GABITRIL tiagabine hydrochloride tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Lake Erie Medical & Surgial Supply DBA Quality Care Products LLC

SNN (starptautisko nepatentēto nosaukumu):

TIAGABINE HYDROCHLORIDE

Kompozīcija:

TIAGABINE HYDROCHLORIDE 4 mg

Receptes veids:

PRESCRIPTION DRUG

Autorizācija statuss:

New Drug Application

Produkta apraksts

GABITRIL - TIAGABINE HYDROCHLORIDE TABLET
LAKE ERIE MEDICAL & SURGIAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
----------
GABITRIL®
(TIAGABINE HYDROCHLORIDE)
TABLETS
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.
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.