HP Gabapentin Capsule 300 mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

GABAPENTIN

Boleh didapati daripada:

Hovid Pharmacy Sdn. Bhd.

INN (Nama Antarabangsa):

GABAPENTIN

Unit dalam pakej:

100capsule Capsules

Dikeluarkan oleh:

HOVID BERHAD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
HP GABAPENTIN CAPSULE 300MG
GABAPENTIN (300MG)
1
WHAT IS IN THIS LEAFLET?
1.
What
HP
Gabapentin
Capsule 300 mg is used for
2.
How
HP
Gabapentin
Capsule
300 mg works
3.
Before
you
HP Gabapentin
Capsule 300 mg
4.
How
to
take
HP
Gabapentin
Capsule 300 mg
5.
While
you
are
using
HP
Gabapentin Capsule 300 mg
6.
Side effects
7.
After
using
HP
Gabapentin
Capsule 300 mg
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
WHAT HP GABAPENTIN CAPSULE 300
MG IS USED FOR
To
•
Control
epilepsy
(a
condition
where you have repeated seizures)
in
adults
and
children
aged
3
years and above.
•
Treat
neuropathic
pain
(pain
caused
by
nerve
damage)
in
adults aged 18 years and above.
HOW HP GABAPENTIN CAPSULE 300
MG WORKS
This medicine belongs to a group of
medicines called anti-convulsants. It
is said to work by controlling brain
chemicals
which
send
signals
to
nerves
to
help
control
seizures
or
neuropathic pain.
BEFORE
YOU
USE
HP
GABAPENTIN
CAPSULE 300 MG
_When you must not take it _
Do not take this medicine if:
•
you are allergic to gabapentin or
any of its excipients
•
your
child has
epilepsy
and
is
under 3 years old
•
your child has neuropathic pain
and is younger than 18 years old.
_Before you start to take it _
Tell your doctor if:
•
you have allergies to any other
medicines,
especially
barbiturates
or
any
other
anti-
convulsant
medicines,
foods,
preservatives or dyes.
•
you
are
pregnant
or
plan
to
become pregnant
•
you are breastfeeding or plan to
breastfeed.
If you have kidney problems, nervous
system disorders, respiratory disorders
or you are more than 65 years old,
your doctor may prescribe a different
dosing regimen.
_Taking other medicines _
Talk to your doctor or pharmacist if:
•
you
are
taking
any
other
medicines in any form including
any
that
you
buy
or
obtained
without a prescription.
•
you
are
taking
or
have
been
recently taking any medicines for
convulsions,
sleeping
disorders,
depression, anxiety, or any ot

Ciri produk

HP GABAPENTIN CAPSULE 300 MG
VIGABxx-0
544
DESCRIPTION
Light yellow opaque / light yellow opaque with ‘GP300’ printed on
one end and ‘hovid’ on the other end of the size 1 capsule filled
with white to off-white powder.
COMPOSITION
Each capsule contains: Gabapentin 300 mg
PHARMACODYNAMICS
The mechanism of action is unknown. Gabapentin does not react with
GABA receptors, is not metabolized to a GABA agonist or to
GABA, and does not inhibit GABA uptake or degradation. In rats,
gabapentin interacts with a novel binding site on cortical neurons
that may be associated with the L-system amino acid transporter of
brain cell membranes.
PHARMACOKINETICS
ABSORPTION
Rapid. Gabapentin is absorbed in part by the L-amino acid transport
system, which is a carrier-mediated, saturable transport
system; as the dose increases, bioavailability decreases.
Bioavailability ranges from approximately 60% for a 300mg dose to
approximately 35% for a 1600mg dose. Absorption is unaffected by food.
DISTRIBUTION
Volume of distribution (Vol
D
) is approximately 50 to 60 L. Gabapentin penetrates the blood-brain
barrier, yielding cerebrospinal fluid
(CSF) concentrations approximately equal to 20% of corresponding
steady-state plasma through concentrations in patients with
epilepsy. Brain tissue concentrations in one patient undergoing
temporal lobectomy were approximately 80% of corresponding
plasma concentrations.
PROTEIN BINDING
Very low (< 5%)
BIOTRANSFORMATION
Gabapentin is not metabolized.
ELIMINATION
Renal – Entire absorbed dose, as unchanged drug. Gabapentin
clearance is directly proportional to creatinine clearance.
In dialysis – Gabapentin can be removed from plasma by hemodialysis.
The elimination half-life of Gabapentin is independent of
dose and averages 5 to 7 hours.
INDICATIONS
•
EPILEPSY: Gabapentin is indicated as adjunctive therapy in the
treatment of partial seizures with and without secondary
generalization in adults and children aged 3 years and above. Safety
and effectiveness for adjunctive therapy in pediatric
p