Fentanyl 87.5mcg/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
Mu-opioid Receptor Agonist
Pregnancy Category
C
FDA Approved
Aug 1990
DEA Schedule
Schedule II
Overview
What is this medicine?
Fentanyl is a strong opioid 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 opioid pain medicines. The patch slowly releases medicine into your body over 3 days (72 hours) 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 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 the patch each time you change it.
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.
Wearing the Patch
You can bathe, shower, or swim for short periods while wearing the patch. To keep it in place, cover the patch 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, but be sure to use the correct type of dressing. Avoid covering 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 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 the patch at room temperature in a dry place, away from bathrooms. 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 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 the patch each time you change it.
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.
Wearing the Patch
You can bathe, shower, or swim for short periods while wearing the patch. To keep it in place, cover the patch 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, but be sure to use the correct type of dressing. Avoid covering 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 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 the patch at room temperature in a dry place, away from bathrooms. 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
- Avoid exposing the patch to direct heat (e.g., heating pads, electric blankets, hot tubs, saunas, direct sunlight, fever) as this can cause too much medicine to be absorbed, leading to overdose.
- Do not cut, chew, or swallow the patch.
- Do not apply the patch to irritated, broken, or radiated skin.
- Apply the patch to a clean, dry, flat area of skin on the torso or upper arm. Rotate application sites.
- Press firmly for 30 seconds to ensure good adhesion.
- Wash hands immediately after handling the patch.
- Keep all patches, new and used, out of reach of children and pets.
- Fold used patches in half so the sticky sides adhere to each other, then flush down the toilet or dispose of as instructed by your pharmacist/doctor (e.g., in a secure, child-proof container).
- 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.
Available Forms & Alternatives
Available Strengths:
- Fentanyl 25mcg/hr Patch
- Fentanyl 50mcg/hr Patch
- Fentanyl 75mcg/hr Patch
- Fentanyl 100mcg/hr Patch
- Fentanyl Cit 0.05mg/ml Inj, 20ml
- Fentanyl Cit 0.05mg/ml Inj, 2ml
- Fentanyl Cit 0.05mg/ml Inj, 50ml
- Fentanyl Cit 0.05mg/ml Inj, 5ml
- Fentanyl Cit 800mcg Oral Transmcsl
- Fentanyl Cit 1200mcg Oral Transmcsl
- Fentanyl Cit 600mcg Oral Transmcsl
- Fentanyl Cit 1600mcg Oral Transmcsl
- Fentanyl Cit 400mcg Oral Transmcsl
- Fentanyl Cit 200mcg Oral Transmcsl
- Fentanyl 62.5mcg/hr Patch
- Fentanyl 87.5mcg/hr Patch
- Fentanyl Cit 600mcg Oraltransmcsl
- Fentanyl Cit 800mcg Oral Transmcsl
- Fentanyl Cit 1600mcg Oral Transmcsl
- Fentanyl Cit 100mcg Tablets
- Fentanyl Cit 200mcg Tablets
- Fentanyl 37.5mcg/hr Patch
- Fentanyl 62.5mcg/hr Patch
- Fentanyl Cit 50mcg/ml Pf Inj, 1ml
- Fentanyl 12mcg/hr Patch
- Fentanyl Cit 50mcg/1ml Inj, 10ml
- Fentanyl Cit 100mcg/2ml Pf Inj, 2ml
- Fentanyl Cit 25mcg/0.5ml Pf Inj
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized, typically initiated at 12 mcg/hr for opioid-tolerant patients, titrated every 3 days based on analgesic response and tolerability. 87.5 mcg/hr is a higher dose for patients requiring significant opioid analgesia.
Dose Range:
12 - 100 mg
Condition-Specific Dosing:
opioidTolerantChronicPain:
Initial dose based on previous 24-hour opioid requirement. Conversion tables are used. For example, 87.5 mcg/hr patch may be equivalent to approximately 180-224 mg oral morphine per day. Patch is applied every 72 hours.
notForOpioidNaive:
Fentanyl transdermal system is NOT for opioid-naive patients. Use in opioid-naive patients has resulted in fatal respiratory depression.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for chronic pain. Safety and efficacy in children under 2 years of age have not been established. Use in children 2 years of age and older who are opioid tolerant and require continuous opioid analgesia is based on conversion from oral opioids, similar to adults.
Adolescent:
Dosing similar to adults for opioid-tolerant adolescents requiring continuous opioid analgesia, based on conversion from oral opioids.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor for signs of opioid toxicity.
Moderate:
Use with caution; consider dose reduction and close monitoring due to potential for increased plasma concentrations and prolonged effects.
Severe:
Not recommended due to potential for increased plasma concentrations and prolonged effects. If absolutely necessary, initiate at lowest dose and monitor closely.
Dialysis:
Not well studied; fentanyl is not significantly removed by dialysis. Use with extreme caution and close monitoring.
Hepatic Impairment:
Mild:
Use with caution; monitor for signs of opioid toxicity.
Moderate:
Use with caution; consider dose reduction and close monitoring due to potential for increased plasma concentrations and prolonged effects.
Severe:
Not recommended due to potential for increased plasma concentrations and prolonged effects. If absolutely necessary, initiate at lowest dose and monitor closely.
Pharmacology
Mechanism of Action
Fentanyl is a potent, synthetic opioid analgesic that primarily acts as an agonist at mu-opioid receptors in the central nervous system (CNS). Its principal therapeutic actions are analgesia and sedation. Other effects include respiratory depression, miosis, euphoria, and physical dependence.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable for transdermal patch (bypasses first-pass metabolism). Systemic absorption is dependent on skin temperature, condition, and blood flow. Initial absorption from skin depot occurs over 24-48 hours.
Tmax:
24-72 hours (after initial application, steady state reached after 2-3 applications)
FoodEffect:
Not applicable (transdermal)
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 blood-brain barrier)
Elimination:
HalfLife:
13-22 hours (terminal elimination 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:
6-12 hours (after initial application)
PeakEffect:
24-72 hours (after initial application)
DurationOfAction:
72 hours (patch applied every 72 hours)
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE: Fentanyl transdermal system 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 system, and monitor all patients regularly for the development of these behaviors and conditions.
RISK EVALUATION AND MITIGATION STRATEGY (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 a REMS-compliant education program, and to patients, a Medication Guide that contains information about the safe use of these products.
RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur with use of Fentanyl transdermal system. Monitor for respiratory depression, especially during initiation of Fentanyl transdermal system or following a dose increase. Accidental exposure to Fentanyl transdermal system, especially in children, can result in a fatal overdose.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use of Fentanyl transdermal system 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: The concomitant use of Fentanyl transdermal system with all CYP3A4 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 CYP3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving Fentanyl transdermal system and any CYP3A4 inhibitor or inducer.
ACCIDENTAL EXPOSURE: Accidental exposure to Fentanyl transdermal system, especially in children, can result in a fatal overdose. Keep Fentanyl transdermal system out of reach of children and dispose of used patches properly.
RISK EVALUATION AND MITIGATION STRATEGY (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 a REMS-compliant education program, and to patients, a Medication Guide that contains information about the safe use of these products.
RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur with use of Fentanyl transdermal system. Monitor for respiratory depression, especially during initiation of Fentanyl transdermal system or following a dose increase. Accidental exposure to Fentanyl transdermal system, especially in children, can result in a fatal overdose.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use of Fentanyl transdermal system 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: The concomitant use of Fentanyl transdermal system with all CYP3A4 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 CYP3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving Fentanyl transdermal system and any CYP3A4 inhibitor or inducer.
ACCIDENTAL EXPOSURE: Accidental exposure to Fentanyl transdermal system, especially in children, can result in a fatal overdose. Keep Fentanyl transdermal system out of reach of children and dispose of used patches properly.
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 medical attention immediately:
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
+ Breathing problems during sleep (sleep apnea)
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 irregular)
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
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 experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
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
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 medical attention immediately:
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
+ Breathing problems during sleep (sleep apnea)
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 irregular)
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
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 experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
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
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
- Blue lips or fingernails
- Confusion or disorientation
- Dizziness or lightheadedness
- Pinpoint pupils
- Severe constipation
- 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, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
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
This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems to your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your existing health conditions and medications. 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, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
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
This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems to your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your existing health conditions and medications. Never start, stop, or adjust 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 will help ensure your safety and prevent potential interactions with other treatments.
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 position, and be cautious when climbing stairs.
Long-Term Use and Tolerance
If you have been taking this medication for an extended period or at high doses, it may become less effective, and you may require higher doses to achieve the same pain relief. This is known as tolerance. If you notice that the medication is no longer working as well, contact your doctor. Do not take more than the prescribed dose.
Dependence and Withdrawal
Long-term or regular use of opioid medications like this one can lead to dependence. Suddenly lowering the dose or stopping the medication may increase the risk of withdrawal or other severe problems. Consult your doctor before reducing the dose or discontinuing the medication, and follow their instructions carefully. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.
Safe Use and Dosage
Do not exceed the prescribed dose, frequency, or duration of treatment. Taking more than recommended may increase the risk of severe side effects. Do not combine this medication with other strong pain medications or use a pain patch without consulting your doctor first.
Monitoring and Follow-Up
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 can lead to unsafe and potentially deadly 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 may lead to lower sex hormone levels. If you experience decreased libido, 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. If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and harm your baby. Seek medical attention immediately if your baby appears excessively sleepy, limp, or has breathing difficulties.
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent potential interactions with other treatments.
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 position, and be cautious when climbing stairs.
Long-Term Use and Tolerance
If you have been taking this medication for an extended period or at high doses, it may become less effective, and you may require higher doses to achieve the same pain relief. This is known as tolerance. If you notice that the medication is no longer working as well, contact your doctor. Do not take more than the prescribed dose.
Dependence and Withdrawal
Long-term or regular use of opioid medications like this one can lead to dependence. Suddenly lowering the dose or stopping the medication may increase the risk of withdrawal or other severe problems. Consult your doctor before reducing the dose or discontinuing the medication, and follow their instructions carefully. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.
Safe Use and Dosage
Do not exceed the prescribed dose, frequency, or duration of treatment. Taking more than recommended may increase the risk of severe side effects. Do not combine this medication with other strong pain medications or use a pain patch without consulting your doctor first.
Monitoring and Follow-Up
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 can lead to unsafe and potentially deadly 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 may lead to lower sex hormone levels. If you experience decreased libido, 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. If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and harm your baby. Seek medical attention immediately if your baby appears excessively sleepy, limp, or has breathing difficulties.
Overdose Information
Overdose Symptoms:
- Slowed or stopped breathing
- Extreme drowsiness or inability to wake up
- Pinpoint pupils
- Limp muscles
- Cold, clammy skin
- Blue discoloration of lips or fingernails
- Loss of consciousness
What to Do:
If you suspect an overdose, remove the patch immediately. Call 911 or your local emergency number right away. 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) for additional guidance.
Drug Interactions
Contraindicated Interactions
- CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, erythromycin, verapamil, diltiazem, grapefruit juice) - concurrent use can increase fentanyl plasma concentrations, leading to increased or prolonged opioid effects, including fatal respiratory depression.
- Benzodiazepines or other CNS depressants (e.g., other opioids, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, alcohol) - concurrent use can result in profound sedation, respiratory depression, coma, and death.
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation can result in severe, unpredictable, and potentially fatal reactions (e.g., serotonin syndrome, respiratory depression, coma).
Major Interactions
- 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 the analgesic effect of fentanyl and/or precipitate withdrawal symptoms.
- Partial agonist opioids (e.g., buprenorphine) - may reduce the analgesic effect of fentanyl and/or precipitate withdrawal symptoms.
Moderate Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort) - may decrease fentanyl plasma concentrations, leading to reduced efficacy and potential withdrawal symptoms.
- Anticholinergic drugs - increased risk of urinary retention and/or severe constipation/paralytic ileus.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Pain assessment (intensity, character, location)
Rationale: To establish baseline pain level and guide initial dosing/titration.
Timing: Prior to initiation and at each follow-up visit.
Opioid tolerance assessment
Rationale: Fentanyl patch is only for opioid-tolerant patients. To ensure patient meets criteria for safe use.
Timing: Prior to initiation.
Respiratory rate and depth
Rationale: To assess baseline respiratory function and identify risk for respiratory depression.
Timing: Prior to initiation.
Level of consciousness/sedation
Rationale: To assess baseline mental status and identify risk for excessive sedation.
Timing: Prior to initiation.
Routine Monitoring
Pain relief and adverse effects
Frequency: Daily, especially during titration; then regularly (e.g., weekly to monthly) once stable.
Target: Acceptable pain control with tolerable side effects.
Action Threshold: Inadequate pain control or intolerable side effects warrant dose adjustment or alternative therapy.
Respiratory rate and depth
Frequency: Regularly, especially during initiation and dose titration. Instruct patient/caregiver on signs of respiratory depression.
Target: Normal for patient (e.g., 12-20 breaths/min).
Action Threshold: <10 breaths/min, shallow breathing, or signs of hypoventilation require immediate medical attention.
Level of consciousness/sedation
Frequency: Regularly, especially during initiation and dose titration. Instruct patient/caregiver on signs of excessive sedation.
Target: Alert and oriented, able to perform activities of daily living.
Action Threshold: Excessive drowsiness, difficulty arousing, confusion, or disorientation require immediate medical attention.
Bowel function
Frequency: Regularly.
Target: Regular bowel movements.
Action Threshold: Constipation; initiate bowel regimen as needed.
Signs of opioid withdrawal
Frequency: Regularly, especially if dose is reduced or discontinued.
Target: Absence of withdrawal symptoms.
Action Threshold: Symptoms (e.g., restlessness, lacrimation, rhinorrhea, yawning, sweating, muscle aches, nausea, vomiting, diarrhea) indicate need for slower taper or re-evaluation.
Symptom Monitoring
- Severe drowsiness
- Dizziness
- Confusion
- Slow or shallow breathing
- Difficulty breathing
- Pinpoint pupils
- Extreme fatigue
- Cold, clammy skin
- Blue lips or fingernails
- Difficulty walking or speaking
- Fainting
- 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
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. Advise pregnant patients of the risk of 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 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 respiratory depression and sedation. Monitor infants for signs of sedation and respiratory depression. Consider alternative pain management or temporary discontinuation of breastfeeding.
Infant Risk:
L3 (Moderate risk)
Pediatric Use
Fentanyl transdermal system is not indicated for acute pain or in opioid-naive patients. Safety and efficacy have not been established in children under 2 years of age. Use in children 2 years of age and older is restricted to opioid-tolerant patients requiring continuous opioid analgesia. Accidental exposure in children can be fatal.
Geriatric Use
Elderly patients may be more sensitive to the effects of fentanyl, particularly respiratory depression. Start with lower doses and titrate slowly. Monitor closely for adverse effects, especially respiratory depression and sedation. Consider age-related decreases in renal and hepatic function.
Clinical Information
Clinical Pearls
- Fentanyl transdermal patch 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.
- Heat exposure (e.g., fever, heating pads, hot baths) can significantly increase fentanyl absorption, leading to overdose. Advise patients to avoid heat on the patch site.
- Proper disposal of used patches is critical to prevent accidental exposure, especially to children and pets. Fold sticky sides together and flush down the toilet or dispose of in a secure, child-proof container as per local regulations.
- Patients may require breakthrough pain medication (short-acting opioid) in addition to the patch.
- Titration should occur no more frequently than every 3 days (72 hours) due to the time required to reach steady-state concentrations.
- When discontinuing, taper the dose gradually to prevent withdrawal symptoms. Due to the skin depot, fentanyl levels will decline slowly after patch removal.
- Educate patients and caregivers thoroughly on safe use, storage, and disposal, and signs of overdose.
Alternative Therapies
- Other long-acting opioids (e.g., extended-release morphine, oxycodone, hydromorphone, methadone)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin, tricyclic antidepressants) for neuropathic or chronic pain components
- Interventional pain procedures (e.g., nerve blocks, spinal cord stimulation)
- Physical therapy, occupational therapy, psychological therapies (e.g., CBT)
Cost & Coverage
Average Cost:
Varies widely by brand/generic and pharmacy. Typically $100-$500+ per 5 patches
Generic Available:
Yes
Insurance Coverage:
Often Tier 2 or 3, may require prior authorization due to abuse potential and cost.
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 treat the condition. 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 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 detailed information about the overdose, 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 treat the condition. 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 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 detailed information about the overdose, including what was taken, the quantity, and the time of the incident.