Fentanyl 50mcg/hr Patch
WARNING: This is an opioid drug. Opioid drugs can put you at risk for drug use disorder. These can lead to overdose and death. You will be watched closely while taking this drug.Severe breathing problems may happen with this drug. The risk is highest when you first start taking this drug or any time your dose is raised. These breathing problems can be deadly. Call your doctor right away if you have slow, shallow, or trouble breathing. Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.Severe side effects have happened when opioid drugs were used with benzodiazepines, alcohol, marijuana, other forms of cannabis, or street drugs. This includes severe drowsiness, breathing problems, and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. If you have questions, talk with the doctor.Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs.Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.Avoid hot baths, sunbathing, and use of heat sources (including tanning beds, heating pads, and hot tubs). Avoid activities like heavy exercise. Tell your doctor if you get a fever. A rise in body temperature may cause too much drug to pass into your body. This can cause overdose and deadly breathing problems.If you are pregnant or plan to get pregnant, talk with your doctor right away about the benefits and risks of using this drug during pregnancy. Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. Withdrawal in the newborn can be life- threatening if not treated. @ COMMON USES: It is used to manage pain.This drug is not for mild pain or pain that only lasts a short time (like headaches, toothaches, or pain after surgery).This drug is only for use by people who have been taking pain drugs (opioids) and are used to their effects. Talk with the doctor.
Drug Class
Opioid analgesic
Pharmacologic Class
Opioid agonist
Pregnancy Category
Category C
FDA Approved
Aug 1990
DEA Schedule
Schedule II
Overview
What is this medicine?
Fentanyl is a 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 help control your pain. It's very important to use it exactly as prescribed because it's a very powerful medicine that can be dangerous if not used correctly.
How to Use This Medicine
Proper Use of Your Medication Patch
To use your medication patch safely and effectively, follow these steps:
1. Follow Your Doctor's Instructions: Use your medication patch exactly as directed by your doctor. Read all the information provided with your medication and follow the instructions carefully.
2. Handle the Patch with Care: Wash your hands before and after handling the patch. Touch the sticky side of the patch as little as possible, as it contains a significant amount of medication even after use.
3. Apply the Patch Correctly: Remove the old patch before applying a new one. Place the new patch on clean, dry, healthy skin on your chest, back, upper leg, or upper arm. Choose a new area each time you change the patch.
4. Prepare the Skin: If there is hair where you plan to apply the patch, clip it as close to the skin as possible. Do not shave the hair. Avoid applying the patch to skin that has recently been treated with creams, oils, lotions, or other skin products.
5. Avoid Certain Areas: Do not apply the patch to the belt line, bra line, or skin folds. You do not need to apply the patch directly to the area where you are experiencing pain for it to be effective.
6. Bathing and Swimming: 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.
7. Replacing a Fallen Patch: If the patch falls off, apply a new one immediately.
8. Securing the Patch: If the patch is not sticking well, you can use first aid tape on the edges to hold it in place. 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 with your patch. 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 or even death.
Misusing or abusing this medication by placing it in the mouth, chewing, swallowing, injecting, or snorting it can lead to overdose and death.
Storage and Disposal
Store your medication patches 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 you remember, after removing the old one.
* Do not apply a double dose or extra doses to make up for a missed dose.
To use your medication patch safely and effectively, follow these steps:
1. Follow Your Doctor's Instructions: Use your medication patch exactly as directed by your doctor. Read all the information provided with your medication and follow the instructions carefully.
2. Handle the Patch with Care: Wash your hands before and after handling the patch. Touch the sticky side of the patch as little as possible, as it contains a significant amount of medication even after use.
3. Apply the Patch Correctly: Remove the old patch before applying a new one. Place the new patch on clean, dry, healthy skin on your chest, back, upper leg, or upper arm. Choose a new area each time you change the patch.
4. Prepare the Skin: If there is hair where you plan to apply the patch, clip it as close to the skin as possible. Do not shave the hair. Avoid applying the patch to skin that has recently been treated with creams, oils, lotions, or other skin products.
5. Avoid Certain Areas: Do not apply the patch to the belt line, bra line, or skin folds. You do not need to apply the patch directly to the area where you are experiencing pain for it to be effective.
6. Bathing and Swimming: 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.
7. Replacing a Fallen Patch: If the patch falls off, apply a new one immediately.
8. Securing the Patch: If the patch is not sticking well, you can use first aid tape on the edges to hold it in place. 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 with your patch. 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 or even death.
Misusing or abusing this medication by placing it in the mouth, chewing, swallowing, injecting, or snorting it can lead to overdose and death.
Storage and Disposal
Store your medication patches 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 you remember, after removing the old one.
* Do not apply a double dose or extra doses to make up for a missed dose.
Lifestyle & Tips
- Avoid exposing the patch to direct heat (e.g., heating pads, electric blankets, hot tubs, saunas, prolonged sun exposure) as this can increase fentanyl absorption and lead to overdose.
- Do not cut, chew, or swallow the patch.
- Avoid alcohol and other sedating medications (e.g., benzodiazepines, sleeping pills) unless specifically approved by your doctor, as this can increase the risk of dangerous side effects like severe drowsiness and breathing problems.
- Do not drive or operate heavy machinery until you know how fentanyl affects you, as it can cause dizziness and drowsiness.
- Keep all patches, used and unused, out of reach of children and pets. Even a small amount can be fatal to a child or pet.
- Properly dispose of used patches by folding the sticky sides together and flushing them down the toilet immediately after removal, or as directed by local regulations. Do not throw them in the trash.
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:
For opioid-tolerant patients, replace previous opioid with an equianalgesic dose of fentanyl transdermal. A 50 mcg/hr patch is typically used for patients requiring approximately 90-134 mg/day oral morphine equivalent. Apply one patch every 72 hours.
Dose Range:
12 - 100 mg
Condition-Specific Dosing:
opioid_naive:
Contraindicated for opioid-naive patients due to risk of fatal respiratory depression.
titration:
Initial dose typically 12 or 25 mcg/hr, titrated upwards in 12 or 25 mcg/hr increments no more frequently than every 3 days after the initial dose, and every 6 days thereafter, based on analgesic response and tolerability.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for opioid-naive. For opioid-tolerant children ≥2 years of age, dosing must be individualized and carefully titrated based on previous opioid intake and patient response. Consult specific guidelines.
Adolescent:
Similar to adult opioid-tolerant dosing, individualized.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor closely for increased opioid effects.
Moderate:
Monitor closely for increased opioid effects; consider lower initial doses and slower titration.
Severe:
Monitor closely for increased opioid effects; consider lower initial doses and slower titration. Use with extreme caution.
Dialysis:
Fentanyl is not dialyzable. Monitor closely for increased opioid effects.
Hepatic Impairment:
Mild:
Monitor closely for increased opioid effects.
Moderate:
Monitor closely for increased opioid effects; consider lower initial doses and slower titration.
Severe:
Monitor closely for increased opioid effects; consider lower initial doses and slower titration. Use with extreme caution.
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 primary therapeutic effects are analgesia and sedation. It also produces respiratory depression, miosis, euphoria, and physical dependence.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 92% (transdermal)
Tmax:
24-72 hours (initial application), steady state reached in 2-3 applications (3-6 days)
FoodEffect:
Not applicable for transdermal patch.
Distribution:
Vd:
4 L/kg (high)
ProteinBinding:
80-85% (primarily to alpha-1-acid glycoprotein)
CnssPenetration:
Yes (readily crosses blood-brain barrier)
Elimination:
HalfLife:
17-27 hours (terminal half-life after patch removal, due to skin depot)
Clearance:
0.5 L/hr/kg
ExcretionRoute:
Renal (75% as metabolites, <10% as unchanged drug), Fecal (9% as metabolites, <1% as unchanged drug)
Unchanged:
<10% (renal)
Pharmacodynamics
OnsetOfAction:
6-12 hours (transdermal)
PeakEffect:
24-72 hours (transdermal)
DurationOfAction:
72 hours (transdermal)
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE; REMS; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and CYTOCHROME P450 3A4 INTERACTION.
Addiction, Abuse, and Misuse: Fentanyl 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, and monitor all patients regularly for the development of these behaviors and conditions.
Opioid Analgesic 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 and their caregivers, a Medication Guide and information on safe disposal of unused product.
Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with use of fentanyl. Monitor for respiratory depression, especially during initiation of fentanyl or following a dose increase. Instruct patients to remove fentanyl patches immediately if they experience difficulty breathing or shallow breathing.
Accidental Exposure: Accidental exposure to even one dose of fentanyl, especially in children, can result in a fatal overdose. Accidental exposure can occur if the patch is transferred from the patient to another person, if the patch is ingested, or if the patch is handled improperly. Ensure patients store and dispose of fentanyl out of the reach of children and pets.
Neonatal Opioid Withdrawal Syndrome: Prolonged use of fentanyl 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 of fentanyl 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 and any CYP3A4 inhibitor or inducer.
Addiction, Abuse, and Misuse: Fentanyl 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, and monitor all patients regularly for the development of these behaviors and conditions.
Opioid Analgesic 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 and their caregivers, a Medication Guide and information on safe disposal of unused product.
Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with use of fentanyl. Monitor for respiratory depression, especially during initiation of fentanyl or following a dose increase. Instruct patients to remove fentanyl patches immediately if they experience difficulty breathing or shallow breathing.
Accidental Exposure: Accidental exposure to even one dose of fentanyl, especially in children, can result in a fatal overdose. Accidental exposure can occur if the patch is transferred from the patient to another person, if the patch is ingested, or if the patch is handled improperly. Ensure patients store and dispose of fentanyl out of the reach of children and pets.
Neonatal Opioid Withdrawal Syndrome: Prolonged use of fentanyl 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 of fentanyl 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 and any CYP3A4 inhibitor or inducer.
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 Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk of developing serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
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. Contact your doctor immediately if you experience:
Extreme tiredness or weakness
Passing out
Severe dizziness
Upset stomach
Vomiting
Decreased appetite
Other Possible Side Effects
While many people may not experience side effects or may only have mild 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 you experience any of these side effects or any other symptoms that concern you, contact your doctor for advice. 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 Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk of developing serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
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. Contact your doctor immediately if you experience:
Extreme tiredness or weakness
Passing out
Severe dizziness
Upset stomach
Vomiting
Decreased appetite
Other Possible Side Effects
While many people may not experience side effects or may only have mild 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 you experience any of these side effects or any other symptoms that concern you, contact your doctor for advice. 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:
- Slow or shallow breathing
- Extreme drowsiness or difficulty waking up
- Dizziness or lightheadedness
- Confusion
- Blue lips or fingernails
- Severe constipation
- Signs of allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty 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 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 all potential interactions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins
Discuss your health problems and any concerns you may have
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 all potential interactions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins
Discuss your health problems and any concerns you may have
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
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 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 can 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 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, 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 can lead to decreased sex hormone levels. If you experience a decrease in 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.
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 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 can 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 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, 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 can lead to decreased sex hormone levels. If you experience a decrease in 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.
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
- Extreme drowsiness or unresponsiveness
- Pinpoint pupils
- Cold, clammy skin
- Limp muscles
- Blue discoloration of lips or fingernails
- Loss of consciousness
What to Do:
If you suspect an overdose, call 911 immediately. Administer naloxone if available and you are 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
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation (risk of serotonin syndrome, severe respiratory depression)
- Patients who are not opioid tolerant
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Known or suspected paralytic ileus
Major Interactions
- CNS depressants (e.g., benzodiazepines, other opioids, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants) - increased risk of profound sedation, respiratory depression, coma, and death.
- CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, erythromycin, verapamil, diltiazem, grapefruit juice) - increased fentanyl plasma concentrations, leading to increased or prolonged opioid effects.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol) - risk of serotonin syndrome.
- Mixed agonist/antagonist opioids (e.g., pentazocine, nalbuphine, butorphanol) - may reduce analgesic effect 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 or 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/titration.
Timing: Prior to initiation of therapy
Respiratory rate and depth
Rationale: To assess baseline respiratory function and identify risk factors for respiratory depression.
Timing: Prior to initiation of therapy
Level of consciousness/sedation
Rationale: To assess baseline mental status and identify risk factors for excessive sedation.
Timing: Prior to initiation of therapy
Bowel function
Rationale: To assess baseline bowel habits and anticipate opioid-induced constipation.
Timing: Prior to initiation of therapy
Opioid tolerance assessment
Rationale: To ensure patient meets criteria for opioid tolerance (e.g., taking at least 60 mg oral morphine/day for ≥1 week).
Timing: Prior to initiation of therapy
Routine Monitoring
Pain assessment
Frequency: Daily, or as needed based on patient report
Target: Acceptable pain level as defined by patient/provider
Action Threshold: Uncontrolled pain or significant increase in pain; consider dose adjustment or alternative therapy.
Respiratory rate and depth
Frequency: Regularly, especially during initiation and titration; daily for stable patients
Target: Typically >10-12 breaths/min, regular rhythm
Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, cyanosis; administer naloxone, seek immediate medical attention.
Sedation level (e.g., Pasero Opioid-Induced Sedation Scale)
Frequency: Regularly, especially during initiation and titration; daily for stable patients
Target: Alert or mildly drowsy, easily aroused
Action Threshold: Difficult to arouse, somnolent, or unarousable; reduce dose, administer naloxone, seek immediate medical attention.
Bowel function
Frequency: Daily
Target: Regular bowel movements (e.g., every 1-3 days)
Action Threshold: Constipation (e.g., no bowel movement for >3 days); initiate or adjust laxative regimen.
Adverse effects (nausea, vomiting, pruritus, dizziness)
Frequency: Daily, or as needed
Target: Minimal to no adverse effects
Action Threshold: Persistent or severe adverse effects; consider dose adjustment, symptomatic treatment, or alternative therapy.
Patch adhesion and skin integrity
Frequency: With each patch change
Target: Patch remains securely adhered, no significant skin irritation
Action Threshold: Poor adhesion, significant skin irritation, rash; ensure proper application, rotate sites, consider alternative formulation.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing, difficulty breathing, blue lips/fingernails)
- Excessive sedation/somnolence (difficulty waking up, confusion, dizziness)
- Severe constipation
- Nausea and vomiting
- Pruritus (itching)
- Urinary retention
- Signs of opioid withdrawal (if dose reduced too quickly or abruptly discontinued: restlessness, lacrimation, rhinorrhea, yawning, sweating, chills, myalgia, arthralgia, abdominal cramps, nausea, vomiting, diarrhea, anxiety, irritability)
- Signs of serotonin syndrome (agitation, hallucinations, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, 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. Fentanyl crosses the placenta. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for congenital malformations, though data are limited and inconsistent for opioids.
Second Trimester:
Risk of NOWS increases with prolonged use.
Third Trimester:
High risk of NOWS with prolonged use. Risk of respiratory depression in the neonate if used near delivery.
Lactation
Fentanyl is excreted into breast milk. Infants exposed to fentanyl through breast milk are at risk for serious adverse reactions, including excess sedation and respiratory depression. Breastfeeding is not recommended during treatment with fentanyl. 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 patches are only indicated for the management of chronic, severe pain in opioid-tolerant pediatric patients 2 years of age and older. Not for opioid-naive children. Extreme caution and careful titration are required due to variability in absorption and metabolism.
Geriatric Use
Elderly patients may be more sensitive to the effects of fentanyl, particularly respiratory depression. Consider lower initial doses and slower titration. Monitor closely for adverse effects, especially respiratory depression and sedation.
Clinical Information
Clinical Pearls
- Fentanyl transdermal patches are for chronic, severe pain in opioid-tolerant patients only. Never use in opioid-naive patients due to high risk of fatal respiratory depression.
- The onset of action is slow (6-12 hours) and peak effect is delayed (24-72 hours) due to the skin depot. Do not expect immediate pain relief.
- Patients may require short-acting 'breakthrough' opioid medication during the initial titration period and for breakthrough pain.
- Proper disposal is critical: fold sticky sides together and flush down the toilet or dispose of as per local regulations to prevent accidental exposure to children or pets.
- Avoid external heat sources (e.g., heating pads, hot baths) on or near the patch, as this can significantly increase fentanyl absorption and lead to overdose.
- Rotate application sites to minimize skin irritation and ensure consistent absorption.
- If a patch falls off, dispose of it properly and apply a new patch to a different skin site. Do not reapply a patch that has lost its adhesion.
Alternative Therapies
- Other long-acting opioid analgesics (e.g., extended-release morphine, oxycodone, hydromorphone, methadone)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin, tricyclic antidepressants) for neuropathic or chronic non-cancer pain, often used 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, typically $100-$500+ per 5 patches (30-day supply)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization or step therapy due to opioid class)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is important 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.
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 an overdose is suspected, 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 immediately. When seeking help, be prepared to provide information about the substance involved, the quantity taken, and the time of the incident.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is important 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.
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 an overdose is suspected, 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 immediately. When seeking help, be prepared to provide information about the substance involved, the quantity taken, and the time of the incident.