Nucynta IR Tablets 50 mg

Երկիր: Սինգապուր

Լեզու: անգլերեն

Աղբյուրը: HSA (Health Sciences Authority)

Ակտիվ բաղադրիչ:

Tapentadol Hydrochloride 58.24 mg eqv Tapentadol

Հասանելի է:

MUNDIPHARMA PHARMACEUTICALS PTE. LTD. (UEN 200411241W)

ATC կոդը:

N02AX06

Դոզան:

50 mg

Դեղագործական ձեւ:

TABLET, FILM COATED

Կազմը:

Tapentadol Hydrochloride 58.24 mg eqv Tapentadol 50 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

Prescription Only

Պատրաստված է:

Janssen Ortho LLC

Լիազորման կարգավիճակը:

ACTIVE

Հաստատման ամսաթիվը:

2014-09-08

Տեղեկատվական թերթիկ

NUCYNTA
®

(tapentadol) immediate-release oral tablets, September 2013, Version # 08

1 
PRODUCT NAME 
NUCYNTA
® 
(tapentadol) immediate-release (IR) oral tablets* 
®
 Registered Trademark of GRÜNENTHAL GmbH, used under license 
* Licensed by Grünenthal GmbH, Germany 

DOSAGE FORMS AND STRENGTHS 
Immediate-release tablet 
Each tablet contains: 

  50 mg tapentadol (as hydrochloride). 

  75 mg tapentadol (as hydrochloride). 

  100 mg tapentadol (as hydrochloride). 

50
mg tablet:  yellow coloured, round marked with “O-M” on one side and “50” on the other 
side 
75
mg tablet:  yellow-orange  round  coloured, marked  with  “O-M” on one side  and “75”  on 
the other side 
100
mg tablet: orange  coloured,  round  marked  with  “O-M”  on  one  side  and  “100”  on  the 
other side 

For excipients, see _List of Excipients_.  

Not all strengths may be marketed. 

CLINICAL INFORMATION 
INDICATIONS 
NUCYNTA
® 
is an opioid analgesic indicated for the relief of moderate to
severe acute pain in 
patients 18 years of age or older. 

DOSAGE AND ADMINISTRATION 
As  with  many  centrally  acting  analgesic  medications,  the  dosing  regimen  should  be 
individualized  according  to  the  severity  of  pain  being  treated,  the  previous  treatment 
experience and the ability to monitor the patient. 

The  recommended  oral  starting  dose  is  50,  75,  or  100  mg  tapentadol  every  4  to  6  hours 
depending upon the initial pain  intensity. On the first  day  of dosing, a  second dose may be 
taken as soon as one hour after the initial dose, if pain control is not achieved. Thereafter, the 
usual  recommended  dose  is  50  to  100  mg  tapentadol  every  4  to  6  hours  and

Ապրանքի հատկությունները

NUCYNTA
®
(tapentadol) immediate-release oral tablets, September 2013, Version #
08
1
PRODUCT NAME
NUCYNTA
®
(tapentadol) immediate-release (IR) oral tablets*
®
Registered Trademark of GRÜNENTHAL GmbH, used under license
* Licensed by Grünenthal GmbH, Germany
DOSAGE FORMS AND STRENGTHS
Immediate-release tablet
Each tablet contains:

50 mg tapentadol (as hydrochloride).

75 mg tapentadol (as hydrochloride).

100 mg tapentadol (as hydrochloride).
50 mg tablet:
yellow coloured, round marked with “O-M” on one side and “50”
on the other
side
75 mg tablet:
yellow-orange round coloured, marked with “O-M” on one side and
“75” on
the other side
100 mg tablet: orange coloured, round marked with “O-M” on one
side and “100” on the
other side
For excipients, see _List of Excipients_.
Not all strengths may be marketed.
CLINICAL INFORMATION
INDICATIONS
NUCYNTA
®
is an opioid analgesic indicated for the relief of moderate to severe
acute pain in
patients 18 years of age or older.
DOSAGE AND ADMINISTRATION
As
with
many
centrally
acting
analgesic
medications,
the
dosing
regimen
should
be
individualized
according
to
the
severity
of
pain
being
treated,
the
previous
treatment
experience and the ability to monitor the patient.
The recommended oral starting dose is 50, 75, or 100 mg tapentadol
every 4 to 6 hours
depending upon the initial pain intensity. On the first day of dosing,
a second dose may be
taken as soon as one hour after the initial dose, if pain control is
not achieved. Thereafter, the
usual recommended dose is 50 to 100 mg tapentadol every 4 to 6 hours
and should be
adjusted to maintain adequate analgesia with acceptable tolerability.
NUCYNTA
®
should be taken whole with sufficient liquid.
NUCYNTA
®
may be administered with or without food.
Total starting daily doses greater than 700 mg tapentadol and
maintenance daily doses greater
than 600 mg tapentadol have not been studied and are therefore, not
recommended.
As with all symptomatic treatments, the continued use of tapentadol
m