TIAGABINE HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

TIAGABINE HYDROCHLORIDE

Composition:

TIAGABINE HYDROCHLORIDE 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Tiagabine hydrochloride tablets are available in two dosage strengths. 2 mg orange, circular, film-coated tablets debossed with “200” on one side and plain on the other side, are available in: Bottles of 30:     Child Resistant Cap             NDC 62756-200-83 Bottles of 1000: Non Child Resistant Cap      NDC 62756-200-18 4 mg yellow, circular, film-coated tablets debossed with “224” on one side and plain on the other side, are available in: Bottles of 30:     Child Resistant Cap             NDC 62756-224-83 Bottles of 100:    Child Resistant Cap             NDC 62756-224-88                          Non Child Resistant Cap      NDC 62756-224-08 Bottles of 1000: Non Child Resistant Cap      NDC 62756-224-18 Recommended Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TIAGABINE HYDROCHLORIDE - TIAGABINE HYDROCHLORIDE TABLET, FILM COATED
Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE
Tiagabine Hydrochloride(tye-AG-a-been hye-droe-KLOR-ide)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 tablets?
Do not stop taking tiagabine hydrochloride tablets without first
talking to your healthcare provider.
Stopping tiagabine hydrochloride tablets suddenly can cause serious
problems.
Tiagabine hydrochloride tablets can cause serious side effects,
including:
1.
Tiagabine hydrochloride tablets may cause seizures in people who do
not have epilepsy. If you do
not have a seizure disorder and you take tiagabine hydrochloride
tablets, 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 tablets
for epilepsy.
2.
Like other antiepileptic drugs, tiagabine hydrochloride tablets 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 • new or worse irritability
• attempts to commit suicide • acting aggressive, being angry, or
violent
• new or worse depression • acting on dangerous impulses
• new or worse anxiety • an extreme increase in activity and panic
attacks
• feeling agitated or restless talking (mania)
• trouble sleeping (insomnia) • 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 caus

Summary of Product characteristics

TIAGABINE HYDROCHLORIDE - TIAGABINE HYDROCHLORIDE TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES, INC.
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TIAGABINE HYDROCHLORIDE TABLETS
DESCRIPTION
Tiagabine hydrochloride, USP is an antiepilepsy drug available as 2 mg
and 4 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. Tiagabine
hydrochloride 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 hydrochloride tablets contain the following inactive
ingredients: Hydrogenated vegetable
oil, anhydrous lactose, butylated hydroxyanisole, pregelatinized maize
starch, colloidal silicon dioxide,
talc, crospovidone, titanium dioxide, hypromellose, polyethylene
glycol.
In addition, individual tablets contain:
2 mg tablets: FD&C Yellow No. 6 and polysorbate 80.
4 mg tablets: Lactose monohydrate and D&C Yellow No. 10.
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 space of the gl