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Fentanyl

    DEA Class; Rx

    Common Brand Names; Sublimaze

    • Opioid Analgesics; 
    • Synthetic, Opioids

    fentanyl transmucosal (Rx)

    Brand and Other Names:Actiq, Fentora, Abstral, Onsolis, Subsys
    • Classes: Opioid Analgesics; 
    • Opioids, Anilidopiperidine

    fentanyl intranasal (Rx)

    Brand and Other Names:Lazanda
    • Classes: Opioid Analgesics

    fentanyl transdermal (Rx)

    Brand and Other Names:Duragesic
    • Classes: Opioid Analgesics
     

    Phenylpiperidine synthetic opiate agonist
    Used with general, regional, and spinal anesthesia; also for chronic and breakthrough pain
    Formulations not interchangeable on a mcg-to-mcg basis, even those administered via same route, due to significant pharmacokinetic differences

    Indicated for the control of moderate pain or severe pain.

    Indicated only for breakthrough cancer pain in adults who are tolerant to opioid therapy for their underlying persistent cancer 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

    For adjuvant management of general anesthesia maintenance and intraoperative pain control.
    For general anesthesia induction when attenuation of the responses to surgical stress is especially important such as during major surgery like open heart surgery or complicated neurological or orthopedic procedures.
    For analgesia and/or sedation maintenance in mechanically-ventilated intensive care patients.
    For sedation and analgesia prior to rapid-sequence intubation (RSI).
    For the management of dyspnea in patients with end-stage cancer or lung disease.
    For procedural sedation of non-intubated patients during diagnostic, surgical, or other procedures.

    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

    • 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

    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

    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

    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

    Adults

    4 doses/day of Actiq, Fentora, or Onsolis transmucosal; 800 mcg/dose, 2 doses/break-thru pain episode, and 4 treated episodes/day of Abstral sublingual; 1600 mcg/dose, 2 doses/break-thru pain episode, and 4 treated episodes/day of Subsys sublingual; 800 mcg/dose and 4 doses/day of Lazanda nasal spray; 40 mcg/dose and 80 doses/day with Ionsys; with appropriate dosage titration, there is no maximum dose of other dosage forms.

    Geriatric

    4 doses/day of Actiq, Fentora, or Onsolis transmucosal; 800 mcg/dose, 2 doses/break-through pain episode, and 4 treated episodes/day of Abstral sublingual; 1600 mcg/dose, 2 doses/break-thru pain episode, and 4 treated episodes/day of Subsys sublingual; 800 mcg/dose and 4 doses/day of Lazanda nasal spray; 40 mcg/dose and 80 doses/day with Ionsys; with appropriate dosage titration, there is no maximum dose of other dosage forms.

    Adolescents

    16 to 17 years: 4 units/day of fentanyl transmucosal lozenge (i.e., Actiq). With appropriate dosage titration, there is no maximum dose of transdermal or intravenous fentanyl. The safety and efficacy of other dosage forms have not been established.
     
    13 to 15 years: With appropriate dosage titration, there is no maximum dose of transdermal or intravenous fentanyl. The safety and efficacy of other dosage forms have not been established.

    Children

    2 to 12 years: With appropriate dosage titration, there is no maximum dose of transdermal or intravenous fentanyl. The safety and efficacy of other dosage forms have not been established.
     
    1 year: With appropriate dosage titration, there is no maximum dose of intravenous fentanyl The safety and efficacy of other dosage forms have not been established.

    Infants

    With appropriate dosage titration, there is no maximum dose of intravenous fentanyl. The safety and efficacy of other dosage forms have not been established.

    Neonates

    With appropriate dosage titration, there is no maximum dose of intravenous fentanyl. The safety and efficacy of other dosage forms have not been established.

    Fentanyl citrate

    injection solution: Schedule II

    • 0.05mg/mL

    troche/lozenge (Actiq): Schedule II

    • 200mcg
    • 400mcg
    • 600mcg
    • 800mcg
    • 1200mcg
    • 1600mcg

    tablet, sublingual (Abstral): Schedule II

    • 100mcg
    • 200mcg
    • 300mcg
    • 400mcg
    • 600mcg
    • 800mcg

    buccal tablet (Fentora): Schedule II

    • 100mcg
    • 200mcg
    • 400mcg
    • 600mcg
    • 800mcg

    soluble film (Onsolis): Schedule II

    • 200mcg
    • 400mcg
    • 600mcg
    • 800mcg
    • 1200mcg

    sublingual spray (Subsys): Schedule II

    • 100mcg/spray
    • 200mcg/spray
    • 400mcg/spray
    • 600mcg/spray
    • 800mcg/spray

    intranasal: Schedule II

    • 100mcg/100mcL spray (8 sprays/bottle)
    • 300mcg/100mcL spray (8 sprays/bottle)
    • 400mcg/100mcL spray (8 sprays/bottle)

    transdermal patch: Schedule II

    • 12mcg/hr
    • 25mcg/hr
    • 50mcg/hr
    • 75mcg/hr
    • 100mcg/hr