TIAGABINE HYDROCHLORIDE- tiagabine tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Amneal Pharmaceuticals NY LLC

INN (Internationale Bezeichnung):

TIAGABINE HYDROCHLORIDE

Zusammensetzung:

TIAGABINE HYDROCHLORIDE 2 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

Tiagabine HCl tablets, 2 mg are supplied as orange-peach colored, round shaped, biconvex film-coated tablets, debossed with “AA” on one side and “21” on the other side. They are available as follows: Bottles of 30:              NDC 69238-1104-3 Tiagabine HCl tablets, 4 mg are supplied as yellow colored, round shaped, biconvex film-coated tablets, debossed with “AA” on one side and “22” on the other side. They are available as follows: Bottles of 30:              NDC 69238-1105-3 Tiagabine HCl tablets, 12 mg are supplied as bluish green colored, ovaloid shaped, biconvex film-coated tablets, debossed with “AA” on one side and “23” on the other side. They are available as follows: Bottles of 30:              NDC 69238-1106-3 Tiagabine HCl tablets, 16 mg are supplied as blue colored, ovaloid shaped, biconvex film-coated tablets, debossed with “AA” on one side and “24” on the other side. They are available as follows: Bottles of 30:              NDC 69238-1107-3 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

TIAGABINE HYDROCHLORIDE- TIAGABINE TABLET
AMNEAL PHARMACEUTICALS NY LLC
----------
TIAGABINE HYDROCHLORIDE TABLETS
(2 MG, 4 MG, 12 MG & 16 MG)
RX ONLY
DESCRIPTION
Tiagabine Hydrochloride tablets are 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, USP 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
Tiagabine HCl tablets contain the following inactive ingredients:
anhydrous lactose,
ascorbic acid, colloidal silicon dioxide, crospovidone Type A,
hydrogenated vegetable oil
Type 1 (cottonseed oil), hydroxypropyl cellulose, hypromellose,
magnesium stearate,
microcrystalline cellulose, pregelatinized starch, stearic acid, and
titanium dioxide.
In addition, individual tablets contain:
2 mg tablets: FD&C Yellow No. 6 aluminum lake.
4 mg tablets: D&C Yellow No. 10 aluminum lake.
12 mg tablets: D&C Yellow No. 10 aluminum lake and FD&C Blue No. 1
aluminum lake.
16 mg tablets: FD&C Blue No. 2 aluminum lake and talc.
20
25
2 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 ce