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DURAGESIC® is a rectangular transparent unit comprising a protective liner and four
functional layers. Proceeding from the outer surface toward the surface adhering to skin,
these layers are:
1) a backing layer of polyester film; 2) a drug reservoir of fentanyl and alcohol USP
gelled with hydroxyethyl cellulose; 3) an ethylene-vinyl acetate copolymer membrane
that controls the rate of fentanyl delivery to the skin surface; and 4) a fentanyl containing
silicone adhesive. Before use, a protective liner covering the adhesive layer is removed
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DURAGESIC is indicated for the management of pain in opioid-tolerant patients, severe enough
to require daily, around-the-clock, long-term opioid treatment and for which alternative
treatment options are inadequate.
Patients considered opioid-tolerant are those who are taking, for one week or longer, at least
60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day,
8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone
per day, or an equianalgesic dose of another opioid.
Limitations of Use
• Because of the risks of addiction, abuse, and misuse with opioids, even at recommended
doses, and because of the greater risks of overdose and death with extended-release/longacting
opioid formulations [see Warnings and Precautions (5.1)], reserve DURAGESIC
for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or
immediate-release opioids) are ineffective, not tolerated, or would be otherwise
inadequate to provide sufficient management of pain.
• DURAGESIC is not indicated as an as-needed (prn) analgesic.
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DURAGESIC PATCHES ARE FOR TRANSDERMAL USE ONLY.
Proper handling of DURAGESIC is necessary in order to prevent serious adverse outcomes,
including death, associated with accidental secondary exposure to DURAGESIC [see Warnings
and Precautions (5.3)].
Application and Handling Instructions
• Patients should apply DURAGESIC to intact, non-irritated, and non-irradiated skin on a flat
surface such as the chest, back, flank, or upper arm. In young children and persons with
cognitive impairment, adhesion should be monitored and the upper back is the preferred
location to minimize the potential of inappropriate patch removal. Hair at the application site
may be clipped (not shaved) prior to system application. If the site of DURAGESIC
application must be cleansed prior to application of the patch, do so with clear water. Do not
use soaps, oils, lotions, alcohol, or any other agents that might irritate the skin or alter its
characteristics. Allow the skin to dry completely prior to patch application.
• Patients should apply DURAGESIC immediately upon removal from the sealed package.
The patch must not be altered (e.g., cut) in any way prior to application. DURAGESIC
should not be used if the pouch seal is broken or if the patch is cut or damaged.
• The transdermal system is pressed firmly in place with the palm of the hand for 30 seconds,
making sure the contact is complete, especially around the edges.
Each DURAGESIC patch may be worn continuously for 72 hours. The next patch is applied
to a different skin site after removal of the previous transdermal system.
• If problems with adhesion of the DURAGESIC patch occur, the edges of the patch may be
taped with first aid tape. If problems with adhesion persist, the patch may be overlayed with a
transparent adhesive film dressing.
• If the patch falls off before 72 hours, dispose of it by folding in half and flushing down the
toilet. A new patch may be applied to a different skin site.
• Patients (or caregivers who apply DURAGESIC) should wash their hands immediately with
soap and water after applying DURAGESIC.
• Contact with unwashed or unclothed application sites can result in secondary exposure to
DURAGESIC and should be avoided. Examples of accidental exposure include transfer of a
DURAGESIC patch from an adult’s body to a child while hugging, sharing the same bed as
the patient, accidental sitting on a patch and possible accidental exposure of a caregiver’s
skin to the medication in the patch while applying or removing the patch.
• Instruct patients, family members, and caregivers to keep patches in a secure location out of
the reach of children and of others for whom DURAGESIC was not prescribed.
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Addiction, Abuse, and Misuse
DURAGESIC contains fentanyl, an opioid agonist and a Schedule II controlled substance. As an
opioid, DURAGESIC exposes users to the risks of addiction, abuse, and misuse. Because
modified-release products such as DURAGESIC deliver the opioid over an extended period of
time, there is a greater risk for overdose and death due to the larger amount of fentanyl present
[see Drug Abuse and Dependence (9)].
Although the risk of addiction in any individual is unknown, it can occur in patients
appropriately prescribed DURAGESIC. Addiction can occur at recommended doses and if the
drug is misused or abused.
Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing
DURAGESIC, and monitor all patients receiving DURAGESIC for the development of these
behaviors and conditions. Risks are increased in patients with a personal or family history of
substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major
depression). The potential for these risks should not, however, prevent the proper management of
pain in any given patient. Patients at increased risk may be prescribed opioids such as
DURAGESIC, but use in such patients necessitates intensive counseling about the risks and
proper use of DURAGESIC along with intensive monitoring for signs of addiction, abuse, and
Abuse or misuse of DURAGESIC by placing it in the mouth, chewing it, swallowing it, or using
it in ways other than indicated may cause choking, overdose, and death [see Overdosage (10)].
Opioids are sought by drug abusers and people with addiction disorders and are subject to
criminal diversion. Consider these risks when prescribing or dispensing DURAGESIC.
Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity
and advising the patient on the proper disposal of unused drug [see Patient Counseling
Information (17)]. Contact local state professional licensing board or state controlled substances
authority for information on how to prevent and detect abuse or diversion of this product.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids,
even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may
include close observation, supportive measures, and use of opioid antagonists, depending on the
patient’s clinical status [see Overdosage (10)]. Carbon dioxide (CO2) retention from opioidinduced
respiratory depression can exacerbate the sedating effects of opioids.
DURAGESIC is indicated only in opioid tolerant patients because of the risk for respiratory
depression and death. While serious, life-threatening, or fatal respiratory depression can occur at
any time during the use of DURAGESIC, the risk is greatest during the initiation of therapy or
following a dosage increase. Monitor patients closely for respiratory depression within the first
24-72 hours of initiating therapy with and following dosage increases of DURAGESIC.
To reduce the risk of respiratory depression, proper dosing and titration of DURAGESIC are
essential [see Dosage and Administration (2)]. Overestimating the DURAGESIC dosage when
converting patients from another opioid product can result in fatal overdose with the first dose.
Accidental exposure to DURAGESIC, especially in children, can result in respiratory depression
and death due to an overdose of fentanyl.
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DURAGESIC is contraindicated in:
• patients who are not opioid-tolerant.
• the management of acute or intermittent pain, or in patients who require opioid analgesia for
a short period of time.
• the management of post-operative pain, including use after out-patient or day surgeries, (e.g.,
• the management of mild pain.
• patients with significant respiratory depression
• in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence
of resuscitative equipment
• in patients with known or suspected gastrointestinal obstruction, including paralytic ileus
• in patients with hypersensitivity to fentanyl (e.g., anaphylaxis) or any components of the
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