fentanyl (Rx)

Brand and Other Names:Sublimaze
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

injection solution: Schedule II

  • 0.05mg/mL
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Surgery Premedication

50-100 mcg/dose IM or slow IV 30-60 min prior to surgery

Adjunct to regional anesthesia: 25-100 mcg/dose slow IV over 1-2 min

General Anesthesia

Minor surgical procedures: 0.5-2 mcg/kg/dose IV

Major surgery: 2-20 mcg/kg/dose initially; 1-2 mcg/kg/hr maintenance infusion IV; discontinue infusion 30-60 min prior to end of surgery; limit total fentanyl doses to 10-15 mcg/kg for fast tracking and early extubation

Adjunct to general anesthesia (rarely used): 20-50 mcg/kg/dose IV

Analgesia (Off-label)

Analgesia: 1-2 mcg/kg IV bolus or 25-100 mcg/dose PRN or 1-2 mcg/kg/hr by continuous IV infusion or 25-200 mcg/hr 

Severe pain: 50-100 mcg/dose IV/IM q1-2hr PRN (patients with prior opioid exposure may tolerate higher initial doses)

Patient controlled anesthesia (PCA): 10 mcg/mL IV (usual concentration); 20 mcg demand dose with 5-10 min lockout time interval and base rate of ≤50mcg/hr

Dosage Forms & Strengths

injection solution: Schedule II

  • 0.05mg/mL
more...

Surgery Premedication (Off-label)

1-12 years: 0.5-2 mcg/kg IV given 3 min prior to procedure; may repeat q1-2hr 

>12 years: 0.5-2 mcg/kg/dose; not to exceed 50 mcg/dose; give 3 min prior to procedure; may repeate in 5 min if necessary; if more than two doses needed, may repeat up to 5 times at 25 mcg/dose maximum

Continuous Sedation/Analgesia

0.5-2 mcg/kg/hr; titrate to desired effect

Adjunct Anesthesia

<2 years: Safety and efficacy not established

>2 years: 2-3 mcg/kg IV/IM q1-2hr PRN 

Elderly patients are twice as sensitive to effects of fentanyl as young patients are; take into account weight and physical status when administering the drug

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Interactions

Interaction Checker

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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

            Coma

            Dysphoria

            Faintness

            Fever

            Flatulence

            Flushing

            Hiccups

            Mental clouding

            Micturition disorder

            Myocardial infarction (MI)

            Oliguria

            Paranoid reaction

            Paresthesia

            QT-interval prolongation

            Rash

            Respiratory arrest

            Respiratory/circulatory depression

            Rhinitis

            Sedation

            Seizures

            Severe cardiac arrhythmias

            Shock Sinusitis

            Speech disorder

            ST-segment elevation

            Sweating

            Syncope

            Tremor

            Urinary retention

            Ventricular tachycardia

            Visual disturbances

            Warmness of face/neck/upper thorax, urticaria

            Weakness

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            Warnings

            Black Box Warnings

            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

            Accidental ingestion

            • Accidental ingestion 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
            • 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

            Risks from 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; reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to minimum required; follow patients for signs and symptoms of respiratory depression and sedation

            Contraindications

            Significant respiratory depression

            Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment

            Known or suspected gastrointestinal obstruction, including paralytic ileus

            Hypersensitivity to drug or components of the formulation

            Within 2 weeks of monoamine oxidase inhibitor (MAOI) use

            Cautions

            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

            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 occur within several hours to a few days of concomitant use, but may occur later than that; discontinue therapy immediately if serotonin syndrome is suspected

            Therapy may cause severe hypotension 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 (e.g., 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 (e.g., 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 clinical course in a patient with a head injury; avoid the use in patients with impaired consciousness or coma

            Contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus; may cause spasm of sphincter of Oddi; opioids may cause increases in serum amylase; monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms

            Therapy may increase frequency of seizures in patients with seizure disorders and in other clinical settings associated with seizures; monitor patients for worsened seizure control during therapy

            Avoid use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic; mixed agonist/antagonist and partial agonist analgesics may reduce analgesic effect and/or precipitate withdrawal symptoms; when discontinuing therapy in physically-dependent patient, gradually taper dosage; do not abruptly discontinue therapy in these patients

            Warn patients not to drive or operate dangerous machinery unless they are tolerant to effects of drug and know how they will react to medication

            While serious, life-threatening, or fatal respiratory depression can occur at any time during therapy, risk is greatest during initiation of therapy or following dosage increase; monitor patients closely for respiratory depression, especially within first 24 to 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

            Concomitant use with a CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., 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

            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; reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to minimum required; follow patients for signs and symptoms of respiratory depression and sedation

            Profound sedation, respiratory depression, coma, and death may result from concomitant administration with benzodiazepines or other CNS depressants (e.g., 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

            Use in patients with acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment is contraindicated; patients with significant chronic obstructive pulmonary disease or cor pulmonale, and with substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages

            Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients; monitor closely

            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 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 patient off of 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 dosage for an elderly patient, usually starting at low end of dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function and of 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

            Risks of potentially fatal respiratory depression, pruritus (despite little histamine release), and abuse or addiction

            May produce bradycardia, which may be treated with atropine

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            Pregnancy & Lactation

            Pregnancy

            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 placenta and may produce respiratory depression and psycho-physiologic 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 prior to 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

            Fertility

            • Due to 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

            Lactation

            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 opioid; 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 mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

            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.

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            Pharmacology

            Mechanism of Action

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

            Absorption

            Bioavailability: 50%

            Onset: IV, immediate; IM, 7-15 min

            Duration: IV, 0.5-1 hr; IM, 1-2 hr

            Peak plasma time: IV (≤100 mcg), 30-60 min; IM, 1-2 hr

            Concentration: 0.2-2 ng/mL (adverse effects occur at >2 ng/mL) 

            Distribution

            Protein bound: 80-85%

            Vd: 4-6 L/kg 

            Metabolism

            Metabolized in liver by CYP3A4 

            Elimination

            Half-life: 2-4 hr

            Total plasma clearance: 8.3 mL/min/kg

            Excretion: Urine (75%), feces (9%) 

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            Administration

            IV Incompatibilities

            Additive: Fluorouracil, lidocaine(?), methohexital, pentobarbital, thiopental

            Syringe: Methohexital, pentobarbital, thiopental

            Y-site: Azithromycin, methohexital(?), phenytoin, pentobarbital(?), thiopental(?)

            IV Compatibilities

            Solution: D5W, NS

            Additive: Bupivacaine, bupivacaine-clonidine, ropivacaine

            Syringe (partial list): Atropine, chlorpromazine, dimenhydrinate, diphenhydramine, heparin, hydroxyzine, meperidine, metoclopramide, midazolam, morphine, ondansetron, prochlorperazine, promethazine, ranitidine

            Y-site (partial list): Amiodarone, amphotericin B cholesteryl sulfate, atropine, bivalirudin, dexamethasone sodium phosphate, diazepam, diltiazem, diphenhydamine, dobutamine, dopamine, epinephrine, esmolol, furosemide, haloperidol, heparin, hydrocortisone, labetalol, lorazepam, metoclopramide, midazolam, morphine, nitroglycerin, norepinephrine, potassium chloride, propofol, vitamins B and C

            IV Preparation

            Use undiluted or diluted in 250 mL of D5W

            IV/IM Administration

            IM: Injection

            IV: Injection or continuous infusion

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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.
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            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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