Fentanyl 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
Jan 1970
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 for people who are already used to taking strong pain medicines. The patch slowly releases the medicine into your body over 3 days (72 hours) to help control your pain.
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 the patch each time you change it.
6. If there is hair where you plan to apply the patch, clip it as close to the skin as possible. 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.
Caring for the Patch
1. You can bathe, shower, or swim for short periods while wearing the patch. To help keep it in place, cover the patch with plastic wrap and tape.
2. If the patch falls off, replace it with a new one.
3. 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.
4. Do not cover the patch with any other bandage or tape.
5. Do not cut or divide the patches.
6. Do not use damaged patches.
7. Avoid touching the area where the patch was applied to 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.
Important Safety Information
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
1. Store the medication at room temperature in a dry place, away from the bathroom.
2. 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.
What to Do If You Miss 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 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 the patch each time you change it.
6. If there is hair where you plan to apply the patch, clip it as close to the skin as possible. 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.
Caring for the Patch
1. You can bathe, shower, or swim for short periods while wearing the patch. To help keep it in place, cover the patch with plastic wrap and tape.
2. If the patch falls off, replace it with a new one.
3. 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.
4. Do not cover the patch with any other bandage or tape.
5. Do not cut or divide the patches.
6. Do not use damaged patches.
7. Avoid touching the area where the patch was applied to 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.
Important Safety Information
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
1. Store the medication at room temperature in a dry place, away from the bathroom.
2. 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.
What to Do If You Miss 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
- Avoid exposing 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 absorbed, leading to overdose.
- Do not cut, chew, or swallow the patch.
- Do not apply more patches than prescribed or change them more frequently than every 72 hours.
- Avoid alcohol and other sedating medications unless specifically approved by your doctor.
- Store patches securely away from children and pets.
- Dispose of used patches by folding the sticky sides together and flushing down the toilet or placing in a secure, child-proof container as instructed by your pharmacist or doctor.
- Inform all healthcare providers that you are using a fentanyl patch.
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:
Individualized, typically initiated at 12-25 mcg/hr for opioid-tolerant patients, titrated every 72 hours based on response. 100 mcg/hr is a high dose for opioid-tolerant patients requiring significant pain control.
Dose Range:
12 - 100 mg
Condition-Specific Dosing:
chronic_severe_pain:
For management of chronic, severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time and for which alternative treatment options are inadequate.
opioid_tolerance_definition:
Patients considered opioid tolerant are those receiving, for 1 week or longer, at least 60 mg/day oral morphine, 30 mg/day oral oxycodone, 25 mg/day oral hydromorphone, or an equianalgesic dose of another opioid.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (contraindicated in children under 2 years of age)
Child:
Limited use for chronic severe pain in opioid-tolerant children ≥2 years of age. Dosing is highly individualized and requires careful titration based on prior opioid exposure and pain severity. Initial dose typically 12 mcg/hr.
Adolescent:
Similar to adult dosing for opioid-tolerant adolescents, highly individualized.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor for increased opioid effects.
Moderate:
Use with caution; consider dose reduction and close monitoring due to potential accumulation of metabolites.
Severe:
Use with extreme caution; consider significant dose reduction and extended dosing intervals. Close monitoring for respiratory depression and sedation is essential.
Dialysis:
Fentanyl is not dialyzable. Monitor closely for prolonged effects.
Hepatic Impairment:
Mild:
Use with caution; monitor for increased opioid effects.
Moderate:
Use with caution; consider dose reduction and close monitoring due to decreased clearance.
Severe:
Use with extreme caution; consider significant dose reduction and extended dosing intervals. Close monitoring for respiratory depression and sedation is essential.
Pharmacology
Mechanism of Action
Fentanyl is a potent, synthetic opioid analgesic that acts primarily as an agonist at mu-opioid receptors in the central nervous system (CNS). Its primary therapeutic action is analgesia. Other effects include respiratory depression, euphoria, miosis, and physical dependence.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 92% (transdermal, relative to IV)
Tmax:
24-72 hours (after initial application of patch)
FoodEffect:
Not applicable (transdermal)
Distribution:
Vd:
4 L/kg (large volume of distribution)
ProteinBinding:
80-85% (primarily to alpha-1-acid glycoprotein)
CnssPenetration:
Yes
Elimination:
HalfLife:
13-25 hours (after patch removal, due to continued absorption from skin depot)
Clearance:
Not readily quantifiable for transdermal due to depot effect; systemic clearance is approximately 0.8 L/hr/kg
ExcretionRoute:
Primarily renal (75% as metabolites, <10% as unchanged drug); fecal (9% as metabolites)
Unchanged:
<10% (urine)
Pharmacodynamics
OnsetOfAction:
6-12 hours (after initial patch application)
PeakEffect:
24-72 hours (after initial patch application)
DurationOfAction:
72 hours (per patch application)
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE; REMS; RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 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 can result in a fatal overdose. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome. Concomitant use with CYP3A4 inhibitors or discontinuation of CYP3A4 inducers can result in a fatal overdose. Concomitant use with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek 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 fainting
Confusion
Severe constipation or stomach pain, which may indicate a severe bowel problem
Breathing difficulties, such as:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Chest pain
Abnormal heartbeat (fast or slow)
Seizures
Depression
Trouble controlling body movements
Swelling in the arms or legs
Changes in eyesight
Serotonin Syndrome: A Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk of developing serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Abnormal heartbeat (fast or slow)
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea
Upset stomach
Vomiting
Severe headache
Adrenal Gland Problems: A Rare but Serious Condition
Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Contact your doctor immediately if you experience:
Extreme fatigue or weakness
Fainting
Severe dizziness
Upset stomach
Vomiting
Decreased appetite
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:
Dizziness
Drowsiness
Fatigue
Weakness
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Headache
Feeling cold
Sleep disturbances
Excessive sweating
Irritation at the site of administration
If you experience any of these side effects or have concerns about others, contact your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or visit https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek 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 fainting
Confusion
Severe constipation or stomach pain, which may indicate a severe bowel problem
Breathing difficulties, such as:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Chest pain
Abnormal heartbeat (fast or slow)
Seizures
Depression
Trouble controlling body movements
Swelling in the arms or legs
Changes in eyesight
Serotonin Syndrome: A Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk of developing serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Abnormal heartbeat (fast or slow)
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea
Upset stomach
Vomiting
Severe headache
Adrenal Gland Problems: A Rare but Serious Condition
Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Contact your doctor immediately if you experience:
Extreme fatigue or weakness
Fainting
Severe dizziness
Upset stomach
Vomiting
Decreased appetite
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:
Dizziness
Drowsiness
Fatigue
Weakness
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Headache
Feeling cold
Sleep disturbances
Excessive sweating
Irritation at the site of administration
If you experience any of these side effects or have concerns about others, contact your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or visit https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Extreme drowsiness or difficulty waking up
- Slow, shallow, or difficult breathing
- Pinpoint pupils
- Dizziness or lightheadedness when standing up
- Confusion
- 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Kidney or liver disease
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
* Current use of certain medications, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your existing health conditions and medications. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Kidney or liver disease
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
* Current use of certain medications, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your existing health conditions and medications. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and performing 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 Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose.
Additionally, regular use of opioid medications like this one can cause dependence. Stopping or reducing the dose abruptly may increase the risk of withdrawal or other severe problems. Consult your doctor before changing your dose or stopping the medication. 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 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.
If your pain worsens, you become more sensitive to pain, or 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 may cause 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 Populations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Breastfeeding
Inform your doctor if you are breastfeeding, as this medication passes into breast milk and may harm your baby. Seek medical attention immediately if your baby appears overly 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 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 Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose.
Additionally, regular use of opioid medications like this one can cause dependence. Stopping or reducing the dose abruptly may increase the risk of withdrawal or other severe problems. Consult your doctor before changing your dose or stopping the medication. 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 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.
If your pain worsens, you become more sensitive to pain, or 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 may cause 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 Populations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Breastfeeding
Inform your doctor if you are breastfeeding, as this medication passes into breast milk and may harm your baby. Seek medical attention immediately if your baby appears overly sleepy, limp, or has breathing difficulties.
Overdose Information
Overdose Symptoms:
- Slowed or stopped breathing (respiratory depression)
- Extreme drowsiness or inability to wake up
- Pinpoint pupils
- Limp muscles
- Cold, clammy skin
- Bluish discoloration of lips and fingernails
- Severely decreased heart rate and blood pressure
- Coma
What to Do:
IMMEDIATELY call 911 or emergency services. Administer naloxone (Narcan) if available and trained to do so. Remove the fentanyl patch. Stay with the person until help arrives. Call 1-800-222-1222 (Poison Control Center) for additional guidance.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) within 14 days (risk of serotonin syndrome or severe respiratory depression)
- Patients who are not opioid tolerant
- Acute or post-operative pain (risk of life-threatening hypoventilation)
- Mild or intermittent pain management
- Significant respiratory depression
Major Interactions
- 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 (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, erythromycin, verapamil, diltiazem, grapefruit juice): Increased fentanyl plasma concentrations, leading to increased opioid effects and potentially fatal respiratory depression.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol): Risk of serotonin syndrome.
- Mixed agonist/antagonist opioids (e.g., pentazocine, nalbuphine, butorphanol, buprenorphine): May reduce the analgesic effect of fentanyl or precipitate withdrawal symptoms.
Moderate Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): May decrease fentanyl plasma concentrations, leading to reduced efficacy and potential withdrawal symptoms.
- Anticholinergics: Increased risk of urinary retention and/or severe constipation.
Minor Interactions
- Not many specific minor interactions are typically highlighted for fentanyl transdermal patches beyond the major categories due to its potency and risk profile.
Monitoring
Baseline Monitoring
Pain assessment (intensity, quality, location)
Rationale: To establish baseline pain level and guide initial dosing/titration.
Timing: Prior to initiation of therapy
Respiratory rate and depth
Rationale: To assess baseline respiratory function and identify risk for respiratory depression.
Timing: Prior to initiation of therapy
Level of consciousness/sedation
Rationale: To assess baseline neurological status and identify risk for excessive sedation.
Timing: Prior to initiation of therapy
Bowel function
Rationale: To assess baseline and anticipate opioid-induced constipation.
Timing: Prior to initiation of therapy
Opioid tolerance status
Rationale: Fentanyl patches are only for opioid-tolerant patients; essential for safe initiation.
Timing: Prior to initiation of therapy
Routine Monitoring
Pain control efficacy
Frequency: Daily, or as needed
Target: Acceptable pain level, improved function
Action Threshold: Uncontrolled pain, requiring rescue medication frequently; consider dose adjustment or alternative.
Respiratory rate and depth
Frequency: Regularly, especially during initiation and dose titration; daily thereafter
Target: Normal for patient (e.g., 12-20 breaths/min)
Action Threshold: <10 breaths/min, shallow breathing, signs of hypoventilation; intervene immediately.
Level of consciousness/sedation
Frequency: Regularly, especially during initiation and dose titration; daily thereafter
Target: Alert, easily aroused
Action Threshold: Excessive sedation (e.g., somnolent, difficult to arouse); reduce dose or discontinue.
Bowel function
Frequency: Daily
Target: Regular bowel movements
Action Threshold: Constipation, abdominal distension; initiate bowel regimen.
Signs of opioid withdrawal
Frequency: If dose reduced or discontinued
Target: Absence of withdrawal symptoms
Action Threshold: Restlessness, yawning, lacrimation, rhinorrhea, piloerection, muscle aches, nausea, vomiting, diarrhea; manage withdrawal.
Patch adherence and site integrity
Frequency: Every 72 hours (at patch change)
Target: Patch intact, skin free of irritation
Action Threshold: Patch peeling, skin irritation, signs of tampering; reapply or change site.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation/somnolence
- Dizziness
- Nausea
- Vomiting
- Constipation
- Pruritus (itching)
- Confusion
- Miosis (pinpoint pupils)
- Hypotension
- Signs of opioid withdrawal (if dose reduced or discontinued)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated. Monitor newborns for signs of NOWS.
Trimester-Specific Risks:
First Trimester:
Potential for congenital malformations, though data are limited and conflicting for opioids in general.
Second Trimester:
Risk of fetal growth restriction and adverse neurodevelopmental outcomes.
Third Trimester:
High risk of neonatal opioid withdrawal syndrome (NOWS) if used chronically. Risk of respiratory depression in the neonate if used close to delivery.
Lactation
Fentanyl is excreted into breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., sedation, respiratory depression), breastfeeding is not recommended. If breastfeeding cannot be avoided, monitor infants closely for signs of sedation and respiratory depression.
Infant Risk:
L3 (Moderate risk). Risk of sedation, respiratory depression, and poor feeding in the infant.
Pediatric Use
Contraindicated in children under 2 years of age. Use in opioid-tolerant children ≥2 years of age for chronic severe pain is highly individualized and requires careful titration. Accidental exposure in children can be fatal. Ensure patches are stored and disposed of safely.
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 and constipation. Reduced hepatic and renal function may lead to increased plasma concentrations.
Clinical Information
Clinical Pearls
- Fentanyl patches are for opioid-tolerant patients only. Use in opioid-naïve patients can be fatal.
- Always ensure the previous opioid dose is converted appropriately to the fentanyl patch dose to avoid over- or under-dosing.
- Instruct patients to avoid external heat sources (e.g., heating pads, hot baths, fever) on the patch site, as this can significantly increase fentanyl absorption and lead to overdose.
- Emphasize proper patch application (clean, dry, non-hairy skin) and disposal (fold sticky sides together, flush down toilet or dispose per local guidelines) to prevent accidental exposure.
- Monitor for respiratory depression, especially during initiation and dose titration, and when co-administered with other CNS depressants.
- Opioid-induced constipation is common; proactively manage with a bowel regimen.
- Patients should be educated on signs of overdose and the availability of naloxone.
- Do not cut the patch, as this can alter drug release and lead to rapid absorption.
Alternative Therapies
- Other long-acting opioid analgesics (e.g., extended-release morphine, oxycodone, hydromorphone, methadone)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin, tricyclic antidepressants) for neuropathic pain components
- Interventional pain management (e.g., nerve blocks, spinal cord stimulation)
- Physical therapy, occupational therapy
- Psychological therapies (e.g., cognitive behavioral therapy, mindfulness-based stress reduction)
Cost & Coverage
Average Cost:
Varies widely, typically $100-$500+ per 5 patches (100 mcg/hr)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization due to high potency and abuse potential)
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, and never 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 it. Discuss with your doctor or pharmacist how to obtain or use naloxone. 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 or show what was taken, how much, and when the incident happened to ensure you receive appropriate care.
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 it. Discuss with your doctor or pharmacist how to obtain or use naloxone. 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 or show what was taken, how much, and when the incident happened to ensure you receive appropriate care.