TETRABENAZINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ingenus Pharmaceuticals NJ, LLC

INN (International Name):

TETRABENAZINE

Composition:

TETRABENAZINE 12.5 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TETRABENAZINE- TETRABENAZINE TABLET
INGENUS PHARMACEUTICALS NJ, LLC
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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 (5.2).
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) or an