NUCYNTA- tapentadol hydrochloride tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

tapentadol hydrochloride (UNII: 71204KII53) (tapentadol - UNII:H8A007M585)

Διαθέσιμο από:

Janssen Pharmaceuticals, Inc.

INN (Διεθνής Όνομα):

tapentadol hydrochloride

Σύνθεση:

tapentadol 50 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

NUCYNTA (tapentadol) tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve NUCYNTA tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products: - Have not been tolerated, or are not expected to be tolerated, - Have not provided adequate analgesia, or are not expected to provide adequate analgesia NUCYNTA tablets are contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions (5.2)] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.5)] - Known or suspected gastrointestinal obstruction, including suspected paralytic ileus [see Warnings and Precauti

Περίληψη προϊόντος:

NUCYNTA Tablets are available in the following strengths and packages. All tablets are round and biconvex-shaped. 50 mg tablets are yellow and debossed with "O-M" on one side and "50" on the other side, and are available in bottles of 100 (NDC 50458-820-04) and hospital unit dose blister packs of 10 (NDC 50458-820-02). 75 mg tablets are yellow-orange and debossed with "O-M" on one side and "75" on the other side, and are available in bottles of 100 (NDC 50458-830-04) and hospital unit dose blister packs of 10 (NDC 50458-830-02). 100 mg tablets are orange and debossed with "O-M" on one side and "100" on the other side, and are available in bottles of 100 (NDC 50458-840-04) and hospital unit dose blister packs of 10 (NDC 50458-840-02). Storage and Handling Store up to 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Keep NUCYNTA tablets in a secure place out of reach of children. NUCYNTA tablets that are no longer needed should be destroyed by flushing down the toilet.

Καθεστώς αδειοδότησης:

New Drug Application

Φύλλο οδηγιών χρήσης

Janssen Pharmaceuticals, Inc.
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This Medication Guide has been approved by the U.S. Food and
Drug Administration
NUC-022-C.1 Issued: 12/2016
Medication Guide
NUCYNTA (new-SINN-tah)
(tapentadol) tablets , CII
NUCYNTA tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage short
term (acute) pain in adults, when other pain treatments such as
non-opioid pain medicines do not
treat your pain well enough or you cannot tolerate them.
•
An 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.
Important information about NUCYNTA tablets:
•
Get emergency help right away if you take too much NUCYNTA (overdose)
tablets. When you
first start taking NUCYNTA tablets, 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 tablets 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 else your NUCYNTA tablets. They could die from
taking it. Store
NUCYNTA tablets away from children and in a safe place to prevent
stealing or abuse. Selling or
giving away NUCYNTA tablets is against the law.
Do not take NUCYNTA tablets if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
Before taking NUCYNTA tablets, tell your healthcare provider if you
have a history of:
•
head injury, seizures
•
problems urinating
•
abuse of street or prescription drugs, alcohol addiction, or mental
health problems.
•
liver, kidney, thyroid problems
•
pancreas or gallbladder problems
Tell your healthcare provider if you are:
•
pregnant or planning to become pregnant. Pr

Αρχείο Π.Χ.Π.

NUCYNTA- TAPENTADOL HYDROCHLORIDE TABLET, FILM COATED
JANSSEN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NUCYNTA® TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NUCYNTA® TABLETS.
NUCYNTA® (TAPENTADOL) 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; AND RISKS
FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
NUCYNTA TABLETS EXPOSE 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 AND
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 INGESTION OF NUCYNTA TABLETS, ESPECIALLY BY CHILDREN, CAN
RESULT IN A FATAL OVERDOSE OF
TAPENTADOL. (5.2)
PROLONGED USE OF NUCYNTA TABLETS DURING PREGNANCY CAN RESULT IN
NEONATAL OPIOID WITHDRAWAL
SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED.
IF PROLONGED OPIOID USE IS
REQUIRED 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)
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
CONCOMITANT PRESCRIBING FOR USE IN PATIENTS FOR WHOM ALTERNATIVE
TREATMENT OPTIONS ARE INADEQUATE;
LIMIT DOSAGES AND DURATIONS TO THE MINIMUM REQUIRED; AND FOLLOW
PATIENTS FOR SIGNS AND SYMPTOMS OF
RESPIRATORY DEPRESSION AND SEDATION (5.4), (7).
RECENT MAJOR CHANGES
Boxed Warning
12/2016
Indications and Usage (1)
12/2016
Dosage and Administration (2)
12/2016
C