Duragesic 12mcg/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 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 opioid pain medicines. The patch slowly releases the medicine into your body over 3 days to provide continuous pain relief.
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 minimize contact with the sticky side of the patch, as it contains a significant amount of medication even after use. Carefully follow the guidelines for handling, storing, and disposing of this medication, 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 at the application site, clip it close to the skin, but do not shave.
5. Avoid applying the patch to skin that has been treated with creams, oils, lotions, or other skin products.
6. Do not apply the patch to the belt line, bra line, or skin folds.
7. You do not need to apply the patch directly to the area of 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 the patch is not sticking properly, 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, but be sure to use the correct type of dressing. 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 anyone else's skin.
If the patch accidentally gets on 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 and 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 this medication at room temperature in a dry place, away from the bathroom.
After removing a used patch, fold the sticky sides together and dispose of it in a secure location where children and pets cannot access it.
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 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 minimize contact with the sticky side of the patch, as it contains a significant amount of medication even after use. Carefully follow the guidelines for handling, storing, and disposing of this medication, 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 at the application site, clip it close to the skin, but do not shave.
5. Avoid applying the patch to skin that has been treated with creams, oils, lotions, or other skin products.
6. Do not apply the patch to the belt line, bra line, or skin folds.
7. You do not need to apply the patch directly to the area of 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 the patch is not sticking properly, 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, but be sure to use the correct type of dressing. 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 anyone else's skin.
If the patch accidentally gets on 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 and 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 this medication at room temperature in a dry place, away from the bathroom.
After removing a used patch, fold the sticky sides together and dispose of it in a secure location where children and pets cannot access it.
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.
Lifestyle & Tips
- Apply the patch to a clean, dry, flat area of skin (e.g., upper torso, arm). Avoid hairy areas. Press firmly for 30 seconds.
- Change the patch every 72 hours (3 days) at the same time of day. Remove the old patch before applying a new one.
- Rotate application sites to prevent skin irritation. Do not apply to the same site for at least 7 days.
- 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 cut, chew, or swallow the patch.
- Do not use alcohol or other sedatives while using this patch.
- Keep all patches, new and used, out of reach of children and pets. Fold used patches in half with the sticky sides together and flush down the toilet immediately or dispose of as instructed by your pharmacist/doctor.
- Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
- Inform all healthcare providers that you are using a fentanyl patch, especially before any surgery or dental procedures.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose for opioid-tolerant patients: 12 mcg/hr patch applied transdermally every 72 hours. Dosage is individualized based on patient's opioid tolerance and analgesic requirements.
Dose Range:
12 - 100 mg
Condition-Specific Dosing:
opioid_naive:
Contraindicated. Fentanyl transdermal is only for opioid-tolerant patients.
conversion_from_oral_opioids:
Use an equianalgesic conversion table. For example, a patient receiving 60 mg/day oral morphine equivalent may be converted to a 25 mcg/hr fentanyl patch. The 12 mcg/hr patch is the lowest available dose and typically used for patients requiring lower opioid doses or during titration.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established for children under 2 years of age or for children under 18 years of age who are not opioid tolerant).
Adolescent:
Not established (Safety and efficacy not established for children under 18 years of age who are not opioid tolerant).
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor for signs of opioid toxicity.
Moderate:
Use with caution; monitor for signs of opioid toxicity. Consider dose reduction or extended dosing interval.
Severe:
Use with extreme caution; monitor for signs of opioid toxicity. Consider dose reduction or extended dosing interval.
Dialysis:
Fentanyl is not significantly removed by dialysis. Use with extreme caution; monitor for signs of opioid toxicity.
Hepatic Impairment:
Mild:
Use with caution; monitor for signs of opioid toxicity.
Moderate:
Use with caution; monitor for signs of opioid toxicity. Consider dose reduction or extended dosing interval.
Severe:
Use with extreme caution; monitor for signs of opioid toxicity. Consider dose reduction or extended dosing interval.
Confidence:
Medium
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 primary therapeutic effects are analgesia and sedation. It also produces respiratory depression, miosis, euphoria, and physical dependence.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (transdermal absorption is slow and dependent on skin characteristics, temperature, and patch size).
Tmax:
24-72 hours (for serum concentration to plateau after initial application).
FoodEffect:
Not applicable for transdermal patch.
Distribution:
Vd:
4 L/kg (large volume of distribution, indicating extensive tissue binding).
ProteinBinding:
80-85% (primarily to alpha-1-acid glycoprotein).
CnssPenetration:
Yes (readily crosses the blood-brain barrier).
Elimination:
HalfLife:
20-27 hours (terminal elimination half-life after patch removal, due to continued absorption from skin depot).
Clearance:
0.5 L/hr/kg (systemic clearance).
ExcretionRoute:
Renal (75% as metabolites, <10% as unchanged drug); Fecal (9% as metabolites).
Unchanged:
Less than 10% (renal).
Pharmacodynamics
OnsetOfAction:
6-12 hours (after initial application of transdermal patch).
PeakEffect:
24-72 hours (after initial application).
DurationOfAction:
Up to 72 hours (after patch application). Analgesic effects may persist for several hours after patch removal due to continued absorption from skin depot.
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE; REMS; RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS.
* **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.
* **REMS:** To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a Risk Evaluation and Mitigation Strategy (REMS) for these products.
* **Respiratory Depression:** Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of fentanyl transdermal 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 of fentanyl transdermal 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. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
* **CYP3A4 Interaction:** Concomitant use with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma levels. Monitor patients receiving fentanyl transdermal and any CYP3A4 inhibitor or inducer.
* **Concomitant Use with Benzodiazepines or Other CNS Depressants:** Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
* **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.
* **REMS:** To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a Risk Evaluation and Mitigation Strategy (REMS) for these products.
* **Respiratory Depression:** Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of fentanyl transdermal 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 of fentanyl transdermal 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. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
* **CYP3A4 Interaction:** Concomitant use with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma levels. Monitor patients receiving fentanyl transdermal and any CYP3A4 inhibitor or inducer.
* **Concomitant Use with Benzodiazepines or Other CNS Depressants:** Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of 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
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or passing out
Feeling confused
Severe constipation or stomach pain, which may indicate a severe bowel problem
Breathing difficulties, such as:
+ Trouble breathing
+ Slow breathing
+ 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 eyesight
Serotonin Syndrome: A Rare but Serious Condition
If you take this medication with certain other drugs, you may be at risk of developing serotonin syndrome, a potentially life-threatening condition. Seek medical help immediately if you experience:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Abnormal heartbeat (fast or slow)
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea
Upset stomach
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. Seek medical help immediately if you experience:
Extreme fatigue or weakness
Passing out
Severe dizziness
Upset stomach
Vomiting
Decreased appetite
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following possible side effects:
Feeling dizzy, sleepy, tired, or weak
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Headache
Feeling cold
Trouble sleeping
Excessive sweating
* Irritation at the site of administration
If any of these side effects bother you or persist, contact your doctor for guidance. This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to your doctor.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and answering any questions you may have.
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
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or passing out
Feeling confused
Severe constipation or stomach pain, which may indicate a severe bowel problem
Breathing difficulties, such as:
+ Trouble breathing
+ Slow breathing
+ 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 eyesight
Serotonin Syndrome: A Rare but Serious Condition
If you take this medication with certain other drugs, you may be at risk of developing serotonin syndrome, a potentially life-threatening condition. Seek medical help immediately if you experience:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Abnormal heartbeat (fast or slow)
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea
Upset stomach
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. Seek medical help immediately if you experience:
Extreme fatigue or weakness
Passing out
Severe dizziness
Upset stomach
Vomiting
Decreased appetite
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following possible side effects:
Feeling dizzy, sleepy, tired, or weak
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Headache
Feeling cold
Trouble sleeping
Excessive sweating
* Irritation at the site of administration
If any of these side effects bother you or persist, contact your doctor for guidance. This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to your doctor.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and answering any questions you may have.
Seek Immediate Medical Attention If You Experience:
- Slow or shallow breathing
- Extreme drowsiness or difficulty waking up
- Dizziness or lightheadedness when standing up
- Confusion or disorientation
- Pinpoint pupils
- Severe constipation
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea)
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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Respiratory problems, including asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Kidney or liver disease
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
Current use of certain medications, such as buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
Please note that this is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all prescription and over-the-counter medications, natural products, and vitamins you are taking
Discuss your health problems and medical history with your doctor
Verify that it is safe to take this medication with your existing medications and health conditions
* Avoid starting, stopping, or changing the dosage of any medication without 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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Respiratory problems, including asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Kidney or liver disease
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
Current use of certain medications, such as buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
Please note that this is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all prescription and over-the-counter medications, natural products, and vitamins you are taking
Discuss your health problems and medical history with your doctor
Verify that it is safe to take this medication with your existing medications and health conditions
* Avoid starting, stopping, or changing the dosage of any medication without consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial to ensure your safety and prevent potential interactions.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position. Be cautious when climbing stairs.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the drug becomes less effective, and you may need higher doses 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 lower your dose or stop taking this medication, consult your doctor first, as sudden changes can increase the risk of withdrawal or other severe problems. Follow your doctor's instructions carefully, and report any adverse effects, such as increased pain, mood changes, suicidal thoughts, or other concerns.
Safe Use
Do not exceed the prescribed dose, frequency, or duration of treatment, as this can 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 become more sensitive to pain, or you experience 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 can 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 a higher risk of seizures while taking this medication.
Hormonal Effects
Long-term use of opioid medications can lead to lower sex hormone levels. If you experience a decreased interest in sex, fertility problems, irregular menstrual periods, or ejaculation problems, 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
Inform your doctor if you are breastfeeding, 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.
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial to ensure your safety and prevent potential interactions.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position. Be cautious when climbing stairs.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the drug becomes less effective, and you may need higher doses 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 lower your dose or stop taking this medication, consult your doctor first, as sudden changes can increase the risk of withdrawal or other severe problems. Follow your doctor's instructions carefully, and report any adverse effects, such as increased pain, mood changes, suicidal thoughts, or other concerns.
Safe Use
Do not exceed the prescribed dose, frequency, or duration of treatment, as this can 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 become more sensitive to pain, or you experience 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 can 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 a higher risk of seizures while taking this medication.
Hormonal Effects
Long-term use of opioid medications can lead to lower sex hormone levels. If you experience a decreased interest in sex, fertility problems, irregular menstrual periods, or ejaculation problems, 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
Inform your doctor if you are breastfeeding, 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:
- Slow, shallow, or stopped breathing
- Extreme drowsiness or inability to wake up
- Limp body
- Cold, clammy skin
- Pinpoint pupils
- Blue lips or fingernails
What to Do:
If you suspect an overdose, call 911 immediately. Administer naloxone if available and trained to do so. Stay with the person until emergency medical help arrives. Call 1-800-222-1222 (Poison Control Center) for additional guidance.
Drug Interactions
Contraindicated Interactions
- CYP3A4 inhibitors (strong, e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, saquinavir, troleandomycin, voriconazole) - concurrent use can increase fentanyl plasma concentrations, leading to increased opioid effects and potentially fatal respiratory depression.
- Benzodiazepines or other CNS depressants (e.g., other opioids, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, alcohol) - concurrent use significantly increases risk of profound sedation, respiratory depression, coma, and death.
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation due to risk of severe, unpredictable, and potentially fatal reactions (e.g., serotonin syndrome, opioid toxicity).
Major Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort) - can decrease fentanyl plasma concentrations, leading to reduced efficacy and potential withdrawal symptoms.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol) - increased risk of serotonin syndrome.
- Anticholinergic drugs - increased risk of urinary retention and/or severe constipation.
- Diuretics - opioids can reduce the efficacy of diuretics by causing the release of antidiuretic hormone.
Moderate Interactions
- Antihypertensives - additive hypotensive effects.
- Muscle relaxants - enhanced neuromuscular blockade.
- Other opioids - additive CNS and respiratory depression.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Pain assessment (intensity, character, location)
Rationale: To establish baseline pain level and guide initial dosing.
Timing: Prior to initiation of therapy.
Respiratory rate and depth
Rationale: To assess baseline respiratory function and identify risk for respiratory depression.
Timing: Prior to initiation of therapy.
Level of consciousness/sedation
Rationale: To assess baseline mental status and identify risk for excessive sedation.
Timing: Prior to initiation of therapy.
Opioid tolerance status
Rationale: Fentanyl transdermal is only for opioid-tolerant patients. Verify patient meets criteria.
Timing: Prior to initiation of therapy.
Concomitant medications review (especially CNS depressants, CYP3A4 inhibitors/inducers)
Rationale: To identify potential drug interactions that could lead to toxicity or reduced efficacy.
Timing: Prior to initiation of therapy.
Routine Monitoring
Pain assessment
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 re-evaluation.
Respiratory rate and depth
Frequency: Regularly, especially during initiation and dose titration (e.g., every 4-8 hours initially, then daily).
Target: Typically >10-12 breaths/min, regular rhythm.
Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or signs of hypoventilation (e.g., cyanosis, somnolence) require immediate intervention (e.g., naloxone, respiratory support).
Level of consciousness/sedation (e.g., Pasero Opioid-Induced Sedation Scale)
Frequency: Regularly, especially during initiation and dose titration (e.g., every 4-8 hours initially, then daily).
Target: Alert or mildly drowsy, easily aroused.
Action Threshold: Somnolent, difficult to arouse, or unarousable requires immediate intervention.
Signs of opioid toxicity (e.g., miosis, constipation, nausea, vomiting, pruritus)
Frequency: Daily.
Target: Minimal or manageable side effects.
Action Threshold: Severe or unmanageable side effects may require dose reduction or discontinuation.
Patch adhesion and skin integrity at application site
Frequency: Daily.
Target: Patch remains intact and adhered; no significant skin irritation.
Action Threshold: Poor adhesion, detachment, or severe skin reaction requires reapplication to a new site or discontinuation.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing, difficulty breathing, blue lips/skin)
- Excessive sedation/somnolence
- Dizziness, lightheadedness
- Nausea, vomiting
- Constipation
- Pruritus (itching)
- Confusion, disorientation
- Miosis (pinpoint pupils)
- Signs of overdose (extreme drowsiness, inability to wake up, slow/shallow breathing, limp body, cold/clammy skin, pinpoint pupils)
- Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, shivering, muscle stiffness/twitching, loss of coordination, nausea, vomiting, diarrhea)
Special Patient Groups
Pregnancy
Use during pregnancy is generally not recommended unless the potential benefit justifies the potential risk to the fetus. Prolonged use during pregnancy can lead to neonatal opioid withdrawal syndrome (NOWS).
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for congenital malformations with opioid exposure. Risk generally considered low for fentanyl.
Second Trimester:
Risk of NOWS increases with prolonged exposure.
Third Trimester:
High risk of neonatal opioid withdrawal syndrome (NOWS) if used chronically. Monitor neonates for signs of withdrawal (irritability, hyperactivity, abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, poor feeding, sweating, yawning, sneezing, fever).
Lactation
Fentanyl is excreted into breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., sedation, respiratory depression), breastfeeding is not recommended during treatment with fentanyl transdermal. If breastfeeding cannot be avoided, monitor the infant closely for signs of sedation and respiratory depression.
Infant Risk:
L4 (Potentially hazardous)
Pediatric Use
Fentanyl transdermal is not indicated for use in opioid-non-tolerant pediatric patients. Safety and efficacy have not been established in children under 2 years of age. Use in pediatric patients 2 years of age and older who are opioid tolerant should be done with extreme caution and only if the potential benefits outweigh the risks. Closely monitor for respiratory depression and other opioid-related adverse events.
Geriatric Use
Elderly patients may be more sensitive to the effects of fentanyl, particularly respiratory depression. Start with the lowest effective dose and titrate slowly. Monitor closely for signs of respiratory depression, sedation, and other adverse effects. Consider age-related decreases in renal and hepatic function.
Clinical Information
Clinical Pearls
- Fentanyl transdermal is for opioid-tolerant patients only. Using it in opioid-naive patients can cause fatal respiratory depression.
- The 12 mcg/hr patch is the lowest dose and is often used for initial titration or for patients converting from lower doses of other opioids.
- Heat exposure (e.g., fever, heating pads, hot baths) can significantly increase fentanyl absorption, leading to overdose. Advise patients to avoid heat sources.
- Proper disposal of used patches is critical to prevent accidental exposure to children and pets. Fold sticky sides together and flush down the toilet or dispose of as per local guidelines.
- Patients may experience continued opioid effects for hours after patch removal due to a skin depot effect.
- Constipation is a common and often persistent side effect of opioid therapy; proactive management (e.g., stool softeners, laxatives) is essential.
- Always assess for signs of respiratory depression and sedation, especially during initiation and dose changes. Have naloxone readily available.
- Counsel patients and caregivers on the risks of addiction, abuse, and misuse, and the importance of safe storage.
Alternative Therapies
- Other long-acting opioid analgesics (e.g., extended-release morphine, oxycodone, hydromorphone, methadone, buprenorphine transdermal)
- Short-acting opioid analgesics (for breakthrough pain, in conjunction with long-acting opioids)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin, tricyclic antidepressants, SNRIs)
- Interventional pain management (e.g., nerve blocks, spinal cord stimulation)
- Physical therapy, occupational therapy, psychological therapies (e.g., CBT)
Cost & Coverage
Average Cost:
Varies widely, typically $100-$300+ per 5 patches (12 mcg/hr)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (for generic), Tier 3 or 4 (for brand). Often requires prior authorization.
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the safety of others, never share your medication with anyone, and do not take medication prescribed to someone else.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is essential to read this guide carefully and review it again each time you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be used as part of the treatment. Consult with your doctor or pharmacist to learn more about obtaining and using naloxone. 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 seeking help, be prepared to provide critical information, including the substance involved, the quantity taken, and the time of the incident.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is essential to read this guide carefully and review it again each time you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be used as part of the treatment. Consult with your doctor or pharmacist to learn more about obtaining and using naloxone. 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 seeking help, be prepared to provide critical information, including the substance involved, the quantity taken, and the time of the incident.