GABITRIL- tiagabine hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

STAT RX USA LLC

INN (International Name):

TIAGABINE HYDROCHLORIDE

Composition:

TIAGABINE 12 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

GABITRIL 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 63459-402-30). • 4 mg yellow, round tablets, debossed with on one side and 404 on the opposite side, are available in bottles of 30 (NDC 63459-404-30). • 12 mg green, ovaloid tablets, debossed with on one side and 412 on the opposite side, are available in bottles of 30 (NDC 63459-412-30). • 16 mg blue, ovaloid tablets, debossed with on one side and 416 on the opposite side, are available in bottles of 30 (NDC 63459-416-30). Recommended Storage: Store tablets at controlled room temperature, between 20-25°C (68-77°F). See USP. Protect from light and moisture.

Authorization status:

New Drug Application

Patient Information leaflet

GABITRIL - TIAGABINE HYDROCHLORIDE TABLET
STAT RX USA LLC
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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 provider as scheduled.
•

Summary of Product characteristics

GABITRIL - TIAGABINE HYDROCHLORIDE TABLET
STAT RX USA LLC
----------
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 and C Yellow No. 6.
4 mg tablets: D and C Yellow No. 10.
12 mg tablets: D and C Yellow No. 10 and FD and C Blue No. 1.
16 mg tablets: FD and 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. Tiagabine increases the amount of
GABA available in the
extracellular spac