TETRABENAZINE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

AvKARE

INN (Διεθνής Όνομα):

TETRABENAZINE

Σύνθεση:

TETRABENAZINE 12.5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Tetrabenazine tablet is indicated for the treatment of chorea associated with Huntington's disease. Tetrabenazine tablet is contraindicated in patients: - Who are actively suicidal, or in patients with untreated or inadequately treated depression [see Warnings and Precautions (5.2)]. - With hepatic impairment [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)]. - Taking monoamine oxidase inhibitors (MAOIs). Tetrabenazine tablet 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 tablet [see Drug Interactions (7.2)]. Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Tetrabenazine tablet should be us

Περίληψη προϊόντος:

Tetrabenazine tablets are available in the following strengths and packages: Description of 12.5 mg: white cylindrical biplanar tablets with beveled edges, de-bossed '707' on one side and plain on the other side. Bottles of 30: 42291-806-30 Description of 25 mg: yellowish-buff, cylindrical biplanar tablets with beveled edges, debossed '708' on one side and scored on the other side. Bottles of 30: NDC 42291-807-30 Store at 25°C (77° F); excursions permitted to 15-30 °C (59-86°F) [see USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

AvKARE
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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
•
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 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 effective in

Αρχείο Π.Χ.Π.

TETRABENAZINE- TETRABENAZINE TABLET
AVKARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
TETRABENAZINE TABLETS
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 ( 5.2).
Balance risks of depression and suicidality with the clinical need for
control of chorea when
considering the use of Tetrabenazine tablet (5.1)
Monitor patients for the emergence or worsening of depression,
suicidality, or unusual changes in
behavior ( 5.2).
Inform patients, caregivers and families of the risk of depression and
suicidality and instruct to
report behaviors of concern promptly to the treating physician ( 5.2).
Exercise caution when treating patients with a history of depression
or prior suicide attempts or
ideation ( 5.2).
Tetrabenazine tablet is contraindicated in patients who are actively
suicidal, and in patients with
untreated or inadequately treated depression ( 4, 5.2).
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 genotyped for
the drug metabolizing enzyme
CYP2D6 to determine if the patient is a poor metabolizer (PM)