Description:

Tetrabenazine tablets 25mg is a generic VMAT2 inhibitor medication used to treat chorea (involuntary, irregular movements) associated with Huntington’s disease. It depletes monoamines (dopamine, norepinephrine, serotonin) in the central nervous system by inhibiting vesicular monoamine transporter 2 (VMAT2), reducing excessive dopaminergic activity that causes chorea. It is not a cure for Huntington’s but provides symptomatic relief of chorea. It is also used off-label in some cases for other hyperkinetic movement disorders (e.g., tardive dyskinesia, hemiballismus), though primary approved use is Huntington’s chorea.

Prescription:

Prescription-only (Rx).

Therapeutic Category:

VMAT2 inhibitor / Central monoamine depleting agent  symptomatic treatment for hyperkinetic movement disorders, primarily Huntington’s chorea).

Active Ingredients/Composition:

Each tablet contains: Tetrabenazine 25 mg. Excipients: Lactose, maize starch, talc, magnesium stearate, yellow iron oxide (for 25mg strength coloring), and others (standard film-coated or uncoated tablet; refer to label for full list).

Variant: 25 mg tablets (standard strength for titration and maintenance; often film-coated or uncoated, round/oval; packs commonly 10’s, 30’s, or 60’s; differs from 12.5 mg starting dose tablets).

Consume Type:

Oral (tablet; swallow whole with water; can be taken with or without food).

Directions/Usage: Adults: Start low to minimize side effects.

• Initial dose: 12.5 mg once daily in the morning (half a 25 mg tablet or 12.5 mg strength if available).
• Titration: Increase by 12.5 mg every 3-7 days based on response and tolerability.
• Maintenance: Usually 25-50 mg/day in divided doses (e.g., 25 mg 2-3 times daily); max 100 mg/day (higher doses under specialist supervision).
• Doses 37.5-50 mg/day: Give in 3 divided doses.
• Max single dose: 25 mg (to reduce peak-related side effects).
• CYP2D6 poor metabolizers: Max total daily dose 50 mg, max single dose 25 mg (genetic testing recommended). Take as prescribed; regular monitoring for depression/suicidality and efficacy required. Duration: Long-term for chronic chorea, but reassess periodically.

Common Side Effects:

• Sedation/drowsiness, fatigue
• Depression, anxiety, agitation
• Insomnia or sleep disturbances
• Parkinsonism (tremor, rigidity, bradykinesia)
• Akathisia (restlessness)
• Nausea, vomiting
• Orthostatic hypotension
• Weight gain Serious: Suicidality (boxed warning—monitor closely, especially at start/dose changes), neuroleptic malignant syndrome-like symptoms, QT prolongation, parkinsonism worsening.

Package Type:

Blister packs (commonly 10 tablets per strip; packs of 30, 60, or 100 tablets in carton box; tablets yellow/off-white, round/oval, scored or debossed).

Storage Advice: Store at room temperature (below 25-30°C), in a cool, dry place away from direct sunlight, heat, and moisture. Keep in original packaging. Keep out of reach of children.

Safety Advice:

• Boxed warning: Increases risk of depression and suicidality—monitor patients/ caregivers closely for mood/behavior changes; consider discontinuation if severe.
• Contraindicated in suicidal ideation/history, untreated/undertreated depression, hepatic impairment, or with MAOIs/reserpine (within 20 days).
• Caution in Parkinson’s disease (worsens symptoms), history of QT prolongation, or poor CYP2D6 metabolizers (higher exposure/toxicity).
• Avoid alcohol (enhances sedation).
• Pregnancy: Use only if benefits outweigh risks (limited data). Breastfeeding: Caution (excreted in milk).
• Interactions: Strong CYP2D6 inhibitors (increase levels—reduce dose), MAOIs, reserpine (additive depletion), drugs prolonging QT.
• Report immediately: New/worsening depression, suicidal thoughts, parkinsonism, or neuroleptic malignant syndrome symptoms (fever, rigidity).
• Not for acute chorea without specialist oversight.

Manufacturer/Marketer:

Intas Pharmaceuticals Ltd.

Country of Origin:

India.