GABALEX MLABS gabapentin 100 mg capsule blister pack

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

gabapentin, Quantity: 100 mg

Доступна з:

Micro Labs Pty Ltd

ІПН (Міжнародна Ім'я):

Gabapentin

Фармацевтична форма:

Capsule, hard

Склад:

Excipient Ingredients: purified talc; maize starch; titanium dioxide; purified water; Gelatin; sodium lauryl sulfate

Адміністрація маршрут:

Oral

Одиниць в упаковці:

PVC/ PVDC-Aluminium blister pack of 100 capsules (10x10C in carton)

Тип рецепту:

(S4) Prescription Only Medicine

Терапевтичні свідчення:

Gabapentin is indicated for the treatment of partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children age 3 years and above who have not achieved adequate control with standard anti-epileptic drugs.,Gabapentin is indicated for the treatment of neuropathic pain.

Огляд продуктів:

Visual Identification: White-White colour size'3' hard gelatin capsule contains free flowing white crystalline powder.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Авторизація:

Licence status A

Дата Авторизація:

2017-04-28

Характеристики продукта

PRODUCT INFORMATION
GABALEX MLABS
100 MG, 300 MG AND 400 MG CAPSULES
NAME OF THE MEDICINE
Gabapentin
Chemical name:
1-(aminomethyl) cyclohexaneacetic acid
Structural formula:
Molecular formula:
C
9
H
17
NO
2
Molecular weight:
171.24
CAS Registry Number:
60142-96-3.
DESCRIPTION
Gabapentin is a white to off-white crystalline powder. It is freely
soluble in water and both
basic and acidic aqueous solutions.
Gabalex MLabs capsules also contain the following inactive
ingredients: maize starch,
purified talc, gelatin, titanium dioxide and sodium lauryl sulfate.
The 300 mg capsule also
contains iron oxide yellow and the 400 mg capsule also contains both
iron oxide yellow and
iron oxide red.
PHARMACOLOGY
PHARMACODYNAMICS
The mechanism by which gabapentin exerts its anticonvulsant action is
unknown. Gabapentin
is structurally related to the neurotransmitter GABA
(gamma-aminobutyric acid) but its
mechanism of action is different from that of several other drugs that
interact with GABA
synapses including valproate, barbiturates, benzodiazepines, GABA
transaminase inhibitors,
GABA
uptake
inhibitors,
GABA
agonists,
and
GABA
prodrugs.
_In _
_vitro_
studies
with
radiolabelled gabapentin have characterised a novel peptide binding
site in rat brain tissues
including neocortex and hippocampus that may relate to anticonvulsant
activity of gabapentin
and its structural derivatives. However, the identification and
function of the gabapentin
binding site remains to be elucidated. Gabapentin at relevant clinical
concentrations does not
bind to other common drug or neurotransmitter receptors of the brain
including GABA
A
,
GABA
B
, 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. Several test systems ordinarily used to assess activity
at the NMDA receptor
complex have been examined. Results are contradictory. Accordingly no
general statement
about the effects, if any, of gabapentin at the NMDA receptor can b