TETRABENAZINE tablet, coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Camber Pharmaceuticals, Inc.

INN (International Name):

TETRABENAZINE

Sammensetning:

TETRABENAZINE 12.5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Tetrabenazine tablets are indicated for the treatment of chorea associated with Huntington's disease. Tetrabenazine tablets are 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 tablets 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 tablets [see Drug Interactions (7.2)]. • Taking deutetrabenazine or valbenazine [see Drug Interactions (7.7)]. Teratogenic Effects: Risk Summary There are no adequate data on the developmental risk associated with the use of tetrabenazine in pregnant women. Administration of tetrabenazi

Produkt oppsummering:

Tetrabenazine tablets are available in the following strengths and packages: The 12.5 mg tetrabenazine tablets are white to off white, round, flat bevel edged tablets, non-scored, debossed with 'H' on one side and 'T5' on other side. They are supplied as follows: Bottles of 56 tablets   (NDC 31722-821-56) Bottles of 112 tablets (NDC 31722-821-11) Blister pack of 100 (10x10) unit dose tablets (NDC 31722-821-32) The 25 mg tetrabenazine tablets are yellowish-buff, round, flat bevel edged tablets, scored, debossed with 'H' on one side and 'T6' with score line on other side. They are supplied as follows: Bottles of 56 tablets   (NDC 31722-822-56) Bottles of 112 tablets (NDC 31722-822-11) Blister pack of 100 (10x10) unit dose tablets (NDC 31722-822-32) Store at 20º to 25ºC (68º to 77º F). [see USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Camber Pharmaceuticals, Inc.
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MEDICATION GUIDE
Tetrabenazine Tablets
(teh-trah-BEN-ah-zeen)
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. A Tetrabenazine tablet 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 emotions.
It is not known whether tetrabenazine tablets ar

Preparatomtale

TETRABENAZINE - TETRABENAZINE TABLET, COATED
CAMBER 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 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)
RECENT MAJOR CHANGES
Contraindications(4) 9/2017
Warnings and Precautions, Tardive Dyskinesia (5.12-removal) 9/2017
INDICATIONS AND USAGE
Tetrabenazine tablet 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 1st 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)
•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. (