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

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Quality Care Products, LLC

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 contraindicated in patients with: - Sign

उत्पाद समीक्षा:

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 55700-796-60 100 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 55700-797-60 150 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  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  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  Storage and Handling Store at 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.

प्राधिकरण का दर्जा:

New Drug Application

सूचना पत्रक

Quality Care Products, LLC
----------
Medication Guide
NUCYNTA® ER (new-SINN-tah E-R) (tapentadol) extended-release oral
tablets, CII
This Medication Guide has been approved by the U.S.
Food and Drug Administration
NUCX-012-C.1 Revised: 12/2016
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, or ot

उत्पाद विशेषताएं

NUCYNTA ER- TAPENTADOL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
QUALITY CARE PRODUCTS, LLC
----------
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; RISK EVALUATION AND MITIGATION
STRATEGY (REMS); 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)
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. INSTRUCT
PATIENTS TO SWALLOW
NUCYNTA ER TABLETS WHOLE TO AVOID EXPOSURE TO A POTENTIALLY FATAL DOSE
OF
TAPENTADOL. (5. 3)
ACCIDENTAL INGESTION OF NUCYNTA ER, ESPECIALLY IN CHILDREN, CAN RESULT
IN FATAL
OVERDOSE OF TAPENTADOL. (5.3)
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 (5.4).
INSTRUCT PATIENTS NOT TO CONSUME ALCOHOL OR ANY PRODUCTS CONTAINING
ALCOHOL WHILE
TAKING NUCYNTA ER BECAUS