TETRABENAZINE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Lupin Pharmaceuticals, Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Tetrabenazine tablets are indicated for the treatment of chorea associated with Huntington's disease. Tetrabenazine is contraindicated in patients: - Who are actively suicidal, or in patients with untreated or inadequately treated depression [see WARNINGS AND PRECAUTIONS (5.1)] . - With hepatic impairment [see USE IN SPECIFIC POPULATIONS (8.6), CLINICAL PHARMACOLOGY (12.3)] . - Taking monoamine oxidase inhibitors (MAOIs). Tetrabenazine should not be used in combination with an MAOI, or within a minimum of 14 days of discontinuing therapy with an MAOI [see DRUG INTERACTIONS (7.3)] . - Taking reserpine. At least 20 days should elapse after stopping reserpine before starting tetrabenazine [see DRUG INTERACTIONS (7.2)] . - Taking deutetrabenazine or valbenazine [see DRUG INTERACTIONS ( 7.7)]. There are no adequate data on the developmental risk associated with the use of tetrabenazine in pregnant women. Administration of tetrabenazine to rats throughout preg

Produkt oppsummering:

Tetrabenazine tablets are available in the following strengths and packages: The 12.5 mg: White to off-white, round shaped, flat faced tablets with bevelled edges, non-scored, debossed with 'LU' one side and 'L71' on the other side.. Bottles of 112 NDC 68180-408-58. The 25 mg: Light yellow colored, round shaped, flat faced tablets with bevelled edges, debossed with 'L' and 'U' separated by scoreline on one side and 'L72' on other side.. Bottles of 112 NDC 68180-409-58. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Lupin Pharmaceuticals, Inc.
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MEDICATION GUIDE
Tetrabenazine (TET-ra-BEN-a-zine) 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:
•
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 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 tetrabenazine t

Preparatomtale

TETRABENAZINE- TETRABENAZINE TABLET
LUPIN PHARMACEUTICALS, INC.
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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._
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)
RECENT MAJOR CHANGES
Contraindications (4)
9/2017
Warnings and Precautions, Tardive Dyskinesia (5.12-removal)
9/2017
INDICATIONS AND USAGE
Tetrabenazine is a vesicular monoamine transporter 2 (VMAT) inhibitor
indicated for the treatment of chorea associated
with Huntington's disease (1)
DOSAGE AND ADMINISTRATION
Individualization of dose with careful weekly titration is required.
The 1
week's starting dose is 12.5 mg daily; 2
we e k,
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)
Doses of 37.5 mg and up to 50 mg per day should be administered in
three divided doses per day with a maximum
recommended single dose not to exceed 25 mg (2.2)
Patients requiring doses above 50 mg per day should be genotyped fo