FENTANYL TRANSDERMAL SYSTEM- fentanyl transdermal system patch, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

FENTANYL

Composition:

FENTANYL 50 ug in 1 h

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: -  in patients who are not opioid‑tolerant [see Warnings and Precautions (5.2)]. - in the management of acute or intermittent pain, or in patients who require opioid analgesia for a short period of tim

Product summary:

Fentanyl Transdermal System is supplied in cartons containing 4 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-25 7.8 2.75 0406-9025-76 Fentanyl transdermal system-50 15.6 5.50 0406-9050-76 Fentanyl transdermal system-75 23.4 8.25 0406-9075-76 Fentanyl transdermal system-100 31.2 11.0 0406-9000-76 Store in original unopened pouch. Store up to 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FENTANYL TRANSDERMAL SYSTEM- FENTANYL TRANSDERMAL SYSTEM PATCH,
EXTENDED RELEASE
Lake Erie Medical DBA Quality Care Products LLC
----------
Medication Guide
Fentanyl Transdermal System, CII
(fĕn´ tә-nĭl)
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 syste

Summary of Product characteristics

FENTANYL TRANSDERMAL SYSTEM- FENTANYL TRANSDERMAL SYSTEM 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: ABUSE POTENTIAL, RESPIRATORY DEPRESSION AND DEATH, ACCIDENTAL
EXPOSURE,
CYTOCHROME P450 3A4 INTERACTION, AND EXPOSURE TO HEAT
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
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)
CYP 3A4 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)
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
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)
Fentanyl transdermal system is NOT intended for use as an as-needed
analgesic. (