Fentanyl 37.5mcg/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
C
FDA Approved
Aug 1990
DEA Schedule
Schedule II
Overview
What is this medicine?
Fentanyl is a very strong pain medicine that comes as a patch you stick on your skin. It's used for severe, ongoing pain that needs around-the-clock treatment, especially when other pain medicines haven't worked well enough. 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 touch the sticky side of the patch as little as possible, as it contains a significant amount of medication even after use. Carefully follow the guidelines for handling, storing, and disposing of the patch, and consult your doctor if you have any questions.
Applying the Patch
1. Remove the old patch before applying a new one.
2. Place the patch on clean, dry, healthy skin on your chest, back, upper leg, or upper arm.
3. Choose a new area for the patch each time you change it.
4. If there is hair where you plan to apply the patch, clip it as close to the skin as possible. Avoid shaving the area.
5. Do not apply the patch to skin that has been treated with creams, oils, lotions, or other skin products.
6. Avoid placing the patch on the belt line, bra line, or skin folds.
7. You do not need to apply the patch directly to the area where you are experiencing pain for it to be effective.
Caring for the Patch
You can bathe, shower, or swim for short periods while wearing the patch. To keep it in place, cover it with plastic wrap and tape.
If the patch falls off, replace it with a new one.
If the patch is not sticking properly, you can use first aid tape on the edges to secure it. Alternatively, you can use a see-through film dressing (such as Bioclusive or Askina Derm) over the patch. Make sure you know what type of dressing is suitable for use.
Do not cover the patch with any other bandage or tape.
Do not cut or divide patches, and do not use damaged patches.
Important Safety Precautions
Avoid letting the area where the patch was applied touch someone else's skin.
If the patch accidentally gets on someone else's skin, remove it immediately and wash the area with water. Seek medical help right away, as this can cause severe side effects and even death.
Misusing or abusing this medication by placing it in the mouth, chewing, swallowing, injecting, or snorting it can lead to overdose and death.
Storing and Disposing of the Patch
Store the patch 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 use this medication correctly, follow your doctor's instructions and read all the information provided. Wash your hands before and after handling the patch. It's essential to touch the sticky side of the patch as little as possible, as it contains a significant amount of medication even after use. Carefully follow the guidelines for handling, storing, and disposing of the patch, and consult your doctor if you have any questions.
Applying the Patch
1. Remove the old patch before applying a new one.
2. Place the patch on clean, dry, healthy skin on your chest, back, upper leg, or upper arm.
3. Choose a new area for the patch each time you change it.
4. If there is hair where you plan to apply the patch, clip it as close to the skin as possible. Avoid shaving the area.
5. Do not apply the patch to skin that has been treated with creams, oils, lotions, or other skin products.
6. Avoid placing the patch on the belt line, bra line, or skin folds.
7. You do not need to apply the patch directly to the area where you are experiencing pain for it to be effective.
Caring for the Patch
You can bathe, shower, or swim for short periods while wearing the patch. To keep it in place, cover it with plastic wrap and tape.
If the patch falls off, replace it with a new one.
If the patch is not sticking properly, you can use first aid tape on the edges to secure it. Alternatively, you can use a see-through film dressing (such as Bioclusive or Askina Derm) over the patch. Make sure you know what type of dressing is suitable for use.
Do not cover the patch with any other bandage or tape.
Do not cut or divide patches, and do not use damaged patches.
Important Safety Precautions
Avoid letting the area where the patch was applied touch someone else's skin.
If the patch accidentally gets on someone else's skin, remove it immediately and wash the area with water. Seek medical help right away, as this can cause severe side effects and even death.
Misusing or abusing this medication by placing it in the mouth, chewing, swallowing, injecting, or snorting it can lead to overdose and death.
Storing and Disposing of the Patch
Store the patch 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.
Lifestyle & Tips
- Apply the patch to a clean, dry, flat area of skin (e.g., upper torso, arm). Avoid hairy areas. Press firmly for 30 seconds.
- Change the patch every 72 hours (3 days) at the same time of day. Rotate application sites to prevent skin irritation.
- Do NOT cut, chew, or swallow the patch. Do NOT apply heat (e.g., heating pads, hot baths, saunas, direct sunlight) to the patch or application site, as this can cause too much medicine to be absorbed, leading to overdose.
- Avoid alcohol and other sedating medications unless specifically approved by your doctor.
- Properly dispose of used patches by folding the sticky sides together and flushing down the toilet or placing in a secure, child-proof container as per local regulations. Keep all patches out of reach of children and pets.
- Do not stop using the patch suddenly without consulting your doctor, as this can cause withdrawal symptoms.
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 typically 12.5 mcg/hr or 25 mcg/hr for opioid-tolerant patients, titrated every 72 hours based on analgesic response and tolerability. 37.5 mcg/hr is a specific strength used during titration.
Dose Range:
12.5 - 100 mg
Condition-Specific Dosing:
chronic_pain:
Apply one patch transdermally every 72 hours. Dosage should be individualized based on patient's prior opioid exposure and titrated to effect. Do not use in opioid-naive patients for initial therapy.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for opioid-naive children. For chronic pain in opioid-tolerant children ≥ 2 years of age, initial dose based on prior opioid intake, typically starting at 12 mcg/hr.
Adolescent:
Similar to adult dosing for opioid-tolerant adolescents, with careful titration.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor closely for increased opioid effects.
Moderate:
Use with caution; consider lower initial doses and slower titration due to potential for accumulation of fentanyl and its metabolites. Monitor closely for respiratory depression.
Severe:
Use with extreme caution; consider significant dose reduction or alternative analgesics. Monitor closely for respiratory depression and prolonged effects.
Dialysis:
Fentanyl is not dialyzable. Monitor closely for prolonged effects and respiratory depression.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but monitor closely for increased opioid effects.
Moderate:
Use with caution; consider lower initial doses and slower titration due to reduced clearance. Monitor closely for respiratory depression.
Severe:
Use with extreme caution; consider significant dose reduction or alternative analgesics. Monitor closely for respiratory depression and prolonged effects.
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 principal therapeutic actions are analgesia and sedation. It produces its analgesic effects by binding to and activating mu-opioid receptors, which are G-protein coupled receptors, leading to inhibition of adenylate cyclase, decreased intracellular cAMP, and modulation of ion channel activity (e.g., opening of potassium channels, closing of calcium channels), ultimately reducing neuronal excitability and neurotransmitter release involved in pain transmission.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (transdermal). Systemic absorption is slow and continuous over 72 hours. Peak serum concentrations are typically achieved 24-72 hours after initial application.
Tmax:
24-72 hours (after initial application)
FoodEffect:
Not applicable (transdermal)
Distribution:
Vd:
4 L/kg (large, reflecting extensive tissue distribution)
ProteinBinding:
80-85% (primarily to alpha-1-acid glycoprotein)
CnssPenetration:
Yes (readily crosses blood-brain barrier due to high lipophilicity)
Elimination:
HalfLife:
20-27 hours (terminal half-life after patch removal, due to reservoir effect in skin)
Clearance:
Not available (highly variable)
ExcretionRoute:
Renal (approximately 75% as metabolites), Fecal (approximately 9% as metabolites)
Unchanged:
Less than 7% (renal), Less than 1% (fecal)
Pharmacodynamics
OnsetOfAction:
6-12 hours (after initial application)
PeakEffect:
24-72 hours (after initial application)
DurationOfAction:
Up to 72 hours (after patch application)
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (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.
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 training program on pain management, including safe prescribing of opioid analgesics, and must ensure that patients have access to information about safe use, storage, and disposal of opioid analgesics.
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.
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 unused 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.
Cytochrome P450 3A4 Interaction: The 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.
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 training program on pain management, including safe prescribing of opioid analgesics, and must ensure that patients have access to information about safe use, storage, and disposal of opioid analgesics.
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.
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 unused 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.
Cytochrome P450 3A4 Interaction: The 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 experience 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 immediately 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 right away if you experience:
Feeling very tired or weak
Passing out
Severe dizziness
Very upset stomach
Throwing up
Decreased appetite
Other Possible Side Effects
While many people may not experience side effects or may only have minor side effects, 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
Throwing up
Decreased appetite
Headache
Feeling cold
Trouble sleeping
Sweating a lot
* Irritation where the medication was administered
If you experience any of these side effects or have concerns about other side effects, contact your doctor for medical 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 experience 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 immediately 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 right away if you experience:
Feeling very tired or weak
Passing out
Severe dizziness
Very upset stomach
Throwing up
Decreased appetite
Other Possible Side Effects
While many people may not experience side effects or may only have minor side effects, 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
Throwing up
Decreased appetite
Headache
Feeling cold
Trouble sleeping
Sweating a lot
* Irritation where the medication was administered
If you experience any of these side effects or have concerns about other side effects, contact your doctor for medical 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
- Pinpoint pupils
- Cold, clammy skin
- Severe constipation
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
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 issues 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 dosage of any medication without consulting your doctor first.
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. Be sure to describe the allergic reaction and its symptoms.
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 issues 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 dosage of any medication without consulting your doctor first.
Precautions & Cautions
Important Warnings and Cautions
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and performing other tasks 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 Dosage
If you have been taking this medication for an extended period or at high doses, it may become less effective, and you may require higher doses to achieve the same effect, a condition known as tolerance. If you notice this medication is no longer working as well, contact your doctor. Do not exceed the prescribed dose.
Dependence and Withdrawal
Long-term or regular use of opioid medications like this one can lead to dependence. Suddenly lowering the dose or stopping this medication may increase the risk of withdrawal or severe problems. Consult your doctor before reducing the dose or discontinuing this medication, and follow their instructions. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.
Safe Use
Do not take more than the prescribed dose, and do not take it more frequently or for a longer duration than recommended, as this may increase the risk of severe side effects. Avoid taking this medication with other strong pain medications or using a pain patch without consulting your doctor first.
Monitoring Pain
If your pain worsens, you become more sensitive to pain, or you experience new pain after taking this medication, contact your doctor immediately. Do not exceed the prescribed dose.
Interactions with Other Substances
If you consume grapefruit juice or eat grapefruit regularly, discuss this with your doctor. Do not take this medication with alcohol or products containing alcohol, as this may lead to unsafe and potentially fatal effects.
Seizure Risk
This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
Hormonal Effects
Long-term use of opioid medications may lead to decreased sex hormone levels. If you experience a decreased interest in sex, 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 Considerations
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.
Caution with Daily Activities
Avoid driving and performing other tasks 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 Dosage
If you have been taking this medication for an extended period or at high doses, it may become less effective, and you may require higher doses to achieve the same effect, a condition known as tolerance. If you notice this medication is no longer working as well, contact your doctor. Do not exceed the prescribed dose.
Dependence and Withdrawal
Long-term or regular use of opioid medications like this one can lead to dependence. Suddenly lowering the dose or stopping this medication may increase the risk of withdrawal or severe problems. Consult your doctor before reducing the dose or discontinuing this medication, and follow their instructions. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.
Safe Use
Do not take more than the prescribed dose, and do not take it more frequently or for a longer duration than recommended, as this may increase the risk of severe side effects. Avoid taking this medication with other strong pain medications or using a pain patch without consulting your doctor first.
Monitoring Pain
If your pain worsens, you become more sensitive to pain, or you experience new pain after taking this medication, contact your doctor immediately. Do not exceed the prescribed dose.
Interactions with Other Substances
If you consume grapefruit juice or eat grapefruit regularly, discuss this with your doctor. Do not take this medication with alcohol or products containing alcohol, as this may lead to unsafe and potentially fatal effects.
Seizure Risk
This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
Hormonal Effects
Long-term use of opioid medications may lead to decreased sex hormone levels. If you experience a decreased interest in sex, 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 Considerations
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:
- Slowed or stopped breathing
- Extreme drowsiness, inability to wake up
- Limp body
- Cold, clammy skin
- Blue lips or fingernails
- Pinpoint pupils
- Loss of consciousness
What to Do:
If you suspect an overdose, remove the patch immediately. Call 911 or your local emergency number. Administer naloxone if available and trained to do so. Stay with the person until emergency medical help arrives. Call 1-800-222-1222 (Poison Control) for additional guidance.
Drug Interactions
Contraindicated Interactions
- Concomitant use with strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, saquinavir, troleandomycin, voriconazole) in patients not already receiving fentanyl, or for initiation of fentanyl therapy.
- 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): Increased risk of respiratory depression, profound sedation, coma, and death.
- CYP3A4 inhibitors (moderate, e.g., erythromycin, diltiazem, verapamil, fluconazole, grapefruit juice): Increased fentanyl plasma concentrations, leading to increased or prolonged opioid effects.
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): Decreased fentanyl plasma concentrations, leading to reduced efficacy and potential for withdrawal symptoms.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, MAOIs): Increased risk of serotonin syndrome.
- Mixed agonist/antagonist opioids (e.g., pentazocine, nalbuphine, butorphanol): May reduce the analgesic effect of fentanyl and/or precipitate withdrawal symptoms.
- MAOIs: Concomitant use or within 14 days of MAOI discontinuation is contraindicated due to potential for severe, unpredictable reactions including serotonin syndrome or opioid toxicity.
Moderate Interactions
- Anticholinergics: Increased risk of urinary retention and/or severe constipation.
- Diuretics: Opioids may reduce the efficacy of diuretics by causing the release of antidiuretic hormone.
Minor Interactions
- Not specifically categorized as minor for fentanyl transdermal patch due to its potency and risk profile. All interactions should be considered significant.
Monitoring
Baseline Monitoring
Pain assessment (intensity, location, quality)
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 for excessive sedation.
Timing: Prior to initiation of therapy
Bowel function/history of constipation
Rationale: To anticipate and manage opioid-induced constipation.
Timing: Prior to initiation of therapy
Opioid tolerance assessment
Rationale: Fentanyl patch is for opioid-tolerant patients only; essential to confirm prior opioid exposure.
Timing: Prior to initiation of therapy
Routine Monitoring
Pain assessment
Frequency: Daily, or as needed, especially after dose changes
Target: Acceptable pain level as defined by patient
Action Threshold: Uncontrolled pain may indicate need for dose adjustment or alternative therapy; excessive pain relief with sedation may indicate overdose.
Respiratory rate and depth
Frequency: Regularly, especially during initial therapy and after dose changes
Target: Typically >10-12 breaths/min, regular rhythm
Action Threshold: <10 breaths/min, shallow breathing, or signs of hypoventilation require immediate intervention.
Level of consciousness/sedation
Frequency: Regularly, especially during initial therapy and after dose changes
Target: Alert and oriented, or easily aroused
Action Threshold: Excessive sedation (e.g., somnolence, difficulty arousing) requires immediate intervention.
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) requires laxative intervention.
Patch adherence and site reaction
Frequency: With each patch change
Target: Patch intact, no significant skin irritation
Action Threshold: Loose patch, severe erythema, blistering, or rash may require site change or discontinuation.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation/drowsiness
- Dizziness
- Nausea and vomiting
- Constipation
- Confusion
- Pinpoint pupils
- Cold, clammy skin
- Difficulty speaking
- Weakness
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 should be used during pregnancy 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 in general.
Second Trimester:
Risk of NOWS increases with prolonged exposure.
Third Trimester:
High risk of NOWS if used near term. Risk of respiratory depression in the neonate.
Lactation
Fentanyl is excreted in breast milk. Breastfeeding is not recommended during treatment with fentanyl due to the potential for serious adverse reactions in the breastfed infant, including sedation, respiratory depression, and death. If breastfeeding cannot be avoided, monitor infants for signs of sedation and respiratory depression.
Infant Risk:
High (L4 - Possibly hazardous)
Pediatric Use
Fentanyl transdermal patch is not indicated for acute pain or for opioid-naive children. Use in opioid-tolerant children ≥ 2 years of age for chronic pain requires careful titration and monitoring due to increased risk of hypoventilation and other serious adverse events. Accidental exposure in children can be fatal.
Geriatric Use
Elderly patients may be more sensitive to the effects of fentanyl, including respiratory depression. Start with lower doses and titrate slowly. Monitor closely for adverse effects, especially respiratory depression and constipation, due to potential for decreased hepatic and renal 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 due to the risk of fatal respiratory depression.
- Always ensure proper disposal of used patches (folding sticky sides together and flushing or placing in a secure container) to prevent accidental exposure to children or pets.
- Educate patients thoroughly on avoiding heat exposure to the patch site, as this significantly increases fentanyl absorption and risk of overdose.
- The onset of action is slow (6-12 hours), and peak effect is delayed (24-72 hours). Patients may require short-acting opioid analgesics for breakthrough pain during the initial titration period.
- The terminal half-life is prolonged (20-27 hours) due to the skin reservoir effect, meaning effects can persist for many hours after patch removal.
- Monitor for signs of opioid-induced constipation and initiate a bowel regimen proactively.
Alternative Therapies
- Other strong opioid analgesics (e.g., oxycodone extended-release, morphine extended-release, hydromorphone extended-release, methadone)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for less severe pain or as adjuncts
- Adjuvant analgesics (e.g., gabapentin, pregabalin for neuropathic pain; tricyclic antidepressants)
- Non-pharmacological pain management (e.g., physical therapy, cognitive behavioral therapy, interventional procedures)
Cost & Coverage
Average Cost:
Varies widely (e.g., $50 - $300+) per 5 patches
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, do not share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, 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 reporting the incident, be prepared to disclose what was taken, the quantity, and the time of the incident to ensure prompt and effective treatment.
This medication is accompanied by a Medication Guide, 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 reporting the incident, be prepared to disclose what was taken, the quantity, and the time of the incident to ensure prompt and effective treatment.