"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
(fentanyl) Transdermal System
ABUSE POTENTIAL , RESPIRATORY DEPRESSION and DEATH, ACCIDENTAL EXPOSURE, CYTOCHROME P450 3A4 INTERACTION, AND EXPOSURE TO HEAT
DURAGESIC contains fentanyl, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. DURAGESIC can be abused in a manner similar to other opioid agonists, legal or illicit. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Assess patients for their clinical risks for opioid abuse or addiction prior to prescribing DURAGESIC and then routinely monitor all patients for signs of misuse, abuse and addiction during treatment [see WARNINGS AND PRECAUTIONS and Drug Abuse and Dependence].
Respiratory Depression and Death
Respiratory depression and death may occur with use of DURAGESIC, even when DURAGESIC has been used as recommended and not misused or abused. Proper dosing and titration are essential and DURAGESIC should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. DURAGESIC is contraindicated for use in conditions in which the risk of life-threatening respiratory depression is significantly increased, including use as an as-needed analgesic, use in non-opioid tolerant patients, acute pain, and postoperative pain. Monitor for respiratory depression, especially during the first two applications following initiation of dosing, or following an increase in dosage [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].
Death and other serious medical problems have occurred when children and adults were accidentally exposed to DURAGESIC. Advise patients about strict adherence to the recommended handling and disposal instructions in order to prevent accidental exposure [see DOSAGE AND ADMINISTRATION and 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. Monitor patients receiving DURAGESIC and any CYP3A4 inhibitor [see WARNINGS AND PRECAUTIONS, and CLINICAL PHARMACOLOGY].
Exposure To Heat
The DURAGESIC application site and surrounding area must not be exposed 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. Exposure to heat may increase fentanyl absorption and there have been reports of overdose and death as a result of exposure to heat (5.9). 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 (5.10).
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:
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)|
|**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.
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...
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),...
Last reviewed on RxList: 10/29/2013
This monograph has been modified to include the generic and brand name in many instances.
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