FENTANYL patch

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Lake Erie Medical DBA Quality Care Products LLC

INN:

FENTANYL

composition:

FENTANYL 12 ug in 1 h

administration_route:

TRANSDERMAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Fentanyl transdermal system is a transdermal formulation of fentanyl indicated for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age and older when a continuous, around-the-clock opioid analgesic is required for an extended period of time, and the patient cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids. Patients considered opioid-tolerant are those who are taking 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 for a week or longer. Fentanyl transdermal system is contraindicated in the following patients and situations due to the risk of fatal respiratory depression: Fentanyl transdermal system is also contraindicated: Pregnancy C: There are no adequate and well-controlled studies in pregnant women. Fentanyl transdermal system should be used during pregnancy only

leaflet_short:

Fentanyl transdermal system is supplied in cartons containing 5 individually packaged systems. See chart for information regarding individual systems. Fentanyl Transdermal System Dose (mcg/hr) System Size (cm2 ) Fentanyl Content (mg) NDC Number Fentanyl Transdermal System - 12* 3.13 1.28 0378-9119-98 Fentanyl Transdermal System - 25 6.25 2.55 0378-9121-98 Fentanyl Transdermal System - 50 12.5 5.10 0378-9122-98 Fentanyl Transdermal System - 75 18.75 7.65 0378-9123-98 Fentanyl Transdermal System - 100 25 10.20 0378-9124-98 Store in original unopened pouch. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

authorization_status:

Abbreviated New Drug Application

PIL

Lake Erie Medical DBA Quality Care Products LLC
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MEDICATION GUIDE
Fentanyl Transdermal System, CII
(fen’ ta nil)
Issue: 7/2012
Fentanyl
Transdermal
System is:
•A strong
prescription pain
medicine that
contains an
opioid (narcotic)
that is used to
treat moderate to
severe around-
the-clock pain, in
people who are
already regularly
using opioid pain
medicine.
Important
information about
Fentanyl
Transdermal
System:
•Get emergency
help right away if
you use too much
fentanyl
transdermal
system
(overdose).
Fentanyl
transdermal
system overdose
can cause life
threatening
breathing
problems that can
lead to
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.
Do not use
fentanyl
transdermal
system if
you have:
•severe
asthma,
trouble
breathing,
or other
lung
problems.•a
bowel
blockage or
have
narrowing
of the
stomach or
intestines.
Before applying
fentanyl
transdermal
system, tell your
healthcare
provider if you
have a history
of:
•head injury,
seizures
•liver, kidney,
thyroid
problems•proble
ms urinating
•pancreas or
gallbladder
problems•abuse
of street or
prescription
drugs, alcohol
addiction, or
mental health
problems.
Tell your
healthcare
provider if you:
•have a fever•are
pregnant or
planning to
become
pregnant.
Fentanyl
transdermal
system may
harm your
unborn
baby.•are
breastfeeding.
Fentanyl passes
into breast milk
and may harm
your baby.•are
taking
prescription or
over-the-counter
medicines,
vitamins, or
herbal
supplements.
When using
fentanyl
transdermal
system:
•Do not change
your dose. Apply
fentanyl
transdermal
system exactly as
prescribed by
your healthcare
provider.•See the
detailed
Instructions for
Use for
information about
how to apply and
dispose of the
fentanyl
transdermal
system.•Do not
wear more than 1
patch at the same
time unless your
healthc

SPC

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: ABUSE POTENTIAL, RESPIRATORY DEPRESSION AND DEATH, ACCIDENTAL
EXPOSURE,
CYTOCHROME P450 3A4 INTERACTION, AND EXPOSURE TO HEAT
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
•
•
•
•
•
RECENT MAJOR CHANGES
Boxed Warning 7/2012
Indications and Usage (1) 7/2012
Dosage and Administration (2) 7/2012
Contraindications (4) 7/2012
Warnings and Precautions (5) 7/2012
INDICATIONS AND USAGE
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
CONTAINS A HIGH CONCENTRATION OF FENTANYL, A SCHEDULE II CONTROLLED
SUBSTANCE, WHICH IS SUBJECT TO
MISUSE, ABUSE, ADDICTION, AND CRIMINAL DIVERSION. (9)
FATAL RESPIRATORY DEPRESSION COULD OCCUR IN PATIENTS WHO ARE NOT
OPIOID-TOLERANT AND IN PATIENTS THAT
ARE OPIOID-TOLERANT EVEN IF FENTANYL TRANSDERMAL SYSTEM IS NOT MISUSED
OR ABUSED. (5)
ACCIDENTAL EXPOSURE OF FENTANYL TRANSDERMAL SYSTEM, ESPECIALLY IN
CHILDREN, CAN RESULT IN A FATAL
OVERDOSE OF FENTANYL. (5)
CYP3A4 INHIBITORS CAN RESULT IN A FATAL OVERDOSE OF FENTANYL FROM
FENTANYL TRANSDERMAL SYSTEM. (5)
AVOID EXPOSING THE FENTANYL TRANSDERMAL SYSTEM APPLICATION SITE AND
SURROUNDING AREA TO DIRECT
EXTERNAL HEAT SOURCES. TEMPERATURE DEPENDENT INCREASES IN FENTANYL
RELEASE FROM THE SYSTEM MAY
RESULT IN OVERDOSE AND DEATH. (5)
Fentanyl transdermal system contains fentanyl, a full opioid agonist.
Fentanyl transdermal system is indicated for the management of
persistent, moderate to severe chronic pain in
OPIOID-TOLERANT patients 2 years of age and older when a continuous,
around-the-clock opioid analgesic is needed for
an extended period of time. (1)
F