FENTANYL patch

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Lake Erie Medical DBA Quality Care Products LLC

प्रशासन का मार्ग:

TRANSDERMAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 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. Limitations of Use Fentanyl transdermal system is contraindicated in the following patients and situations: Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Observe newborns for symptoms of neonatal opioid withdrawal syndrome, such as poor feeding, diarrhea, irritability, tremor, rigidity, and seizures, and manage accordingly . [see ]

उत्पाद समीक्षा:

NDC:35356-634-05 in a CARTON of 5 PATCHS

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

Lake Erie Medical DBA Quality Care Products LLC
----------
Medication
Guide
Fentanyl
Transdermal
System, CII
(fen’ ta nil)
Issue:
4/2014
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:
•
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. Get
emergency help
right away if you
use too much
fentanyl
transdermal
system
(overdose).
•
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 lead
to death or other
serious medical
problems.
•
Proper disposal
of fentanyl
transdermal
system after use
and for unused
patches when no
longer needed:
Fold the sticky
sides of the patch
together and
flush down the
toilet. Do not put
patches in a trash
can.
Do not use Fentanyl
Transdermal System if
you have:
•

उत्पाद विशेषताएं

FENTANYL- FENTANYL PATCH
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
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; LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME
P450 3A4
INTERACTION, AND EXPOSURE TO HEAT
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
•
•
•
RECENT MAJOR CHANGES
04/2014 Boxed Warning
Indications and Usage ( ) 04/2014 1
Dosage and Administration ( ) 04/2014 2
Warnings and Precautions ( ) 04/2014 5
INDICATIONS AND USAGE
•
•
Limitations of use:
•
DOSAGE AND ADMINISTRATION
•
•
•
FENTANYL TRANSDERMAL SYSTEM EXPOSES USERS TO RISKS OF ADDICTION,
ABUSE, AND MISUSE, WHICH CAN LEAD
TO OVERDOSE AND DEATH. ASSESS EACH PATIENT’S RISK BEFORE
PRESCRIBING, AND MONITOR REGULARLY FOR
DEVELOPMENT OF THESE BEHAVIORS OR CONDITIONS. ( ) 5.1
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. ( ) 5.2
ACCIDENTAL EXPOSURE TO FENTANYL TRANSDERMAL SYSTEM, ESPECIALLY IN
CHILDREN, CAN RESULT IN FATAL
OVERDOSE OF FENTANYL. ( ) 5.3
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. ( ) 5.4
INITIATION OF CYP 3A4 INHIBITORS (OR DISCONTINUATION OF CYP 3A4
INDUCERS) CAN RESULT IN A FATAL
OVERDOSE OF FENTANYL FROM FENTANYL TRANSDERMAL SYSTEM. ( ) 5.10
AVOID EXPOSING THE FENTANYL TRANSDERMAL SYSTEM APPLI