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:

Bryant Ranch Prepack

INN (International Name):

FENTANYL

Composition:

FENTANYL 100 ug in 1 h

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FENTANYL TRANSDERMAL SYSTEM- FENTANYL TRANSDERMAL SYSTEM PATCH,
EXTENDED RELEASE
BRYANT RANCH PREPACK
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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
RELEASE FROM THE SYSTEM MAY
RESULT IN OVERDOSE AND DEATH. (5.11)
RECENT MAJOR CHANGES
Boxed Warning 04/2014
Indications and Usage (1) 04/2014
Dosa