HIGHLIGHTS OF PRESCRIBING INFORMATION

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Janssen Pharmaceuticals, Inc.

Pot uporabe:

TRANSDERMAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

DURAGESIC® (fentanyl transdermal system) is supplied in cartons containing 5 individual child-resistant 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)] .

Status dovoljenje:

New Drug Application

Navodilo za uporabo

Janssen Pharmaceuticals, Inc.
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This Medication Guide has been approved by the
U.S. Food and Drug Administration.
Revised 04/2022
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 or call 911 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. Talk to
your healthcare provider about naloxone, a medicine for the emergency
treatment of an opioid
overdose.
•
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,

Lastnosti izdelka

DURAGESIC (FENTANYL SYSTEM)- FENTANYL PATCH
JANSSEN PHARMACEUTICALS, INC.
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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), 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 EXTERNAL
HEAT SOURC