ONEGABA 600 ( Gabapentin Tablets 600mg)

Country: Malaysia

Language: English

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

Active ingredient:

GABAPENTIN

Available from:

UNIMED SDN BHD

INN (International Name):

GABAPENTIN

Units in package:

30tablet Tablets; 30tablet Tablets; 30tablet Tablets; 30tablet Tablets

Manufactured by:

Aurobindo Pharma Limited, Unit-VII (SEZ)

Summary of Product characteristics

ONEGABA 600
GABAPENTIN TABLETS 600 MG
QUALITATIVE
AND
QUANTITATIVE
COMPOSITIONS:
E a c h
f i l m - c o a t e d
t a b l e t
contain
s
Gabapentin 600 mg
Excipients:
Maize
starch,
Crospovidone,
Copovidone,
Isopropyl
Alcohol,
Cellulose,
microcrystalline
(Avicel
PH102 & Ceolus KG1000), Magnesium stearate, Opadry
White YS-1-18111 and Methylene Chloride.
PRODUCT DESCRIPTION:
White, biconvex, elliptical, film-coated tablets, with deep
break line on both sides and debossed with ‘D’ and ‘24’ on
either side of the break line on one side and plain on other
side.
PHARMACOLOGICAL PROPERTIES:
PHARMACODYNAMICS PROPERTIES:
Gabapentin is structurally related to the neurotransmitter
GABA (gamma-aminobutyric acid) but its mechanism of
action is different from that of several other active substances
that
interact
with
GABA
synapses
including
valproate,
barbiturates,
benzodiazepines,
GABA
transaminase
inhibitors, GABA uptake inhibitors, GABA agonists, and
GABA prodrugs. In vitro studies with radiolabeled gabapentin
have characterized a novel peptide binding site in rat brain
tissues including neocortex and hippocampus that may relate
to anticonvulsant and analgesic activity of gabapentin and its
structural derivatives. The binding site for gabapentin has
been identified as the alpha 2-delta subunit of voltagegated
calcium channels.
Gabapentin at relevant concentrations does not bind to other
common drug or neurotransmitter receptors of the brain
including
GABAA,
GABAB,
benzodiazepine,
glutamate,
glycine or N-methyl-d-aspartate receptors.
Gabapentin
does
not
interact
with
sodium
channels
in
vitro and so differs from phenytoin and carbamazepine.
Gabapentin partially reduces responses to the glutamate
agonist Nmethyl-D-aspartate (NMDA) in some test systems
in vitro, but only at concentrations greater than 100 μm,
which are not achieved in vivo. Gabapentin slightly reduces
the release of monoamine neurotransmitters in vitro.
PHARMACOKINETIC PROPERTIES:
_ABSORPTION_
Following
oral
administration,
peak
plasma
gabapentin
concentrati