FENTANYL TRANSDERMAL SYSTEM patch, extended release

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Bryant Ranch Prepack

Via de administração:

TRANSDERMAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, 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/long-acting opioid formulations [see Warnings and Precautions (5.1)] , 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 o

Resumo do produto:

NDC: 71335-0683-1 1 h in a BOTTLE NDC: 71335-0683-2 2 h in a BOTTLE NDC: 71335-0683-3 5 h in a BOTTLE

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

Bryant Ranch Prepack
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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 or call 911 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. Talk to your healthcare
provider about naloxone, a medicine for the emergency treatment of
an opioid overdose.
•
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 taking it. Selling or giving away fentanyl
transdermal system is against the law.
•
Store fentanyl transdermal system, securely, out of sight and reach
of children, and in a location not accessible by others, including
visitors to the home.
•
If the patch accidentally sticks to a family member while in close
contact, take the patch off, wash the area wit

Características técnicas

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, CII
INITIAL U.S. APPROVAL: 1968
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION
STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL
EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4
INTERACTION; RISK OF INCREASED FENTANYL ABSORPTION WITH APPLICATION OF
EXTERNAL HEAT; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR
OTHER CNS DEPRESSANTS
_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 PATIENT’S RISK
BEFORE
PRESCRIBING, AND MONITOR REGULARLY FOR THESE BEHAVIORS OR CONDITIONS.
(5.1)
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION,
ABUSE, AND MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED
A RISK
EVALUATION AND MITIGATION STRATEGY (REMS) FOR THESE PRODUCTS. (5.2)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY,
ESPECIALLY UPON INITIATION OR FOLLOWING A DOSE INCREASE. (5.3)
ACCIDENTAL EXPOSURE TO FENTANYL TRANSDERMAL SYSTEM, ESPECIALLY IN
CHILDREN, CAN
RESULT IN FATAL OVERDOSE OF FENTANYL. (5.4)
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.
(5.5)
CONCOMITANT USE WITH CYP3A4 INHIBITORS (OR DISCONTINUATION OF CYP3A4
INDUCERS) CAN
RESULT IN A FATAL OVERDOSE OF