Epiven Capsule 300mg

Država: Malezija

Jezik: engleski

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

Aktivni sastojci:

GABAPENTIN

Dostupno od:

AVERROES PHARMACEUTICALS SDN. BHD.

INN (International ime):

GABAPENTIN

Jedinice u paketu:

30capsule Capsules

Proizveden od:

PT NOVELL PHARMACEUTICAL LABORATORIES.

Uputa o lijeku

EPIVEN CAPSULE 300MG
_Consumer Medication Information Leaflet (RiMUP)_
Gabapentin 300mg
1
EPIVEN® CAPSULE
GABAPENTIN 300 MG
WHAT IS IN THIS LEAFLET
- WHAT EPIVEN IS USED FOR
- HOW EPIVEN WORKS
- BEFORE YOU USE EPIVEN
- HOW TO TAKE EPIVEN
- WHILE YOU ARE USING EPIVEN
- SIDE EFFECTS
- STORAGE AND DISPOSAL OF EPIVEN
- PRODUCT DESCRIPTION
- MANUFACTURER
- PRODUCT REGISTRATION HOLDER
- DATE OF REVISION
WHAT EPIVEN IS USED FOR
Epilepsy:
Epiven
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
pediatric patients below the age of 3
years have not been established.
Neuropathic pain:
Epiven is indicated for the treatment
of neuropathic pain which includes
diabetic
neuropathy,
post-herpetic
neuralgia and trigeminal neuralgia in
adults age 18 years and above. Safety
and effectiveness in patients below
the age of 18 years have not been
established.
HOW EPIVEN WORKS
Epiven
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 EPIVEN
• When you must not take it:
Do not take Epiven:
- If you are allergic (hypersensitive) to
gabapentin
or
any
of
the
other
ingredients of
Epiven
• Before you start to take it:
Important
information
about
potentially serious reactions
A
small
number
of
people
taking
Epiven
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 Epiven.
Tell your doctor if you are pregnant or
intend to become pregnant.
Epiven should not be taken during
pregnancy,
unless
you
are
told
otherwise by your doctor. Effective
contraception must be used by women
of child-bearing potential.
There
have
been
no
studies
specifically
looking
at
the
use
of
gabapentin in pregnant women, but
other
medications
used
to
treat
seizure

Svojstava lijeka

EPIVEN CAPSULE 300MG
GABAPENTIN
DESCRIPTION
Capsule type: Hard capsule No.1
Capsule color:
Cap: Yellow opaque
Body: Yellow opaque
Capsule content: white granules
COMPOSITION
Each capsule contains of Gabapentin 300mg.
MODE OF ACTION
Gabapentin is structurally related to the neurotransmitter GABA;
however, gabapentin and its
metabolites do not bind to GABA (A) or GABA (B) receptors or influence
the degradation or
uptake of GABA. The analgesic action of gabapentin has been
demonstrated in animal models
of analgesia where gabapentin prevented allodynia and hyperalgesia.
Pain related responses in
neuropathic pain models and in peripheral inflammation models were
prevented or decreased
by gabapentin. Immediate pain-related behaviors were not altered.
The mechanism by which gabapentin exerts its analgesic effects is
unknown. It has been
suggested the mechanism of action may be by gabapentin preventing
thrombospondin from
binding
to
alpha-2
delta-1
(a
receptor
involved
in
excitatory
synapse
formation).
The
anticonvulsant action of gabapentin has been demonstrated in animal
test systems; however,
the mechanism by which gabapentin prevents seizure activity is
unknown.
SUMMARY OF PHARMACODYNAMICS AND PHARMACOKINETICS
ABSORPTION
Gabapentin
bioavailability
is
not
dose-proportional.
That
is,
as
the
dose
is
increased,
bioavailability decreases.
Gabapentin is absorbed from the gastrointestinal tract by means of a
saturable mechanism.
After multiple dosing peak plasma concentrations usually occur within
2 to 3 hours of a dose
and a steady state within 1 to 2 days.
Absolute bioavailability of gabapentin capsules is approximately 60%.
DISTRIBUTION
Gabapentin is distributed into breast milk.
It is widely distributed throughout the body but binding to plasma
proteins is minimal. It has a
volume of distribution equal to 57.7 liters.
METABOLISM
Gabapentin is excreted unchanged in the urine, and is not appreciably
metabolized.
EXCRETION
The elimination half-life of gabapentin is independent of dose and
averages 5 to 7 hours.
The renal c