FENTANYL patch

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Quality Care Products, LLC

INN (Alþjóðlegt nafn):

FENTANYL

Samsetning:

FENTANYL 25 ug in 1 h

Stjórnsýsluleið:

TRANSDERMAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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 Fentanyl transdermal system is contraindicated in: Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.5)] . Available data with fentanyl transdermal system in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, fentanyl administration to pregnant rats during organogenesis was

Vörulýsing:

Fentanyl Transdermal System is supplied in cartons containing 5 individually packaged systems. The 12 mcg/hour* transdermal system is 3.13 cm2 and contains 1.28 mg fentanyl. Each transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 12 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date. They are available as follows: NDC 0378-9119-98 carton containing 5 transdermal systems The 25 mcg/hour transdermal system is 6.25 cm2 and contains 2.55 mg fentanyl. Each transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 25 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date. They are available as follows: NDC 0378-9121-98 carton containing 5 transdermal systems The 37.5 mcg/hour transdermal system is 9.38 cm2 and contains 3.83 mg fentanyl. Each transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 37.5 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date. They are available as follows: NDC 0378-9125-98 carton containing 5 transdermal systems The 50 mcg/hour transdermal system is 12.5 cm2 and contains 5.10 mg fentanyl. Each transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 50 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date. They are available as follows: NDC 0378-9122-98 carton containing 5 transdermal systems The 62.5 mcg/hour transdermal system is 15.63 cm2 and contains 6.38 mg fentanyl. Each transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 62.5 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date. They are available as follows: NDC 0378-9126-98 carton containing 5 transdermal systems The 75 mcg/hour transdermal system is 18.75 cm2 and contains 7.65 mg fentanyl. Each transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 75 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date. They are available as follows: NDC 0378-9123-98 carton containing 5 transdermal systems The 87.5 mcg/hour transdermal system is 21.88 cm2 and contains 8.93 mg fentanyl. Each transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 87.5 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date. They are available as follows: NDC 0378-9127-98 carton containing 5 transdermal systems The 100 mcg/hour transdermal system is 25 cm2 and contains 10.20 mg fentanyl. Each transdermal system consists of a translucent rectangular patch with rounded corners, printed with “Fentanyl 100 mcg/hr” and diagonal stripes in blue ink, on a removable release liner. The patch is overlaid and underlaid with additional release liners, and is contained in a square pouch. The pouch is labeled with the lot number and expiration date. They are available as follows: NDC 0378-9124-98 carton containing 5 transdermal systems *This lowest strength is designated as 12 mcg/hour (however, the actual strength is 12.5 mcg/hour) to distinguish it from a 125 mcg/hour strength that could be prescribed by using multiple transdermal systems. Store in original unopened pouch. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] PHARMACIST: Dispense a Medication Guide with each prescription.

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

Quality Care Products, LLC
Reference Label Set Id: d287d93b-a764-4682-bcdb-958112d26473
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MEDICATION GUIDE
Fentanyl Transdermal System, CII
(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 many fentanyl transdermal
systems (overdose).
When you first start taking fentanyl transdermal system, when your
dose is changed, or if you use
too many (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 system can lead to dea

Vara einkenni

FENTANYL- FENTANYL PATCH
QUALITY CARE PRODUCTS, LLC
REFERENCE LABEL SET ID: D287D93B-A764-4682-BCDB-958112D26473
----------
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._
•
•
•
•
•
•
•
•
RECENT MAJOR CHANGES
Dosage and Administration (2) 1/2018
Boxed Warning 09/2018
Warnings and Precautions (5.2) 09/2018
INDICATIONS AND USAGE
Fentanyl transdermal system contains fentanyl, an opioid agonist, and
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. (1)
Patients considered opioid-tolerant are those taking, for one week or
longer, at least 60 mg oral 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. (2.1)
Limitations of use:
•
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
A