NUCYNTA- tapentadol hydrochloride tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

TAPENTADOL (UNII: H8A007M585) (TAPENTADOL - UNII:H8A007M585)

可用日期:

Lake Erie Medical DBA Quality Care Products LLC

INN（国际名称）:

TAPENTADOL

组成:

TAPENTADOL 50 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

1 INDICATIONS AND USAGE NUCYNTA® (tapentadol) is indicated for the relief of moderate to severe acute pain in patients 18 years of age or older. 4 CONTRAINDICATIONS 4.1 Impaired Pulmonary Function Like other drugs with mu-opioid agonist activity, NUCYNTA® is contraindicated in patients with significant respiratory depression in unmonitored settings or the absence of resuscitative equipment. NUCYNTA® is also contraindicated in patients with acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence of resuscitative equipment [see Warnings and Precautions (5.1)] . 4.2 Paralytic Ileus Like drugs with mu-opioid agonist activity, NUCYNTA® is contraindicated in any patient who has or is suspected of having paralytic ileus. 4.3 Monoamine Oxidase Inhibitors NUCYNTA® is contraindicated in patients who are receiving monoamine oxidase (MAO) inhibitors or who have taken them within the last 14 days due to potential additive effects on norepinephrine levels which ma

產品總結:

16 HOW SUPPLIED/STORAGE AND HANDLING 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). Store up to 25ºC (77ºF); excursions permitted to 15º – 30ºC (59º – 86ºF) [see USP Controlled Room Temperature]. Protect from moisture. Keep out of reach of children.

授权状态:

New Drug Application

资料单张

NUCYNTA- TAPENTADOL HYDROCHLORIDE TABLET, FILM COATED
Lake Erie Medical DBA Quality Care Products LLC
----------
NUCYNTA - tapentadol hydrochloride tablet, film coated
Ortho-McNeil-Janssen Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
NUCYNTA® (new-SINN-tah)
(tapentadol)
immediate-release oral tablets C-II
•
NUCYNTA® is a federally controlled substance (C-II) because it can be
abused. Keep
NUCYNTA® in a safe place to prevent theft. Selling or giving away
NUCYNTA® may harm
others, and is against the law.
•
Tell your doctor if you (or a family member) have ever abused or been
dependent on alcohol,
prescription medicines, or street drugs.
Read the Medication Guide that comes with NUCYNTA® before you start
taking it and each time you
get a new prescription. There may be new information. This Medication
Guide does not take the place of
talking to your doctor about your medical condition or your treatment.
Talk to your doctor if you have
any questions.
What is the most important information I should know about NUCYNTA®?
NUCYNTA® is a tablet that contains tapentadol, a strong medicine that
is a pain medicine.
Use NUCYNTA® exactly how your doctor tells you to. Do not use
NUCYNTA® if it has not been
prescribed for you.
You should not take NUCYNTA® if your pain is mild and can be
controlled with other pain medicines
such as non-steroidal anti-inflammatory medicines (NSAIDS) or
acetaminophen.
What is NUCYNTA®?
•
NUCYNTA® is a prescription medicine that is used in adults 18 years
of age or older to treat
moderate to severe pain that is expected to last a short time.
NUCYNTA® is for short-term use only because the risks for withdrawal
symptoms, abuse and
addiction are higher when NUCYNTA® is used longer.
Who should not take NUCYNTA®?
Do not take NUCYNTA® if you:
•
have severe lung problems
•
have a gastrointestinal problem called paralytic ileus in which the
intestines are not working
normally.
•
take a monoamine oxidase inhibitor (MAOI) medicine or have taken an
MAOI within the last 14
days. A

产品特点

NUCYNTA- TAPENTADOL HYDROCHLORIDE TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
NUCYNTA 50 MG
11 DESCRIPTION
NUCYNTA (tapentadol) Tablets are immediate-release film-coated tablets
for oral administration.
The chemical name is
3-[(1_R_,2_R_)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol
monohydrochloride. The structural formula is:
The molecular weight of tapentadol HCl is 257.80, and the molecular
formula is C
H NO•HCl. The
n-octanol:water partition coefficient log P value is 2.87. The pKa
values are 9.34 and 10.45. In addition
to the active ingredient tapentadol HCl, tablets also contain the
following inactive ingredients:
microcrystalline cellulose, lactose monohydrate, croscarmellose
sodium, povidone, magnesium
stearate, and Opadry
II, a proprietary film-coating mixture containing polyvinyl alcohol,
titanium
dioxide, polyethylene glycol, talc, and aluminum lake coloring.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Tapentadol is a centrally-acting synthetic analgesic. Although its
exact mechanism is unknown,
analgesic efficacy is thought to be due to mu-opioid agonist activity
and the inhibition of
norepinephrine reuptake.
12.2 Pharmacodynamics
Tapentadol is a centrally-acting synthetic analgesic. It is 18 times
less potent than morphine in binding to
the human mu-opioid receptor and is 2–3 times less potent in
producing analgesia in animal models.
Tapentadol has been shown to inhibit norepinephrine reuptake in the
brains of rats resulting in increased
norepinephrine concentrations. In preclinical models, the analgesic
activity due to the mu-opioid
receptor agonist activity of tapentadol can be antagonized by
selective mu-opioid antagonists (e.g.,
naloxone), whereas the norepinephrine reuptake inhibition is sensitive
to norepinephrine modulators.
Tapentadol exerts its analgesic effects without a pharmacologically
active metabolite.
Effects on the cardiovascular system: There was no effect of
therapeutic and supratherapeutic doses of
tapentadol on the QT interval. In