TETRABENAZINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ajanta Pharma USA Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tetrabenazine tablets are indicated for the treatment of chorea associated with Huntington’s disease. Tetrabenazine 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). 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 an increase in

Product summary:

Tetrabenazine tablets are available in the following strengths and packages: The 12.5 mg tetrabenazine tablets are light yellow to yellow colored, round, flat faced beveled edge, non-scored tablets debossed with ‘T1’ on one side and plain on other side. Bottles of 112: NDC 27241-176-13. The 25 mg tetrabenazine tablets are light yellow to yellow colored, round, flat faced beveled edge, functionally scored tablets debossed with ‘T’ on both side of scored line and plain on other side. Bottles of 112: NDC 27241-177-13. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Ajanta Pharma USA Inc.
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MEDICATION GUIDE
Tetrabenazine Tablets
(tet″ ra ben′ a 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:
•
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 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 medicines those are used to treat the
involuntary movements (chorea) of
Huntington’s disease. Tetrabenazine tablets 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 tetrabe

Summary of Product characteristics

TETRABENAZINE - TETRABENAZINE TABLET
AJANTA PHARMA USA 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 (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)
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) or an
extens