Fentanyl, Fentanyl Citrate, Fentanyl Hydrochloride and Prematurity

• Generic Name: fentanyl
• Dosage Forms: n.a.
• Other Brand Names: Duragesic, Abstral, Fentora, Subsys, Actiq, Ionsys, Lazanda, Onsolis, Sublimaze

Preoperatively, during surgery, and in the immediate postoperative period parenterally for its strong analgesic action.

Parenterally for pain that likely will be of short duration (e.g., that associated with diagnostic procedures, orthopedic manipulation) and can be controlled with a short-acting opiate agonist such as fentanyl.

IM to alleviate postoperative pain and discomfort. However, the IV route (including patient-controlled analgesia) is preferred for administration of opiate agonists after major surgery since repeated IM injections may cause pain and trauma.

Transdermally as fentanyl hydrochloride iontophoretic transdermal system for short-term management of acute postoperative pain in patients requiring opiate analgesia in a hospital setting. Initiate only after acceptable analgesia has been achieved using other opiate analgesics. Use only in patients who are sufficiently alert and have adequate cognitive ability to understand directions for use. Must be discontinued prior to hospital discharge.

Because of the risk of life-threatening respiratory depression, fentanyl transdermal systems (e.g., Duragesic) and transmucosal immediate-release preparations (buccal lozenges, buccal tablets, sublingual tablets, sublingual spray, nasal spray) are contraindicated in the management of acute or postoperative pain. (See Contraindications under Cautions.)

In symptomatic treatment of acute pain, reserve opiate analgesics for pain resulting from severe injuries, severe medical conditions, or surgical procedures, or when nonopiate alternatives for relieving pain and restoring function are expected to be ineffective or are contraindicated. Use smallest effective dosage for shortest possible duration since long-term opiate use often begins with treatment of acute pain. Optimize concomitant use of other appropriate therapies. (See Managing Opiate Therapy for Acute Pain under Dosage and Administration.)

Transdermally as fentanyl transdermal system (e.g., Duragesic) in opiate-tolerant patients for the management of pain that is severe enough to require long-term, daily, around-the-clock use of an opiate analgesic. Because of the risks of addiction, abuse, and misuse associated with opiates, even at recommended doses, and because of the greater risks of overdose and death with extended-release opiate formulations, reserve for use when alternative treatment options (e.g., nonopiate analgesics, immediate-release opiates) are inadequate or not tolerated.

Transmucosally as an immediate-release preparation (buccal lozenges, buccal tablets, sublingual tablets, sublingual spray, nasal spray) for the management of breakthrough pain only in patients who are already being treated with, and are tolerant of, opiates used around-the-clock for persistent cancer pain. Patient must continue receiving around-the-clock opiate therapy while receiving these transmucosal immediate-release preparations for relief of breakthrough pain.

Do not use fentanyl transdermal systems or transmucosal immediate-release preparations in patients who are not opiate tolerant.

Patients are considered opiate tolerant if they have been receiving around-the-clock opiate therapy consisting of at least 60 mg of oral morphine sulfate daily, 25 mcg of transdermal fentanyl per hour, 30 mg of oral oxycodone daily, 8 mg of oral hydromorphone hydrochloride daily, 25 mg of oral oxymorphone hydrochloride daily, or an equianalgesic dosage of another opiate daily for at least 1 week.

In the management of severe chronic pain associated with a terminal illness such as cancer, the principal goal of analgesic therapy is to make the patient relatively pain-free while maintaining as good a quality of life as possible.

Although consideration of the dependence potential of opiate agonists has often limited their effective use by many clinicians in terminally ill patients with severe chronic pain, such consideration is irrelevant in the context of terminal illness.

Transdermally as fentanyl transdermal system (e.g., Duragesic) in opiate-tolerant patients for the management of pain that is severe enough to require long-term, daily, around-the-clock use of an opiate analgesic. Because of the risks of addiction, abuse, and misuse associated with opiates, even at recommended doses, and because of the greater risks of overdose and death with extended-release opiate formulations, reserve for use when alternative treatment options (e.g., nonopiate analgesics, immediate-release opiates) are inadequate or not tolerated.

Patients are considered opiate tolerant if they have been receiving around-the-clock opiate therapy consisting of at least 60 mg of oral morphine sulfate daily, 25 mcg of transdermal fentanyl per hour, 30 mg of oral oxycodone daily, 8 mg of oral hydromorphone hydrochloride daily, 25 mg of oral oxymorphone hydrochloride daily, or an equianalgesic dosage of another opiate daily for at least 1 week.

Generally use opiates for management of chronic pain (i.e., pain lasting >3 months or past the time of normal tissue healing ) that is not associated with active cancer treatment, palliative care, or end-of-life care only if other appropriate nonpharmacologic and nonopiate pharmacologic strategies have been ineffective and expected benefits for both pain relief and functional improvement are anticipated to outweigh risks.

If used for chronic pain, opiate analgesics should be part of an integrated approach that also includes appropriate nonpharmacologic modalities (e.g., cognitive-behavioral therapy, relaxation techniques, biofeedback, functional restoration, exercise therapy, certain interventional procedures) and other appropriate pharmacologic therapies (e.g., nonopiate analgesics, analgesic adjuncts such as selected anticonvulsants and antidepressants for certain neuropathic pain conditions).

Available evidence insufficient to determine whether long-term opiate therapy for chronic pain results in sustained pain relief or improvements in function and quality of life or is superior to other pharmacologic or nonpharmacologic treatments. Use is associated with serious risks (e.g., opiate use disorder, overdose). (See Managing Opiate Therapy for Chronic Noncancer Pain under Dosage and Administration.)

A supplement to general or regional anesthesia, including neuroleptanalgesia in which it often is used in combination with droperidol.

For induction and maintenance of anesthesia to provide preinduction sedation and analgesia, provide analgesia for additional vascular line placement, blunt hemodynamic and stress response to laryngoscopy and intubation, reduce requirements for other anesthetics, promote perioperative hemodynamic stability, and provide postoperative analgesia.

As the opiate component of balanced anesthesia or total IV anesthesia (balanced anesthesia in which the IV anesthetic completely replaces the inhalation anesthetic).

May be especially useful preoperatively before surgery of short duration or minor surgery in outpatients and in diagnostic procedures or treatments that require the patient to be awake or very lightly anesthetized.

When attenuation of the response to surgical stress is especially important, may be administered with oxygen and a skeletal muscle relaxant to provide anesthesia without the use of additional anesthetic agents.

To prevent or relieve tachypnea and postoperative emergence delirium.

Previously was available for restricted use as an intrabuccal (transmucosal) premedicant (Fentanyl Oralet) prior to anesthesia or for inducing conscious sedation prior to diagnostic or therapeutic procedures in a monitored anesthesia setting. However, this preparation no longer is commercially available for such use in the US and the currently available buccal preparations (Actiq lozenge, Fentora tablet, generic oral transmucosal fentanyl citrate lozenge) are labeled only for management of breakthrough pain in opiate-tolerant patients with chronic cancer pain.