TETRABENAZINE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Tetrabenazine (UNII: Z9O08YRN8O) (Tetrabenazine - UNII:Z9O08YRN8O)

Tilgjengelig fra:

Dr. Reddys Laboratories 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 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)]. Risk Summary There are no adequate data on the developmental risk associated with the use of tetrabenazine in pregnant women. Administration of tetrabenazine to rats throughout pregnancy and lactation resulted in

Produkt oppsummering:

Tetrabenazine tablets are available in the following strengths and packages:  The 12.5 mg tetrabenazine tablets are light yellow to yellow, round flat-faced beveled edge uncoated tablets, plain on one side and debossed with “394” on other side.  Bottles of 112’s NDC 43598-394-67 Bottles of 500’s NDC 43598-394-05    The 25 mg tetrabenazine tablets are light yellow to yellow, round flat-faced beveled edge uncoated tablets, breakline on one side and debossed with “395” on other side. Bottles of 112’s NDC 43598-395-67 Bottles of 500’s NDC 43598-395-05 Store at 20ºC to 25ºC (68ºF to 77ºF); [See USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Dr. Reddys Laboratories Inc
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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 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 usualfeel 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 is tetrabenazine?
Tetrabenazine is a medicine that is used to treat the involuntary
movements (chorea) of Huntington’s disease.
Tetrabenazine 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 is safe and effective in
children.
W

Preparatomtale

TETRABENAZINE- TETRABENAZINE TABLET
DR. REDDYS LABORATORIES INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TETRABENAZINE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FORTETRABENAZINE 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 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 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. (2.2)
• Patients