SINEMET CR 50200 TABLET

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CARBIDOPA; LEVODOPA

Available from:

ORGANON SINGAPORE PTE. LTD.

ATC code:

N04BA02

Dosage:

50 mg

Pharmaceutical form:

TABLET

Composition:

CARBIDOPA 50 mg; LEVODOPA 200 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

MERCK SHARP & DOHME (AUSTRALIA) PTY LTD

Authorization status:

ACTIVE

Authorization date:

1992-10-12

Patient Information leaflet

S-IPC-MK0295B-CR-082013                         

LOCAL PRODUCT CIRCULAR 

SINEMET
®
 CR

(car b id o p a an d  levo d o p a) 

SINEMET
®
  CR

is  a  co m b in at io n   o f   car b id o p a,  an   ar o m at ic  am in o   acid   d ecar b o xylase 
in h ib it o r , an d  levo d o p a, t h e m et ab o lic p r ecu r so r  o f  d o p am in e, in  a p o lym er -b ased  
co n t r o lled -r elease  t ab let   f o r m u lat io n ,  f o r   u se  in   t h e  t r eat m en t   o f   Par kin so n 's 
d isease  an d   syn d r o m e.  SINEMET  CR  is  p ar t icu lar ly   u sef u l  t o   r ed u ce  "o f f "  t im e  in  
p at ien t s  t r eat ed  p r evio u sly  w it h  a co n ven t io n al levo d o p a/ d ecar b o xy lase in h ib it o r  
co m b in at io n   w h o   h av e  h ad   p r ed ict ab le  p eak -d o se  d yskin esias  an d   u n p r ed ict ab le 
m o t o r  f lu ct u at io n s.  

Pat ien t s  w it h   Par kin so n 's  d isease  t r eat ed   w it h   p r ep ar at io n s  co n t ain in g   levo d o p a 
m ay  d evelo p   m o t o r   f lu ct u at io n s  ch ar act er ized   b y   en d -o f -d o se  f ailu r e,  p eak  d o se 
d yskin esia,  an d   akin esia.  Th e  ad v an ced   f o r m   o f   m o t o r   f lu ct u at io n s  ("o n -o f f " 
p h en o m en o n )  is  ch ar act er ized   b y  u n p r ed ict ab le  sw in g s  f r o m   m o b ilit 

Summary of Product characteristics

S-IPC-OG0295B-CR-062023
LOCAL PRODUCT CIRCULAR
SINEMET® CR
(carbidopa and levodopa)
SINEMET® CR
is a combination of carbidopa, an aromatic amino acid decarboxylase
inhibitor, and
levodopa, the metabolic precursor of dopamine, in a polymer-based
controlled-release tablet
formulation, for use in the treatment of Parkinson's disease and
syndrome. SINEMET CR is
particularly
useful
to
reduce
"off"
time
in
patients
treated
previously
with
a
conventional
levodopa/decarboxylase inhibitor combination who have had predictable
peak-dose dyskinesias
and unpredictable motor fluctuations.
Patients with Parkinson's disease treated with preparations containing
levodopa may develop
motor fluctuations characterized by end-of-dose failure, peak dose
dyskinesia, and akinesia. The
advanced form of motor fluctuations ("on-off" phenomenon) is
characterized by unpredictable
swings from mobility to immobility. Although the causes of the motor
fluctuations are not completely
understood, it has been demonstrated that they can be attenuated by
treatment regimens that
produce steady plasma levels of levodopa.
Levodopa relieves the symptoms of Parkinson's disease by being
decarboxylated to dopamine in
the brain. Carbidopa, which does not cross the blood-brain barrier,
inhibits only the extracerebral
decarboxylation of levodopa, making more levodopa available for
transport to the brain and
subsequent conversion to dopamine. This normally obviates the
necessity for large doses of
levodopa at frequent intervals. The lower dosage reduces or may help
eliminate gastrointestinal
and cardiovascular side effects, especially those which are
attributable to dopamine being formed
in extracerebral tissues.
SINEMET CR is designed to release the active ingredients over a 4- to
6-hour period. With this
formulation there is less variation in plasma levodopa levels and the
peak plasma level is 60%
lower than with conventional SINEMET.
In clinical trials, patients with motor fluctuations experienced
reduced "off" time with SINEMET CR
when compared with SINEME