Fentanyl 62.5mcg/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
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 releases medicine slowly over 3 days to help manage severe, ongoing pain, usually for people who are already used to strong pain medicines. It's very important to use it exactly as prescribed because it can be very dangerous if not used correctly.
How to Use This Medicine
Proper Use of This Medication
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely.
Handling and Applying the Patch
1. Wash your hands before and after handling the patch.
2. Touch the sticky side of the patch as little as possible to avoid transferring the medication to your hands.
3. Remove the old patch before applying a new one.
4. Apply the patch to clean, dry, healthy skin on your chest, back, upper leg, or upper arm.
5. Choose a new area for each patch to avoid skin irritation.
6. If there is hair where you plan to apply the patch, clip it close to the skin, but do not shave.
7. Avoid applying the patch to skin that has been treated with creams, oils, lotions, or other skin products.
8. Do not apply the patch to the belt line, bra line, or skin folds.
9. 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 it with plastic wrap and tape.
If the patch falls off, replace it with a new one.
If the patch is not sticking well, you can use first aid tape on the edges to 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.
Do not cover the patch with any other bandage or tape.
Important Safety Precautions
Do not cut or divide patches.
Do not use patches that are damaged.
Avoid touching the area where the patch was applied to anyone else's skin.
If the patch accidentally gets on someone else's skin, remove it immediately and wash the area with water. Seek medical help right away, as this can cause severe side effects and even death.
Misusing or abusing this medication by placing it in the mouth, chewing, swallowing, injecting, or snorting it can lead to overdose and death.
Storage and Disposal
Store the patches at room temperature in a dry place, away from the bathroom.
After removing a used patch, fold the sticky sides together and dispose of it in a secure location where children and pets cannot access it.
Missing a 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 this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely.
Handling and Applying the Patch
1. Wash your hands before and after handling the patch.
2. Touch the sticky side of the patch as little as possible to avoid transferring the medication to your hands.
3. Remove the old patch before applying a new one.
4. Apply the patch to clean, dry, healthy skin on your chest, back, upper leg, or upper arm.
5. Choose a new area for each patch to avoid skin irritation.
6. If there is hair where you plan to apply the patch, clip it close to the skin, but do not shave.
7. Avoid applying the patch to skin that has been treated with creams, oils, lotions, or other skin products.
8. Do not apply the patch to the belt line, bra line, or skin folds.
9. 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 it with plastic wrap and tape.
If the patch falls off, replace it with a new one.
If the patch is not sticking well, you can use first aid tape on the edges to 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.
Do not cover the patch with any other bandage or tape.
Important Safety Precautions
Do not cut or divide patches.
Do not use patches that are damaged.
Avoid touching the area where the patch was applied to anyone else's skin.
If the patch accidentally gets on someone else's skin, remove it immediately and wash the area with water. Seek medical help right away, as this can cause severe side effects and even death.
Misusing or abusing this medication by placing it in the mouth, chewing, swallowing, injecting, or snorting it can lead to overdose and death.
Storage and Disposal
Store the patches at room temperature in a dry place, away from the bathroom.
After removing a used patch, fold the sticky sides together and dispose of it in a secure location where children and pets cannot access it.
Missing a 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
- Do not apply heat (e.g., heating pads, electric blankets, hot baths, saunas, direct sunlight) to the patch or the area around it, as this can cause too much medicine to be absorbed and lead to overdose.
- Avoid alcohol and other sedating medications unless specifically approved by your doctor, as this can increase the risk of serious side effects like 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 in a secure, child-proof container as instructed by your pharmacist or doctor.
- Do not cut, chew, or swallow the patch.
- If the patch falls off, dispose of it properly and apply a new one to a different skin area. Inform your doctor.
- Be aware of signs of overdose and have naloxone available if prescribed.
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:
Highly individualized; 62.5 mcg/hr patch is a specific strength used for maintenance, not typically an initial dose. Initial dosing for opioid-tolerant patients typically starts at 12-25 mcg/hr, titrated every 72 hours based on analgesic response and tolerability.
Dose Range:
12.5 - 100 mg
Condition-Specific Dosing:
chronic_pain_opioid_tolerant:
Apply one patch transdermally every 72 hours. Dose titration should occur no more frequently than every 3 days after the initial application, and no more frequently than every 6 days thereafter, based on patient response and supplemental analgesic requirements. The 62.5 mcg/hr patch is used for patients requiring this specific dose after titration.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for initial opioid-naïve use. For opioid-tolerant children 2 years of age and older, initial dosing is based on prior opioid intake, similar to adult conversion guidelines, with careful titration.
Adolescent:
Similar to adult opioid-tolerant dosing, with careful titration.
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. Accumulation of active and inactive metabolites may occur.
Dialysis:
Fentanyl is not dialyzable. Monitor closely for increased opioid effects.
Hepatic Impairment:
Mild:
Monitor closely for increased opioid effects; consider lower initial doses and slower titration.
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. Reduced clearance may lead to higher plasma concentrations.
Pharmacology
Mechanism of Action
Fentanyl is a potent, synthetic opioid analgesic that primarily acts as an agonist at the mu-opioid receptors in the central nervous system (CNS). Its primary therapeutic effects are analgesia and sedation. It also produces respiratory depression, miosis, euphoria, and physical dependence.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 92% (transdermal, due to first-pass metabolism and skin depot formation)
Tmax:
24-72 hours (after initial application, due to skin depot formation)
FoodEffect:
Not applicable for transdermal patch
Distribution:
Vd:
4 L/kg (high)
ProteinBinding:
80-85%
CnssPenetration:
Yes
Elimination:
HalfLife:
20-27 hours (terminal half-life after patch removal, due to continued absorption from skin depot)
Clearance:
Not available (highly variable)
ExcretionRoute:
Urine (75%), Feces (9%)
Unchanged:
Less than 7% (urine)
Pharmacodynamics
OnsetOfAction:
6-12 hours (after initial application)
PeakEffect:
24-72 hours (after initial application)
DurationOfAction:
72 hours (after patch application, due to continuous release)
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE; REMS; 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.
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.
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 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.
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.
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 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 be signs of a severe bowel problem
Trouble breathing, slow breathing, or shallow breathing
Noisy breathing
Breathing problems during sleep (sleep apnea)
Chest pain
Fast or slow heartbeat
Seizures
Depression
Trouble controlling body movements
Swelling in the arms or legs
Change in eyesight
Serotonin Syndrome: A Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk for a severe and potentially deadly condition called serotonin syndrome. Seek medical help right away if you experience:
Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Sweating a lot
Severe diarrhea
Upset stomach
Throwing up
Severe headache
Adrenal Gland Problem: 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:
Feeling very tired or weak
Passing out
Severe dizziness
Very upset stomach
Throwing up
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 notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Feeling dizzy, sleepy, tired, or weak
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Throwing up
Decreased appetite
Headache
Feeling cold
Trouble sleeping
Sweating a lot
* Irritation where the medication was administered
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 be signs of a severe bowel problem
Trouble breathing, slow breathing, or shallow breathing
Noisy breathing
Breathing problems during sleep (sleep apnea)
Chest pain
Fast or slow heartbeat
Seizures
Depression
Trouble controlling body movements
Swelling in the arms or legs
Change in eyesight
Serotonin Syndrome: A Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk for a severe and potentially deadly condition called serotonin syndrome. Seek medical help right away if you experience:
Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Sweating a lot
Severe diarrhea
Upset stomach
Throwing up
Severe headache
Adrenal Gland Problem: 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:
Feeling very tired or weak
Passing out
Severe dizziness
Very upset stomach
Throwing up
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 notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Feeling dizzy, sleepy, tired, or weak
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Throwing up
Decreased appetite
Headache
Feeling cold
Trouble sleeping
Sweating a lot
* Irritation where the medication was administered
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:
- Slow, shallow, or difficult breathing
- Extreme drowsiness or inability to wake up
- Dizziness or lightheadedness when standing up
- Confusion or disorientation
- Pinpoint pupils
- Cold, clammy skin
- Blue lips or fingernails
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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if 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 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if 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
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you understand how this medication affects you, avoid driving and engaging in other activities that require your full attention. 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 you may require higher doses 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 result in dependence. If you need to reduce the dose or stop taking this medication, consult your doctor first, as suddenly lowering the dose or stopping the medication 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 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 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 can pass into breast milk and harm your baby. Seek medical attention immediately if your baby appears excessively sleepy, limp, or has breathing difficulties.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you understand how this medication affects you, avoid driving and engaging in other activities that require your full attention. 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 you may require higher doses 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 result in dependence. If you need to reduce the dose or stop taking this medication, consult your doctor first, as suddenly lowering the dose or stopping the medication 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 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 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 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:
- Severe respiratory depression (slowed or stopped breathing)
- Extreme somnolence progressing to stupor or coma
- Skeletal muscle flaccidity
- Cold and clammy skin
- Miosis (pinpoint pupils)
- Bradycardia
- Hypotension
- Circulatory collapse
- Cardiac arrest
- Death
What to Do:
IMMEDIATELY call 911 or emergency services. Administer naloxone if available and trained to do so. Stay with the person until help arrives. Remove the patch if possible.
Drug Interactions
Contraindicated Interactions
- Concomitant use with CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, erythromycin, verapamil, diltiazem, grapefruit juice) in opioid-naïve patients or for acute pain.
- Concomitant use with benzodiazepines or other CNS depressants in patients for whom alternatives are not adequate.
- Patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.
- Patients with known or suspected paralytic ileus.
- Significant respiratory depression.
Major Interactions
- Other CNS depressants (e.g., benzodiazepines, other opioids, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, gabapentinoids): Increased risk of respiratory depression, profound sedation, coma, and death.
- CYP3A4 inhibitors (strong and moderate): Increased fentanyl plasma concentrations, leading to increased or prolonged opioid effects, including respiratory depression.
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): Decreased fentanyl plasma concentrations, leading to reduced efficacy and potential withdrawal symptoms.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, MAOIs): Increased risk of serotonin syndrome.
- Mixed agonist/antagonist and partial agonist opioids (e.g., butorphanol, nalbuphine, pentazocine, buprenorphine): May precipitate withdrawal symptoms or reduce analgesic effect.
- Anticholinergic drugs: Increased risk of urinary retention and severe constipation.
Moderate Interactions
- Diuretics: Opioids may reduce the efficacy of diuretics by causing the release of antidiuretic hormone.
- Antihypertensives: May cause additive hypotensive effects.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Pain assessment (intensity, location, quality)
Rationale: To establish baseline and guide initial dosing/titration.
Timing: Prior to initiation and at each dose adjustment.
Respiratory rate and depth
Rationale: To assess baseline respiratory function and risk of respiratory depression.
Timing: Prior to initiation.
Level of consciousness/sedation
Rationale: To assess baseline mental status and risk of excessive sedation.
Timing: Prior to initiation.
Bowel function
Rationale: To assess baseline and anticipate opioid-induced constipation.
Timing: Prior to initiation.
Opioid tolerance status
Rationale: Fentanyl patches are only for opioid-tolerant patients to prevent fatal respiratory depression.
Timing: Prior to initiation.
Routine Monitoring
Pain assessment
Frequency: Regularly, especially during titration and with changes in pain.
Target: Acceptable pain control with minimal side effects.
Action Threshold: Uncontrolled pain or excessive side effects warrant dose adjustment or re-evaluation.
Respiratory rate and depth
Frequency: Frequently during initiation and dose titration (e.g., every 2-4 hours for first 24 hours after new patch, then daily).
Target: Normal for patient (e.g., 12-20 breaths/min), unlabored.
Action Threshold: Respiratory rate < 10 breaths/min, shallow breathing, cyanosis, or signs of hypoventilation; administer naloxone and seek emergency medical attention.
Level of consciousness/sedation
Frequency: Frequently during initiation and dose titration, then daily.
Target: Alert and oriented, or easily arousable.
Action Threshold: Excessive sedation (e.g., difficult to arouse, somnolence); reduce dose, remove patch, or administer naloxone.
Bowel function
Frequency: Daily
Target: Regular bowel movements (e.g., every 1-2 days).
Action Threshold: Constipation; initiate or adjust laxative regimen.
Signs of opioid withdrawal
Frequency: Regularly, especially during dose reduction or discontinuation.
Target: Absence of withdrawal symptoms.
Action Threshold: Symptoms like restlessness, yawning, lacrimation, rhinorrhea, piloerection, sweating, muscle aches, nausea, vomiting, diarrhea; consider slower taper or re-evaluation.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation/somnolence
- Dizziness
- Nausea and vomiting
- Constipation
- Pruritus (itching)
- Confusion
- Miosis (pinpoint pupils)
- Hypotension
- Signs of serotonin syndrome (agitation, hallucinations, tachycardia, fever, sweating, muscle rigidity, tremor, 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. 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 exposure.
Third Trimester:
High risk of NOWS with prolonged exposure. Risk of respiratory depression in the neonate if used close to 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.
Infant Risk:
High (L3 - Moderately safe, but monitor infant for sedation, respiratory depression, poor feeding, and developmental delay. Consider alternative if possible.)
Pediatric Use
Fentanyl transdermal system is indicated only for the management of chronic pain in opioid-tolerant patients 2 years of age and older. Due to the risk of fatal respiratory depression, fentanyl patches are contraindicated in opioid-naïve patients. Careful titration and monitoring are essential.
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, including respiratory depression, sedation, and constipation.
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-naïve patients due to the risk of fatal respiratory depression.
- 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.
- Avoid external heat sources (heating pads, hot baths, saunas, direct sunlight) on or near the patch, as this can significantly increase fentanyl absorption and lead to overdose.
- Patients should be stable on their opioid regimen before converting to fentanyl patch. Use conversion tables carefully and monitor closely.
- The full analgesic effect of a new patch may not be seen for 24-72 hours. Patients may need short-acting opioids for breakthrough pain during this period.
- If signs of overdose occur, remove the patch immediately and administer naloxone if available. Call emergency services.
- Counsel patients on the risks of addiction, abuse, and misuse, and the importance of safe storage and disposal.
Alternative Therapies
- Other long-acting opioid analgesics (e.g., extended-release oxycodone, extended-release morphine, methadone, hydromorphone ER)
- Non-opioid pain management strategies (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin, tricyclic antidepressants, SNRIs)
- Interventional pain procedures
- Physical therapy, occupational therapy
- Cognitive behavioral therapy
Cost & Coverage
Average Cost:
Varies widely, typically $100-$500+ per 5 patches
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization or step therapy)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information. 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.
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 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, which is a patient fact sheet that provides crucial information. 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.
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 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.