hovid-Levetiracetam Tablets 500 mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LEVETIRACETAM

Boleh didapati daripada:

HOVID BERHAD

INN (Nama Antarabangsa):

LEVETIRACETAM

Unit dalam pakej:

3x10 Tablets; 6x10 Tablets

Dikeluarkan oleh:

Jubilant Generics Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
HOVID-LEVETIRACETAM TABLETS 500 MG
_ _
Levetiracetam Tablet 500 mg
1
WHAT IS IN THIS LEAFLET
1.
What hovid-Levetiracetam
Tablets 500 mg is used for
2.
How hovid-Levetiracetam
Tablets 500 mg works
3.
Before you use hovid-
Levetiracetam Tablets 500 mg
4.
How to use hovid-Levetiracetam
Tablets 500 mg
5.
While you are using hovid-
Levetiracetam Tablets 500 mg
6.
Side effects
7.
Storage and disposal of hovid-
Levetiracetam Tablets 500 mg
8.
Product description
9.
Manufacturer and product
registration holder
10.
Date of revision
11.
Serial Number
WHAT HOVID-LEVETIRACETAM TABLETS
500 MG IS USED FOR
hovid-Levetiracetam Tablets is used
on its own in adults and adolescents
from 16 years of age with a certain
type of newly diagnosed epilepsy.
Epilepsy is a condition where the
patients have repeated fits (seizures).
Levetiracetam is used for the epilepsy
form in which the fits initially affect
only one side of the brain, but could
thereafter extend to larger areas on
both sides of the brain (partial onset
seizures with or without secondary
generalization). hovid-Levetiracetam
Tablets has been given to you by your
doctor to reduce the number of fits.
hovid-Levetiracetam Tablets is also
used 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.
HOW HOVID-LEVETIRACETAM TABLETS
500 MG WORKS
hovid-Levetiracetam Tablets contains
Levetiracetam as active substance,
which treats seizure in epilepsy.
BEFORE YOU USE HOVID-
LEVETIRACETAM TABLETS 500 MG
_- When you must not use it_
Do not take hovid-Levetiracetam
Tablets if you

Ciri produk

x x x
D
E
S
C
R
I
P
T
I
O
N
hovid-Levetiracetam Tablet 500 mg is a yellow coloured, oblong shaped
film-coated tablet, with a
scoreline on one side and debossed with “500” on the other side of
tablet.
C
O
M
P
O
S
I
T
I
O
N
Each film coated tablet consists of 500 mg Levetiracetam Ph. Eur.
P
H
A
R
M
A
C
O
D
Y
N
A
M
I
C
S
Levetiracetam
is
a
pyrrolidone
derivative
(S-enantiomer
of
α-ethyl-2-oxo-1-pyrrolidine
acetamide). In man, an activity in both partial and generalised
epilepsy conditions (epileptiform
discharge/photoparoxysmal response) has confirmed the broad spectrum
pharmacological
profile of levetiracetam. The primary metabolite of levetiracetam is
inactive.
P
H
A
R
M
A
C
O
K
I
N
E
T
I
C
S
Levetiracetam is a highly soluble and permeable compound. Due to its
complete and linear
absorption, plasma levels can be predicted from the oral dose of
levetiracetam expressed as
mg/kg bodyweight. Therefore, there is no need for plasma level
monitoring of levetiracetam.
ABSORPTION
Levetiracetam is rapidly absorbed after oral administration. Oral
absolute bioavailability is close
to 100 %. 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. The
volume of distribution of levetiracetam is close to the total body
water volume.
BIOTRANSFORMATION
Levetiracetam is not extensively metabolised in humans. The major
metabolic pathway 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 blood cells. The
metabolite ucb L057 is
pharmacologically inactive. Levetiracetam had little or no effect on
CYP1A2, SULT1E1 or
UGT1A1. Levetiracetam caused mild induction of CYP2B6 and CYP3A4.
ELIMINATION
The plasma half life in adults does not vary with dose, route of
administration or repeated
administration. Levetiracetam is excreted ma