Duragesic 100mcg/hr Patch
WARNING: This is an opioid drug. Opioid drugs can put you at risk for drug use disorder. These can lead to overdose and death. You will be watched closely while taking this drug.Severe breathing problems may happen with this drug. The risk is highest when you first start taking this drug or any time your dose is raised. These breathing problems can be deadly. Call your doctor right away if you have slow, shallow, or trouble breathing. Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.Severe side effects have happened when opioid drugs were used with benzodiazepines, alcohol, marijuana, other forms of cannabis, or street drugs. This includes severe drowsiness, breathing problems, and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. If you have questions, talk with the doctor.Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs.Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.Avoid hot baths, sunbathing, and use of heat sources (including tanning beds, heating pads, and hot tubs). Avoid activities like heavy exercise. Tell your doctor if you get a fever. A rise in body temperature may cause too much drug to pass into your body. This can cause overdose and deadly breathing problems.If you are pregnant or plan to get pregnant, talk with your doctor right away about the benefits and risks of using this drug during pregnancy. Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. Withdrawal in the newborn can be life- threatening if not treated. @ COMMON USES: It is used to manage pain.This drug is not for mild pain or pain that only lasts a short time (like headaches, toothaches, or pain after surgery).This drug is only for use by people who have been taking pain drugs (opioids) and are used to their effects. Talk with the doctor.
Drug Class
Opioid analgesic
Pharmacologic Class
Opioid agonist
Pregnancy Category
Category C
FDA Approved
Aug 1990
DEA Schedule
Schedule II
Overview
What is this medicine?
Fentanyl is a strong pain medicine that comes as a patch you stick on your skin. It's used for severe, ongoing pain that needs around-the-clock treatment, especially for people who are already used to taking strong opioid pain medicines. The patch slowly releases the medicine into your body over three days.
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. Do not shave the area.
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 damaged patches.
Avoid touching the area where the patch was applied to anyone else's skin.
If the patch accidentally gets on someone else's skin, remove it immediately and wash the area with water. Seek medical help right away, as this can cause severe side effects or even death.
Misusing or abusing this medication by placing it in the mouth, chewing, swallowing, injecting, or snorting it can lead to overdose and death.
Storage and Disposal
Store 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.
Missed Dose
If you miss a dose, apply a new patch as soon as you remember, after removing the old one.
* Do not apply a double dose or extra doses to make up for a missed dose.
To use 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. Do not shave the area.
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 damaged patches.
Avoid touching the area where the patch was applied to anyone else's skin.
If the patch accidentally gets on someone else's skin, remove it immediately and wash the area with water. Seek medical help right away, as this can cause severe side effects or even death.
Misusing or abusing this medication by placing it in the mouth, chewing, swallowing, injecting, or snorting it can lead to overdose and death.
Storage and Disposal
Store 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.
Missed Dose
If you miss a dose, apply a new patch as soon as you remember, after removing the old one.
* Do not apply a double dose or extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply the patch to a clean, dry, flat area of skin on the torso or upper arm. Avoid hairy areas.
- Press firmly for 30 seconds to ensure good contact.
- Change the patch every 72 hours (3 days), even if it seems like there's still medicine in it.
- Rotate application sites to prevent skin irritation.
- DO NOT cut, chew, or damage the patch in any way, as this can lead to a dangerous overdose.
- DO NOT expose the patch to direct heat (e.g., heating pads, electric blankets, hot tubs, saunas, prolonged sun exposure), as this can cause too much medicine to be released and lead to overdose.
- 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.
- Avoid alcohol and other sedating medications unless approved by your doctor.
- Do not drive or operate heavy machinery until you know how this medication affects you.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
For opioid-tolerant patients, initial dose based on prior opioid use, typically 25 mcg/hr. The 100 mcg/hr patch is for patients requiring higher doses of opioid analgesia. Apply one patch every 72 hours.
Dose Range:
12.5 - 100 mg
Condition-Specific Dosing:
chronic_severe_pain:
Individualized titration based on patient response and tolerability. Not for acute or post-operative pain in opioid-naive patients.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Only for opioid-tolerant children 2 years of age and older, with initial dosing based on prior opioid intake. Not for opioid-naive children.
Adolescent:
Only for opioid-tolerant adolescents, with initial dosing based on prior opioid intake. Not for opioid-naive adolescents.
Dose Adjustments
Renal Impairment:
Mild:
Monitor closely for signs of opioid toxicity. Dose reduction may be necessary.
Moderate:
Monitor closely for signs of opioid toxicity. Consider dose reduction and extended dosing intervals.
Severe:
Use with extreme caution. Significant dose reduction and extended dosing intervals are likely necessary. Monitor closely for respiratory depression and sedation.
Dialysis:
Fentanyl is not dialyzable. Use with extreme caution, significant dose reduction, and extended dosing intervals.
Hepatic Impairment:
Mild:
Monitor closely for signs of opioid toxicity. Dose reduction may be necessary.
Moderate:
Monitor closely for signs of opioid toxicity. Consider dose reduction and extended dosing intervals.
Severe:
Use with extreme caution. Significant dose reduction and extended dosing intervals are likely necessary. Monitor closely for respiratory depression and sedation.
Pharmacology
Mechanism of Action
Fentanyl is a potent, synthetic opioid analgesic that primarily interacts with the mu-opioid receptor. Its primary therapeutic actions are analgesia and sedation. It produces its effects by binding to opioid receptors in the central nervous system, inhibiting ascending pain pathways, altering the perception of and response to pain.
Pharmacokinetics
Absorption:
Bioavailability:
Varies (transdermal absorption is slow and sustained, reaching steady-state plasma concentrations in 24-72 hours)
Tmax:
24-72 hours (after initial application)
FoodEffect:
Not applicable (transdermal)
Distribution:
Vd:
4 L/kg
ProteinBinding:
80-85%
CnssPenetration:
Yes
Elimination:
HalfLife:
13-48 hours (after patch removal, due to continued absorption from skin depot)
Clearance:
Not available (highly variable transdermal absorption)
ExcretionRoute:
Renal (75% as metabolites, <10% as unchanged drug), Fecal (9% as metabolites)
Unchanged:
<10% (renal)
Pharmacodynamics
OnsetOfAction:
6-12 hours (after initial application)
PeakEffect:
24-72 hours
DurationOfAction:
Up to 72 hours (per patch application)
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE; REMS; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYP3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS. Fentanyl transdermal system exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing fentanyl transdermal system, and monitor all patients regularly for the development of these behaviors and conditions. Serious, life-threatening, or fatal respiratory depression may occur. Accidental exposure to even one dose of fentanyl transdermal system, especially in children, can result in a fatal overdose. Prolonged use of fentanyl transdermal system during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. Concomitant use with CYP3A4 inhibitors or discontinuation of CYP3A4 inducers can result in a fatal overdose. 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 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
Breathing difficulties, such as:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Breathing problems during sleep (sleep apnea)
Chest pain
Abnormal heartbeat (fast or slow)
Seizures
Depression
Trouble controlling body movements
Swelling in the arms or legs
Changes in eyesight
Serotonin Syndrome: A Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk of developing serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea
Upset stomach
Vomiting
Severe headache
Adrenal Gland Problems: A Rare but Serious Condition
Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Contact your doctor immediately if you experience:
Extreme fatigue or weakness
Passing out
Severe dizziness
Upset stomach
Vomiting
Decreased appetite
Other Possible Side Effects
While many people may not experience side effects or may only have 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
Vomiting
Decreased appetite
Headache
Feeling cold
Trouble sleeping
Excessive sweating
* Irritation at the site of administration
If you experience any of these side effects or any other symptoms that concern you, contact your doctor or seek medical attention. 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
Breathing difficulties, such as:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Breathing problems during sleep (sleep apnea)
Chest pain
Abnormal heartbeat (fast or slow)
Seizures
Depression
Trouble controlling body movements
Swelling in the arms or legs
Changes in eyesight
Serotonin Syndrome: A Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk of developing serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea
Upset stomach
Vomiting
Severe headache
Adrenal Gland Problems: A Rare but Serious Condition
Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Contact your doctor immediately if you experience:
Extreme fatigue or weakness
Passing out
Severe dizziness
Upset stomach
Vomiting
Decreased appetite
Other Possible Side Effects
While many people may not experience side effects or may only have 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
Vomiting
Decreased appetite
Headache
Feeling cold
Trouble sleeping
Excessive sweating
* Irritation at the site of administration
If you experience any of these side effects or any other symptoms that concern you, contact your doctor or seek medical attention. 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
- Blue lips or fingernails
- Severe constipation or abdominal pain
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Respiratory problems, including asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Kidney or liver disease
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
Current use of certain medications, such as buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins
Discuss your health problems and any potential interactions with this medication
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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Respiratory problems, including asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Kidney or liver disease
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
Current use of certain medications, such as buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins
Discuss your health problems and any potential interactions with this medication
Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and 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 need 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 cause dependence. If you need to lower your dose or stop taking this medication, consult your doctor first, as suddenly stopping or reducing the dose can lead to 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 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 can lead to lower sex hormone levels. If you experience decreased libido, fertility problems, irregular menstrual periods, or ejaculation problems, contact your doctor.
MRI Precautions
The patch may contain metal, so remove it before undergoing an MRI.
Special Populations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Breastfeeding
If you are breastfeeding, inform your doctor, as this medication passes into breast milk and may harm your baby. Seek medical attention immediately if your baby appears overly sleepy, limp, or has breathing difficulties.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and 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 need 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 cause dependence. If you need to lower your dose or stop taking this medication, consult your doctor first, as suddenly stopping or reducing the dose can lead to 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 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 can lead to lower sex hormone levels. If you experience decreased libido, fertility problems, irregular menstrual periods, or ejaculation problems, contact your doctor.
MRI Precautions
The patch may contain metal, so remove it before undergoing an MRI.
Special Populations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Breastfeeding
If you are breastfeeding, inform your doctor, as this medication passes into breast milk and may harm your baby. Seek medical attention immediately if your baby appears overly sleepy, limp, or has breathing difficulties.
Overdose Information
Overdose Symptoms:
- Severe respiratory depression (extremely slow or shallow breathing, cessation of breathing)
- Profound sedation or coma
- Pinpoint pupils
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Cold, clammy skin
- Flaccid skeletal muscle
- Pulmonary edema
What to Do:
Immediately remove the patch. Call 911 or emergency medical services. Administer naloxone if available and trained to do so. Continue to monitor breathing and consciousness. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) within 14 days
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, nelfinavir, troleandomycin, nefazodone)
- Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, alcohol)
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, linezolid, methylene blue) - risk of serotonin syndrome
Moderate Interactions
- Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, fluconazole, grapefruit juice)
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort) - risk of reduced efficacy
Minor Interactions
- Anticholinergic drugs (e.g., atropine, scopolamine) - increased risk of urinary retention and/or severe constipation
Monitoring
Baseline Monitoring
Pain assessment (intensity, location, quality)
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 transdermal is only for opioid-tolerant patients. Assess prior opioid use and conversion.
Timing: Prior to initiation of therapy
Liver and renal function tests (LFTs, Cr, BUN)
Rationale: To assess organ function that may affect fentanyl metabolism and excretion.
Timing: Prior to initiation of therapy (if clinically indicated)
Routine Monitoring
Pain control
Frequency: Daily, or as needed
Target: Acceptable pain level for the patient
Action Threshold: Uncontrolled pain, requiring dose adjustment or supplemental analgesia
Respiratory rate and depth
Frequency: Regularly, especially during initiation and dose titration
Target: >10 breaths/min, unlabored
Action Threshold: <10 breaths/min, shallow breathing, signs of hypoventilation (e.g., cyanosis, somnolence)
Level of consciousness/sedation
Frequency: Regularly, especially during initiation and dose titration
Target: Alert and oriented, or easily aroused
Action Threshold: Excessive sedation, somnolence, difficulty arousing
Bowel function (constipation)
Frequency: Daily
Target: Regular bowel movements
Action Threshold: No bowel movement for >3 days, severe straining, abdominal discomfort
Patch adherence and skin integrity
Frequency: With each patch change
Target: Patch intact, no significant skin irritation
Action Threshold: Patch peeling off, severe skin redness, rash, blistering
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation or somnolence
- Dizziness
- Nausea
- Vomiting
- Constipation
- Pruritus (itching)
- Confusion
- Hypotension
- Signs of opioid withdrawal (if abruptly discontinued)
Special Patient Groups
Pregnancy
Use during pregnancy is generally not recommended due to the risk of neonatal opioid withdrawal syndrome (NOWS) and potential for respiratory depression in the neonate. Benefits must outweigh risks.
Trimester-Specific Risks:
First Trimester:
Potential for congenital malformations, though data for fentanyl specifically is limited. Risk of NOWS if prolonged use continues into later trimesters.
Second Trimester:
Risk of NOWS if prolonged use continues into later trimesters. Potential for fetal respiratory depression.
Third Trimester:
High risk of neonatal opioid withdrawal syndrome (NOWS) if used chronically. Risk of fetal and neonatal respiratory depression, especially if used near delivery.
Lactation
Fentanyl is excreted into breast milk. Due to the potential for serious adverse reactions in breastfed infants, including respiratory depression, sedation, and death, breastfeeding is not recommended during treatment with fentanyl transdermal system.
Infant Risk:
High risk (L3 - Moderate concern; potential for adverse effects on infant)
Pediatric Use
Fentanyl transdermal system is only indicated for the management of chronic, severe pain in opioid-tolerant pediatric patients 2 years of age and older. Not for opioid-naive children. Extreme caution is required due to the risk of fatal respiratory depression, especially with accidental exposure.
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 transdermal is for chronic, severe pain in opioid-tolerant patients only. It is NOT for acute pain, post-operative pain, or opioid-naive patients due to the risk of fatal respiratory depression.
- Proper disposal of used patches is critical to prevent accidental exposure, especially to children or pets. Fold sticky sides together and flush down the toilet or dispose of in a secure, child-proof manner.
- Avoid external heat sources (e.g., heating pads, hot baths, direct sunlight) on or near the patch, as this can increase fentanyl absorption and lead to overdose.
- Patients should be stable on their opioid regimen before converting to fentanyl transdermal. Careful conversion calculations are essential.
- Respiratory depression is the most serious adverse effect. Educate patients and caregivers on signs of respiratory depression and the importance of seeking immediate medical attention.
- Constipation is a common side effect of opioid therapy; proactive management with laxatives is often necessary.
Alternative Therapies
- Other strong opioid analgesics (e.g., extended-release morphine, oxycodone, hydromorphone)
- Methadone (for chronic pain, often in specialized settings)
- Non-opioid pain management strategies (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin, tricyclic antidepressants, SNRIs)
- Interventional pain procedures
- Physical therapy, occupational therapy, psychological therapies (e.g., CBT)
Cost & Coverage
Average Cost:
Varies widely by pharmacy and insurance plan per patch
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (generics may be Tier 1 or 2)
General Drug Facts
If your symptoms or health problems do not improve or worsen, contact your doctor immediately. It is essential to use your prescribed medication responsibly: do not share it with others, and never take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. Read this guide carefully when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help counteract its effects. 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 right away. When seeking help, be prepared to provide information about what was taken, the quantity, and the time of the incident.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. Read this guide carefully when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help counteract its effects. 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 right away. When seeking help, be prepared to provide information about what was taken, the quantity, and the time of the incident.