhibitors in patients receiving fentanyl transdermal. If co-administration is necessary, monitor patients closely for respiratory depression and sedation.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or fainting
Confusion
Severe constipation or stomach pain, which may indicate a severe bowel problem
Breathing difficulties, such as:
+ Trouble breathing
+ Slow or shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Chest pain
Abnormal heartbeat (fast or slow)
Seizures
Depression
Trouble controlling body movements
Swelling in the arms or legs
Changes in vision
Serotonin Syndrome: A Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk of developing serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
Balance problems
Confusion
Hallucinations
Fever
Abnormal heartbeat (fast or irregular)
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Adrenal Gland Problems: A Rare but Serious Condition
Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Contact your doctor right away if you experience:
Extreme fatigue or weakness
Fainting
Severe dizziness
Nausea or vomiting
Decreased appetite
Other Possible Side Effects
Like all medications, this drug may cause side effects in some people. While many individuals may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you notice any of the following side effects, contact your doctor or seek medical help if they bother you or persist:
Dizziness, drowsiness, fatigue, or weakness
Dry mouth
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Headache
Feeling cold
Sleep disturbances
Excessive sweating
* Irritation at the site of administration
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor or report them to the FDA at 1-800-332-1088 or https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or fainting
Confusion
Severe constipation or stomach pain, which may indicate a severe bowel problem
Breathing difficulties, such as:
+ Trouble breathing
+ Slow or shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Chest pain
Abnormal heartbeat (fast or slow)
Seizures
Depression
Trouble controlling body movements
Swelling in the arms or legs
Changes in vision
Serotonin Syndrome: A Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk of developing serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
Balance problems
Confusion
Hallucinations
Fever
Abnormal heartbeat (fast or irregular)
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Adrenal Gland Problems: A Rare but Serious Condition
Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Contact your doctor right away if you experience:
Extreme fatigue or weakness
Fainting
Severe dizziness
Nausea or vomiting
Decreased appetite
Other Possible Side Effects
Like all medications, this drug may cause side effects in some people. While many individuals may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you notice any of the following side effects, contact your doctor or seek medical help if they bother you or persist:
Dizziness, drowsiness, fatigue, or weakness
Dry mouth
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Headache
Feeling cold
Sleep disturbances
Excessive sweating
* Irritation at the site of administration
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor or report them to the FDA at 1-800-332-1088 or https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Extreme drowsiness or difficulty waking up
- Slow, shallow, or difficult breathing
- Bluish lips or fingernails
- Confusion or disorientation
- Severe dizziness or lightheadedness
- Pinpoint pupils
- Cold, clammy skin
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel blockage or narrowing
Kidney or liver disease
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
* Current use of certain medications, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
Please note that this is not an exhaustive list of all potential interactions. Therefore, it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel blockage or narrowing
Kidney or liver disease
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
* Current use of certain medications, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
Please note that this is not an exhaustive list of all potential interactions. Therefore, it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you understand how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you experience a decrease in the medication's effectiveness, consult your doctor. Do not take more than the prescribed dose.
Additionally, regular use of opioid medications like this one can cause dependence. If you need to reduce the dose or stop taking this medication, consult your doctor first, as sudden changes may lead to withdrawal or other severe problems. Follow your doctor's instructions carefully, and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.
Safe Use Guidelines
Do not exceed the prescribed dose, frequency, or duration of treatment, as this may increase the risk of severe side effects. Avoid taking this medication with other strong pain medications or using a pain patch without consulting your doctor first.
If your pain worsens, you experience increased sensitivity to pain, or you develop new pain, contact your doctor immediately. Do not take more than the prescribed dose.
Interactions and Contraindications
If you consume grapefruit juice or eat grapefruit regularly, discuss this with your doctor. Do not take this medication with alcohol or products containing alcohol, as this may lead to unsafe and potentially fatal effects.
Seizure Risk
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Consult your doctor to determine if you are at higher risk.
Hormonal Effects
Long-term use of opioid medications like this one may lead to decreased sex hormone levels. If you experience a decrease in libido, fertility problems, irregular menstrual periods, or ejaculation difficulties, contact your doctor.
MRI Precautions
The patch may contain metal, so remove it before undergoing an MRI.
Special Populations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Breastfeeding
If you are breastfeeding, inform your doctor, as this medication passes into breast milk and may harm your baby. Seek medical attention immediately if your baby appears overly sleepy, limp, or has breathing difficulties.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you understand how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you experience a decrease in the medication's effectiveness, consult your doctor. Do not take more than the prescribed dose.
Additionally, regular use of opioid medications like this one can cause dependence. If you need to reduce the dose or stop taking this medication, consult your doctor first, as sudden changes may lead to withdrawal or other severe problems. Follow your doctor's instructions carefully, and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.
Safe Use Guidelines
Do not exceed the prescribed dose, frequency, or duration of treatment, as this may increase the risk of severe side effects. Avoid taking this medication with other strong pain medications or using a pain patch without consulting your doctor first.
If your pain worsens, you experience increased sensitivity to pain, or you develop new pain, contact your doctor immediately. Do not take more than the prescribed dose.
Interactions and Contraindications
If you consume grapefruit juice or eat grapefruit regularly, discuss this with your doctor. Do not take this medication with alcohol or products containing alcohol, as this may lead to unsafe and potentially fatal effects.
Seizure Risk
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Consult your doctor to determine if you are at higher risk.
Hormonal Effects
Long-term use of opioid medications like this one may lead to decreased sex hormone levels. If you experience a decrease in libido, fertility problems, irregular menstrual periods, or ejaculation difficulties, contact your doctor.
MRI Precautions
The patch may contain metal, so remove it before undergoing an MRI.
Special Populations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Breastfeeding
If you are breastfeeding, inform your doctor, as this medication passes into breast milk and may harm your baby. Seek medical attention immediately if your baby appears overly sleepy, limp, or has breathing difficulties.
Overdose Information
Overdose Symptoms:
- Severe respiratory depression (slowed or stopped breathing)
- Extreme somnolence progressing to stupor or coma
- Skeletal muscle flaccidity
- Cold and clammy skin
- Miosis (pinpoint pupils)
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Circulatory collapse
- Death
What to Do:
If you suspect an overdose, remove the patch immediately. Call 911 (emergency services) right away. If available, administer naloxone (Narcan) if the person is unresponsive or has severe breathing problems, and continue to monitor until emergency help arrives. Naloxone may need to be given multiple times due to the prolonged absorption of fentanyl from the skin depot.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) within 14 days (risk of severe, unpredictable reactions)
- Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, nelfinavir, troleandomycin) in opioid-naive patients or for initiation of fentanyl transdermal (risk of fatal respiratory depression)
Major Interactions
- Other CNS depressants (e.g., benzodiazepines, other opioids, sedatives/hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, alcohol) - increased risk of profound sedation, respiratory depression, coma, and death.
- Strong CYP3A4 inhibitors (e.g., voriconazole, posaconazole, erythromycin, diltiazem, verapamil, grapefruit juice) - increased fentanyl plasma concentrations, leading to increased opioid effects and potentially fatal respiratory depression.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol) - risk of serotonin syndrome.
- Mixed agonist/antagonist opioids (e.g., pentazocine, nalbuphine, butorphanol) - may reduce analgesic effect and/or precipitate withdrawal symptoms.
Moderate Interactions
- Moderate CYP3A4 inhibitors (e.g., fluconazole, aprepitant) - monitor for increased fentanyl effects.
- Anticholinergics (e.g., oxybutynin, benztropine) - increased risk of urinary retention and/or severe constipation/paralytic ileus.
- Diuretics - opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
Minor Interactions
- Not many specific minor interactions are clinically significant enough to warrant a separate category for fentanyl transdermal beyond the above.
Monitoring
Baseline Monitoring
Pain assessment (intensity, location, quality)
Rationale: To establish baseline pain level and determine appropriateness of opioid therapy.
Timing: Prior to initiation of therapy
Opioid tolerance assessment
Rationale: Fentanyl transdermal is only for opioid-tolerant patients to prevent fatal respiratory depression.
Timing: Prior to initiation of therapy
Respiratory rate and depth
Rationale: To assess baseline respiratory function and identify risk factors for respiratory depression.
Timing: Prior to initiation of therapy
Mental status (sedation level, cognitive function)
Rationale: To assess baseline neurological status and identify risk factors for CNS depression.
Timing: Prior to initiation of therapy
Bowel function
Rationale: To assess baseline and anticipate opioid-induced constipation.
Timing: Prior to initiation of therapy
Routine Monitoring
Pain level and efficacy of analgesia
Frequency: Daily, or as needed, especially during titration
Target: Acceptable pain control with minimal side effects
Action Threshold: Uncontrolled pain or excessive side effects warrant dose adjustment or alternative therapy.
Respiratory rate and depth
Frequency: Regularly, especially during initiation and dose titration, and if sedation increases
Target: Typically >10-12 breaths/min, regular rhythm
Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or signs of hypoventilation require immediate intervention (e.g., naloxone, respiratory support).
Sedation level (e.g., using Pasero Opioid-Induced Sedation Scale)
Frequency: Regularly, especially during initiation and dose titration
Target: Alert or mildly drowsy, easily aroused
Action Threshold: Somnolent, difficult to arouse, or unarousable requires immediate intervention.
Bowel function (frequency, consistency)
Frequency: Daily
Target: Regular bowel movements (e.g., every 1-2 days)
Action Threshold: Constipation (e.g., no bowel movement for >3 days) requires laxative intervention.
Signs of opioid withdrawal or overdose
Frequency: Ongoing
Target: Absence of signs
Action Threshold: Presence of signs requires immediate assessment and management.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation or somnolence
- Dizziness or lightheadedness
- Nausea and vomiting
- Constipation
- Pruritus (itching)
- Confusion or disorientation
- Miosis (pinpoint pupils)
- Signs of allergic reaction at patch site (rash, redness, swelling)
Special Patient Groups
Pregnancy
Not recommended during pregnancy, especially prolonged use, due to the risk of neonatal opioid withdrawal syndrome (NOWS) in the newborn. Fentanyl crosses the placenta. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for congenital malformations, though data are limited and inconsistent for opioids.
Second Trimester:
Risk of fetal growth restriction and adverse neurodevelopmental outcomes.
Third Trimester:
High risk of neonatal opioid withdrawal syndrome (NOWS) if used chronically, requiring prolonged hospitalization and treatment. Risk of respiratory depression in the neonate if used near delivery.
Lactation
Not recommended during breastfeeding. Fentanyl is excreted into breast milk and can cause serious adverse reactions in breastfed infants, including sedation, respiratory depression, and death. Advise mothers not to breastfeed during treatment with fentanyl transdermal and for at least 72 hours after the last patch removal.
Infant Risk:
High risk of sedation, respiratory depression, poor feeding, and potentially fatal outcomes.
Pediatric Use
Fentanyl transdermal is not indicated for opioid-naive pediatric patients. Use in opioid-tolerant children >2 years of age requires extreme caution, individualized dosing, and close monitoring due to the risk of fatal respiratory depression. Not recommended for children under 2 years of age.
Geriatric Use
Use with caution in elderly patients. Start with lower doses and titrate slowly due to increased sensitivity to opioid effects, decreased hepatic and renal function, and increased risk of respiratory depression, sedation, and falls. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Fentanyl transdermal is for chronic, severe pain in opioid-tolerant patients only. It is NOT for acute pain, post-operative pain, or opioid-naive patients due to the risk of fatal respiratory depression.
- Patients must be converted from their previous opioid regimen to fentanyl transdermal using an equipotent analgesic conversion table. Inaccurate conversion can lead to overdose or withdrawal.
- Instruct patients on proper application, removal, and disposal of patches. Emphasize the danger of accidental exposure, especially to children and pets.
- Warn patients about the increased absorption of fentanyl with heat exposure (e.g., fever, heating pads, hot baths/showers), which can lead to overdose.
- Due to the skin depot effect, fentanyl continues to be absorbed for up to 24 hours or more after patch removal. Monitor for delayed respiratory depression.
- Constipation is a common and often persistent side effect of opioid therapy; proactive management with laxatives is essential.
- Monitor for signs of opioid-induced hyperalgesia, a paradoxical increase in pain sensitivity with chronic opioid use.
Alternative Therapies
- Other long-acting opioid analgesics (e.g., extended-release morphine, oxycodone, hydromorphone, methadone)
- Short-acting opioid analgesics (for breakthrough pain, if appropriate)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin, tricyclic antidepressants)
- Interventional pain management (e.g., nerve blocks, spinal cord stimulation)
- Physical therapy, occupational therapy, psychological therapies (e.g., CBT, mindfulness)
Cost & Coverage
Average Cost:
$100 - $400+ per 5 patches (depending on strength and generic/brand)
Generic Available:
Yes
Insurance Coverage:
Generics typically Tier 1 or 2; Brand (Duragesic) typically Tier 3 or 4, often requiring prior authorization.
General Drug Facts
If your symptoms or health problems do not improve or worsen, contact your doctor immediately. It is essential to use your prescribed medication responsibly: do not share it with others, and never take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. Read this guide carefully when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help counteract the effects. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When reporting the incident, be prepared to provide the necessary information, including what was taken, the quantity, and the time of the incident.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. Read this guide carefully when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help counteract the effects. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When reporting the incident, be prepared to provide the necessary information, including what was taken, the quantity, and the time of the incident.