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Fentanyl transdermal system, CII 50 mcg/hr

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING  RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; AND EXPOSURE TO HEAT

Addiction, Abuse, and Misuse

Fentanyl transdermal system exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing fentanyl transdermal system, 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 with use of fentanyl transdermal system, even when used as recommended. Monitor for respiratory depression, especially during initiation of fentanyl transdermal system or following a dose increase. Because of the risk of respiratory depression, fentanyl transdermal system is contraindicated for use as an as-needed analgesic, in non-opioid tolerant patients, in acute pain, and in postoperative pain.

Accidental Exposure

Deaths due to a fatal overdose of fentanyl have occurred when children and adults were accidentally exposed to fentanyl transdermal system. Strict adherence to the recommended handling and disposal instructions is of the utmost importance to prevent accidental exposure.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of fentanyl transdermal system 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.

Cytochrome P450 3A4 Interaction

The concomitant use of fentanyl transdermal system with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations , which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving fentanyl transdermal system and any CYP3A4 inhibitor or inducer.

Exposure To Heat

Exposure of the fentanyl transdermal system application site and surrounding area to direct external heat sources, such as heating pads or electric blankets , heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds may increase fentanyl absorption and has resulted in fatal overdose of fentanyl and death. Patients wearing fentanyl transdermal systems who develop fever or increased core body temperature due to strenuous exertion are also at risk for increased fentanyl exposure and may require an adjustment in the dose of fentanyl transdermal system to avoid overdose and death.

Description Rectangular transparent patch
Compares To DURAGESIC® 50 mcg/hr
Dosage Strength 50 mcg/hr
Identification Code Rectangular transparent unit comprising a protective liner and four functional layers. Color coded on patch, carton and blister package as 50 mcg/hr in Clover Green color

Order Information

NDC # Package Size Case Quantity
0406-9050-76 5 24

For additional information on Fentanyl transdermal system, CII 50 mcg/hr, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.

DURAGESIC is a registered trademark of Johnson & Johnson