FENTANYL- fentanyl patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Par Pharmaceutical Inc.

INN (International Name):

FENTANYL

Composition:

FENTANYL 25 ug in 1 h

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fentanyl transdermal system is contraindicated in the following patients and situations: Clinical Considerations Fetal/neonatal adverse reactions 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 Warnings Precautions (5.4)]. Teratogenic Effects Pregnancy C: There are no adequate and well-controlled studies in pregnant women. Fentanyl transdermal system should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The potential effects of fentanyl on embryo-fetal development were studied in the rat, mouse, and rabbit models. Published literature reports that administration of fentanyl (0, 10, 100, or 500 mcg/kg/day) to pregnant female Sprague-Dawley

Product summary:

Fentanyl transdermal system is supplied in cartons containing 5 individually packaged systems. See chart for information regarding individual systems. Fentanyl Transdermal System-25 10 2.5 49884-761-78 Fentanyl Transdermal System-50 20 5 49884-762-78 Fentanyl Transdermal System-75 30 7.5 49884-763-78 Fentanyl Transdermal System-100 40 10 49884-764-78 Store in original unopened pouch. Do not store above 77°F (25°C).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FENTANYL- FENTANYL PATCH
Par Pharmaceutical Inc.
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MEDICATION GUIDE
Fentanyl Transdermal System, CII
Rx only
Fentanyl Transdermal System, CII
Rx only
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 medication 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.
•
Get emergency help right away if you use too much

Summary of Product characteristics

FENTANYL- FENTANYL PATCH
PAR PHARMACEUTICAL INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
FENTANYL TRANSDERMAL SYSTEM, CII
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FENTANYL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR FENTANYL.
FENTANYL (FENTANYL) PATCH FOR TRANSDERMAL USE.
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
Boxed Warning 4/2014
Indications and Usage ( 1) 4/2014
Dosage and Administration ( 2) 4/2014
Warnings and Precautions ( 5) 4/2014
INDICATIONS AND USAGE
•
•
•
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 OF 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 DEPENDE