GABATOR CAPSULES 400 MG

国: マレーシア

言語: 英語

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

有効成分:

GABAPENTIN

から入手可能:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN（国際名）:

GABAPENTIN

パッケージ内のユニット:

100capsule Capsules; 30capsule Capsules

製:

TORRENT PHARMACEUTICAL LIMITED

情報リーフレット

GABATOR CAPSULES
Gabapentin (300mg, 400 mg)
_ _
_ _
1
_ _
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is Gabator used for
2.
How Gabator works
3.
Before you use Gabator
4.
How to use Gabator
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Gabator
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT GABATOR IS USED FOR
EPILEPSY
:
Gabapentin is indicated as adjunctive
therapy
in
the
treatment
of
partial
seizures
with
and
without
secondary
generalization
in
adults
and
children
age
3
years
and
above.
Safety
and
effectiveness for adjunctive therapy in
paediatric patients below the age of 3
years have not been established.
NEUROPATHIC PAIN (COMPLEX, CHRONIC
PAIN
STATE
THAT
USUALLY
IS
ACCOMPANIED BY TISSUE INJURY)
:
Gabapentin
is
indicated
for
the
treatment
of
neuropathic
pain
which
includes
diabetic
neuropathy
(nerve
damage
that
can
occur
if
you
have
diabetes),
post-herpetic
neuralgia
(persistent
nerve
pain
and
shingles
(painful rash) that can occur as a result
of
herpes
zoster
virus
(commonly
known
as
chicken
pox
virus))
and
trigeminal
neuralgia
(chronic,
severe
facial pain) in adults’ age 18 years and
above.
Safety
and
effectiveness
in
patients below the age of 18 years have
not been established.
HOW GABATOR WORKS
Gabator
belongs
to
a
group
of
medicines
used
to
treat
epilepsy
and
peripheral
neuropathic
pain
(long
lasting pain caused by damage to the
nerves).
BEFORE YOU USE GABATOR
-
_When you must not use it _
Do not take Gabator:
•
If you are allergic (hypersensitive)
to
Gabapentin
or
to
any
of
the
other ingredients of Gabator.
_Pregnancy and lactation_
_ _
Tell your doctor if you are pregnant or
intend to become pregnant.
Gabator
should
not
be
taken
during
pregnancy,
unless
you
are
told
otherwise by your doctor. Contact your
doctor
immediately
if
you
become
pregnant, think you might be pregnant
or
are
planning
to
become
pregnant
while taking Gabator. Do not suddenly
discontinue taking this m

製品の特徴

Proposed Prescribing Information
For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory
GABATOR CAPSULES 300MG/ GABATOR CAPSULES 400MG
GABAPENTIN CAPSULES 300 MG / GABAPENTIN CAPSULES 400 MG
BRAND OR PRODUCT NAME
GABATOR CAPSULES 300mg/ GABATOR CAPSULES 400mg
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
GABATOR CAPSULES 300mg
Each hard Gelatin Capsule contains
Gabapentin USP……..300 mg
Excipients……………q.s
Approved colours used in the capsule shell
GABATOR CAPSULES 400mg
Each hard Gelatin Capsule contains
Gabapentin USP ……..400 mg
Excipients…………….q.s
Approved colours used in the capsule shell
PRODUCT DESCRIPTION
GABATOR CAPSULES 300mg:
Yellow/Yellow coloured, size ‘1’, capsules printed with ‘300’
in black colour on the cap and Torrent logo
(Square emblem only) in black colour on the body of capsule shell
containing white to off-white powder
GABATOR CAPSULES 400mg:
Orange/Orange coloured, size ‘0’, capsules printed with ‘400’
in black colour on the cap and Torrent
logo (Square emblem only) in black colour on the body of capsule shell
containing white to offwhite
powder
DOSAGE FORM
Hard Gelatin Capsule
PHARMACODYNAMICS / PHARMACOKINETICS
PHARMACODYNAMICS
Pharmacotherapeutic groups: Other antiepileptics ATC code: N03AX12
Mechanism of action
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 in animals. Broad panel screening
does not suggest any other
drug targets other than α2δ.
Evidence from several pre-clinical models inform that the
pharmacological activity of gabapentin
may