Dyna Gabapentin Capsule 300mg

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

GABAPENTIN

Verfügbar ab:

DYNAPHARM (M) SDN BHD

INN (Internationale Bezeichnung):

GABAPENTIN

Einheiten im Paket:

500capsule Capsules; 100capsule Capsules

Hergestellt von:

DYNAPHARM (M) SDN BHD

Gebrauchsinformation

Consumer Medication Information Leaflet (RiMUP)
DYNA GABAPENTIN CAPSULE 300MG
Gabapentin (300mg)
1
What is in this leaflet
1.
What GABAPENTIN is used for
2.
How GABAPENTIN works
3.
Before you use GABAPENTIN
4.
How to use GABAPENTIN
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
GABAPENTIN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
1.
What GABAPENTIN 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
pediatric patients below the age of 3
years have not been established.
Neuropathic pain:
Gabapentin 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.
2.
How GABAPENTIN works
Gabapentin belongs to a group of
medicines used to treat epilepsy and
peripheral neuropathic pain (long
lasting pain caused by damage to the
nerves).
3.
Before you use GABAPENTIN
-
When you must not use it
DO NOT TAKE this medication if
you are allergic (hypersensitive) to
gabapentin or any of the other
ingredients.
Take special care with Gabapentin
-
If you suffer from kidney problems
your doctor may prescribe a
different dosing schedule
-
If you are on haemodialysis (to
remove waste products because of
kidney failure), tell your doctor
-
If you develop muscle pain and/or
weakness
-
If you develop signs such as
persistent stomach pain, feeling sick
and being sick contact your doctor
immediately as these may be
symptoms of acute pancreatitis (an
inflamed pancreas).
-
A small number of people being
treated with anti-epileptics such as
gabapentin have had thoughts of
harming or killing themselves. If at
any time you have these thoughts,
immediately contact your doct

Fachinformation

DYNA GABAPENTIN CAPSULE 300MG
MAL17055007AZ
Each capsule contains 300 mg of the active ingredient gabapentin.
PRODUCT DESCRIPTION
Yellow cap & yellow body hard gelatin capsule of size ‘1’
containing white to off-white
powder
PHARMACODYNAMICS
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.
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 clearance of gabape