fentanyl transdermal system
Duragesic-25, Duragesic-50, Duragesic-75, Duragesic-100
fentanyl transmucosal
Fentanyl Oralet
Controlled Substance Schedule II
Pregnancy Risk Category C
How supplied
Injection: 50 mcg/ml
Transdermal system: patches designed to release 25 mcg, 50 mcg, 75 mcg, or 100 mcg of fentanyl per hour
Transmucosal: 100 mcg, 200 mcg, 300 mcg, 400 mcg
Action
Binds with opiate receptors in the CNS, altering both perception of and emotional response to pain through an unknown mechanism.
Indications & dosage
Adjunct to general anesthetic--
Adults: for low-dose therapy, 2 mcg/kg I.V. For moderate-dose therapy, 2 to 20 mcg/kg I.V.; then 25 to 100 mcg I.V., p.r.n. For high-dose therapy, 20 to 50 mcg/kg I.V.; then 25 mcg to one-half initial loading dose I.V., p.r.n.
Adjunct to regional anesthesia--
Adults: 50 to 100 mcg I.M. or slowly I.V. over 1 to 2 minutes, p.r.n.
Induction and maintenance of anesthesia--
Children ages 2 to 12: 2 to 3 mcg/kg I.V.
Postoperatively--
Adults: 50 to 100 mcg I.M. q 1 to 2 hours, p.r.n.
Preoperatively--
Adults: 50 to 100 mcg I.M. 30 to 60 minutes before surgery. Or, 5 mcg/kg dispensed as oralet unit, 20 to 40 minutes before need of desired effects.
Management of chronic pain--
Adults: one transdermal system applied to a portion of the upper torso on an area of skin that isn't irritated and hasn't been irradiated. Therapy initiated with the 25-mcg/hour system; dosage adjusted as needed and tolerated. Each system may be worn for 72 hours, although some patients may require systems to be applied q 48 hours. Upward adjustment may be done q 3 days after initial dose; then 6 days thereafter.
Adverse reactions
CNS: sedation, somnolence, clouded sensorium, euphoria, dizziness, headache, confusion, asthenia, nervousness, hallucinations, anxiety, depression, seizures.
CV: hypotension, hypertension, arrhythmias, chest pain.
GI: nausea, vomiting, constipation, ileus, abdominal pain, dry mouth, anorexia, diarrhea, dyspepsia.
GU: urine retention.
Respiratory: respiratory depression, hypoventilation, dyspnea, apnea.
Skin: reaction at application site, pruritus, diaphoresis.
Other: physical dependence, increased plasma amylase and lipase levels.
Interactions
Drug-drug. CNS depressants, general anesthetics, hypnotics, MAO inhibitors, other narcotic analgesics, sedatives, tricyclic antidepressants: additive effects. Use together with extreme caution. Fentanyl dose should be reduced by one-quarter to one-third. Also give above drugs in reduced dosages.
Diazepam: CV depression when given with high doses of fentanyl. Monitor closely.
Droperidol: hypotension and decreased pulmonary arterial pressure. Use together cautiously.
Drug-lifestyle. Alcohol use: additive effects. Use together cautiously.
Effects on diagnostic tests
None reported.
Contraindications
Contraindicated in patients with known intolerance of drug. Fentanyl patch is contraindicated for pain management following surgery, mild or intermittent pain that can be managed with nonnarcotic agents, or in doses exceeding 25 mcg/hour initially.
Nursing considerations
- Use with caution in patients with head injury, increased CSF pressure, COPD, decreased respiratory reserve, potentially compromised respirations, hepatic or renal disease, and cardiac bradyarrhythmias. Also use with caution in elderly or debilitated patients.
- For better analgesic effect, administer drug before patient has intense pain.
- Alert:
High doses can produce muscle rigidity, which can be reversed with neuromuscular blockers; however, patient must be artificially ventilated.
- Monitor circulatory and respiratory status and urinary function carefully. Drug may cause respiratory depression, hypotension, urine retention, nausea, vomiting, ileus, or altered level of consciousness without regard to route of administration.
- Periodically monitor postoperative vital signs and bladder function. Because drug decreases both rate and depth of respirations, monitoring of arterial oxygen saturation (Sao2) may help assess respiratory depression. Immediately report respiratory rate below 12 breaths/minute, decreased respiratory volume, or decreased Sao2.
Transdermal form
- Transdermal fentanyl isn't recommended for postoperative pain.
- Don't give transdermal fentanyl to patients under age 12 or patients under age 18 weighing less than 110 lb (50 kg).
- Dosage equivalent charts are available to calculate the fentanyl transdermal dose based on the daily morphine intake--for example, for every 90 mg of oral morphine or 15 mg of I.M. morphine per 24 hours, 25 mcg/hour of transdermal fentanyl is needed.
- Dosage adjustments in patients using the transdermal system should be made gradually. Reaching steady-state levels of a new dosage may take up to 6 days; delay dosage adjustment until after at least two applications.
- Monitor patients who develop adverse reactions to the transdermal system for at least 12 hours after removal. Serum levels of fentanyl drop gradually and may take as long as 17 hours to decline by 50%.
- Most patients experience good control of pain for 3 days while wearing the transdermal system, but a few may need a new application after 48 hours.
- Because serum fentanyl level rises for the first 24 hours after application, analgesic effect can't be evaluated on the first day. Be sure patient has adequate supplemental analgesic to prevent breakthrough pain.
- When reducing opiate therapy or switching to a different analgesic, the transdermal system should be withdrawn gradually. Because fentanyl's serum level drops gradually after removal, give half of the equianalgesic dose of the new analgesic 12 to 18 hours after removal, as ordered.
Transmucosal form
- Remove foil overwrap of fentanyl oralet just before administration.
- Have patient place the fentanyl oralet in mouth and suck (not chew or swallow) it.
- Remove fentanyl oralet unit, using the handle, after it has been consumed, patient shows adequate effect, or patient shows signs of respiratory depression. Place any remaining portion in the plastic overwrap provided, and dispose accordingly for Schedule II drugs.
- Alert:
Don't confuse fentanyl with alfentanil.
I.V. administration
- Only staff trained in administration of I.V. anesthetics and management of their potential adverse effects should administer I.V. fentanyl.
- Drug is often used I.V. with droperidol to produce neuroleptanalgesia.
- Keep narcotic antagonist (naloxone) and resuscitation equipment available when giving drug I.V.
Patient teaching
- When used for pain control, instruct patient to ask for drug before pain becomes intense.
- When drug is used postoperatively, encourage patient to turn, cough, and breathe deeply to prevent atelectasis.
- Instruct patient to avoid performing hazardous activities until CNS effects subside.
- Tell home care patient to avoid drinking alcohol or taking other CNS-type drugs while receiving fentanyl because additive effects can occur.
- Teach patient about the proper application of the prescribed transdermal patch. Tell patient to clip hair at application site, but not to use a razor, which may irritate the skin. Wash area with clear water if necessary, but not with soaps, oils, lotions, alcohol, or other substances that may irritate the skin or prevent adhesion. Dry area completely before application.
- Tell patient to remove transdermal system from package just before applying, hold in place for 30 seconds, and be sure the edges of patch adhere to skin.
- Teach patient to dispose of the transdermal patch by folding so the adhesive side adheres to itself and then flushing it down the toilet.
- Tell patient that, if another patch is needed after 48 to 72 hours, to apply it to a new site.
- Inform patient that heat from fever or environment, such as from heating pads, electric blankets, heat lamps, hot tubs, or water beds, may increase transdermal delivery and cause toxicity requiring dosage adjustment. Instruct patient to notify doctor if fever occurs or if he'll be spending time in a hot climate.
*Liquid contains alcohol. **May contain tartrazine. †Canada ‡Australia §U.K. OTCOver the counter
Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE-THREATENING