TORLEVA 250 MG TABLETS

Country: Малезија

Језик: Енглески

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

Активни састојак:

LEVETIRACETAM

Доступно од:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (Међународно име):

LEVETIRACETAM

Јединице у пакету:

60tablet Tablets; 100tablet Tablets

Произведен од:

TORRENT PHARMACEUTICALS LTD.

Информативни летак

TORLEVA TABLETS
Levetiracetam 250 mg
_ _
_ _
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is TORLEVA used for
2.
How TORLEVA works
3.
Before you use TORLEVA
4.
How to use TORLEVA
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
TORLEVA
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT TORLEVA IS USED FOR

Torleva
is
indicated
as
monotherapy
in
the
treatment
of
partial
onset
seizures
with
or
without
secondary
generalization
in
patients
from
16
years
newly
diagnosed with epilepsy

Torleva
is
indicated
in
the
treatment of partial onset seizures
with
or
without
secondary
generalization
in
adults
and
children from 4 years of age with
epilepsy.

Torleva is used in the treatment of
myoclonic
seizures
(brief,
shock-
like
muscle
jerks)
in
adults
and
adolescents from 12 years of age
with Juvenile Myoclonic Epilepsy.

In
the
treatment
of
primary
generalized
tonic-clonic
seizures
(grand mal seizures) in adults and
children from 12 years of age with
Idiopathic Generalised Epilepsy.
HOW TORLEVA WORKS
Levetiracetam
is
an
antiepileptic
medicine
(a
medicine
used
to
treat
seizures in epilepsy).
It is used to treat a certain form of
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
seizure
with
or
without
secondary
generalization). Levetiracetam has been
given to you by your doctor to reduce
the number of fits.
It works by inhibiting N-type Ca2+ in
brain.
BEFORE YOU USE TORLEVA
-
_When you must not use it _
If you are allergic (hypersensitive) to
levetiracetam, pyrrolidone or any of the
other ingredients of this medicine.
_Pregnancy and lactation_
_ _
Do
not
take
TORLEVA
if
you
are
pregnant, trying to get pregnant or think
you
may
be
pregnant.
If
you
get
pregnant while taking TORLEVA, stop
ta

Карактеристике производа

Proposed Prescribing Information
For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory
TORLEVA 250 MG TABLETS
LEVETIRACETAM TABLETS 250MG
BRAND OR PRODUCT NAME
TORLEVA 250 MG TABLETS
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
TORLEVA 250 MG TABLETS
Each film coated tablet contains:
Levetiracetam USP……………250mg
Colours: Lake of Indigo Carmine and Titanium dioxide
PRODUCT DESCRIPTION
Blue colored, oval shaped, film coated tablets debossed with break
line separating ‘250’and ‘MG’ on one side
and ‘1014’ on other side
DOSAGE FORM
Film coated tablet
PROUCT DESCRIPTION
The chemical name of levetiracetam, a single enantiomer, is (-)
-(S)-α-ethyl-2-oxo-1-pyrrolidine
acetamide, its molecular formula is C
8
H
14
N
2
O
2
and its molecular weight is 170.21. Levetiracetam is
chemically unrelated to existing antiepileptic drugs (AEDs). It has
the following structural formula:
Levetiracetam is a white to off-white crystalline powder with a faint
odor and a bitter taste. It is very
soluble in water (104.0 g/100 mL). It is freely soluble in chloroform
(65.3 g/100 mL) and in
methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL),
sparingly soluble in acetonitrile (5.7
g/100 mL) and practically insoluble in n-hexane
PHARMACODYNAMICS / PHARMACOKINETICS
PHARMACODYNAMICS
Levetiracetam affects intra neuronal Ca2+ levels by partial inhibition
of N-type Ca2+ currents and
by reducing the release of Ca2+ from intraneuronal stores. In
addition, it partially reverses the
reductions in GABA- and glycine-gated currents induced by zinc and
β-carbolines. Levetiracetam
and related analogs had affinity for binding to the synaptic vesicle
protein 2A which correlates with
the potency of their anti-seizure protection.
PHARMACOKINETICS
Levetiracetam is readily absorbed from the gastrointestinal tract with
a bioavailability of almost
100%; peak plasma concentrations are usually achieved within 1.3 hours
of oral doses and steady
state achieved after 2 days. Plasma protein binding is minimal at less
than