Fentanyl 12mcg/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 patch is a strong pain medicine that is applied to your skin to provide continuous pain relief for severe, ongoing pain. It is only for people who are already taking other strong opioid pain medicines regularly and whose bodies are used to them. It works by changing how your brain and nervous system respond to 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 each patch to avoid skin irritation.
6. If there is hair where you plan to apply the patch, clip it close to the skin, but do not shave.
7. Avoid applying the patch to skin that has been treated with creams, oils, lotions, or other skin products.
8. Do not apply the patch to the belt line, bra line, or skin folds.
9. You do not need to apply the patch directly to the area where you are experiencing pain for it to be effective.
Caring for the Patch
1. You can bathe, shower, or swim for short periods while wearing the patch.
2. To keep the patch in place, cover it with plastic wrap and tape.
3. If the patch falls off, replace it with a new one.
4. If the patch does not stick 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 safe to use.
5. Do not cover the patch with any other bandage or tape.
Important Safety Precautions
1. Do not cut or divide patches.
2. Do not use damaged patches.
3. Avoid touching the area where the patch was applied to anyone else's skin.
4. 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.
5. 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.
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 use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely.
Handling and Applying the Patch
1. Wash your hands before and after handling the patch.
2. Touch the sticky side of the patch as little as possible to avoid transferring the medication to your hands.
3. Remove the old patch before applying a new one.
4. Apply the patch to clean, dry, healthy skin on your chest, back, upper leg, or upper arm.
5. Choose a new area for each patch to avoid skin irritation.
6. If there is hair where you plan to apply the patch, clip it close to the skin, but do not shave.
7. Avoid applying the patch to skin that has been treated with creams, oils, lotions, or other skin products.
8. Do not apply the patch to the belt line, bra line, or skin folds.
9. You do not need to apply the patch directly to the area where you are experiencing pain for it to be effective.
Caring for the Patch
1. You can bathe, shower, or swim for short periods while wearing the patch.
2. To keep the patch in place, cover it with plastic wrap and tape.
3. If the patch falls off, replace it with a new one.
4. If the patch does not stick 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 safe to use.
5. Do not cover the patch with any other bandage or tape.
Important Safety Precautions
1. Do not cut or divide patches.
2. Do not use damaged patches.
3. Avoid touching the area where the patch was applied to anyone else's skin.
4. 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.
5. 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.
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.
Lifestyle & Tips
- Do not apply heat directly to the patch (e.g., heating pads, electric blankets, hot baths, saunas, prolonged sun exposure) as this can cause too much medicine to be absorbed, leading to overdose.
- Avoid alcohol and other sedating medications (e.g., sleeping pills, anxiety medications) unless specifically approved by your doctor, as this can increase the risk of serious breathing problems and sedation.
- Store patches securely out of reach of children and pets. After use, fold the patch in half with the sticky sides together and flush it down the toilet immediately or dispose of it as instructed by your pharmacist/doctor.
- Do not cut, chew, or swallow the patch.
- Change the patch exactly as prescribed, usually every 72 hours (3 days). Do not wear more than one patch at a time unless directed by your doctor.
- If a patch falls off, dispose of it properly and apply a new patch to a different skin area. Inform your doctor.
- Avoid activities requiring mental alertness, such as driving or operating machinery, until you know how the medication affects you.
Available Forms & Alternatives
Available Strengths:
- Fentanyl 25mcg/hr Patch
- Fentanyl 50mcg/hr Patch
- Fentanyl 75mcg/hr Patch
- Fentanyl 100mcg/hr Patch
- Fentanyl Cit 0.05mg/ml Inj, 20ml
- Fentanyl Cit 0.05mg/ml Inj, 2ml
- Fentanyl Cit 0.05mg/ml Inj, 50ml
- Fentanyl Cit 0.05mg/ml Inj, 5ml
- Fentanyl Cit 800mcg Oral Transmcsl
- Fentanyl Cit 1200mcg Oral Transmcsl
- Fentanyl Cit 600mcg Oral Transmcsl
- Fentanyl Cit 1600mcg Oral Transmcsl
- Fentanyl Cit 400mcg Oral Transmcsl
- Fentanyl Cit 200mcg Oral Transmcsl
- Fentanyl 62.5mcg/hr Patch
- Fentanyl 87.5mcg/hr Patch
- Fentanyl Cit 600mcg Oraltransmcsl
- Fentanyl Cit 800mcg Oral Transmcsl
- Fentanyl Cit 1600mcg Oral Transmcsl
- Fentanyl Cit 100mcg Tablets
- Fentanyl Cit 200mcg Tablets
- Fentanyl 37.5mcg/hr Patch
- Fentanyl 62.5mcg/hr Patch
- Fentanyl Cit 50mcg/ml Pf Inj, 1ml
- Fentanyl 12mcg/hr Patch
- Fentanyl Cit 50mcg/1ml Inj, 10ml
- Fentanyl Cit 100mcg/2ml Pf Inj, 2ml
- Fentanyl Cit 25mcg/0.5ml Pf Inj
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose for opioid-tolerant patients: 12 mcg/hr patch applied transdermally every 72 hours. Titrate dose based on analgesic response and tolerability.
Dose Range:
12 - 100 mg
Condition-Specific Dosing:
opioid_naive:
Contraindicated for opioid-naive patients due to risk of fatal respiratory depression.
conversion_from_oral_opioids:
Conversion from oral opioids requires careful calculation using equianalgesic tables and clinical judgment. Initial patch strength is typically 12 mcg/hr or 25 mcg/hr based on prior opioid dose.
dose_titration:
Dose may be increased no more frequently than every 3 days after the initial dose, and no more frequently than every 6 days thereafter, in increments of 12 mcg/hr or 25 mcg/hr.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 2 years of age. For children 2 years and older, only for opioid-tolerant patients, with careful titration and monitoring. Initial dose typically 12 mcg/hr.
Adolescent:
Similar to adult dosing for opioid-tolerant adolescents, with careful titration and monitoring.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor for signs of opioid toxicity.
Moderate:
Use with caution; monitor for signs of opioid toxicity. Consider lower initial doses and slower titration.
Severe:
Use with extreme caution; monitor for signs of opioid toxicity. Consider lower initial doses and slower titration. Accumulation of fentanyl and its metabolites may occur.
Dialysis:
Fentanyl is not dialyzable. Use with extreme caution; monitor for signs of opioid toxicity. Consider lower initial doses and slower titration.
Hepatic Impairment:
Mild:
Use with caution; monitor for signs of opioid toxicity.
Moderate:
Use with caution; monitor for signs of opioid toxicity. Consider lower initial doses and slower titration.
Severe:
Use with extreme caution; monitor for signs of opioid toxicity. Consider lower initial doses and slower titration. Accumulation of fentanyl and its metabolites may occur.
Pharmacology
Mechanism of Action
Fentanyl is a potent, synthetic opioid analgesic that primarily acts as an agonist at mu-opioid receptors in the central nervous system (CNS). Its primary therapeutic effects are analgesia and sedation. Activation of mu-opioid receptors leads to inhibition of ascending pain pathways, altering the perception of and response to pain. It also produces respiratory depression, miosis, euphoria, and physical dependence.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (transdermal absorption is slow and sustained)
Tmax:
24-72 hours (after initial application, steady state reached in 2-3 days)
FoodEffect:
Not applicable (transdermal)
Distribution:
Vd:
4 L/kg (high)
ProteinBinding:
80-85%
CnssPenetration:
Yes
Elimination:
HalfLife:
20-27 hours (terminal half-life after patch removal, due to skin depot effect)
Clearance:
Not available (highly variable)
ExcretionRoute:
Renal (75% as metabolites, <10% as unchanged drug), Fecal (9% as metabolites)
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
6-12 hours (after initial application)
PeakEffect:
24-72 hours (after initial application)
DurationOfAction:
72 hours (after patch application, but effects may persist for hours after removal due to skin depot)
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE; REMS; RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYP3A4 INTERACTION; and RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS.
* **Addiction, Abuse, and Misuse:** Fentanyl exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Fentanyl, and monitor all patients regularly for the development of these behaviors and conditions.
* **REMS:** To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a Risk Evaluation and Mitigation Strategy (REMS) for these products.
* **Respiratory Depression:** Serious, life-threatening, or fatal respiratory depression may occur with use of Fentanyl. Monitor for respiratory depression, especially during initiation of Fentanyl or following a dose increase.
* **Accidental Exposure:** Accidental exposure to even one dose of Fentanyl, especially in children, can result in a fatal overdose.
* **Neonatal Opioid Withdrawal Syndrome:** Prolonged use of Fentanyl during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
* **CYP3A4 Interaction:** Concomitant use of Fentanyl with all CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used CYP3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving Fentanyl and any CYP3A4 inhibitor or inducer.
* **Concomitant Use with Benzodiazepines or Other CNS Depressants:** Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
* **Addiction, Abuse, and Misuse:** Fentanyl exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Fentanyl, and monitor all patients regularly for the development of these behaviors and conditions.
* **REMS:** To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a Risk Evaluation and Mitigation Strategy (REMS) for these products.
* **Respiratory Depression:** Serious, life-threatening, or fatal respiratory depression may occur with use of Fentanyl. Monitor for respiratory depression, especially during initiation of Fentanyl or following a dose increase.
* **Accidental Exposure:** Accidental exposure to even one dose of Fentanyl, especially in children, can result in a fatal overdose.
* **Neonatal Opioid Withdrawal Syndrome:** Prolonged use of Fentanyl during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
* **CYP3A4 Interaction:** Concomitant use of Fentanyl with all CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used CYP3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving Fentanyl and any CYP3A4 inhibitor or inducer.
* **Concomitant Use with Benzodiazepines or Other CNS Depressants:** Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek 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 Rare but Serious Condition
If you take this medication with certain other drugs, you may be at risk of developing serotonin syndrome, a potentially life-threatening 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. Seek medical help immediately if you experience:
Extreme fatigue or weakness
Fainting
Severe dizziness
Upset stomach
Vomiting
Decreased appetite
Other Possible Side Effects
Like all medications, this drug may cause side effects in some people. While many individuals may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:
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
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or 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 Rare but Serious Condition
If you take this medication with certain other drugs, you may be at risk of developing serotonin syndrome, a potentially life-threatening 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. Seek medical help immediately if you experience:
Extreme fatigue or weakness
Fainting
Severe dizziness
Upset stomach
Vomiting
Decreased appetite
Other Possible Side Effects
Like all medications, this drug may cause side effects in some people. While many individuals may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:
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
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Extreme drowsiness or difficulty waking up
- Slow, shallow, or difficult breathing
- Bluish lips or fingernails
- Severe dizziness or lightheadedness
- Confusion
- Pinpoint pupils
- 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
Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, 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. 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
Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, or adjust the dosage of any medication without consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying 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 require higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose.
Additionally, long-term or 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 increase the risk of withdrawal or other severe problems. Follow your doctor's instructions carefully, and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.
Safe Use
Do not exceed the prescribed dose, frequency, or duration of treatment, as this can increase the risk of severe side effects. Avoid taking this medication with other strong pain medications or using a pain patch without consulting your doctor first.
If your pain worsens, you become more sensitive to pain, or you experience new pain after taking this medication, 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 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 like this one can lead to lower 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
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 crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying 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 require higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose.
Additionally, long-term or 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 increase the risk of withdrawal or other severe problems. Follow your doctor's instructions carefully, and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.
Safe Use
Do not exceed the prescribed dose, frequency, or duration of treatment, as this can increase the risk of severe side effects. Avoid taking this medication with other strong pain medications or using a pain patch without consulting your doctor first.
If your pain worsens, you become more sensitive to pain, or you experience new pain after taking this medication, 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 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 like this one can lead to lower 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
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:
- Slowed or stopped breathing
- Extreme drowsiness or inability to wake up
- Limp muscles
- Cold, clammy skin
- Pinpoint pupils
- Slowed heartbeat
- Severe low blood pressure
- Coma
What to Do:
Seek immediate emergency medical attention. Call 911 or your local emergency number. Administer naloxone if available and trained to do so. Stay with the person until emergency help arrives. Call 1-800-222-1222 for Poison Control.
Drug Interactions
Contraindicated Interactions
- CYP3A4 inhibitors (strong and moderate) - concurrent use can increase fentanyl plasma concentrations, leading to increased opioid effects, including fatal respiratory depression.
- Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, alcohol) - concurrent use can result in profound sedation, respiratory depression, coma, and death.
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use within 14 days can result in severe, unpredictable, and potentially fatal reactions (e.g., serotonin syndrome, respiratory depression, coma).
Major Interactions
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol) - 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.
- Partial agonist opioids (e.g., buprenorphine) - may reduce the analgesic effect of fentanyl and/or precipitate withdrawal symptoms.
- Diuretics - opioids can reduce the efficacy of diuretics by causing the release of antidiuretic hormone.
- Anticholinergics - increased risk of urinary retention and/or severe constipation.
Moderate Interactions
- Antihypertensives - enhanced hypotensive effect.
- Muscle relaxants - enhanced neuromuscular blocking effects and increased risk of respiratory depression.
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) - may decrease fentanyl plasma concentrations, leading to reduced efficacy and potential withdrawal symptoms.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Pain assessment (intensity, quality, location)
Rationale: To establish baseline pain level and guide initial dosing/titration.
Timing: Prior to initiation and at each dose adjustment.
Respiratory rate and depth
Rationale: To assess baseline respiratory function and identify risk for respiratory depression.
Timing: Prior to initiation.
Level of consciousness/sedation
Rationale: To assess baseline mental status and identify risk for excessive sedation.
Timing: Prior to initiation.
Blood pressure and heart rate
Rationale: To assess baseline cardiovascular status.
Timing: Prior to initiation.
Opioid tolerance status
Rationale: Fentanyl patch is only for opioid-tolerant patients. Essential to confirm prior opioid use and equivalent daily dose.
Timing: Prior to initiation.
Concomitant medications (especially CNS depressants, CYP3A4 inhibitors)
Rationale: To identify potential drug interactions that increase risk of adverse effects.
Timing: Prior to initiation.
Routine Monitoring
Pain assessment
Frequency: Regularly, especially during titration and with any change in clinical status (e.g., daily, or as needed).
Target: Acceptable pain control with minimal side effects.
Action Threshold: Uncontrolled pain or excessive side effects warrant dose adjustment or alternative therapy.
Respiratory rate and depth
Frequency: Frequently during initiation and titration (e.g., every 2-4 hours for first 24 hours, then daily or as needed).
Target: Normal for patient (e.g., >10-12 breaths/min, unlabored).
Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or signs of hypoventilation (e.g., cyanosis, somnolence) require immediate intervention (e.g., naloxone, respiratory support).
Level of consciousness/sedation (e.g., Pasero Opioid-Induced Sedation Scale)
Frequency: Frequently during initiation and titration (e.g., every 2-4 hours for first 24 hours, then daily or as needed).
Target: Alert or mildly drowsy, easily aroused.
Action Threshold: Difficult to arouse, somnolent, or unarousable requires immediate intervention.
Signs of opioid toxicity (e.g., miosis, constipation, nausea, vomiting, pruritus)
Frequency: Daily or as needed.
Target: Minimal or manageable side effects.
Action Threshold: Severe or unmanageable side effects warrant dose reduction or discontinuation.
Patch adhesion and skin integrity at application site
Frequency: Daily or with each patch change.
Target: Patch remains securely adhered; no significant skin irritation.
Action Threshold: Poor adhesion, detachment, or severe skin irritation requires reapplication to a new site or consideration of alternative therapy.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation/somnolence
- Dizziness
- Confusion
- Nausea
- Vomiting
- Constipation
- Pruritus (itching)
- Miosis (pinpoint pupils)
- Hypotension
- Bradycardia
- Signs of opioid withdrawal (if abruptly discontinued or dose reduced too quickly)
- Signs of serotonin syndrome (agitation, hallucinations, tachycardia, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
Special Patient Groups
Pregnancy
Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for congenital malformations with opioid exposure. Risk generally considered low for specific malformations, but overall risk of adverse pregnancy outcomes may be increased.
Second Trimester:
Risk of NOWS increases with prolonged exposure. Monitor for signs of fetal distress.
Third Trimester:
High risk of NOWS if used chronically. Risk of respiratory depression in the neonate if used close to delivery. Avoid use during labor and delivery.
Lactation
Fentanyl is excreted into breast milk. Infants exposed through breast milk are at risk for serious adverse reactions, including excess sedation and respiratory depression. Breastfeeding is not recommended during treatment with fentanyl transdermal patches.
Infant Risk:
L3 (Moderate risk) - Potential for serious adverse effects in the infant. Monitor infants for signs of sedation, respiratory depression, and poor feeding. Consider alternative pain management or formula feeding.
Pediatric Use
Fentanyl transdermal patches are only indicated for opioid-tolerant pediatric patients 2 years of age and older. Due to the risk of fatal respiratory depression, it is contraindicated in opioid-naive pediatric patients. Extreme caution and careful titration are required. Accidental exposure in children can be fatal.
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 sedation. Consider age-related decreases in renal and hepatic function.
Clinical Information
Clinical Pearls
- Fentanyl transdermal patch is NOT for acute pain, post-operative pain, or opioid-naive patients. It is for chronic, severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia.
- Proper disposal is critical: fold sticky sides together and flush down the toilet immediately after removal to prevent accidental exposure to children or pets.
- Avoid external heat sources (e.g., heating pads, hot baths, fever) on or near the patch application site, as this can significantly increase fentanyl absorption and lead to overdose.
- Patients should be stable on their opioid regimen before converting to fentanyl patch. Conversion calculations must be done carefully, and patients monitored closely for the first 24-72 hours.
- Respiratory depression is the most serious adverse effect. Educate patients and caregivers on signs of overdose and the importance of immediate medical attention.
- The patch continues to release fentanyl for several hours after removal due to a skin depot effect. Monitor for continued opioid effects after patch removal.
- Rotate application sites to minimize skin irritation. Apply to a clean, dry, non-hairy area of the torso or upper arm.
Alternative Therapies
- Other long-acting opioid analgesics (e.g., extended-release morphine, extended-release oxycodone, methadone, hydromorphone ER)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin, tricyclic antidepressants) for neuropathic pain components or as adjuncts.
- Interventional pain management techniques (e.g., nerve blocks, spinal cord stimulation)
- Physical therapy, occupational therapy, psychological therapies (e.g., CBT) for chronic pain management.
Cost & Coverage
Average Cost:
Varies widely by strength and quantity (e.g., $100-$500+) per 5 patches
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization due to opioid class and cost)
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 obtaining and using naloxone with your doctor or pharmacist. If an overdose is suspected, 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 it. Discuss obtaining and using naloxone with your doctor or pharmacist. If an overdose is suspected, 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.