NUCYNTA ER- tapentadol hydrochloride tablet, film coated, extended release

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

TAPENTADOL HYDROCHLORIDE (UNII: 71204KII53) (TAPENTADOL - UNII:H8A007M585)

Dostępny od:

Janssen Pharmaceuticals, Inc.

INN (International Nazwa):

TAPENTADOL HYDROCHLORIDE

Skład:

TAPENTADOL 50 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

NUCYNTA ER (tapentadol) is indicated for the management of: - pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate - neuropathic pain associated with diabetic peripheral neuropathy (DPN) severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. 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 opioid formulations [see Warnings and Precautions (5.1)] , reserve NUCYNTA ER 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 otherwise inadequate to provide sufficient management of pain. NUCYNTA ER is not indicated as an as-needed (prn) analgesic. - NUCYNTA ER is not indicated as an as-neede

Podsumowanie produktu:

NUCYNTA ER tablets are available in the following strengths and packages: 50 mg extended-release tablets are white oblong-shaped with a black print "OMJ 50" on one side and are available in bottles of 60 with child-resistant closure (NDC 50458-860-01) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 50458-860-02). 100 mg extended-release tablets are light-blue oblong-shaped with a black print "OMJ 100" on one side and are available in bottles of 60 with child-resistant closure (NDC 50458-861-01) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 50458-861-02). 150 mg extended-release tablets are blue-green oblong-shaped with a black print "OMJ 150" on one side and are available in bottles of 60 with child-resistant closure (NDC 50458-862-01) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 50458-862-02). 200 mg extended-release tablets are blue oblong-shaped with a depression in the middle running lengthwise on each side and with a black print "OMJ 200" on one side, and are available in bottles of 60 with child- resistant closure (NDC 50458-863-01) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 50458-863-02). 250 mg extended-release tablets are dark blue oblong-shaped with a depression in the middle running lengthwise on each side and with a white print "OMJ 250" on one side, and are available in bottles of 60 with child-resistant closure (NDC 50458-864-01) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 50458-864-02). Storage and Handling Store up to 20°C - 25°C (68°F - 77°F); excursions permitted to 15° C - 30°C (59° F - 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Status autoryzacji:

New Drug Application

Ulotka dla pacjenta

Janssen Pharmaceuticals, Inc.
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
NUCX-012-C.1 Revised: 12/2016
Medication Guide
NUCYNTA® ER (new-SINN-tah E-R) (tapentadol) extended-release oral
tablets, CII
NUCYNTA ER 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, 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.
•
Also used to manage pain from damaged nerves (neuropathic pain) that
happens with diabetes
and is severe enough to require daily around-the-clock, long-term
treatment with an opioid, when
other pain treatments such as non-opioid pain 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 used to treat pain that is not around-the-clock pain.
Important information about NUCYNTA ER:
•
Get emergency help right away if you take too much NUCYNTA ER
(overdose). When you first
start taking NUCYNTA ER, 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 NUCYNTA ER with other opioid medicines, benzodiazepines,
alcohol, or other central
nervous system depressants (including street drugs) can cause severe
drowsiness, decreased
awareness, breathing problems, coma, and death.
•
Never give anyone your NUCYNTA ER. They could die from taking it.
Store NUCYNTA ER
away from children and in a safe place to prevent stealing or abuse.
Selling or giving away
NUCYNTA ER is against the law.
Do not take NUCYNTA ER if you have:
•
severe asthma, trouble breathing, o

Charakterystyka produktu

NUCYNTA ER- TAPENTADOL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
JANSSEN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NUCYNTA ER SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR NUCYNTA ER
NUCYNTA ER (TAPENTADOL) EXTENDED-RELEASE TABLETS FOR ORAL USE
C-II INITIAL U.S. APPROVAL: 2008
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE- THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION
WITH
ALCOHOL AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER
CNS
DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
NUCYNTA ER 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. INSTRUCT PATIENTS TO SWALLOW
NUCYNTA ER TABLETS WHOLE TO
AVOID EXPOSURE TO A POTENTIALLY FATAL DOSE OF TAPENTADOL. (5.2)
ACCIDENTAL INGESTION OF NUCYNTA ER, ESPECIALLY IN CHILDREN, CAN RESULT
IN FATAL OVERDOSE OF
TAPENTADOL. (5.2)
PROLONGED USE OF NUCYNTA ER 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 (5.3).
INSTRUCT PATIENTS NOT TO CONSUME ALCOHOL OR ANY PRODUCTS CONTAINING
ALCOHOL WHILE TAKING NUCYNTA
ER BECAUSE CO-INGESTION CAN RESULT IN FATAL PLASMA TAPENTADOL LEVELS.
(5.4)
CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM (CNS) DEPRESSANTS,
INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDATION, RESPIRATORY
DEPRESSION, COMA, AND DEATH. RESERVE
CONCOMI