TIAGABINE HYDROCHLORIDE tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

TIAGABINE HYDROCHLORIDE

Sammensetning:

TIAGABINE HYDROCHLORIDE 2 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Tiagabine HCl is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures. Tiagabine HCl is 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.

Produkt oppsummering:

Tiagabine HCl tablets are available in four dosage strengths. 2 mg orange-peach, round tablets, debossed with on one side and 402 on the opposite side, are available in bottles of 30 (NDC 0093-5030-56). 4 mg yellow, round tablets, debossed with on one side and 404 on the opposite side, are available in bottles of 30 (NDC 0093-5031-56). 12 mg green, ovaloid tablets, debossed with on one side and 412 on the opposite side, are available in bottles of 30 (NDC 0093-8072-56). 16 mg blue, ovaloid tablets, debossed with on one side and 416 on the opposite side, are available in bottles of 30 (NDC 0093-8076-56). Recommended Storage: Store tablets at controlled room temperature, between 20-25°C (68-77°F). See USP. Protect from light and moisture.

Autorisasjon status:

New Drug Application Authorized Generic

Informasjon til brukeren

Teva Pharmaceuticals USA, Inc.
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Medication Guide
Tiagabine Hydrochloride Tablets
Read this Medication Guide before you start taking tiagabine
hydrochloride tablets 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 tiagabine
hydrochloride?
Do not stop taking tiagabine hydrochloride without first talking to
your healthcare provider.
Stopping tiagabine hydrochloride suddenly can cause serious problems.
Tiagabine hydrochloride can cause serious side effects, including:
1. Tiagabine HCl may cause seizures in people who do not have
epilepsy. If you do not have a seizure
disorder and you take tiagabine hydrochloride, 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 tiagabine
hydrochloride for epilepsy.
2. Like other antiepileptic drugs, tiagabine hydrochloride 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.

Preparatomtale

TIAGABINE HYDROCHLORIDE- TIAGABINE HYDROCHLORIDE TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
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TIAGABINE HYDROCHLORIDE TABLETS
RX ONLY
DESCRIPTION
Tiagabine hydrochloride 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
Tiagabine HCl 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,
20
25
2 2
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 potential