Levisat 500mg Film Coated tablet

Страна: Малайзия

Язык: английский

Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активный ингредиент:

LEVETIRACETAM

Доступна с:

SM PHARMACEUTICALS SDN. BHD.

ИНН (Международная Имя):

LEVETIRACETAM

Штук в упаковке:

10x10 Tablets

Производитель:

SM PHARMACEUTICALS SDN. BHD.

тонкая брошюра

_Consumer Medication Information Leaflet (RiMUP) _
LEVISAT 500MG FILM COATED TABLET
Levetiracetam 500mg Film Coated Tablet
_ _
______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1. WHAT LEVISAT 500MG FIM COATED TABLET IS USED FOR
2. HOW LEVISAT500MG FILM COATED TABLET WORKS
3. BEFORE YOU TAKE LEVISAT 500MG FILM COATED TABLET
4. HOW TO TAKE LEVISAT 500MG FILM COATED TABLET
5. WHILE YOU ARE USING LEVISAT 500MG FILM COATED TABLET
6. SIDE EFFECTS
7. STORAGE AND DISPOSAL OF LEVISAT 500MG FILM COATED TABLET
8. PRODUCT DESCRIPTION
9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER
10. DATE OF REVISION
11.
RIMUP SERIAL NUMBER.
WHAT LEVISAT 500MG FILM COATED
TABLET IS USED FOR
•
on its own in adults and adolescents
from 16 years of age with a certain
typeof
newly
diagnosed
epilepsy.
Epilepsy
is
acondition
where
the
patients haverepeated fits (seizures).
Levetiracetam isused for the epilepsy
form in which thefits initially affect
only one side of thebrain, but could
thereafter extend tolarger areas on
both sides of the brain(partial onset
seizures
with
or
withoutsecondary
generalization).
Levisat
hasbeen
given to you by your doctor toreduce
the number of fits.
•
as an add-on to other antiepileptic
medicines to treat:
- partial onset seizures with or without
secondary generalization in adults and
children from 4 years of age with
epilepsy.
- myoclonic seizures (short, shock-like
jerks of a muscle or group of muscles) in
adults and adolescents from 12 years of
age with juvenile myoclonic epilepsy
- primary generalized tonic-clonic
seizures (major fits, including loss of
consciousness) in adults and children
from 12 years of age with Idiopathic
Generalized Epilepsy.
LEVISAT
500MG
FILM
COATED
TABLET
WORKS
Levisat is an antiepileptic medicine (a
medicine used to treat seizures in
epilepsy).
BEFORE
YOU
TAKE
LEVIAT
500MG
FILM
COATED T

Характеристики продукта

SM PHARMACEUTICALS SDN BHD
LEVISAT 500MG FILM COATED TABLET
DESCRIPTION:
Yellow colored, oblong-shaped biconvex film coated tablet, debossed
with
“L” and “U” on either side of break line on one side and
“X02” on the other
side.
COMPOSITION:
Each film coated tablet contains:
Levetiracetam 500 mg
ACTIONS AND MODE OR MECHANISMS OF ACTION:
MECHANISMS OF ACTION:
The
mechanism
of
action
of
levetiracetam
still
remains
to
be
fully
elucidated.
Clinical efficacy and safety
Adjunctive therapy in the treatment of partial onset seizures with or
without
secondary generalization in adults, adolescents and children from 4
years of
age with epilepsy.
PHARMACOLOGY (SUMMARY OF PHARMACODYNAMICS AND
PHARMACOKINETICS):
PHARMACODYNAMICS
Pharmacotherapeutic group: antiepileptics, other antiepileptics. The
active
substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of
α
-
ethyl-2-oxo-1-pyrrolidine
acetamide),
chemically
unrelated
to
existing
antiepileptic active substances.
PHARMACOKINETICS
Levetiracetam
is
a
highly
soluble
and
permeable
compound.
The
pharmacokinetic profile is linear with low intra- and inter-subject
variability.
There is no modification of the clearance after repeated
administration.
ABSORPTION
Levetiracetam is rapidly absorbed after oral administration. Oral
absolute
bioavailability is close to 100 %. Peak plasma concentrations (C
max
) are
achieved at 1.3 hours after dosing. Steady-state is achieved after two
days of
a twice daily administration schedule. The extent of absorption is
dose-
independent and is not altered by food.
DISTRIBUTION
Neither levetiracetam nor its primary metabolite are significantly
bound to
plasma proteins (< 10 %).
METABOLISM
Levetiracetam
is
not
extensively
metabolized
in
humans.
The
major
metabolic pathway (24 % of the dose) is an enzymatic hydrolysis of the
acetamide group. Production of the primary metabolite, UCB L057, is
not
supported by liver cytochrome P
450
isoforms. Hydrolysis of the acetamide
group was measurable in a large number of tissues including b