TETRABENAZINE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

TETRABENAZINE (UNII: Z9O08YRN8O) (TETRABENAZINE - UNII:Z9O08YRN8O)

Διαθέσιμο από:

Oceanside Pharmaceuticals

INN (Διεθνής Όνομα):

TETRABENAZINE

Σύνθεση:

TETRABENAZINE 12.5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Tetrabenazine tablets are indicated for the treatment of chorea associated with Huntington's disease. Tetrabenazine tablets are contraindicated in patients: Risk Summary There are no adequate data on the developmental risk associated with the use of tetrabenazine tablets in pregnant women. Administration of tetrabenazine to rats throughout pregnancy and lactation resulted in an increase in stillbirths and postnatal offspring mortality. Administration of a major human metabolite of tetrabenazine to rats during pregnancy or during pregnancy and lactation produced adverse effects on the developing fetus and offspring (increased mortality, decreased growth, and neurobehavioral and reproductive impairment). The adverse developmental effects of tetrabenazine and a major human metabolite of tetrabenazine in rats occurred at clinically relevant doses [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15

Περίληψη προϊόντος:

Tetrabenazine tablets are available in the following strengths and packages: The 12.5 mg tetrabenazine tablets are white, cylindrical, biplanar tablets with beveled edges, non-scored, embossed on one side with “CL” and “12.5”. NDC 68682-421-12 12.5 mg 112-count bottle The 25 mg tetrabenazine tablets are yellowish-buff, cylindrical, biplanar tablets with beveled edges, scored, embossed on one side with “CL” and “25”. NDC 68682-422-25 25 mg 112-count bottle Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

New Drug Application Authorized Generic

Φύλλο οδηγιών χρήσης

TETRABENAZINE- TETRABENAZINE TABLET
Oceanside Pharmaceuticals
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MEDICATION GUIDE
Tetrabenazine Tablets
Read the Medication Guide that comes with tetrabenazine tablets before
you start taking it and each time
you refill the prescription. There may be new information. This
information does not take the place of
talking with your doctor about your medical condition or your
treatment. You should share this
information with your family members and caregivers.
What is the most important information I should know about
tetrabenazine tablets?
•
Tetrabenazine tablets can cause serious side effects, including:
o
depression
o
suicidal thoughts
o
suicidal actions
•
You should not start taking tetrabenazine tablets if you are depressed
(have untreated depression or
depression that is not well controlled by medicine) or have suicidal
thoughts.
•
Pay close attention to any changes, especially sudden changes, in
mood, behaviors, thoughts or
feelings. This is especially important when tetrabenazine tablets are
started and when the dose is
changed.
Call the doctor right away if you become depressed or have any of the
following symptoms, especially if
they are new, worse, or worry you:
•
feel sad or have crying spells
•
lose interest in seeing your friends or doing things you used to enjoy
•
sleep a lot more or a lot less than usual
•
feel unimportant
•
feel guilty
•
feel hopeless or helpless
•
more irritable, angry or aggressive than usual
•
more or less hungry than usual or notice a big change in your body
weight
•
have trouble paying attention
•
feel tired or sleepy all the time
•
have thoughts about hurting yourself or ending your life
What are tetrabenazine tablets?
Tetrabenazine tablets are a medicine that is used to treat the
involuntary movements (chorea) of
Huntington’s disease. Tetrabenazine tablets do not cure the cause of
the involuntary movements, and it
does not treat other symptoms of Huntington’s disease, such as
problems with thinking or emotions.
It is not known whether tet

Αρχείο Π.Χ.Π.

TETRABENAZINE- TETRABENAZINE TABLET
OCEANSIDE PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TETRABENAZINE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TETRABENAZINE
TABLETS.
TETRABENAZINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2008
WARNING: DEPRESSION AND SUICIDALITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
•
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INDICATIONS AND USAGE
Tetrabenazine tablets are a vesicular monoamine transporter 2 (VMAT)
inhibitor indicated for the treatment of chorea
associated with Huntington's disease. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
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DOSAGE FORMS AND STRENGTHS
Tablets: 12.5 mg non-scored and 25 mg scored (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
•
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Increases the risk of depression and suicidal thoughts and behavior
(suicidality) in patients with Huntington's
disease (5.1)
Balance risks of depression and suicidality with the clinical need for
control of chorea when considering the use
of tetrabenazine tablets (5.2)
Monitor patients for the emergence or worsening of depression,
suicidality, or unusual changes in behavior
(5.1)
Inform patients, caregivers and families of the risk of depression and
suicidality and instruct to report behaviors
of concern promptly to the treating physician (5.1)
Exercise caution when treating patients with a history of depression
or prior suicide attempts or ideation (5.1)
Tetrabenazine tablets are contraindicated in patients who are actively
suicidal, and in patients with untreated or
inadequately treated depression (4, 5.1)
Individualization of dose with careful weekly titration is required.
The 1
week's starting dose is 12.5 mg daily; 2
week, 25 mg (12.5 mg twice daily); then slowly titrate at weekly
intervals by 12.5 mg to a tolerated dose that reduces
chorea. (2.1, 2.2)
s t
n d
Doses of 37.5 mg and up to 50 mg/day should be administered in three
divided doses per day with a maximum
recommended sin