FENTANYL- fentanyl patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Fentanyl (UNII: UF599785JZ) (Fentanyl - UNII:UF599785JZ)

Available from:

Sandoz,Inc.

INN (International Name):

Fentanyl

Composition:

Fentanyl 12.5 ug in 1 h

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 o

Product summary:

Fentanyl Transdermal System (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 to 30°C (59 – 86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Patient Information leaflet

Sandoz,Inc.
----------
This Medication Guide has been approved by the
U.S. Food and Drug Administration.
Revised 08/2018
Medication Guide
Fentanyl Transdermal System, CII
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 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.
•
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 using it. Store
Fentanyl Transdermal System away from children and in a safe place to
prevent stealing or abuse.
Selling or giving away Fentanyl Transdermal System is against the law.
•
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
Fentanyl Transdermal System can lea

Summary of Product characteristics

FENTANYL- FENTANYL PATCH
SANDOZ,INC.
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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 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._
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 CYP 3A4 INHIBITORS (OR DISCONTINUATION OF CYP 3A4
INDUCERS) CAN RESULT IN A
FATAL OVERDOSE OF FENTANYL. (5.6)
EXPOSURE OF THE FEN