Duragesic 25mcg/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 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 Your Medication Patch
To use your medication patch correctly, follow your doctor's instructions and read all the information provided. Wash your hands before and after handling the patch.
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 the patch each time you change it.
4. If there is hair where you plan to apply the patch, clip it close to the skin. Do not shave the area.
5. Avoid applying the patch to skin that has recently been treated with creams, oils, lotions, or other skin products.
6. Do not apply the patch near 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 the patch is not sticking well, 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. Make sure you know what type of dressing is approved for use.
Do not cover the patch with any other bandage or tape.
Important Safety Precautions
Do not cut or divide the patches.
Do not use damaged patches.
Avoid touching the sticky side of the patch as much as possible.
If the patch comes into contact with 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 can lead to overdose and death.
Storage and Disposal
Store the patches 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 you remember, after removing the old one.
* Do not apply a double dose or extra doses.
To use your medication patch correctly, follow your doctor's instructions and read all the information provided. Wash your hands before and after handling the patch.
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 the patch each time you change it.
4. If there is hair where you plan to apply the patch, clip it close to the skin. Do not shave the area.
5. Avoid applying the patch to skin that has recently been treated with creams, oils, lotions, or other skin products.
6. Do not apply the patch near 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 the patch is not sticking well, 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. Make sure you know what type of dressing is approved for use.
Do not cover the patch with any other bandage or tape.
Important Safety Precautions
Do not cut or divide the patches.
Do not use damaged patches.
Avoid touching the sticky side of the patch as much as possible.
If the patch comes into contact with 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 can lead to overdose and death.
Storage and Disposal
Store the patches 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 you remember, after removing the old one.
* Do not apply a double dose or extra doses.
Lifestyle & Tips
- Do not apply heat (e.g., heating pads, electric blankets, hot baths, saunas, direct sunlight) to the patch or application site, as this can cause too much medicine to be absorbed and lead to overdose.
- Avoid activities that increase body temperature (e.g., strenuous exercise) as this can also increase absorption.
- Do not cut, chew, or swallow the patch.
- Keep patches out of reach of children and pets at all times, even used ones. Fold used patches in half with the sticky sides together and flush down the toilet or dispose of as instructed by your pharmacist.
- Avoid alcohol and other sedating medications unless specifically approved by your 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.
- Carry naloxone if prescribed, and ensure family/caregivers know how to use it in case of overdose.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose for opioid-tolerant patients: 25 mcg/hr patch applied transdermally every 72 hours. Dose titration based on analgesic response and tolerability.
Dose Range:
12 - 100 mg
Condition-Specific Dosing:
opioid_naive:
Contraindicated. Only for opioid-tolerant patients.
conversion_from_oral_opioids:
Use conversion tables provided in product labeling. Typically, 25 mcg/hr patch for patients receiving 45-134 mg oral morphine equivalent daily.
Pediatric Dosing
Neonatal:
Not established. Contraindicated due to risk of respiratory depression and accidental exposure.
Infant:
Not established. Contraindicated due to risk of respiratory depression and accidental exposure.
Child:
Not established. Contraindicated due to risk of respiratory depression and accidental exposure.
Adolescent:
Not established. Contraindicated due to risk of respiratory depression and accidental exposure.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution. Monitor closely for signs of opioid toxicity.
Moderate:
Use with caution. Monitor closely for signs of opioid toxicity. Consider dose reduction.
Severe:
Use with caution. Monitor closely for signs of opioid toxicity. Consider dose reduction and extended dosing interval.
Dialysis:
Not well studied. Fentanyl is not significantly removed by dialysis. Use with extreme caution and monitor closely.
Hepatic Impairment:
Mild:
Use with caution. Monitor closely for signs of opioid toxicity.
Moderate:
Use with caution. Monitor closely for signs of opioid toxicity. Consider dose reduction.
Severe:
Use with caution. Monitor closely for signs of opioid toxicity. Consider dose reduction and extended dosing interval.
Confidence:
Medium
Pharmacology
Mechanism of Action
Fentanyl is a potent, synthetic opioid analgesic that primarily interacts with mu-opioid receptors in the central nervous system (CNS). Its primary therapeutic action is analgesia. Other effects include respiratory depression, miosis, euphoria, and physical dependence.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable for transdermal (systemic absorption from skin). For IV, 100%.
Tmax:
24-72 hours (after initial application of patch)
FoodEffect:
Not applicable for transdermal patch.
Distribution:
Vd:
4 L/kg (high)
ProteinBinding:
80-85%
CnssPenetration:
Yes
Elimination:
HalfLife:
20-27 hours (terminal half-life after patch removal, due to continued absorption from skin depot)
Clearance:
Not available (variable)
ExcretionRoute:
Renal (75% as metabolites, <10% as unchanged drug), Fecal (9% as metabolites)
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
6-12 hours (after initial application of patch)
PeakEffect:
24-72 hours (after initial application of patch)
DurationOfAction:
Up to 72 hours (while patch is applied)
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; NEONATAL OPIOID WITHDRAWAL SYNDROME.
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 Fentanyl transdermal, 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 REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make available to healthcare providers REMS-compliant education programs, and to patients and their caregivers, a Medication Guide that contains information about the safe use of 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 Fentanyl transdermal out of reach of children and dispose of used patches properly.
Cytochrome P450 3A4 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 concentration. 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 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.
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 NOWS and ensure that appropriate treatment will be available.
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 Fentanyl transdermal, 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 REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make available to healthcare providers REMS-compliant education programs, and to patients and their caregivers, a Medication Guide that contains information about the safe use of 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 Fentanyl transdermal out of reach of children and dispose of used patches properly.
Cytochrome P450 3A4 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 concentration. 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 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.
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 NOWS and ensure that appropriate treatment will be available.
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 serious 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 Rare but Serious Condition
If you take this medication with certain other drugs, you may be at risk for serotonin syndrome, a potentially life-threatening condition. Seek immediate medical attention 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 serious 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 can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Dizziness
Drowsiness
Fatigue or weakness
Dry mouth
Constipation
Diarrhea
Stomach pain
Nausea or vomiting
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. You can also report side effects to the FDA at 1-800-332-1088 or online at 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 serious 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 Rare but Serious Condition
If you take this medication with certain other drugs, you may be at risk for serotonin syndrome, a potentially life-threatening condition. Seek immediate medical attention 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 serious 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 can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Dizziness
Drowsiness
Fatigue or weakness
Dry mouth
Constipation
Diarrhea
Stomach pain
Nausea or vomiting
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. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Extreme drowsiness or difficulty waking up
- Slow, shallow, or difficult breathing
- Pinpoint pupils
- Severe dizziness or lightheadedness
- Confusion
- Cold, clammy skin
- Blue lips or fingernails
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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 blockage 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
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your existing treatments and health status. Never start, stop, or adjust 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 blockage 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
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your existing treatments and health status. Never start, stop, or adjust the dosage of any medication without 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
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, 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, contact 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 may increase the risk of 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 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 may lead to unsafe and potentially fatal effects.
Seizure Risk
This medication may increase the risk of seizures in some individuals, including 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 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
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, 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, contact 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 may increase the risk of 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 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 may lead to unsafe and potentially fatal effects.
Seizure Risk
This medication may increase the risk of seizures in some individuals, including 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 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:
- Slowed or stopped breathing (respiratory depression)
- Extreme drowsiness or unresponsiveness
- Pinpoint pupils
- Limp muscles
- Cold, clammy skin
- Blue discoloration of lips or fingernails
- Slowed heart rate
- Low blood pressure
- Coma
What to Do:
Seek immediate emergency medical attention. Call 911. Administer naloxone if available and trained to do so. Provide ventilatory support if necessary. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Contraindicated Interactions
- Concomitant use with benzodiazepines or other CNS depressants (unless benefits outweigh risks, and only with careful monitoring)
- Concomitant use with alcohol
- Concomitant use with strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, troleandomycin)
- Patients who are not opioid tolerant
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Significant respiratory depression
- Known or suspected paralytic ileus
- Acute pain or post-operative pain (not for PRN use)
- Mild or intermittent pain
Major Interactions
- Other CNS depressants (e.g., sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines, other opioids): Increased risk of respiratory depression, profound sedation, coma, and death.
- CYP3A4 inhibitors (moderate, e.g., fluconazole, diltiazem, verapamil, erythromycin, grapefruit juice): Increased fentanyl plasma concentrations, leading to increased opioid effects and potential for respiratory depression.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, MAOIs, tramadol, linezolid): Risk of serotonin syndrome.
- Mixed agonist/antagonist opioids (e.g., pentazocine, nalbuphine, butorphanol): May reduce analgesic effect and/or precipitate withdrawal symptoms.
- Partial agonist opioids (e.g., buprenorphine): May reduce analgesic effect and/or precipitate withdrawal symptoms.
Moderate Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): Decreased fentanyl plasma concentrations, leading to reduced efficacy and potential for withdrawal symptoms.
- Anticholinergics: Increased risk of urinary retention and/or severe constipation.
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 daily opioid intake.
Timing: Prior to initiation of therapy
Concomitant medications (especially CNS depressants, CYP3A4 inhibitors/inducers)
Rationale: To identify potential drug interactions and adjust therapy accordingly.
Timing: Prior to initiation of therapy
Routine Monitoring
Pain relief and adverse effects
Frequency: Daily, especially during titration and dose changes
Target: Acceptable pain control with tolerable side effects
Action Threshold: Inadequate pain control or intolerable side effects warrant dose adjustment or discontinuation.
Respiratory rate and depth
Frequency: Regularly, especially during initiation and dose titration (e.g., every 4-8 hours initially, then daily)
Target: >10-12 breaths/min, unlabored
Action Threshold: <10 breaths/min, shallow breathing, or signs of hypoventilation 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: Difficult to arouse, somnolent, or unarousable requires immediate intervention.
Signs of opioid abuse, misuse, or diversion
Frequency: At each visit
Target: Absence of aberrant drug-related behaviors
Action Threshold: Presence of such behaviors requires reassessment of therapy and potential referral for addiction treatment.
Patch adhesion and skin integrity at application site
Frequency: Daily
Target: Patch remains securely adhered; no significant skin irritation
Action Threshold: Poor adhesion or severe skin irritation may necessitate reapplication or change in site.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation/drowsiness
- Dizziness
- Nausea/vomiting
- Constipation
- Pruritus (itching)
- Confusion
- Miosis (pinpoint pupils)
- Signs of opioid withdrawal (if abruptly discontinued or dose reduced too quickly)
Special Patient Groups
Pregnancy
Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for congenital malformations with opioid exposure. Risk generally considered low for specific malformations.
Second Trimester:
Risk of NOWS increases with prolonged use.
Third Trimester:
High risk of NOWS with prolonged use. Risk of respiratory depression in the neonate if used close to delivery.
Lactation
Fentanyl is excreted into breast milk. Infants exposed through breast milk are at risk for serious adverse reactions, including excess sedation and respiratory depression. Monitor infants for signs of sedation and respiratory depression. If opioid use is necessary, consider pumping and discarding milk or using an alternative analgesic.
Infant Risk:
High (L3 - Moderately Safe, but significant risk of adverse effects in infant; monitor closely)
Pediatric Use
Contraindicated in opioid non-tolerant pediatric patients and generally not recommended for use in children due to the risk of fatal respiratory depression and accidental exposure. Accidental exposure in children, even to a used patch, can be fatal.
Geriatric Use
Use with caution. Elderly patients may be more sensitive to the effects of fentanyl, including respiratory depression. Start with lower doses and titrate slowly. 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.
- Proper disposal of patches is critical to prevent accidental exposure, especially in children and pets. Fold sticky sides together and flush down the toilet or dispose of as per local regulations.
- Do not cut or damage the patch, as this can lead to rapid release of fentanyl and overdose.
- Patients should be instructed to remove the old patch before applying a new one.
- Heat exposure (e.g., fever, heating pads, hot baths) can significantly increase fentanyl absorption, leading to overdose. Advise patients to avoid these situations.
- Monitor for signs of respiratory depression and sedation, especially during initiation and dose titration. Naloxone should be readily available.
- Be aware of the potential for drug interactions, particularly with CYP3A4 inhibitors and other CNS depressants.
- The analgesic effect may not be immediate; it takes 6-12 hours for onset and 24-72 hours to reach peak effect after initial application. Patients may need short-acting opioids for breakthrough pain during this period.
- When discontinuing, taper the dose gradually to avoid withdrawal symptoms.
Alternative Therapies
- Other long-acting opioid analgesics (e.g., extended-release oxycodone, extended-release morphine, methadone, hydromorphone ER)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin, tricyclic antidepressants) for neuropathic pain or as adjuncts
- Interventional pain management techniques (e.g., nerve blocks, spinal cord stimulation)
- Physical therapy, occupational therapy, psychological therapies (e.g., CBT)
Cost & Coverage
Average Cost:
Varies widely by dose and pharmacy. For 25 mcg/hr, typically $100-$300+ per 5 patches
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization and/or step therapy due to abuse potential and cost)
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 safe and effective treatment, never share your medication with others or take someone else's medication.
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 your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of an overdose, a medication called naloxone can be used as an emergency treatment. Discuss the availability and use of naloxone with your doctor or pharmacist to ensure you are prepared in case of an emergency. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it was taken.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When reporting the incident, provide as much information as possible about the medication, including the dose, time of ingestion, and any other relevant details to ensure prompt and effective treatment.
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 your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of an overdose, a medication called naloxone can be used as an emergency treatment. Discuss the availability and use of naloxone with your doctor or pharmacist to ensure you are prepared in case of an emergency. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it was taken.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When reporting the incident, provide as much information as possible about the medication, including the dose, time of ingestion, and any other relevant details to ensure prompt and effective treatment.