(fentanyl transdermal system) CII contains a high concentration of a potent Schedule II opioid agonist, fentanyl. Schedule II opioid substances which include fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone have the highest potential for abuse and associated risk of fatal overdose due to respiratory depression. Fentanyl can be abused and is subject to criminal diversion. The high content of fentanyl in the patches (DURAGESIC®
) may be a particular target for abuse and diversion.
is indicated for management of persistent
, moderate to severe chronic pain that:
Requires continuous, around-the-clock opioid administration for an extended period of time, and
Cannot be managed by other means such as nonsteroidal analgesics, opioid combination products, or immediate-release opioids
should ONLY be used in patients who are already receiving opioid
therapy, who have demonstrated opioid tolerance, and who require a
total daily dose at least equivalent to DURAGESIC®
mcg/hr. Patients who are considered opioid-tolerant are those who have
been taking, for a week or longer, at least 60 mg of morphine daily, or
at least 30 mg of oral oxycodone daily, or at least 8 mg of oral
hydromorphone daily or an equianalgesic dose of another opioid.
Because serious or life-threatening hypoventilation could occur, DURAGESIC® is contraindicated:
In patients who are not opioid-tolerant
In the management of acute pain or in patients who require opioid analgesia for a short period of time
In the management of post-operative pain, including use after out-patient or day surgeries (e.g., tonsillectomies)
In the management of mild pain
In the management of intermittent pain (e.g., use on an as needed basis [prn])
(See CONTRAINDICATIONS section of the full Prescribing Information for further information.)
Since the peak fentanyl concentrations generally occur between 20 and
72 hours of treatment, prescribers should be aware that serious or
life-threatening hypoventilation may occur, even in opioid-tolerant
patients, during the initial application period.
The concomitant use of
DURAGESIC® with all cytochrome P450 3A4 inhibitors
(such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil) may result in an increase in fentanyl
plasma concentrations, which could increase or prolong adverse drug
effects and may cause potentially fatal respiratory depression.
Patients receiving DURAGESIC® and any CYP3A4 inhibitors
should be carefully monitored for an extended period of time and dosage
adjustments should be made if warranted. (See CLINICAL
PHARMACOLOGY-Drug Interactions, WARNINGS, PRECAUTIONS, and DOSAGE AND
ADMINISTRATION sections of the full Prescribing Information for further
The safety of DURAGESIC® has not been established in children under 2 years of age. DURAGESIC® should be administered to children only if they are opioid-tolerant and 2 years of age or older.
(See PRECAUTIONS - Pediatric Use section of the full Prescribing Information.)
is ONLY for use in patients who are already tolerant to opioid therapy
of comparable potency. Use in non-opioid tolerant patients may lead to
fatal respiratory depression.
Overestimating the DURAGESIC®
dose when converting patients from another opioid medication can result
in fatal overdose with the first dose (see DOSAGE and ADMINISTRATION –
Dose Selection - section of full
Prescribing Information for further information). Due to the mean
elimination half-life of approximately 20-27 hours, patients who are
thought to have had a serious adverse event, including overdose, will
require monitoring and treatment for at least 24 hours.
can be abused in a manner
similar to other opioid agonists, legal or illicit. This risk should be
considered when administering, prescribing, or dispensing DURAGESIC®
in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion.
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).
Patients should be assessed for their clinical risks for opioid abuse
or addiction prior to being prescribed opioids. All patients receiving
opioids should be routinely monitored for signs of misuse, abuse, and
addiction. Patients at increased risk of opioid abuse may still be
appropriately treated with modified-release opioid formulations;
however, these patients will require intensive monitoring for signs of
misuse, abuse, or addiction.
DURAGESIC® patches are intended for transdermal use (on intact skin) only. Do not use a DURAGESIC® patch if the seal is broken or the patch is cut, damaged, or changed in any way.
Avoid exposing the DURAGESIC®
application site and surrounding area to direct external heat sources,
such as heating pads or electric blankets, heat or tanning lamps,
saunas, hot tubs and heated water beds, while wearing the system. Avoid
taking hot baths or sunbathing. There is a potential for
temperature-dependant increases in fentanyl released from the system
resulting in possible overdose and death. Patients wearing DURAGESIC®
systems who develop fever or increased core body temperature due to
strenuous exertion should be monitored for opioid side effects and the
DURAGESIC® dose should be adjusted if necessary.