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fentanyl transdermal (Rx)Brand and Other Names:Duragesic

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

transdermal patch: Schedule II

  • 12.5mcg/hr
  • 25mcg/hr
  • 50mcg/hr
  • 75mcg/hr
  • 100mcg/hr
more...

Chronic Severe Pain

Indicated for chronic pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate

25-100 mcg/hr, reapplied q72hr until adequate analgesia is achieved

Refer to opioid conversion table in prescribing information

Opioid-tolerant definition

  • Patients who are opioid tolerant are those receiving, for 1 week or longer, at least 60 mg/day PO morphine, 30 mg/day PO oxycodone, 8 mg/day PO hydromorphone, 25 mg/day PO oxymorphone, or an equianalgesic dose of another opioid

Limitations of use

  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve for patients whom alternative treatment options (eg, nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain

Dosing Considerations

Not for use in acute pain or as PRN analgesic

Conversion to transdermal patch: Estimate daily PO morphine equivalent, then decrease by 25-50% to select initial patch; also supply PO opioid for breakthrough pain during transition to patch and titration

Discontinue all other around-the-clock opioid drugs when initiating the fentanyl patch

Initial dose may be approximated from the 24 hr morphine dosage equivalent; titrate to minimize effects; replace patch every 3 days

Patients with adequate relief with a fentanyl infusion may be converted  to transdermal dosing at a rate equivalent to intravenous rate

Dosage should not be titrated more frequently than 3 days after the initial dose or every 6 days thereafter; patient should wear a consistent fentanyl dosage patch through two applications (6 days) before dosage increase based on supplemental opioid dosages can be estimated

Most patients may be controlled on every 72 hr administration; a minority of patients may require every 48hr administration

Dosage Forms & Strengths

transdermal patch: Schedule II

  • 12.5mcg/hr
  • 25mcg/hr
  • 50mcg/hr
  • 75mcg/hr
  • 100mcg/hr
more...

Chronic Pain (Off-label)

Treatment of chronic pain in children who are opioid-tolerant and receiving ≥60 mg/day PO of morphine or equivalent

<2 years: Safety not established

≥2 years: 25-100 mcg/hr, reapplied q72hr until adequate analgesia is achieved

Dosing considerations

  • Not for use in acute pain or as PRN analgesic
  • Conversion to transdermal patch: Estimate daily PO morphine equivalent, then decrease by 25-50% to select initial patch; also supply PO opioid for breakthrough pain during transition to patch and titration
  • Discontinue all other around-the-clock opioid drugs when initiating the fentanyl patch
  • Initial dose may be approximated from the 24 hr morphine dosage equivalent; titrate to minimize effects; replace patch every 3 days
  • Patients with adequate relief with a fentanyl infusion may be converted to transdermal dosing at a rate equivalent to intravenous rate
  • Dosage should not be titrated more frequently than 3 days after the initial dose or every 6 days thereafter; patient should wear a consistent fentanyl dosage patch through two applications (6 days) before dosage increase based on supplemental opioid dosages can be estimated
  • Most patients may be controlled on every 72 hr administration; a minority of patients may require every 48hr administration
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Interactions

Interaction Checker

fentanyl transdermal and

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Asthenia

            Confusion

            Constipation

            Dry mouth

            Nausea

            Somnolence

            Sweating

            Vomiting

            Abdominal pain

            Anorexia

            Anxiety

            Apnea

            Depression

            Diarrhea

            Dizziness

            Dyspepsia

            Dyspnea

            Euphoria

            Fatigue

            Hallucinations

            Headache

            Hemoptysis

            Hypoventilation

            Influenzalike symptoms

            Nervousness

            Pharyngitis

            Pruritus

            Upper respiratory tract infection Urinary retention

            Abnormal coordination, thinking, gait, dreams

            Accidental injury

            Agitation

            Amnesia

            Angina pectoris

            Application-site reaction

            Back pain

            Bradycardia

            Bronchitis

            Cardiac arrest, ST-segment elevation

            Coma

            Dysphoria

            Faintness

            Fever

            Flatulence

            Flushing

            Hiccups

            Mental clouding

            Micturition disorder

            Myocardial infarction

            Oliguria

            Paranoid reaction

            Paresthesia

            Rash

            Respiratory arrest

            Respiratory/circulatory depression

            Rhinitis

            Sedation

            Seizures

            Severe cardiac arrhythmias

            Shock

            Sinusitis

            Speech disorder

            Syncope

            Tremor

            Urinary retention

            Ventricular tachycardia

            Visual disturbances

            Warmness of face/neck/upper thorax, urticaria

            Weakness

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            Warnings

            Black Box Warnings

            Addiction, abuse, and misuse

            • Risk of opioid addiction, abuse, and misuse, which can lead to overdose and death
            • Assess each patient’s risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions

            Life-threatening respiratory depression

            • Serious, life-threatening, or fatal respiratory depression may occur
            • Monitor for respiratory depression, especially during initiation or following a dose increase
            • Instruct patients to swallow tablet/capsule whole; crushing, chewing, or dissolving can cause rapid release and absorption of a potentially fatal dose

            Accidental exposure

            • Accidental of even 1 dose, especially by children, can result in a fatal overdose

            Neonatal opioid withdrawal syndrome

            • Prolonged use 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
            • Syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight
            • Onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn
            • 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 inhibitors

            • Concomitant use of transdermal fentanyl with all cytochrome CYP450 3A4 inhibitors (ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, verapamil) may result in increased fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression
            • Patients receiving fentanyl transdermally and any CYP34A inhibitors should be carefully monitored for extended period, and dosage adjustments should be made if warranted

            Exposure to heat

            • Exposure of the application site and surrounding area to direct external heat sources (eg, heating pads or electric blankets, heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds) may increase fentanyl absorption and has resulted in fatal overdose of fentanyl and death
            • Patients wearing a fentanyl patch who develop fever or increased core body temperature due to strenuous exertion are also at risk for increased fentanyl exposure and may require an adjustment in the dose to avoid overdose and death

            Contraindications

            Hypersensitivity

            Toxin-mediated diarrhea (until toxins are cleared), paralytic ileus, respiratory depression, acute or severe bronchial asthma

            Within 2 weeks of monoamine oxidase inhibitor (MAOI) therapy

            Management of postoperative, mild, or intermittent pain

            Opioid-naive or non-opioid-tolerant patients

            Cautions

            Use caution in acute pancreatitis, Addison disease, benign prostatic hyperplasia, cardiac arrhythmias, central nervpous 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

            Not recommended wihtin 14 days of MAO inhibitor intake

            Only apply to intact skin

            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 opioid present (see Black Box Warnings)

            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)

            Serious, life-threatening, or fatal respiratory depression reported (see Black Box Warnings)

            Accidental exposure reported, including fatalities (see Black Box Warnings)

            Neonatal opioid withdrawal syndrome reported with long-term use during pregnancy (see Black Box Warnings)

            Interactions with CNS depressants (eg, alcohol, sedatives, anxiolytics, hypnotics, neuroleptics, other opioids) can cause additive effects and increase risk for respiratory depression, profound sedation, and hypotension

            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

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Drug distributed in breast milk; breastfeeding not recommended

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Narcotic agonist-analgesic of opiate receptors; inhibits ascending pain pathways; alters pain perception, thus altering response to pain; produces analgesia, respiratory depression, and sedation

            Absorption

            After patch removal, continued systemic absorption occurs from residual fentanyl in skin, so that serum concentrations fall by average of 50% in ~20-27 hr

            Onset: 6 hr

            Duration: 72-96 hr

            Peak plasma time: 28.8-35.8 hr (dose dependent; following first application)

            Peak plasma concentration: 0.38-3.36 ng/mL (dose dependent; following first application)

            Distribution

            Vd: 4-6 L/kg

            Protein binding: 80-85%

            Metabolism

            Metabolized in liver by CYP3A4

            Elimination

            Half-life: 20-27 hr

            Excretion: Urine (75% mostly as metabolites), feces (9% as metabolites)

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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