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_ _
_ _
_Consumer Medication Information Leaflet (RiMUP) _
NEURAN CAPSULE
Gabapentin (300mg)
1
WHAT IS IN THIS LEAFLET
1.
What Neuran is used for
2.
How Neuran works
3.
Before you use Neuran
4.
How to use Neuran
5.
While you are using Neuran
6.
Side effects
7.
Storage and disposal of Neuran
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT NEURAN IS USED FOR
Neuran is used:
•
as
an
additional
therapy
in
the
treatment of partial seizure (occurs
in a limited area of the brain) with
or
without
secondary
generalization
(affect
the
whole
brain) in adults and children aged 3
years and above.
•
to
treat
neuropathic
pain
(pain
caused
by
nerve
damage)
which
includes
diabetic
neuropathy
(nerve
damage
from
diabetes),
post-herpetic neuralgia (nerve pain
at the site of a previous attack of
shingles) and trigeminal neuralgia
(facial pain) in adults age 18 years
and above.
HOW NEURAN 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 NEURAN
_- When you must not use it _
Do not take this medicine if:
•
you are allergic to Neuran 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 use it _
Tell your doctor if:
•
you
have
allergies
to
any
other
medicines
or
any
other
anti-
convulsant
medicines,
foods,
preservatives or dyes.
•
you have kidney problems
•
you have absence seizures (a short
period of “blanking out” or staring
into space).
•
you are pregnant or plan to become
pregnant or you become pregnant
while you are taking gabapentin.
•
you are breastfeeding or plan to
breastfeed. Gabapentin is excreted
in breast milk.
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.
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产品特点
852
VINEU15-var4 (MY)
NEURAN CAPSULE
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
ACTIONS AND PHARMACOLOGY
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
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