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Tetrabenazine
Overview
What is Tetrabenazine?
TETRABENAZINE is a monoamine depletor for oral administration. The molecular weight of tetrabenazine is 317.43; the pKa is 6 .51. Tetrabenazine is a hexahydro-dimethoxy-benzoquinolizine derivative and has the following chemical name: cis rac –1, 3, 4, 6, 7, 11b-hexahydro-9, 10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one.
The empirical formula C
H
NO
is represented by the following structural formula:
Tetrabenazine is a white to slightly yellow crystalline powder that is sparingly soluble in water and soluble in ethanol.
Each Tetrabenazine tablet contains either 12.5 or 25 mg of tetrabenazine as the active ingredient.
Tetrabenazine tablet contain tetrabenazine as the active ingredient and the following inactive ingredients: lactose, magnesium stearate, maize starch, and talc. The 25 mg strength tablet also contains yellow iron oxide as an inactive ingredient.
Tetrabenazine tablet is supplied as a yellowish-buff scored tablet containing 25 mg of TETRABENAZINE or as a white non-scored tablet containing 12.5 mg of TETRABENAZINE.
What does Tetrabenazine look like?
What are the available doses of Tetrabenazine?
Tablets: 12.5 mg non-scored and 25 mg scored (
)
What should I talk to my health care provider before I take Tetrabenazine?
Pregnancy: Based on animal data, tetrabenazine may cause fetal harm. (
)
How should I use Tetrabenazine?
Tetrabenazine tablet is indicated for the treatment of chorea associated with Huntington's disease.
The chronic daily dose of Tetrabenazine tablet used to treat chorea associated with Huntington's disease (HD) is determined individually for each patient. When first prescribed, Tetrabenazine tablet therapy should be titrated slowly over several weeks to identify a dose of Tetrabenazine tablet that reduces chorea and is tolerated. Tetrabenazine tablet can be administered without regard to food
.
What interacts with Tetrabenazine?
Sorry No Records found
What are the warnings of Tetrabenazine?
Sorry No Records found
What are the precautions of Tetrabenazine?
Sorry No Records found
What are the side effects of Tetrabenazine?
Sorry No records found
What should I look out for while using Tetrabenazine?
Tetrabenazine tablet is contraindicated in patients:
Tetrabenazine tablet can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington's disease. Anyone considering the use of Tetrabenazine tablet must balance the risks of depression and suicidality with the clinical need for control of chorea. Close observation of patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior should accompany therapy. Patients, their caregivers, and families should be informed of the risk of depression and suicidality and should be instructed to report behavio rs of concern promptly to the treating physician.
Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington's disease. Tetrabenazine tablet is contraindicated in patients who are actively suicidal, and in patients with untreated or inadequately treated depression
.
What might happen if I take too much Tetrabenazine?
Three episodes of overdose occurred in the open-label trials performed in support of registration. Eight cases of overdose with Tetrabenazine tablet have been reported in the literature. The dose of Tetrabenazine tablet in these patients ranged from 100 mg to 1g. Adverse reactions associated with Tetrabenazine tablet overdose include acute dystonia, oculogyric crisis, nausea and vomiting, sweating, sedation, hypotension, confusion, diarrhea, hallucinations, rubor, and tremor.
Treatment should consist of those general measures employed in the management of overdosage with any CNS-active drug. General supportive and symptomatic measures are recommended. Cardiac rhythm and vital signs should be monitored. In managing overdosage, the possibility of multiple drug involvement should always be considered. The physician should consider contacting a poison control center on the treatment of any overdose.
How should I store and handle Tetrabenazine?
Store at 25°C (77° F); excursions permitted to 15-30 °C (59-86°F) [see USP Controlled Room Temperature].Product: 50090-2195NDC: 50090-2195-0 1 TABLET in a BLISTER PACK NDC: 50090-2195-1 12 TABLET in a BLISTER PACK NDC: 50090-2195-2 2 TABLET in a BLISTER PACK Product: 50090-2195NDC: 50090-2195-0 1 TABLET in a BLISTER PACK NDC: 50090-2195-1 12 TABLET in a BLISTER PACK NDC: 50090-2195-2 2 TABLET in a BLISTER PACK Product: 50090-2195NDC: 50090-2195-0 1 TABLET in a BLISTER PACK NDC: 50090-2195-1 12 TABLET in a BLISTER PACK NDC: 50090-2195-2 2 TABLET in a BLISTER PACK Product: 50090-2195NDC: 50090-2195-0 1 TABLET in a BLISTER PACK NDC: 50090-2195-1 12 TABLET in a BLISTER PACK NDC: 50090-2195-2 2 TABLET in a BLISTER PACK
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The precise mechanism by which TETRABENAZINE exerts its anti-chorea effects is unknown but is believed to be related to its effect as a reversible depletor of monoamines (such as dopamine, serotonin, norepinephrine, and histamine) from nerve terminals. Tetrabenazine reversibly inhibits the human vesicular monoamine transporter type 2 (VMAT 2) (K
≈ 100 nM), resulting in decreased uptake of monoamines into synaptic vesicles and depletion of monoamine stores. Human VMAT2 is also inhibited by dihydrotetrabenazine (HTBZ), a mixture of α-HTBZ and β-HTBZ, α-and β-HTBZ, major circulating metabolites in humans, exhibit high
binding affinity to bovine VMAT2. Tetrabenazine exhibits weak
binding affinity at the dopamine D2 receptor (K
= 2100 nM).
Non-Clinical Toxicology
Tetrabenazine tablet is contraindicated in patients:Tetrabenazine tablet can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington's disease. Anyone considering the use of Tetrabenazine tablet must balance the risks of depression and suicidality with the clinical need for control of chorea. Close observation of patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior should accompany therapy. Patients, their caregivers, and families should be informed of the risk of depression and suicidality and should be instructed to report behavio rs of concern promptly to the treating physician.
Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington's disease. Tetrabenazine tablet is contraindicated in patients who are actively suicidal, and in patients with untreated or inadequately treated depression .
Huntington's disease is a progressive disorder characterized by changes in mood, cognition, chorea, rigidity, and functional capacity over time. In a 12-week controlled trial, Tetrabenazine tablet was also shown to cause slight worsening in mood, cognition, rigidity, and functional capacity. Whether these effects persist, resolve, or worsen with continued treatment is unknown.
Prescribers should periodically re-evaluate the need for Tetrabenazine tablet in their patients by assessing the beneficial effect on chorea and possible adverse effects, including depression, cognitive decline, parkinsonism, dysphagia, sedation/somnolence, akathisia, restlessness and disability. It may be difficult to distinguish between drug-induced side-effects and progression of the underlying disease; decreasing the dose or stopping the drug may help the clinician distinguish between the two possibilities. In some patients, underlying chorea itself may improve over time, decreasing the need for Tetrabenazine tablet.
The following serious adverse reactions are described below and elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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