LETRAM 250 (Levetiracetam Tablets 250mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LEVETIRACETAM

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

LEVETIRACETAM

Unit dalam pakej:

10 X 10tablet Tablets; 10 X 10tablet Tablets

Dikeluarkan oleh:

Hetero Labs Limited

Risalah maklumat

LETRAM (LEVETIRACETAM TABLET)
(Levetiracetam 250mg & 500mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What LETRAM is used for
2.
How LETRAM works
3.
Before you use LETRAM
4.
How to take LETRAM
5.
While you are using LETRAM
6.
Side effects
7.
Storage and Disposal of LETRAM
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT LETRAM IS USED FOR
LETRAM is indicated as monotherapy in
the
treatment
of
partial
onset
seizures
with or without secondary generalization
in patients from 16 years of age with
newly diagnosed epilepsy.
LETRAM is indicated as adjuctive
theraphy:
•
In the treatment of seizures in adults
and children from 4 years of age with
epilepsy.
•
In the treatment of myoclonic seizures
in adults and adolscents from 12 years of
age with Juvenile Myoclonic Epilepsy.
•
In the treatment of primary generalized
tonic-clonic
seizures
in
adults
and
children
from
12
years
of
age
with
Idiopathic Generalized Epilepsy.
HOW LETRAM_ _WORKS
LETRAM is an anti-epileptic medicine
(a
medicine
used
to
treat
seizures
in
epilepsy).
BEFORE YOU USE LETRAM
_When you must not use it _
_ _
Do not take LETRAM
:
•
If you are allergic (hypersensitive)
to
LETRAM
_ _
or any of the other
ingredients of
LETRAM.
PREGNANCY AND LACTATION
Pregnancy
Ask your doctor or pharmacist for advice
before taking any medicine.
If you are pregnant or if you think you
may
be
pregnant,
please
inform
your
doctor.
LETRAM
_ _
should
not
be
used
during
pregnancy
unless
clearly
necessary.
The potential risk to your unborn child is
unknown.
LETRAM
_ _
has
shown
unwanted reproductive effects in animal
studies at dose levels higher than you
would need to control your seizures.
Breastfeeding
Breast-feeding
is
not
recommended
during treatment.
-
_Before you start use it _
Take
special
care
with
LETRAM
and
check
with
your
doctor
or
pharmacist
before
using
this
medicine
if
you
are
suffering or have ever suffered from any
of the following conditions or illnesses:
•
If you suffer fr

Ciri produk

LETRAM 250 (Levetiracetam Tablets 250 Mg)
LETRAM 500 (Levetiracetam Tablets 500 Mg)
DESCRIPTION AND COMPOSITION:
LETRAM 250 (Levetiracetam Tablets 250 Mg):
Blue coloured, oblong shaped, scored film coated tablets debossed with
‘H’ on one side
and ‘87’ on other side.
Each film-coated tablet contains 250 mg of Levetiracetam.
LETRAM 500 (Levetiracetam Tablets 500 Mg):
Yellow coloured, oblong shaped, scored, film coated tablets debossed
with ‘H’ on one
side and ‘88’ on other side.
Each film-coated tablet contains 500 mg of Levetiracetam.
PHARMACODYNAMICS
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.
_ _
_Mechanism of action _
The mechanism of action of Levetiracetam still remains to be fully
elucidated but appears
to be different from the mechanisms of current antiepileptic medicinal
products.
_ _
_Pharmacodynamics effects _
Levetiracetam induces seizure protection in a broad range of animal
models of partial and
primary
generalized
seizures
without
having
pro-convulsant
effect.
The
primary
metabolite is inactive.
In man, activity in both partial and generalized epilepsy conditions
(epileptiform
discharge/photoparoxysmal
response)
has
confirmed
the
broad
spectrum
of
the
preclinical pharmacological profile.
_ _
PHARMACOKINETICS
Levetiracetam is a highly soluble and permeable compound. The
pharmacokinetic profile
is linear and time-independent with low intra- and inter-subject
variability. There is no
modification of the clearance after repeated administration. There is
no evidence for any
relevant gender, race or circadian variability. The pharmacokinetic
profile is comparable
in healthy volunteers and in patients with epilepsy.
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.
A significant correlat