FENTANYL- fentanyl patch, extended release

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Lake Erie Medical DBA Quality Care Products LLC

INN (Международно Name):

FENTANYL

Композиция:

FENTANYL 25 ug in 1 h

Начин на приложение:

TRANSDERMAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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 - 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 opioid formulations, 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 otherwise inadequate to provide sufficient management of pain. Fentanyl transdermal system is contraindicated in the following

Каталог на резюме:

Fentanyl transdermal system is supplied in cartons containing 5 individually packaged systems. See chart for information regarding individual systems. * This lowest dosage is designated as 12 mcg/h (however, the actual dosage is 12.5 mcg/h) to distinguish it from 125 mcg/h dosage that could be prescribed by using multiple patches. Store in original unopened blister. Store up to 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F).

Статус Оторизация:

Abbreviated New Drug Application

Листовка

FENTANYL- FENTANYL PATCH, EXTENDED RELEASE
Lake Erie Medical DBA Quality Care Products LLC
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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 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.
•
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

Данни за продукта

FENTANYL- FENTANYL PATCH, EXTENDED RELEASE
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._
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 APPLICATION SITE AND
SURROUNDING AREA TO DIRECT
EXTERNAL HEAT SOURCES. TEMPERATURE DEPENDENT INCREASES IN FENTANYL
RELEASEFROM THE SYSTEM MAY
RESULT IN OVERDOSE AND DEATH. (5.11)
RECENT MAJOR CHANGES
Boxed Warning 04/2014
Indications and Usage (1) 04/2014
Dosage and Admin