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

可用日期:

STAT RX USA LLC

INN（国际名称）:

TAPENTADOL HYDROCHLORIDE

组成:

TAPENTADOL HYDROCHLORIDE 75 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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)] . Like drugs with mu-opioid agonist activity, NUCYNTA® is contraindicated in any patient who has or is suspected of having paralytic ileus. 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 may result in adverse cardiovascular events [see Drug Interactions (7.4)] . Pregnancy Category C. Tapentadol HCl was evaluated for teratogenic effects in pregnant rats and rabbits following intravenous and subcutaneous exposure during the period of embryofetal organogenesis. W

產品總結:

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
STAT RX USA LLC
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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. Ask your doctor or pharmacist if any of your medicines is an
MAOI.
What should I tell my doctor before taking NUCYNTA®?
NUCYNTA® may not be

产品特点

NUCYNTA - TAPENTADOL HYDROCHLORIDE TABLET, FILM COATED
STAT RX USA LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NUCYNTA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR NUCYNTA .
NUCYNTA (TAPENTADOL) IMMEDIATE-RELEASE ORAL TABLETS C-II
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
NUCYNTA is an opioid analgesic indicated for the relief of moderate to
severe acute pain in patients 18 years of age or
older. (1)
DOSAGE AND ADMINISTRATION
As with many centrally-acting analgesic medications, the dosing
regimen of NUCYNTA should be individualized
according to the severity of pain being treated, the previous
experience with similar drugs and the ability to monitor the
patient. (2)
Initiate NUCYNTA with or without food at a dose of 50 mg, 75 mg, or
100 mg every 4 to 6 hours depending upon pain
intensity. On the first day of dosing, the second dose may be
administered as soon as one hour after the first dose, if
adequate pain relief is not attained with the first dose. Subsequent
dosing is 50 mg, 75 mg, or 100 mg every 4 to 6
hours and should be adjusted to maintain adequate analgesia with
acceptable tolerability. Daily doses greater than 700
mg on the first day of therapy and 600 mg on subsequent days have not
been studied and are, therefore, not
recommended. (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg, 75 mg, 100 mg (3)
CONTRAINDICATIONS
Impaired pulmonary function (significant respiratory depression, acute
or severe bronchial asthma or hypercapnia in
unmonitored settings or the absence of resuscitative equipment) (4.1)
Paralytic ileus (4.2)
Concomitant use with monoamine oxidase inhibitors (MAOI) or use within
14 days (4.3)
WARNINGS AND PRECAUTIONS
Respiratory depression: Increased risk in elderly, debilitated
patients, those suffering from conditions accompanied by
hypoxia, hypercapnia, or upper airway obstruction. (5.1)
CNS effects: Additive CNS depressive effects when used in conjunction
with alcohol, other opioids, or illici