TOPAMAX 100 TABLET 100 mg

Ország: Szingapúr

Nyelv: angol

Forrás: HSA (Health Sciences Authority)

Aktív összetevők:

TOPIRAMATE

Beszerezhető a:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

ATC-kód:

N03AX11

Adagolás:

100 mg

Gyógyszerészeti forma:

TABLET, FILM COATED

Összetétel:

TOPIRAMATE 100 mg

Az alkalmazás módja:

ORAL

Recept típusa:

Prescription Only

Gyártó:

CILAG AG

Engedélyezési státusz:

ACTIVE

Engedély dátuma:

1998-03-24

Betegtájékoztató

 
PRODUCT NAME

TOPAMAX
®
 (topiramate) 

DOSAGE FORMS AND STRENGTHS  

FILM-COATED TABLETS 
The tablets are debossed, engraved or embossed. 

25 MG TABLET 
Round,  white  tablet  imprinted  with  “TOP”  on  one  side  and  “25”  on  the  other.  Each  tablet 
contains 25 mg of topiramate. 

50 MG TABLET 
Round, light yellow tablet imprinted with “TOP” or “TOPAMAX” on one side and “50” on the 
other. Each tablet contains 50 mg of topiramate. 

100 MG TABLET 
Round,  yellow  tablet  imprinted  with  “TOP”  or  “TOPAMAX”  on  one  side  and  “100”  on  the 
other. Each tablet contains 100 mg of topiramate. 

For excipients, see _List of Excipients_. 

CLINICAL INFORMATION 

INDICATIONS 

EPILEPSY 
TOPAMAX
®
 is indicated as monotherapy for adults and children with partial onset seizures and 
generalized seizures, including tonic-clonic seizures.  

TOPAMAX
®
 is indicated as adjunctive therapy for adults and children with
partial onset seizures 
or generalized tonic-clonic seizures and seizures associated
with Lennox Gastaut syndrome. 

MIGRAINE 
TOPAMAX
®
  is  also  indicated  for  adults  for  the  prophylaxis  of  migraine  headache.  The 
usefulness of TOPAMAX
®
 in the acute treatment of migraine headache has not been
studied. 

DOSAGE AND ADMINISTRATION 

DOSAGE  
For  optimal  seizure  control  in  both  adults  and  children,  it  is  recommended  that  therapy  be 
initiated at a low dose followed by titration to
an effective dose. 

_EPILEPSY _
_– ADJUNCTIVE THERAPY _


  ADULTS  
Therapy should begin at 25 to 50 mg nightly for one week. Subsequently, at weekly or bi-weekly 
intervals, the dose should be increased by 25 to 50 mg/day and taken in two divided doses. Dose 
ti

Termékjellemzők

PRODUCT NAME
TOPAMAX
®
(topiramate)
DOSAGE FORMS AND STRENGTHS
FILM-COATED TABLETS
The tablets are debossed, engraved or embossed.
25 MG TABLET
Round, white tablet imprinted with “TOP” on one side and “25”
on the other. Each tablet
contains 25 mg of topiramate.
50 MG TABLET
Round, light yellow tablet imprinted with “TOP” or “TOPAMAX”
on one side and “50” on the
other. Each tablet contains 50 mg of topiramate.
100 MG TABLET
Round, yellow tablet imprinted with “TOP” or “TOPAMAX” on one
side and “100” on the
other. Each tablet contains 100 mg of topiramate.
For excipients, see
_List of Excipients_
.
CLINICAL INFORMATION
INDICATIONS
EPILEPSY
TOPAMAX
®
is indicated as monotherapy for adults and children with partial onset
seizures and
generalized seizures, including tonic-clonic seizures.
TOPAMAX
®
is indicated as adjunctive therapy for adults and children with
partial onset seizures
or generalized tonic-clonic seizures and seizures associated with
Lennox Gastaut syndrome.
MIGRAINE
TOPAMAX
®
is
also
indicated
for
adults
for
the
prophylaxis
of
migraine
headache.
The
usefulness of TOPAMAX
®
in the acute treatment of migraine headache has not been studied.
DOSAGE AND ADMINISTRATION
DOSAGE
For optimal seizure control in both adults and children, it is
recommended that therapy be
initiated at a low dose followed by titration to an effective dose.
_EPILEPSY – ADJUNCTIVE THERAPY_
•
ADULTS
Therapy should begin at 25 to 50 mg nightly for one week.
Subsequently, at weekly or bi-weekly
intervals, the dose should be increased by 25 to 50 mg/day and taken
in two divided doses. Dose
titration should be guided by clinical outcome. Some patients may
achieve efficacy with once-a-
day dosing.
In clinical trials as adjunctive therapy, 200 mg was effective and was
the lowest dosage studied.
This is therefore considered the minimum effective dose. The usual
daily dose is 200 to 400 mg
in two divided doses. Individual patients have received doses as high
as 1600 mg/day.
These dosing recommendations