DURAGESIC- fentanyl patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

fentanyl (UNII: UF599785JZ) (fentanyl - UNII:UF599785JZ)

Available from:

Janssen Pharmaceuticals, Inc.

INN (International Name):

fentanyl

Composition:

fentanyl 12.5 ug in 1 h

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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/long-acting 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 suffi

Product summary:

DURAGESIC (fentanyl transdermal system) is supplied in cartons containing 5 individually packaged systems. See chart for information regarding individual systems. Store in original unopened pouch. Store up to 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Store DURAGESIC securely and dispose of properly [see Patient Counseling Information (17)] .

Authorization status:

New Drug Application

Patient Information leaflet

Janssen Pharmaceuticals, Inc.
----------
This Medication Guide has been approved by the
U.S. Food and Drug Administration.
Revised 10/2019
Medication Guide
DURAGESIC ® (Dur-ah-GEE-zik ) (fentanyl) Transdermal System, CII
DURAGESIC ® is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage pain
severe enough to require daily around-the-clock, long-term treatment
with an opioid, in people who
are already regularly using opioid pain medicine, when other pain
treatments such as non-opioid pain
medicines or immediate-release opioid medicines do not treat your pain
well enough or you cannot
tolerate them.
•
A long-acting (extended-release) opioid pain medicine that can put you
at risk for overdose and
death. Even if you take your dose correctly as prescribed you are at
risk for opioid addiction, abuse,
and misuse that can lead to death.
•
Not for use to treat pain that is not around-the-clock.
Important information about DURAGESIC ® :
•
Get emergency help right away if you use too much DURAGESIC ®
(overdose) . When you first
start taking DURAGESIC ® , when your dose is changed, or if you take
too much (overdose),
serious or life threatening breathing problems that can lead to death
may occur.
•
Taking DURAGESIC ® with other opioid medicines, benzodiazepines,
alcohol, or other central
nervous system depressants (including street drugs) may cause severe
drowsiness, decreased
awareness, breathing difficulties, with slow or shallow breathing,
coma, and death.
•
Never give anyone else your DURAGESIC ® . They could die from taking
it. Selling or giving away
DURAGESIC ® is against the law.
•
Store DURAGESIC ® , securely, out of sight and reach of children, and
in a location not accessible
by others, including visitors to the home.
•
If the patch accidentally sticks to a family member while in close
contact, take the patch off, wash the
area with water, and get emergency help right away because an
accidental exposure to DURAGESIC
® can lead to death or other

Summary of Product characteristics

DURAGESIC- FENTANYL PATCH
JANSSEN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DURAGESIC SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DURAGESIC.
DURAGESIC (FENTANYL TRANSDERMAL SYSTEM) FOR TRANSDERMAL
ADMINISTRATION, CII
INITIAL U.S. APPROVAL: 1968
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION
STRATEGY
(REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE;
NEONATAL
OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISK OF
INCREASED
FENTANYL ABSORPTION WITH APPLICATION OF EXTERNAL HEAT; AND RISKS FROM
CONCOMITANT USE OF BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
DURAGESIC EXPOSES USERS TO RISKS OF ADDICTION, ABUSE, AND MISUSE,
WHICH CAN LEAD TO OVERDOSE AND
DEATH. ASSESS PATIENT'S RISK BEFORE PRESCRIBING, AND MONITOR REGULARLY
FOR THESE BEHAVIORS OR
CONDITIONS. (5.1)
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION, ABUSE, AND MISUSE, THE
FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED A RISK EVALUATION AND
MITIGATION STRATEGY (REMS)
FOR THESE PRODUCTS. (5.2)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. (5.3)
ACCIDENTAL EXPOSURE TO DURAGESIC, ESPECIALLY IN CHILDREN, CAN RESULT
IN FATAL OVERDOSE OF FENTANYL.
(5.4 )
PROLONGED USE OF DURAGESIC DURING PREGNANCY CAN RESULT IN NEONATAL
OPIOID WITHDRAWAL SYNDROME,
WHICH MAY BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED. 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. (5.5)
CONCOMITANT USE WITH CYP3A4 INHIBITORS (OR DISCONTINUATION OF CYP3A4
INDUCERS) CAN RESULT IN A FATAL
OVERDOSE OF FENTANYL. (5.6)
EXPOSURE OF THE DURAGESIC APPLICATION SITE AND SURROUNDING AREA TO
DIRECT EXTER