SABRIL TABLET 500 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

VIGABATRIN

Available from:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC code:

N03AG04

Dosage:

500 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

VIGABATRIN 500 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Patheon France

Authorization status:

ACTIVE

Authorization date:

1994-12-09

Patient Information leaflet

SABRIL
®
500MG
Vigabatrin 
Film-coated tablet 
[sanofi aventis logo] 
COMPOSITION 
Each film-coated tablet contains : vigabatrin (active
ingredient) 500mg – Other excipients : 
microcrystalline cellulose, povidone, sodium, starch
glycolate, magnesium stearate, hypromellose, 
titanium dioxide, Macrogol 8000. 
INDICATIONS 
Treatment in combination with other anti-epileptic drugs for
patients with resistant partial epilepsy with 
or without secondary generalization, that is where all other
appropriate drug combinations have 
proved inadequate or have not been tolerated. 
POSOLOGY AND METHOD OF ADMINISTRATION 
SABRIL treatment may only be initiated by a specialist
in epileptology, neurology. Follow-up should 
be arranged under supervision of a specialist
in epileptology, neurology or paediatric neurology. 
SABRIL is for oral administration once or twice daily and may
be taken before or after meals. Tablets 
are swallowed with half a glass of water. 
If the control of epilepsy is not clinically significantly
improved after an adequate trial, vigabatrin 
treatment should be discontinued. Vigabatrin should
be gradually withdrawn under close medical 
supervision. 
The tablet form is not suitable for children aged less
than 6 years due to the risk of choking. 
ADULTS: 
Maximal efficacy is usually seen in the 2 – 3g/day range. 
A starting dose of 1g daily should be added to the patient’s
current anti-epileptic drug regimen. The 
daily dose should then be titrated in 0.5g increments at weekly
intervals depending on clinical 
response and tolerability. 
The highest recommended dose is 3g/day. 
No direct correlation exists between the plasma concentration and the
efficacy. The duration of the 
effect of the drug is dependent on the rate of GABA transaminase
resynthesis rather than the 
concentration of the drug in the plasma
(see also Sections Properties and Pharmacokinetic�

Summary of Product characteristics

SG/SAB/0621/CCDSv14
SABRIL
®
500MG
Vigabatrin
Film-coated tablet
[sanofi aventis logo]
COMPOSITION
Each
film-coated
tablet
contains
:
vigabatrin
(active
ingredient)
500mg
–
Other
excipients
:
microcrystalline cellulose, povidone, sodium, starch glycolate,
magnesium stearate, hypromellose,
titanium dioxide, Macrogol 8000.
INDICATIONS
Treatment in combination with other anti-epileptic drugs for patients
with resistant partial epilepsy with
or without secondary generalization, that is where all other
appropriate drug combinations have proved
inadequate or have not been tolerated.
POSOLOGY AND METHOD OF ADMINISTRATION
SABRIL treatment may only be initiated by a specialist in
epileptology, neurology. Follow-up should be
arranged under supervision of a specialist in epileptology, neurology
or paediatric neurology.
SABRIL is for oral administration once or twice daily and may be taken
before or after meals. Tablets
are swallowed with half a glass of water.
If the control of epilepsy is not clinically significantly improved
after an adequate trial, vigabatrin
treatment should be discontinued. Vigabatrin should be gradually
withdrawn under close medical
supervision.
The tablet form is not suitable for children aged less than 6 years
due to the risk of choking.
ADULTS:
Maximal efficacy is usually seen in the 2 – 3g/day range.
A starting dose of 1g daily should be added to the patient’s current
anti-epileptic drug regimen. The
daily dose should then be titrated in 0.5g increments at weekly
intervals depending on clinical response
and tolerability.
The highest recommended dose is 3g/day.
No direct correlation exists between the plasma concentration and the
efficacy. The duration of the
effect of the drug is dependent on the rate of GABA transaminase
resynthesis rather than the
concentration of the drug in the plasma (see also Sections Properties
and Pharmacokinetic properties).
CHILDREN:
The recommended starting dose in children is 40mg/kg/day. Maintenance
recommendations in relation
to bodyweight are:
Bodyweight:
10-