- Side Effects
- Drug Interactions
- Warnings and Precautions
Brand Name: Duragesic
Drug Class: Opioid Analgesics
What Is Fentanyl Transdermal and How Does It Work?
Fentanyl Transdermal is a prescription medication used to treat Chronic Severe Pain.
- Fentanyl Transdermal is available under the following different brand names: Duragesic.
What Are Dosages of Fentanyl Transdermal?
Transdermal patch: Schedule II
Chronic Severe Pain
- Discontinue or taper all other extended-release opioids when beginning Fentanyl transdermal therapy
- 25-100 mcg/hr, reapplied every 72 hours until adequate analgesia is achieved
Dosage Considerations – Should be Given as Follows:
- See “Dosages”.
What Are Side Effects Associated with Using Fentanyl Transdermal?
Common side effects of Fentanyl Transdermal include:
- stomach pain,
- itching, redness, or rash where the patch was worn,
- sleep problems (insomnia),
- increased sweating, and
- cold feeling
Serious side effects of Fentanyl Transdermal include:
- chest pain,
- difficulty breathing,
- swelling of the face, lips, tongue, or throat,
- slow breathing with long pauses,
- blue colored lips,
- difficult to wake up,
- slow heart rate,
- weak or shallow breathing,
- breathing that stops during sleep,
- severe drowsiness,
- chest pain,
- fast or pounding heartbeats,
- loss of appetite,
- worsening tiredness,
- fast heart rate,
- muscle stiffness,
- loss of coordination, and
Rare side effects of Fentanyl Transdermal include:
What Other Drugs Interact with Fentanyl Transdermal?
If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.
- Fentanyl Transdermal has severe interactions with the following drugs:
- Fentanyl Transdermal has serious interactions with at least 141 other drugs.
- Fentanyl Transdermal has moderate interactions with at least 84 other drugs.
- Fentanyl Transdermal has minor interactions with no other drugs.
This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drugs interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.
What are warnings and precautions for Fentanyl Transdermal?
- Hypersensitivity to drug or components of the formulation
- Known or suspected gastrointestinal obstruction, including paralytic ileus
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or the absence of resuscitative equipment
- Within 2 weeks of monoamine oxidase inhibitor (MAOI) therapy
- Management of postoperative, mild, or intermittent pain
- Opioid-naive or non-opioid-tolerant patients
Effects of drug abuse
- See “What Are Side Effects Associated with Using Fentanyl Transdermal?”
- See “What Are Side Effects Associated with Using Fentanyl Transdermal?”
- Use caution in acute pancreatitis, Addison disease, benign prostatic hyperplasia, cardiac arrhythmias, central nervous system (CNS) depression, drug abuse or dependence, emotional lability, gallbladder disease, gastrointestinal (GI) disorder, pseudomembranous colitis, GI surgery, head injury, hypothyroidism or untreated myxedema, intracranial hypertension, brain tumor, toxic psychosis, urethral stricture, urinary tract surgery, seizures, acute alcoholism, delirium tremens, shock, cor pulmonale, chronic pulmonary disease, emphysema, hypercapnia, kyphoscoliosis, severe obesity, renal or hepatic impairment, elderly or debilitated patients
- Increased risk of potentially fatal respiratory depression, pruritus (despite little histamine release), and abuse or addiction
- May impair physical or mental abilities; use caution when operating machinery or driving
- Schedule II opioid analgesics expose users to the risks of addiction, abuse, and misuse; there is a greater risk for overdose and death with extended-release opioids due to the larger amount of active opioids present (see Black Box Warnings); addiction can occur at recommended dosages and if the drug is misused or abused
- Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia; opioid use increases the risk of CSA in a dose-dependent fashion; in patients who present with CSA, consider decreasing opioid dosage using best practices for opioid taper
- Severe hypotension may occur including orthostatic hypotension and syncope in ambulatory patients; there is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (eg, phenothiazines or general anesthetics); monitor patients for signs of hypotension after initiating or titrating dosage; in patients with circulatory shock, therapy may cause vasodilation that can further reduce cardiac output and blood pressure; avoid therapy in patients with circulatory shock
- In patients who may be susceptible to intracranial effects of CO2 retention (eg, those with evidence of increased intracranial pressure or brain tumors), therapy may reduce respiratory drive, and resultant CO2 retention can further increase intracranial pressure; monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy; opioids may obscure the clinical course in a patient with a head injury; avoid the use in patients with impaired consciousness or coma
- Addiction, abuse, and misuse risks are increased in patients with a personal or family history of substance abuse or mental illness (eg, major depression); the potential for these risks should not, however, prevent the prescribing of proper pain management in any given patient; intensive monitoring is necessary (see Black Box Warnings)
- Contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus; may cause spasm of the sphincter of Oddi; opioids may cause increases in serum amylase; monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms
- Serious, life-threatening, or fatal respiratory depression was reported (see Black Box Warnings)
- Accidental exposure was reported, including fatalities (see Black Box Warnings)
- Bradycardia may occur; monitor patients with bradyarrhythmias closely for changes in heart rate, particularly when initiating therapy
- Therapy may increase the frequency of seizures in patients with seizure disorders and other clinical settings associated with seizures; monitor patients for worsened seizure control during therapy
- Do not abruptly discontinue buprenorphine in a patient physically dependent on opioids; when discontinuing therapy, in a physically dependent patient, gradually taper the dosage; rapid tapering in a patient physically dependent on opioids may lead to a withdrawal syndrome and return of pain
- Neonatal opioid withdrawal syndrome reported with long-term use during pregnancy (see Black Box Warnings)
- Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients
- While serious, life-threatening, or fatal respiratory depression can occur at any time during therapy, the risk is greatest during initiation of therapy or following dosage increase; monitor patients closely for respiratory depression, especially within the first 24-72 hr of initiating therapy with and following dosage increases; accidental ingestion of even one dose, especially by children, can result in respiratory depression and death due to overdose of opioid
- Deaths have occurred in nursing infants exposed to high levels of opioids in breast milk because mothers were ultra-rapid metabolizers of opioids (see Lactation)
- Cases of adrenal insufficiency reported with opioid use, more often following greater than one month of use; symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure; if adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids; wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers; other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency
- Use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and concomitant disease or other drug therapy; because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and may be useful to monitor renal function
- Opioid pharmacokinetics may be altered in patients with renal failure; clearance may be decreased and metabolites may accumulate much higher plasma levels in patients with renal failure as compared to patients with normal renal function; start with a lower than normal dosage or with longer dosing intervals and titrate slowly while monitoring for signs of respiratory depression, sedation, and hypotension
Opioid analgesic risk evaluation and mitigation strategy (REMS)
- To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products
- Discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and/or their caregivers every time these medicines are prescribed; use the following link to obtain the Patient Counseling Guide (PCG): www.fda.gov/OpioidAnalgesicREMSPCG
- Emphasize to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an opioid analgesic is dispensed to them
- Consider using other tools to improve patient, household, and community safety, such as patient-prescriber agreements that reinforce patient-prescriber responsibilities
- To obtain further information on opioid analgesic REMS and for a list of accredited REMS CME/CE, call 1-800-503-0784, or log on to www.opioidanalgesicrems.com; the FDA Blueprint can be found at www.fda.gov/OpioidAnalgesicREMSBlueprint
- Assess potential need for naloxone; consider prescribing for emergency treatment of opioid overdose
- Consult on availability and ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines
- Educate patients regarding the signs and symptoms of respiratory depression and to call 911 or seek immediate emergency medical help in the event of a known or suspected overdose
Drug interactions overview
- Also, see Black Box Warnings
- Profound sedation, respiratory depression, coma, and death may result from concomitant administration with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol); because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate; if concomitant use with benzodiazepine or muscle relaxant warranted, consider prescribing naloxone for emergency treatment of opioid overdose
- Coadministration with anticholinergic drugs may increase the risk of urinary retention and/or severe constipation, which may lead to paralytic ileus
- Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone
- Monoamine oxidase inhibitors (MAOIs) may potentiate effects of opioid, opioid’s active metabolite, including respiratory depression, coma, and confusion; therapy should not be administered within 14 days of initiating or stopping MAOIs
- Cases of serotonin syndrome, a potentially life-threatening condition, reported with concomitant use of serotonergic drugs; this may occur within the recommended dosage range; the onset of symptoms generally occurs within several hours to a few days of concomitant use, but may occur later than that; discontinue therapy immediately if serotonin syndrome is suspected
- Avoid the use of mixed agonist/antagonist (eg, pentazocine, nalbuphine, and butorphanol) or partial agonist (eg, buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic; mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms; when discontinuing therapy in a physically-dependent patient, gradually taper dosage; do not abruptly discontinue therapy in these patients
- Concomitant use with a CYP3A4 inhibitor, such as macrolide antibiotics (eg, erythromycin), azole-antifungal agents (eg, ketoconazole), and protease inhibitors (eg, ritonavir), may increase plasma concentrations of fentanyl and prolong opioid adverse reactions, which may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of fentanyl injection is achieved; similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in fentanyl-injection treated patients may increase fentanyl plasma concentrations and prolong opioid adverse reactions; when using fentanyl Injection with CYP3A4 inhibitors or discontinuing CYP3A4 inducers in fentanyl-Injection treated patients, monitor patients closely at frequent intervals and consider dosage reduction of fentanyl injection until stable drug effects are achieved
- Concomitant use of fentanyl injection with CYP3A4 inducers or discontinuation of a CYP3A4 inhibitor could decrease fentanyl plasma concentrations, decrease opioid efficacy or, possibly, lead to a withdrawal syndrome in a patient who had developed physical dependence to fentanyl; when using fentanyl injection with CYP3A4 inducers or discontinuing CYP3A4 inhibitors, monitor patients closely at frequent intervals and consider increasing opioid dosage if needed to maintain adequate analgesia or if symptoms of opioid withdrawal occur
- Interactions with CNS depressants (eg, alcohol, sedatives, anxiolytics, hypnotics, neuroleptics, other opioids) can cause additive effects and increase the risk for respiratory depression, profound sedation, and hypotension
Pregnancy and Lactation
- Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth; observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly; opioids cross the placenta and may produce respiratory depression and psychophysiological effects in neonates; an opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate; opioid sulfate is not recommended for use in pregnant women during or immediately before labor when other analgesic techniques are more appropriate; opioid analgesics can prolong labor through actions which temporarily reduce strength, duration, and frequency of uterine contractions
- Due to the effects of androgen deficiency, chronic use of opioids may cause reduced fertility in females and males of reproductive potential; it is not known whether effects on fertility are reversible
- An opioid is secreted into human milk; in women with normal opioid metabolism (normal CYP2D6 activity), the amount of opioid secreted into human milk is low and dose-dependent; some women are ultra-rapid metabolizers of opioids; these women achieve higher-than-expected serum levels of opioid's active metabolite, opioid, leading to higher-than-expected levels of opioid in breast milk and potentially dangerously high serum opioid levels in their breastfed infants that can potentially lead to serious adverse reactions, including death, in nursing infants
- Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from therapy or underlying maternal condition