FENTANYL patch, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FENTANYL (UNII: UF599785JZ) (FENTANYL - UNII:UF599785JZ)

Available from:

Bryant Ranch Prepack

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fentanyl transdermal system 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 fentanyl transdermal system 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

Product summary:

NDC: 71335-1228-1 72 h in a PATCH / 1 in a POUCH/1 in a Case NDC: 71335-1228-2 72 h in a PATCH / 1 in a POUCH/2 in a Case NDC: 71335-1228-3 72 h in a PATCH / 1 in a POUCH/5 in a Case

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FENTANYL- fentanyl patch, extended release
Bryant Ranch Prepack
----------
Medication Guide
Fentanyl Transdermal System, Cll
(fen' ta nil)
Fentanyl transdermal system 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 fentanyl transdermal system:
•
Get emergency help or call 911 right away if you use too much fentanyl
transdermal system
(overdose). When you first start taking fentanyl transdermal system,
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 fentanyl transdermal system 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 fentanyl transdermal system. They could
die from taking it. Selling or
giving away fentanyl transdermal system is against the law.
•
Store fentanyl transdermal system, 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,

Summary of Product characteristics

FENTANYL- FENTANYL PATCH, EXTENDED RELEASE
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FENTANYL TRANSDERMAL
SYSTEM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FENTANYL
TRANSDERMAL SYSTEM.
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._
FENTANYL TRANSDERMAL SYSTEM 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 FENTANYL TRANSDERMAL SYSTEM, ESPECIALLY IN
CHILDREN, CAN
RESULT IN FATAL OVERDOSE OF FENTANYL. (5.4)
PROLONGED USE OF FENTANYL TRANSDERMAL SYSTEM 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 FENTANY