GABITRIL- tiagabine hydrochloride tablet, film coated

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

TIAGABINE HYDROCHLORIDE (UNII: DQH6T6D8OY) (TIAGABINE - UNII:Z80I64HMNP)

Доступна с:

Carilion Materials Management

ИНН (Международная Имя):

TIAGABINE HYDROCHLORIDE

состав:

TIAGABINE HYDROCHLORIDE 4 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

GABITRIL (tiagabine hydrochloride) is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures. GABITRIL is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. The abuse and dependence potential of GABITRIL have not been evaluated in human studies.

Обзор продуктов:

Product: 68151-4235 NDC: 68151-4235-3 1 TABLET, FILM COATED in a PACKAGE

Статус Авторизация:

New Drug Application

тонкая брошюра

GABITRIL- TIAGABINE HYDROCHLORIDE TABLET, FILM COATED
Carilion Materials Management
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MEDICATION GUIDE
GABITRIL® (găb-ĭ-trĭl)
(tiagabine hydrochloride)
Tablets
Read this Medication Guide before you start taking GABITRIL and each
time you get a refill. There may
be new information. This information does not take the place of
talking to your healthcare provider about
your medical condition or treatment.
What is the most important information I should know about GABITRIL?
Do not stop taking GABITRIL without first talking to your healthcare
provider.
Stopping GABITRIL suddenly can cause serious problems.
GABITRIL can cause serious side effects, including:
1. GABITRIL may cause seizures in people who do not have epilepsy. If
you do not have a seizure
disorder and you take GABITRIL, you may have a seizure or seizures
that do not stop (status epilepticus).
Call your healthcare provider right away if you have a seizure and you
are not taking GABITRIL for
epilepsy.
2. Like other antiepileptic drugs, GABITRIL may cause suicidal
thoughts or actions in a very small
number of people, about 1 in 500. Call a healthcare provider right
away if you have any of these
symptoms, especially if they are new, worse, or worry you:
•
thoughts about suicide or dying
•
attempts to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and talking
(mania)
•
other unusual changes in behavior or mood
Suicidal thoughts or actions can be caused by things other than
medicines. If you have suicidal
thoughts or actions, your healthcare provider may check for other
causes.
How can I watch for early symptoms of suicidal thoughts and actions?
•
Pay attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or feelings.
•
Keep all follow-up visits with your healthcare

Характеристики продукта

GABITRIL- TIAGABINE HYDROCHLORIDE TABLET, FILM COATED
CARILION MATERIALS MANAGEMENT
----------
GABITRIL (TIAGABINE HYDROCHLORIDE) TABLETS
RX ONLY
DESCRIPTION
GABITRIL (tiagabine HCl) is an antiepilepsy drug available as 2 mg, 4
mg, 12 mg, and 16 mg tablets
for oral administration. Its chemical name is
(-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic
acid hydrochloride, its molecular formula is C
H NO S HCl, and its molecular weight is 412.0.
Tiagabine HCl is a white to off-white, odorless, crystalline powder.
It is insoluble in heptane, sparingly
soluble in water, and soluble in aqueous base. The structural formula
is:
INACTIVE INGREDIENTS
GABITRIL tablets contain the following inactive ingredients: Ascorbic
acid, colloidal silicon dioxide,
crospovidone, hydrogenated vegetable oil wax, hydroxypropyl cellulose,
hypromellose, lactose,
magnesium stearate, microcrystalline cellulose, pregelatinized starch,
stearic acid, and titanium dioxide.
In addition, individual tablets contain:
2 mg tablets: FD&C Yellow No. 6.
4 mg tablets: D&C Yellow No. 10.
12 mg tablets: D&C Yellow No. 10 and FD&C Blue No. 1.
16 mg tablets: FD&C Blue No. 2.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The precise mechanism by which tiagabine exerts its antiseizure effect
is unknown, although it is
believed to be related to its ability, documented in _in vitro_
experiments, to enhance the activity of gamma
aminobutyric acid (GABA), the major inhibitory neurotransmitter in the
central nervous system. These
experiments have shown that tiagabine binds to recognition sites
associated with the GABA uptake
carrier. It is thought that, by this action, tiagabine blocks GABA
uptake into presynaptic neurons,
permitting more GABA to be available for receptor binding on the
surfaces of post-synaptic cells.
®
®
20
25
2
2
Inhibition of GABA uptake has been shown for synaptosomes, neuronal
cell cultures, and glial cell
cultures. In rat-derived hippocampal slices, tiagabine has been shown
to prolong GABA-mediated
inhibitory post-synaptic potentials. T