GABATA 300 (GABAPENTIN CAPSULES USP 300MG)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

GABAPENTIN

Boleh didapati daripada:

Ascend Laboratories Sdn Bhd

INN (Nama Antarabangsa):

GABAPENTIN

Unit dalam pakej:

5 x 10 Capsules; 10 x 10 Capsules

Dikeluarkan oleh:

ALKEM LABORATORIES LIMITED

Risalah maklumat

GABATA 300/400
Gabapentin Capsules USP 300mg/400mg
_Consumer Medication Information Leaflet (RiMUP) _
Page 1 of 3
WHAT IS IN THIS LEAFLET?
1)
What Gabata 300/400 is used for
2)
How Gabata 300/400 works
3)
Before you use Gabata 300/400
4)
How to use Gabata 300/400
5)
While
you
are using
Gabata
300/400
6)
Side effects
7)
Storage and Disposal of Gabata
300/400
8)
Product Description
9)
Manufacturer
10)
Product Registration Holder
WHAT GABATA 300/400 IS USED FOR
Epilepsy:
Gabata is used as adjunctive therapy in
the treatment of partial seizures (affects
a
small area
of
the
brain)
with and
without
secondary
generalization
(spread to both sides of the brain) in
adults and
children
age
3
years and
above.
Safety
and
effectiveness
for
adjunctive therapy in pediatric patients
below the age of 3 years have not been
established.
Neuropathic pain:
Gabata
is
used
for
the
treatment
of
neuropathic
pain
(long
lasting
pain
caused by damage to the nerves), in
adults age 18 years and above. Safety
and effectiveness in patients below the
age
of
18
years
have
not
been
established.
HOW GABATA 300/400 WORKS
It
works
by
changing
the
way
the
nerves
send messages
to
the
brain.
Brain cells need to work at a certain
rate
to
function
normally.
During
a
seizure, brain cells are forced to work
more rapidly than normal. Gabapentin
is used to control epilepsy and works
by
reducing
the
abnormal
electrical
activity in the brain.
BEFORE YOU USE GABATA 300/400
-
_When you must not use it _
If you are allergic (hypersensitive) to
Gabata or any of the other ingredients
of this medicine if you have ever had
epilepsy
-
_Before you start to use it _
_Important _
_information _
_about _
_potentially serious reactions _
A
small
number
of
people
taking
Gabata
get
an
allergic
reaction
or
potentially serious skin reaction, which
may
develop
into
more
serious
problems if they are not treated. You
need to know these symptoms to look
out for while you are taking Gabata.
Read the description of these symptoms
in Section “Side Effects”.
_Tell your doctor if you

Ciri produk

NAME AND STRENGTH OF ACTIVE INGREDIENT(S)
Gabapentin , 300 mg & 400 mg.
DESCRIPTION AND COMPOSITION:
GABATA 300:
White to off white, crystalline powder filled in size “1” yellow
colour hard gelatin capsules imprinted “215” on body with blue
ink.
Each hard gelatin capsule Contains.
Gabapentin USP ……….. 300 mg
GABATA 400:
White to off white, crystalline powder filled in size “0” orange
colour hard gelatin capsule imprinted “214” on body with blue ink.
Each hard gelatin capsule Contains.
Gabapentin USP ……….. 400 mg
PHARMACODYNAMICS
Gabapentin readily enters the brain and prevents seizures in a number
of animal models of epilepsy. Gabapentin does not possess affinity for
either GABAA or GABAB receptor
nor does it alter the metabolism of GABA. It does not bind to other
neurotransmitter receptors of the brain and does not interact with
sodium channels. Gabapentin binds with high
affinity to the α2δ (alpha-2-delta) subunit of voltage-gated calcium
channels and it is proposed that binding to the α2δ subunit may be
involved in gabapentin's anti-seizure effects
i
n
a n i
m a l
s .
It is proposed that this pharmacological activity of gabapentin may be
mediated via binding to α2δ through a reduction in release of
excitatory neurotransmitters in regions of the
central nervous system. Such activity may underlie gabapentin's
anti-seizure activity. The relevance of these actions of gabapentin to
the anticonvulsant effects in humans
remains to be established.
Gabapentin also has been shown to display efficacy in several animal
pain models. Specific binding of gabapentin to the α2δ subunit is
proposed to result in several different
actions that may be responsible for analgesic activity in animal
models. The analgesic activities of gabapentin may occur in the spinal
cord as well as at higher brain centers
through interactions with descending pain inhibitory pathways. The
relevance of these animal pain models properties to clinical action in
humans is unknown.
PHARMACOKINETICS
Absorption
Gabapenti