Valparin XR 300 Tablet

Country: Malaysia

Language: English

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

Active ingredient:

SODIUM VALPROATE; VALPROIC ACID

Available from:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (International Name):

SODIUM VALPROATE; VALPROIC ACID

Units in package:

10Tablet Tablets; 30 Tablet Tablets; 100 Tablet Tablets

Manufactured by:

TORRENT PHARMACEUTICALS LTD.

Patient Information leaflet

VALPARIN XR 300 TABLET
_ _
Sodium valproate (300mg)
_ _
_ _
1
_ Consumer Medication Information leaflet (RiMUP)_
WHAT IS IN THIS LEAFLET
1.
What is Valparin XR used for
2.
How Valparin XR works
3.
Before you use Valparin XR
4.
How to use Valparin XR
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Valparin
XR
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT VALPARIN XR IS USED FOR
•
The
treatment
of
generalised
or
partial
epilepsy,
particularly
with
the following patterns of seizures:
−
Absence
(short
period
of
“blanking out” or staring into
space).
−
Myoclonic
(brief
shock-like
jerks of a muscle).
−
Atonic (abrupt loss of muscle
tone).
−
Tonic-clonic
(loss
of
consciousness
and
violent
muscle contractions).
−
Mixed.
•
Partial
epilepsy:
simple
(not
affecting awareness or memory) or
complex
seizures,
secondary
generalised seizures (start in one
area and spread to both sides of the
brain)
and
specific
syndromes
(West, Lennox-Gastaut).
•
The
treatment
and
prevention
of
mania
associated
with
bipolar
disorder
(a
brain
disorder
that
causes unusual shifts in mood).
HOW VALPARIN XR WORKS
Valparin
XR
contains
sodium
valproate.
It
belongs
to
a
group
of
medicines
called
anti-convulsants
or
anti-epileptic agents. These medicines
are thought to work by controlling brain
chemicals which send signals to nerves
so that seizures do not happen.
BEFORE YOU USE VALPARIN XR
WARNING
FOR WOMEN AND GIRLS
BEFORE YOU START TO USE IT:
This medicine can seriously harm an
unborn baby.
Always
use
effective
contraception
during treatment with sodium valproate.
If
you
are
thinking
about
becoming
pregnant, or if you are pregnant, contact
your doctor immediately.
You must CONTINUE taking sodium
valproate unless your doctor tell you to
stop.
-
_When you must not use it _
Do not take Valparin XR if you are:
•
Allergic (hypersensitive) to sodium
valproate
or
any
of
the
other
ingredients.
•
Having liver problems or you or
your family have a history of liver
pro

Summary of Product characteristics

xxxxxxxx-5253
COMPOSITION
VALPARIN XR 300 MG TABLET
Each film coated controlled release tablet contains:
Sodium Valproate 199.8 mg
Valproic acid 87 mg
(Both together correspond to Sodium Valproate 300mg)
DESCRIPTION
Valparin XR 300 mg Tablet is a broad spectrum antiepileptic drug
containing sodium
valproate in a Controlled Release Form.
VALPARIN XR 300 mg TABLET: White, round, biconvex film coated tablets.
CLINICAL PHARMACOLOGY
Valproate exerts its effect primarily on the central nervous system.
Its anticonvulsant
properties are exerted against a wide variety of epilepsies
experimental animal
models and humans. Its main mechanism of action seems to
be related to reinforcement of the gabaergic pathway.
The various pharmacokinetic studies conducted with valproate
demonstrate the
following points, some of which may have practical consequences on
prescription:
-
The blood bioavailability of valproate following oral administration
approaches
100 %.
-
The volume of distribution is primarily limited to the blood and to
rapid-exchange
extracellular fluids. Valproate diffuses into the C.S.F. and brain.
-
Half-life is approximately 8 to 20 hours and is usually shorter in
children.
-
Significant therapeutic results are achieved with serum concentrations
between
40 to 100 mg / l, but there is no definite correlation between serum
level and
therapeutic response.
-
The steady state plasma concentration is achieved rapidly (3 to 4
days).
-
Valproate is extensively bound to proteins. Binding is dose-dependent
and
saturable.
-
Valproate is primarily excreted in the urine following glucuronic acid
conjugation
and beta- oxidation.
-
Valproate molecule is dialyzable, but hemodialysis only affects the
free fraction
of valproate in the blood (approximately 10 percent).
-
Valproate does not induce enzymes involved in cytochrome P 450
metabolism:
in contrast to most other antiepileptics, it therefore does not
accelerate its own
degradation or that of other substances such as oral contraceptives
and oral
anticoagulants.
In comparison to