TETRABENAZINE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Slate Run Pharmaceuticals, LLC

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 t

Produktbesonderheiten:

Tetrabenazine tablets are available in the following strengths and packages: Tetrabenazine tablets 12.5 mg are formulated as light yellow to yellow, round shaped, flat, beveled edge tablets, debossed with “T” 12.5 on one side and plain on other side. Bottles of 112: NDC 70436-101-09 Tetrabenazine tablets 25 mg are formulated as light yellow to yellow, round shaped, flat, beveled edge tablets, debossed “T 25” on one side and functional scoreline on other side. Bottles of 112: NDC 70436-102-09 Store at 25º C (77º F); excursions permitted to 15° to 30ºC (59° to 86º F) [see USP Controlled Room Temperature].

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

TETRABENAZINE- TETRABENAZINE TABLET
Slate Run Pharmaceuticals, LLC
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MEDICATION GUIDE
Tetrabenazine Tablets
(TET-ra-BEN-a-zine)
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:
•
depression
•
suicidal thoughts
•
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 is
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 is a medicine that is used to treat the
involuntary movements (chorea) of
Huntington’s disease. Tetrabenazine tablets does 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 emotio

Fachinformation

TETRABENAZINE- TETRABENAZINE TABLET
SLATE RUN PHARMACEUTICALS, LLC
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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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RECENT MAJOR CHANGES
Contraindications (4) 9/2017
Warnings and Precautions, Tardive Dyskinesia (5.12-removal) 9/2017
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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•
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DOSAGE FORMS AND STRENGTHS
Tablets: 12.5 mg non-scored and 25 mg with functional score (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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 (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 IS 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; 2nd 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)
st
Doses