Fentanyl 75mcg/hr Patch

Fentanyl is a potent, synthetic opioid analgesic that primarily acts as an agonist at the mu-opioid receptors in the central nervous system (CNS). Its analgesic effects are mediated through binding to these receptors, leading to inhibition of pain pathways, altered perception of pain, and depression of the respiratory center.

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 immediate medical attention:

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 indicate a severe bowel problem
Trouble breathing, slow breathing, or shallow breathing
Noisy breathing
Breathing problems during sleep (sleep apnea)
Chest pain
Fast or slow heartbeat
Seizures
Depression
Trouble controlling body movements
Swelling in the arms or legs
Change in eyesight

Serotonin Syndrome: A Potentially Life-Threatening Condition

If you take this medication with certain other drugs, you may be at risk for a severe and potentially deadly condition called serotonin syndrome. Seek medical help immediately if you experience:

Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Sweating a lot
Severe diarrhea
Upset stomach
Throwing up
Severe headache

Adrenal Gland Problem: A Rare but Serious Condition

Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Contact your doctor right away if you experience:

Feeling very tired or weak
Passing out
Severe dizziness
Very upset stomach
Throwing up
Decreased appetite

Other Possible Side Effects

Like all medications, this drug may cause side effects in some people. While many individuals may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

Feeling dizzy, sleepy, tired, or weak
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Throwing up
Decreased appetite
Headache
Feeling cold
Trouble sleeping
Sweating a lot
* Irritation where the medication was administered

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

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 blockage 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

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your existing treatments and health status. Never start, stop, or adjust the dosage of any medication without consulting your doctor.

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
Avoid driving and engaging in activities 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 down 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. Suddenly stopping or reducing the dose may increase the risk of withdrawal or other severe problems. Consult your doctor before changing your dose or stopping the medication, and follow their instructions carefully. Monitor for signs of withdrawal, increased pain, mood changes, suicidal thoughts, or other adverse effects, and report them to your doctor.

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 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 cause unsafe and potentially fatal effects.

Seizure Risk
This medication may increase the risk of seizures, particularly in individuals 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 decrease in libido, fertility problems, irregular menstrual periods, or ejaculation difficulties, 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 excessively sleepy, limp, or has breathing difficulties.

• CYP3A4 inhibitors (strong, e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, saquinavir, troleandomycin, voriconazole)
• Benzodiazepines and other CNS depressants (unless benefits outweigh risks and patient is closely monitored)
• Alcohol
• Monoamine Oxidase Inhibitors (MAOIs) (within 14 days)

• Other CNS depressants (e.g., sedatives, hypnotics, anxiolytics, general anesthetics, phenothiazines, skeletal muscle relaxants, other opioids, gabapentinoids): Increased risk of respiratory depression, profound sedation, coma, and death.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol): Risk of serotonin syndrome.
• Mixed agonist/antagonist opioids (e.g., buprenorphine, nalbuphine, pentazocine): May precipitate withdrawal symptoms or reduce analgesic effect.
• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): May decrease fentanyl plasma concentrations, leading to reduced efficacy and potential withdrawal.

• Anticholinergic drugs: Increased risk of urinary retention and/or severe constipation.
• Diuretics: Opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.

• Not available

• Respiratory depression (slow, shallow breathing, cyanosis)
• Excessive sedation/somnolence
• Dizziness, lightheadedness
• Nausea, vomiting
• Constipation
• Pruritus (itching)
• Confusion, disorientation
• Miosis (pinpoint pupils)
• Signs of opioid withdrawal (if abruptly discontinued or dose reduced too quickly)
• Signs of serotonin syndrome (agitation, hallucinations, tachycardia, fever, sweating, muscle rigidity, tremor, incoordination, nausea, vomiting, diarrhea)

Use during pregnancy is generally not recommended unless 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.

Fentanyl is excreted into breast milk. Breastfeeding is generally not recommended while using fentanyl transdermal due to the risk of serious adverse reactions in the infant, including sedation, respiratory depression, and death. If breastfeeding is considered essential, monitor the infant closely for signs of sedation and respiratory depression.

Contraindicated in children under 2 years of age. For children 2 years and older, only for opioid-tolerant patients with chronic severe pain, and only if the child weighs at least 30 kg. Extreme caution and careful dose titration are required due to increased risk of respiratory depression, especially in smaller children or those not truly opioid-tolerant.

Use with caution. Elderly patients may be more sensitive to the effects of fentanyl, particularly respiratory depression, due to decreased hepatic and renal function, and reduced lean body mass. Start with lower doses and titrate slowly. Monitor closely for adverse effects.

• 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.
• Ensure proper patient selection and thorough opioid conversion calculations to avoid overdose or under-dosing.
• Educate patients and caregivers extensively on proper patch application, removal, and disposal (fold adhesive sides together and flush down toilet or use drug take-back program).
• Emphasize the danger of heat exposure to the patch, which can significantly increase fentanyl absorption.
• Always have naloxone readily available for patients prescribed fentanyl transdermal, and educate patients/caregivers on its use.
• Monitor for signs of respiratory depression and excessive sedation, especially during initiation and dose titration.
• Be aware of the prolonged half-life due to the skin depot; effects can persist for hours after patch removal.
• Consider the potential for drug accumulation in patients with hepatic or renal impairment.
• Counsel patients on the risks of addiction, abuse, and misuse, and the importance of safe storage.

• Other long-acting opioid analgesics (e.g., extended-release oxycodone, extended-release morphine, methadone, extended-release hydromorphone)
• Non-opioid analgesics (e.g., NSAIDs, acetaminophen, gabapentinoids, tricyclic antidepressants) for neuropathic pain components
• Interventional pain management techniques (e.g., nerve blocks, spinal cord stimulation)
• Physical therapy, occupational therapy, psychological therapies (e.g., CBT) for chronic pain management

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. 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, which provides crucial information about its use. It is essential 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 for clarification.

In the event of an overdose, a medication called naloxone can be used as part of the treatment. 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. When seeking help, be prepared to provide information about what was taken, the amount, and the time it happened.

In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. Be prepared to provide details about the medication, including the dose and timing of the overdose, to ensure you receive appropriate treatment.