Classes
DEA Class; Rx
Common Brand Names; Sublimaze
- Opioid Analgesics;
- Synthetic, Opioids
fentanyl transmucosal (Rx)
- Classes: Opioid Analgesics;
- Opioids, Anilidopiperidine
fentanyl intranasal (Rx)
- Classes: Opioid Analgesics
fentanyl transdermal (Rx)
- Classes: Opioid Analgesics
Description
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
Indications
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
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
Adverse Effects
- 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
Warnings
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
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
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
Maximum Dosage
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.
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.
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.
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.
With appropriate dosage titration, there is no maximum dose of intravenous fentanyl. The safety and efficacy of other dosage forms have not been established.
With appropriate dosage titration, there is no maximum dose of intravenous fentanyl. The safety and efficacy of other dosage forms have not been established.
How supplied
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