July 23, 2016
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Duragesic

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Duragesic

DURAGESIC®
(Fentanyl) Transdermal System




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

DURAGESIC 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 DURAGESIC, and monitor all patients regularly for the development of these behaviors or conditions [see WARNINGS AND PRECAUTIONS].

Life-threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of DURAGESIC, even when used as recommended. Monitor for respiratory depression, especially during initiation of DURAGESIC or following a dose increase. Because of the risk of respiratory depression, DURAGESIC is contraindicated for use as an as-needed analgesic, in non-opioid tolerant patients, in acute pain, and in postoperative pain [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Accidental Exposure

Deaths due to a fatal overdose of fentanyl have occurred when children and adults were accidentally exposed to DURAGESIC. Strict adherence to the recommended handling and disposal instructions is of the utmost importance to prevent accidental exposure [see WARNINGS AND PRECAUTIONS].

Neonatal Opioid Withdrawal Syndrome

Prolonged use of DURAGESIC 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 [see WARNINGS AND PRECAUTIONS].

Cytochrome P450 3A4 Interaction

The concomitant use of DURAGESIC 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 DURAGESIC and any CYP3A4 inhibitor or inducer [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Exposure To Heat

Exposure of the DURAGESIC application site and surrounding area to direct external heat credits, 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 [see WARNINGS AND PRECAUTIONS]. Patients wearing DURAGESIC 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 DURAGESIC to avoid overdose and death [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

DURAGESIC (fentanyl transdermal system) is a transdermal system containing fentanyl. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is:

DURAGESIC® (Fentanyl) Structural Formula Illustration

The molecular weight of fentanyl base is 336.5, and the empirical formula is C22H28N2O. The n-octanol: water partition coefficient is 860:1. The pKa is 8.4.

System Components And Structure

The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/h per 10.5 cm²). The composition per unit area of all system sizes is identical.

Dose* (mcg/h) Size (cm²) Fentanyl Content (mg)
12** 5.25 2.1
25 10.5 4.2
50 21 8.4
75 31.5 12.6
100 42 16.8
**Nominal delivery rate per hour
***Nominal delivery rate is 12.5 mcg/hr

DURAGESIC is a rectangular transparent unit comprising a protective liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are:

1) a backing layer of polyester/ethyl vinyl acetate film; 2) a drug-in-adhesive layer. Before use, a protective liner covering the adhesive layer is removed and discarded.

DURAGESIC® (Fentanyl Transdermal System) layers - Illustration

What are the possible side effects of a fentanyl transdermal skin patch?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Remove the skin patch and call your doctor at once if you have any of these serious side effects:

  • slow heart rate, weak or shallow breathing, sighing;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe weakness, feeling like you might pass out;
  • cold, clammy skin; or
  • pale skin, easy bruising or bleeding.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Duragesic »

What are the precautions when taking fentanyl transdermal (Duragesic)?

Before using fentanyl, tell your doctor or pharmacist if you are allergic to it; or to adhesives; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus),...

Read All Potential Precautions of Duragesic »

Last reviewed on RxList: 6/16/2016
This monograph has been modified to include the generic and brand name in many instances.

Duragesic - User Reviews

Duragesic User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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