TETRABENAZINE tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

TAGI Pharma, Inc.

INN (Միջազգային անվանումը):

Tetrabenazine

Կազմը:

Tetrabenazine 12.5 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Tetrabenazine tablet is indicated for the treatment of chorea associated with Huntington's disease. Tetrabenazine tablet is contraindicated in patients: Risk Summary There are no adequate data on the development risk associated with the use of Tetrabenazine tablet in pregnant women. Administration of tetrabenazine tablets to rats throughout pregnancy and lactation resulted in an increase in stillbirths and postnatal offsprings mortality. Administration of major human metabolite of tetrabenazine to rats during pregnancy or during pregnancy and lactation produced adverse effects on developing fetus and offspring (increased mortality, decreased growth and neurobehavioral and reproductive impairment). The adverse development 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 to 20%,

Ապրանքի ամփոփագիր:

Tetrabenazine tablets are available in the following strengths and packages: The 12.5 mg Tetrabenazine tablets are white, cylindrical, biplanar tablets with beveled edges, debossed '707' on one side and plain on the other side. Bottles of 112: NDC 51224-425-10 The 25 mg Tetrabenazine tablets are yellowish-buff, cylindrical, biplanar tablets with beveled edges, debossed '708' on one side and scored on the other side. Bottles of 112: NDC 51224-426-10 Store at 25ºC (77º F); excursions permitted to 15-30 ºC (59-86ºF) [see USP Controlled Room Temperature].

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

TAGI Pharma, Inc.
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MEDICATION GUIDE
Tetrabenazine (TET ra BEN a Zeen) Tablets
Read the Medication Guide that comes with Tetrabenazine tablet 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 tablet?
•
Tetrabenazine tablet can cause serious side effects, including:
•
depression
•
suicidal thoughts
•
suicidal actions
•
You should not start taking Tetrabenazine tablet 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 tablet 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
•
loose 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 is Tetrabenazine tablet?
Tetrabenazine tablet is a medicine that is used to treat the
involuntary movements (chorea) of
Huntington's disease. 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 tablet is safe and

Ապրանքի հատկությունները

TETRABENAZINE- TETRABENAZINE TABLET
TAGI PHARMA, 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 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 tablet 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 tablet 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) 01/2018
Warnings and Precautions, Tardive Dyskinesia (5.12-removal) 01/2018
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
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 requiring doses above 50 mg per day should be genotyp