Trobalt Tablet 50 mg

Pajjiż: Singapor

Lingwa: Ingliż

Sors: HSA (Health Sciences Authority)

Ixtrih issa

Ingredjent attiv:

Retigabine

Disponibbli minn:

GLAXOSMITHKLINE PTE LTD

Kodiċi ATC:

N03AX21

Dożaġġ:

50.0 mg

Għamla farmaċewtika:

TABLET, FILM COATED

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

Prescription Only

Manifatturat minn:

GlaxoSmithKline LLC

Data ta 'l-awtorizzazzjoni:

2014-01-24

Fuljett ta 'informazzjoni

                                TROBALT™ 
RETIGABINE 
 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each film-coated tablet contains 50 mg, 100 mg, 200
mg or 300 mg of retigabine. 
 
For a full list of excipients, see section List of Excipients. 
 
 
PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet). 
 
50 mg tablets: Purple, round,
film-coated tablets, marked with “RTG 50” on one side. 
100 mg tablets: Green, round, film-coated tablets, marked with
“RTG 100” on one side. 
200 mg tablets: Yellow, oblong, film-coated tablets, marked with
“RTG-200” on one side.  
300 mg tablets: Green,
oblong, film-coated tablets, marked with “RTG-300” on
one side.  
 
 
CLINICAL PARTICULARS 
 
THERAPEUTIC INDICATIONS 
 
Adjunctive treatment of drug-resistant partial onset seizures,
with or without secondary generalisation, 
in patients with epilepsy where
other appropriate drug combinations have proved inadequate
or have 
not been tolerated. 
 
 
POSOLOGY AND METHOD OF ADMINISTRATION 
 
Posology 
 
Trobalt must be titrated,
according to individual patient response, in order to optimise
the balance 
between efficacy and tolerability. 
 
The maximum total daily starting dose is 300 mg (100 mg three
times daily). Thereafter, the total 
daily dose is increased by a maximum of 150
mg every week, according to the individual patient 
response and tolerability. An effective maintenance dose is
expected to be between 600 mg/day and 
1,200 mg/day. 
 
The maximum total maintenance dose is 1,200 mg/day.
The safety and efficacy of doses higher than 
1,200 mg/day have not been established. 
 
If patients miss one dose or more, it is recommended that
they take a single dose as soon as they 
remember. 
 
After taking a missed dose, at least 3 hours should be allowed
before the next dose and then the 
normal dosing schedule should be resumed. 
 
When withdrawing Trobal
                                
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