Fentanyl 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 wear on your skin. It's used for severe, ongoing pain that needs around-the-clock treatment, especially if you've already been taking other strong pain medicines. The patch slowly releases the medicine into your body over 3 days.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Wash your hands before and after handling the patch. It's essential to minimize contact with the sticky side of the patch, as it contains a significant amount of medication even after use. Carefully follow the guidelines for handling, storing, and disposing of the patch, and consult your doctor if you have any questions.
Applying the Patch
1. Remove the old patch before applying a new one.
2. Place the patch on clean, dry, healthy skin on your chest, back, upper leg, or upper arm.
3. Choose a new area for each patch application.
4. If there is hair at the application site, clip it close to the skin, but do not shave.
5. Avoid applying the patch to skin that has been treated with creams, oils, lotions, or other skin products.
6. Do not apply the patch to the belt line, bra line, or skin folds.
7. You do not need to apply the patch directly to the area 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, apply a new one.
If the patch is not 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. 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 adheres to someone else's skin, remove it immediately and wash the area with water. Seek medical help right away, as this can cause severe side effects 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 location where children and pets cannot access it.
Missed Dose
If you miss a dose, apply a new patch as soon as possible after removing the old one.
Do not apply a double dose or extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Wash your hands before and after handling the patch. It's essential to minimize contact with the sticky side of the patch, as it contains a significant amount of medication even after use. Carefully follow the guidelines for handling, storing, and disposing of the patch, and consult your doctor if you have any questions.
Applying the Patch
1. Remove the old patch before applying a new one.
2. Place the patch on clean, dry, healthy skin on your chest, back, upper leg, or upper arm.
3. Choose a new area for each patch application.
4. If there is hair at the application site, clip it close to the skin, but do not shave.
5. Avoid applying the patch to skin that has been treated with creams, oils, lotions, or other skin products.
6. Do not apply the patch to the belt line, bra line, or skin folds.
7. You do not need to apply the patch directly to the area 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, apply a new one.
If the patch is not 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. 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 adheres to someone else's skin, remove it immediately and wash the area with water. Seek medical help right away, as this can cause severe side effects 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 location where children and pets cannot access it.
Missed Dose
If you miss a dose, apply a new patch as soon as possible after removing the old one.
Do not apply a double dose or extra doses.
Lifestyle & Tips
- Apply the patch to a clean, dry, flat area of skin (e.g., chest, back, upper arm). Avoid hairy areas or shave them if necessary (do not use hair removers).
- Press firmly for 30 seconds to ensure good adhesion.
- Change the patch every 72 hours (3 days) at the same time of day. Remove the old patch before applying a new one.
- Rotate application sites to prevent skin irritation.
- Do NOT cut, chew, or swallow the patch. Do NOT apply heat to the patch (e.g., heating pads, electric blankets, hot baths, saunas, prolonged sun exposure) as this can cause too much medicine to be absorbed, leading to overdose.
- Avoid alcohol and other sedating medications (e.g., benzodiazepines, sleeping pills) unless specifically approved by your doctor, as this can cause dangerous breathing problems.
- Store patches securely out of reach of children and pets. Fold used patches in half with the sticky sides together and flush down the toilet or dispose of as instructed by your pharmacist/doctor.
- Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
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:
Initial dose for opioid-tolerant patients: 25 mcg/hr patch applied transdermally every 72 hours.
Dose Range:
12.5 - 100 mg
Condition-Specific Dosing:
opioid_naive:
Contraindicated for opioid-naive patients due to risk of fatal respiratory depression.
conversion_from_oral_opioids:
Conversion from other opioids requires careful calculation based on equianalgesic dosing tables. Initial dose typically 25 mcg/hr for patients receiving up to 90 mg/day oral morphine equivalent.
dose_titration:
Dose may be increased no sooner than 3 days after the initial application, or 6 days after an increase in dose. Increments typically 25 mcg/hr.
Pediatric Dosing
Neonatal:
Not established (contraindicated in children under 2 years of age).
Infant:
Not established (contraindicated in children under 2 years of age).
Child:
Approved for chronic pain in opioid-tolerant children ≥2 years of age. Initial dose based on opioid conversion table, typically starting at 12 mcg/hr or 25 mcg/hr. Close monitoring is essential.
Adolescent:
Dosing similar to adults for opioid-tolerant adolescents, based on opioid conversion tables.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor closely for signs of opioid toxicity.
Moderate:
Use with caution; consider lower initial doses and slower titration. Monitor closely for signs of opioid toxicity.
Severe:
Use with extreme caution; consider lower initial doses and slower titration. Monitor closely for signs of opioid toxicity. Accumulation of fentanyl and its metabolites may occur.
Dialysis:
Fentanyl is not significantly removed by dialysis. Use with extreme caution; monitor closely.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but monitor closely for signs of opioid toxicity.
Moderate:
Use with caution; consider lower initial doses and slower titration. Monitor closely for signs of opioid toxicity.
Severe:
Use with extreme caution; consider lower initial doses and slower titration. Monitor closely for signs of opioid toxicity. Accumulation of fentanyl and its metabolites may occur.
Pharmacology
Mechanism of Action
Fentanyl is a potent, synthetic opioid analgesic that primarily acts as an agonist at the mu-opioid receptors in the central nervous system (CNS). Its primary therapeutic effects are analgesia and sedation. Activation of mu-opioid receptors leads to inhibition of ascending pain pathways, altering the perception of and response to pain. It also produces respiratory depression, miosis, euphoria, and physical dependence.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 92% (transdermal, due to skin depot formation)
Tmax:
24-72 hours (initial application), 12-24 hours (after subsequent applications)
FoodEffect:
Not applicable (transdermal)
Distribution:
Vd:
4 L/kg (high, indicating extensive tissue distribution)
ProteinBinding:
80-85% (primarily to alpha-1-acid glycoprotein)
CnssPenetration:
Yes (readily crosses blood-brain barrier)
Elimination:
HalfLife:
20-27 hours (terminal half-life after patch removal, due to continued absorption from skin depot)
Clearance:
0.5 L/hr/kg
ExcretionRoute:
Urine (75% as metabolites, <10% as unchanged drug), Feces (9% as metabolites)
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
6-12 hours (transdermal)
PeakEffect:
24-72 hours (transdermal)
DurationOfAction:
72 hours (after patch application)
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE; REMS; RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYP3A4 INTERACTION; RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS.
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.
Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of Fentanyl or following a dose increase.
Accidental Exposure: Accidental exposure to Fentanyl, especially in children, can result in a fatal overdose. Keep Fentanyl out of reach of children and dispose of used patches properly.
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 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 and any CYP3A4 inhibitor or inducer.
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
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.
Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of Fentanyl or following a dose increase.
Accidental Exposure: Accidental exposure to Fentanyl, especially in children, can result in a fatal overdose. Keep Fentanyl out of reach of children and dispose of used patches properly.
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 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 and any CYP3A4 inhibitor or inducer.
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or fainting
Confusion
Severe constipation or stomach pain, which may indicate a severe bowel problem
Breathing difficulties, such as:
+ Trouble breathing
+ Slow or shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Chest pain
Abnormal heartbeat (fast or slow)
Seizures
Depression
Trouble controlling body movements
Swelling in the arms or legs
Changes in 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 irregular)
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Adrenal Gland Problems: A Rare but Serious Condition
Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Contact your doctor right away if you experience:
Extreme fatigue or weakness
Fainting
Severe dizziness
Nausea or vomiting
Decreased appetite
Other Possible Side Effects
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:
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
If you experience any of these side effects or have concerns about other symptoms, contact your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or visit https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or fainting
Confusion
Severe constipation or stomach pain, which may indicate a severe bowel problem
Breathing difficulties, such as:
+ Trouble breathing
+ Slow or shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Chest pain
Abnormal heartbeat (fast or slow)
Seizures
Depression
Trouble controlling body movements
Swelling in the arms or legs
Changes in 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 irregular)
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Adrenal Gland Problems: A Rare but Serious Condition
Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Contact your doctor right away if you experience:
Extreme fatigue or weakness
Fainting
Severe dizziness
Nausea or vomiting
Decreased appetite
Other Possible Side Effects
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:
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
If you experience any of these side effects or have concerns about other symptoms, contact your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or visit 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 when standing up
- Confusion or disorientation
- Severe constipation
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Signs of overdose (see below)
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 obstruction 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. 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 obstruction 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial to ensure your safety and proper care.
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. Be cautious 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 you may require higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, consult your doctor. Do not take more than the prescribed dose.
Additionally, regular use of opioid medications like this one can cause dependence. If you need to reduce the dose or stop taking this medication, consult your doctor first, as suddenly stopping or lowering the dose 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
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, particularly in individuals with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
Hormonal Effects
Long-term use of opioid medications can lead to lower sex hormone levels. If you experience decreased libido, fertility problems, irregular menstrual periods, or ejaculation issues, contact your doctor.
MRI Precautions
The patch may contain metal, so remove it before undergoing an MRI.
Special Populations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Breastfeeding
Inform your doctor if you are breastfeeding, as this medication passes into breast milk and may harm your baby. Seek medical attention immediately if your baby appears 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 is crucial to ensure your safety and proper care.
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. Be cautious 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 you may require higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, consult your doctor. Do not take more than the prescribed dose.
Additionally, regular use of opioid medications like this one can cause dependence. If you need to reduce the dose or stop taking this medication, consult your doctor first, as suddenly stopping or lowering the dose 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
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, particularly in individuals with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
Hormonal Effects
Long-term use of opioid medications can lead to lower sex hormone levels. If you experience decreased libido, fertility problems, irregular menstrual periods, or ejaculation issues, contact your doctor.
MRI Precautions
The patch may contain metal, so remove it before undergoing an MRI.
Special Populations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Breastfeeding
Inform your doctor if you are breastfeeding, as this medication passes into breast milk and may harm your baby. Seek medical attention immediately if your baby appears excessively sleepy, limp, or has breathing difficulties.
Overdose Information
Overdose Symptoms:
- Slow, shallow, or stopped breathing
- Extreme drowsiness or inability to wake up
- Pinpoint pupils
- Cold, clammy skin
- Limp muscles
- Blue 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. If naloxone (Narcan) is available, administer it if the person is unresponsive or has severe breathing problems. Stay with the person until emergency medical help arrives. Call 1-800-222-1222 (Poison Control).
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 and other CNS depressants (e.g., other opioids, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, alcohol) - concurrent use significantly increases risk of profound sedation, respiratory depression, coma, and death.
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation 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) - increased risk of serotonin syndrome.
- Mixed agonist/antagonist and partial agonist opioids (e.g., buprenorphine, nalbuphine, pentazocine) - may precipitate withdrawal symptoms and reduce analgesic effect.
- Diuretics - opioids can reduce the efficacy of diuretics by causing release of antidiuretic hormone.
Moderate Interactions
- Anticholinergics - increased risk of urinary retention and/or severe constipation.
- Antihypertensives - enhanced hypotensive effect.
- Muscle relaxants - enhanced neuromuscular blockade.
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 patch is only for opioid-tolerant patients. Essential to confirm prior opioid use and equivalent daily dose.
Timing: Prior to initiation of therapy
Routine Monitoring
Pain assessment
Frequency: Regularly, especially during titration and with any change in condition (e.g., daily, weekly)
Target: Acceptable pain control with minimal side effects
Action Threshold: Uncontrolled pain or unacceptable side effects warrant dose adjustment or alternative therapy.
Respiratory rate and depth
Frequency: Frequently during initiation and titration (e.g., every 2-4 hours for first 24-72 hours), then periodically.
Target: Normal for patient, typically >10-12 breaths/min
Action Threshold: <10 breaths/min, shallow breathing, or signs of hypoventilation (e.g., cyanosis, somnolence) require immediate intervention (e.g., naloxone, respiratory support).
Level of consciousness/sedation
Frequency: Frequently during initiation and titration, then periodically.
Target: Alert and oriented, or easily aroused
Action Threshold: Excessive sedation (e.g., difficult to arouse, somnolence, stupor) requires immediate intervention.
Signs of opioid withdrawal
Frequency: Periodically, especially if dose is reduced or discontinued.
Target: Absence of withdrawal symptoms
Action Threshold: Symptoms (e.g., restlessness, lacrimation, rhinorrhea, yawning, sweating, piloerection, myalgia, mydriasis, irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, increased blood pressure, respiratory rate, heart rate) indicate need for slower taper or re-evaluation.
Bowel function
Frequency: Daily
Target: Regular bowel movements
Action Threshold: Constipation requires prophylactic laxative regimen.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing, difficulty breathing, blue lips/fingernails)
- Excessive sedation/somnolence
- Dizziness, lightheadedness
- Nausea, vomiting
- Constipation
- Pruritus (itching)
- Confusion, disorientation
- Signs of opioid withdrawal (if dose reduced or discontinued)
- Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, shivering, muscle stiffness/twitching, loss of coordination, nausea, vomiting, diarrhea)
Special Patient Groups
Pregnancy
Use during pregnancy is generally not recommended unless the potential benefit justifies the potential risk to the fetus. Prolonged use can lead to neonatal opioid withdrawal syndrome (NOWS).
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for congenital malformations with opioid exposure. Risk of NOWS if continued.
Second Trimester:
Risk of NOWS if prolonged use. Potential for fetal growth restriction.
Third Trimester:
High risk of neonatal opioid withdrawal syndrome (NOWS) if used chronically. Risk of respiratory depression in the neonate if used close to delivery.
Lactation
Fentanyl is excreted into breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., sedation, respiratory depression), breastfeeding is not recommended during treatment with fentanyl transdermal patches. If breastfeeding cannot be avoided, monitor the infant closely for signs of sedation and respiratory depression.
Infant Risk:
High (L4 - possibly hazardous)
Pediatric Use
Fentanyl transdermal patches are approved for chronic pain in opioid-tolerant children ≥2 years of age. Contraindicated in children under 2 years of age due to risk of fatal respiratory depression. Dosing must be carefully calculated based on opioid tolerance. Close monitoring for respiratory depression and sedation is crucial, especially during initiation and titration.
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, sedation, and constipation. Consider age-related decreases in renal and hepatic function.
Clinical Information
Clinical Pearls
- Fentanyl patches are for chronic, severe pain in opioid-tolerant patients only. They are NOT for acute pain, post-operative pain, or opioid-naive patients.
- Ensure proper patient selection and thorough assessment of opioid tolerance before initiation.
- Emphasize proper patch application and disposal to patients to prevent accidental exposure, especially to children and pets.
- Educate patients on the dangers of applying heat to the patch, which can lead to rapid absorption and overdose.
- Always counsel patients and caregivers on the signs of respiratory depression and overdose, and the importance of having naloxone readily available.
- Be aware of the prolonged half-life due to the skin depot effect; effects can persist for hours after patch removal.
- Titrate dose slowly, waiting at least 3 days between dose adjustments, or 6 days after an increase.
- Constipation is a common and persistent side effect; prophylactic laxative therapy should be initiated concurrently with fentanyl.
- Monitor for signs of addiction, abuse, and misuse, and implement appropriate risk mitigation strategies.
Alternative Therapies
- Other strong opioid analgesics (e.g., hydromorphone, oxymorphone, tapentadol)
- Non-opioid analgesics for chronic pain (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin, duloxetine, tricyclic antidepressants)
- Interventional pain management (e.g., nerve blocks, spinal cord stimulation)
- Physical therapy, occupational therapy, psychological therapies (e.g., CBT)
Cost & Coverage
Average Cost:
$100 - $300 per 5 patches (25 mcg/hr)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (often requires prior authorization and/or step therapy due to opioid class and abuse potential)
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 use. It is vital 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 administered to help counteract the effects. Discuss the availability and use of naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When reporting the incident, be prepared to provide the necessary information, including the substance involved, the quantity taken, and the time of the incident.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. It is vital 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 administered to help counteract the effects. Discuss the availability and use of naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When reporting the incident, be prepared to provide the necessary information, including the substance involved, the quantity taken, and the time of the incident.