XENAZINE- tetrabenazine tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Lundbeck Pharmaceuticals LLC

INN（国际名称）:

TETRABENAZINE

组成:

TETRABENAZINE 12.5 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

XENAZINE is indicated for the treatment of chorea associated with Huntington’s disease. XENAZINE 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). XENAZINE 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 XENAZINE [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 XENAZINE in pregnant women. Administration of tetrabenazine to rats throughout pregnancy and lactation resulted in an increase in stillbirths and postnatal offspri

產品總結:

XENAZINE® (tetrabenazine) tablets are available in the following strengths and packages: The 12.5 mg XENAZINE tablets are white, cylindrical, biplanar tablets with beveled edges, non-scored, embossed on one side with “CL” and “12.5”. The 25 mg XENAZINE tablets are yellowish-buff, cylindrical, biplanar tablets with beveled edges, scored, embossed on one side with “CL” and “25”. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

授权状态:

New Drug Application

资料单张

Lundbeck Pharmaceuticals LLC
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MEDICATION GUIDE
XENAZINE® (ZEN-uh-zeen)
(tetrabenazine) Tablets
Read the Medication Guide that comes with XENAZINE 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 XENAZINE?
•
XENAZINE can cause serious side effects, including:
•
depression
•
suicidal thoughts
•
suicidal actions
•
You should not start taking XENAZINE 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 XENAZINE 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 is XENAZINE?
XENAZINE is a medicine that is used to treat the involuntary movements
(chorea) of Huntington’s disease.
XENAZINE 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 XENAZINE is safe and effective in children.
Who should not take XENAZINE?
Do not take XENAZINE if you:
•
a

产品特点

XENAZINE- TETRABENAZINE TABLET
LUNDBECK PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XENAZINE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XENAZINE.
XENAZINE (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 XENAZINE (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)
XENAZINE is contraindicated in patients who are actively suicidal, and
in patients with untreated or
inadequately treated depression (4, 5.1)
INDICATIONS AND USAGE
XENAZINE 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/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/day should be genotyped for the
drug metabolizing enzyme
CYP2D6 to determine if the patient is a poor metabolizer (PM) or an
extensive metabolizer (EM). (2.2,
5.3)
Maximum daily do