Apo-Lamotrigine 100 mg Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LAMOTRIGINE

Boleh didapati daripada:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

LAMOTRIGINE

Unit dalam pakej:

30Tablet Tablets; 100 Tablet Tablets

Dikeluarkan oleh:

APOTEX INC

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
APO-LAMOTRIGINE TABLET
_ _
Lamotrigine (25mg and 100mg)
1
WHAT IS IN THIS LEAFLET
1.
What Apo-Lamotrigine is used for
2.
How Apo-Lamotrigine works
3.
Before you use Apo-Lamotrigine
4.
How to use Apo-Lamotrigine
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Apo-
Lamotrigine
8.
Product Description
9.
Manufacturer and
Product
Registration Holder
10.
Date of revision
WHAT APO-LAMOTRIGINE IS USED FOR
Apo-Lamotrigine is used alone or in
combination with other medicines to
treat epilepsy or seizures.
HOW APO-LAMOTRIGINE WORKS
This
product
contains
active
ingredient
lamotrigine,
which
is
an
antiepileptic, that stabilizes electrical
signals in the brain to stop seizures.
BEFORE YOU USE APO-LAMOTRIGINE
_-When you must not take it _
Do not use Apo-Lamotrigine if you are:
- Allergic to lamotrigine or any other
ingredients
(listed
in
Product
description)
_-Before you start to take it _
Tell your doctor if you have:
- a condition called Brugada syndrome
(a genetic disease that affects the heart)
-kidney impairment
-any medical problems
_Pregnancy and lactation _
If you are pregnant, planning to get
pregnant or think you may be pregnant,
discuss
with
your
doctor
before
starting any epilepsy medicine.
Lamotrigine must only be used during
pregnancy if the benefits is more than
the risks to the fetus. Women of child-
bearing
age
are
encouraged
to
use
effective
alternative
non-hormonal
methods of contraception.
Lamotrigine
is
secreted
into
breast
milk and may affect your baby. Your
doctor
will
discuss
the
risks
and
benefits of breast feeding while you’re
taking lamotrigine.
_-Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that
you buy without a prescription from a
pharmacy, supermarket or health food
shop.
Tell your doctor if you are taking:
-other medicines used to treat epilepsy
such
as
carbamazepine,
valproate,
phenytoin,
phenobarbitone,
and
primidone.
- hormonal contraceptives pills
-rifampicin
(medicin

Ciri produk

APO–LAMOTRIGINE
Lamotrigine 25 and 100mg Tablets
Antiepileptic
Apo-Lamotrigine
25
mg:
each
white,
shield-shaped,
flat-faced,
radial
edged
tablet,
scored and engraved “25” on one side, other side
“APO”
contains
25mg
of
lamotrigine.
Apo-Lamotrigine
100
mg:
each
peach,
shield-shaped,
flat-faced,
bevelled
edged
tablet,
scored
and engraved “LAM over 100” on one
side,
other
side
“APO”
contains
100mg
of
lamotrigine.
CLINICAL PHARMACOLOGY
MODE OF ACTION
The
results
of
pharmacological
studies
suggest
that
lamotrigine
is
a
use-dependent
blocker
of
voltage
gated
sodium
channels.
It
produces
a
use-
and
voltage
dependent
block
of
sustained
repetitive
firing
in
cultured
neurones
and
inhibits
pathological release
of glutamate (the amino acid which plays a key
role in the generation of epileptic seizures),
as
well
as
inhibiting
glutamate-evoked
bursts
of
action potentials.
PHARMACODYNAMICS
In tests designed to evaluate the central
nervous system effects of drugs, the results
obtained using doses
of
240
mg
lamotrigine
administered
to
healthy volunteers did not
differ from placebo, whereas both 1000 mg
phenytoin and 10 mg diazepam each
significantly impaired fine visual motor co-
ordination and eye movements, increased body
sway
and
produced
subjective
sedative
effects.
In
another
study,
single
oral
doses
of
600mg carbamazepine significantly impaired
fine visual motor co-ordination and eye
movements, while increasing both body sway
and heart rate, whereas results with lamotrigine
at doses of 150mg and 300mg did not differ
from placebo.
PHARMACOKINETICS PROPERTIES
Lamotrigine
is
rapidly
and
completely
absorbed
from
the
gut
with
no
significant
first
pass
metabolism.
Peak
plasma
concentrations occur approximately
2.5
hours
after
oral
drug
administration.
Time
to
maximum
concentration
is
slightly
delayed
after
food
but
the
extent
of
absorption
is
unaffected.
The
pharmacokinetics
are linear up to 450mg, the highest single dose
tested.
There
is
considerable
inter-individual
variation in steady state maximum concentrati