LAMOTRIX 25MG TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LAMOTRIGINE

Boleh didapati daripada:

KOMEDIC SDN BHD

INN (Nama Antarabangsa):

LAMOTRIGINE

Unit dalam pakej:

30Tablet Tablets

Dikeluarkan oleh:

MEDOCHEMIE (FAR EAST) LTD - ORAL FACILITY

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
LAMOTRIX TABLET
Lamotrigine (25mg, 50mg, 100mg, 200mg)
________________________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET:
1.
What LAMOTRIX is used for
2.
How LAMOTRIX works
3.
Before you use LAMOTRIX
4.
How to use LAMOTRIX
5.
While you are using it
6.
Side effects
7.
Storage and disposal of LAMOTRIX
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT LAMOTRIX IS USED FOR
LAMOTRIX is used as:
-
an adjunctive therapy in treatment of
partial seizures and generalised tonic-
clonic seizures.
-
a
supplementary
(add-on)
treatment
against
seizure
in
connection
with
Lennox-Gastaut Syndrome in patients
MORE THAN 3
years of age.
HOW LAMOTRIX WORKS
LAMOTRIX treats epilepsy by blocking
the
signals
in
the
brain
that
trigger
epileptic seizures.
LAMOTRIX is an antiepileptic medicine
of the phenyltriazine class. Brain cells
need to work at a certain rate to function
normally. During a seizure, brain cells are
forced to work much more rapidly than
normal.
BEFORE YOU USE LAMOTRIX
_When you must not use it _
Do not take LAMOTRIX
-
if you are allergic to lamotrigine or
any of the other ingredients of this
medicine
(listed
in
Product
description).
-
If you have liver disease
_ _
_Pregnancy _
_and _
_breast-feeding _
_and _
_fertility _
If you are pregnant or breast-feeding,
think
you
may
be
pregnant
or
are
planning to have a baby, ask your doctor
or pharmacist for advice before taking
this medicine. The medicine should not
be used in pregnancy unless the benefit is
considered to outweigh the potential risk
for the foetus.
Lamotrigine is found in the milk in small
amounts
and
may
affect
breast
fed
infants.
Breastfeeding
is
not
recommended
during lamotrigine therapy.
_Before you start to use it _
Talk to your healthcare providers before
taking LAMOTRIX:
-
If you ever had a rash during previous
treatment
with
lamotrigine or
with
any other antiepileptic drug
-
If you have liver or

Ciri produk

LAMOTRIX ®
(LAMOTRIGINE)
COMPOSITION: LAMOTRIX® tablets contain 25, 50, 100 and 200mg of
lamotrigine.
PHARMACEUTICAL FORM:
LAMOTRIX® 25mg tablets are beige coloured, round, flat, marked MC at
one side, with diameter 6mm.
LAMOTRIX® 50mg tablets are beige coloured, round, flat and have a
break-line, with diameter 8mm.
LAMOTRIX® 100mg tablets are beige coloured, round, flat and have a
break-line, with diameter 9.5mm.
LAMOTRIX® 200mg tablets are beige coloured, round, flat and have a
break-line, with diameter 12.7mm.
PHARMACOLOGY:
_PHARMACOKINETIC PROPERTIES: _Lamotrigine is readily absorbed from the
gut with no significant first pass metabolism. Peak
plasma concentration
occurs in about 2.5 hours. The presence of food would delay the time
to reach maximum
concentration but the extent of absorption is not affected.
The pharmacokinetics are linear up to doses of 450mg. There is
considerable inter-individual variation in steady state
maximum concentrations but within and individual concentrations vary
very little.
About 55% of lamotrigine is protein bind. Displacement from plasma
protein is highly unlikely to lead to toxicity. The volume
of distribution (Vd) is 0.92 to 1.22 l/kg.
When given as monotherapy, lamotrigine induces its own metabolism to a
modest extend depending on dose. Lamotrigine
does not affect the pharmacokinetics of other AEDs or drugs that
metabolised by cytochrome P450 enzymes.
The mean steady state of clearance in healthy adults is 39 ± 14ml/min
and it is independent of the dose. Lamotrigine is
metabolised to 2-N-glucuronide conjugate (inactive) which is the major
metabolite, representing 70% of total metabolites.
Also, to 5-N-glucuronide conjugate (inactive) and to 2-N-methyl
metabolite (inactive). The enzymes responsible for
metabolism of lamotrigine are the up-glucuronyl transferases. Less
than 10% is excreted unchanged in urine and 2% in
faeces. The mean elimination half-life is 24 to 35 hours.
In adults, the co-administration of lamotrigine and enzyme-inducing
drugs such as carbamazepine