Tetrabenazine Tablets (25 mg)
Healthy Inc is a specialized global supplier and exporter of advanced neurological, psychiatric, and orphan-drug therapeutics. We provide ultra-high-purity, kinetically precise Tetrabenazine Tablets (25 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Central VMAT2 Inhibitor” is a premium, high-value export to specialized neurology centers, movement disorder clinics, psychiatric hospitals, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, life-altering intervention for the hyperkinetic movement disorders, specifically the chorea associated with Huntington’s disease.
Product Overview
This formulation contains Tetrabenazine, a highly specific and reversible depleter of monoamines that acts as a profound neuromodulator to quiet uncontrollable, involuntary muscle movements.
The “Hyperkinetic Suppressor & VMAT2” Specialist:
- Mechanism (VMAT2 Inhibition): In hyperkinetic disorders like Huntington’s chorea or Tardive Dyskinesia, the brain’s motor pathways are overstimulated by excessive dopamine. Normal neurons use a protein called Vesicular Monoamine Transporter 2 (VMAT2) to package dopamine safely into vesicles for release. Tetrabenazine aggressively binds to and blocks VMAT2. Without this packaging, the dopamine is left exposed in the nerve terminal and is rapidly destroyed by enzymes (MAO). This drastically depletes the amount of dopamine reaching the motor receptors, effectively “turning down the volume” on uncontrollable bodily movements.
- The Huntington’s Chorea Standard: For patients with Huntington’s disease, the constant, jerky, dancing movements (chorea) are exhausting and physically dangerous. Tetrabenazine is the first globally approved, highly effective oral medication specifically engineered to suppress these movements, vastly improving the patient’s quality of life and physical safety.
- Tardive Dyskinesia & Tourette’s: Tetrabenazine is also heavily utilized (often off-label or as a second-line therapy) to treat severe tic disorders (Tourette Syndrome) and Tardive Dyskinesia—a permanent, uncontrollable movement disorder often caused by long-term exposure to older antipsychotic medications.
Product Composition & Strength
We supply this product as a Precision-Blended Scored Tablet, packed in highly secure, moisture-resistant Alu-PVC or opaque Alu-Alu blister strips, optimized for strict neurological dose titration and chronic dispensing.
| Active Ingredient | Strength | Primary Clinical Use |
|---|---|---|
| Tetrabenazine INN/Ph.Eur. | 25 mg | Standard Titration & Maintenance: Scored to allow for precise 12.5 mg micro-dosing during the critical initiation phase. |
| Excipients | Lactose / Maize Starch / Magnesium Stearate / Iron Oxide Yellow | Diluent / Glidant / Colorant (Engineered for immediate gastric dispersion and precise tablet splitting) |
*Pack Sizes: 10×10 Blisters or HDPE Bottles of 112 Tablets (Optimized for specialized neurological pharmacy dispensing).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Orphan Drug Distributors, and Neurology Networks.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Neurological/CNS) |
| CAS Number | 58-46-8 |
| Dosage Form | Uncoated Tablet (Immediate Release, Scored) |
| Packaging | Alu-PVC / Alu-Alu Blisters or HDPE Bottles. Ensures stability of the API and provides necessary child-resistant, tamper-evident barriers for high-potency CNS drugs. |
| Storage | Store strictly below 25°C in a dry place. Protect from Light. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Dose Uniformity & Geometric Blending: Because the therapeutic window for Tetrabenazine is extremely narrow—and overdosing causes severe Parkinsonism and depression—our facilities utilize advanced high-shear homogenizers and rigorous geometric dilution protocols. This ensures absolute, flawless dose uniformity in the low-strength, scored tablets, preventing toxic “hot spots.”
Therapeutic Indications (Human Use)
Indicated for the highly specialized management of hyperkinetic movement disorders:
- Huntington’s Disease: Treatment of chorea (involuntary, jerky movements) associated with Huntington’s disease.
- Tardive Dyskinesia: Management of moderate to severe drug-induced tardive dyskinesia that is disabling or socially embarrassing.
- Tourette Syndrome (Off-Label): Management of severe, refractory motor and vocal tics.
Dosage & Administration
Recommended Dosage (Strictly as per Movement Disorder Specialist):
- Strict Dose Titration: Therapy must be highly individualized. It typically begins at 12.5 mg (half a 25 mg tablet) daily, slowly titrating upward over weeks to identify the lowest effective dose that controls chorea without inducing intolerable side effects.
- CYP2D6 Genetic Testing (CRITICAL REQUIREMENT): Tetrabenazine is extensively metabolized by the liver enzyme CYP2D6. Patients who require doses higher than 50 mg per day MUST be genetically tested to determine if they are “poor metabolizers.” If they are poor metabolizers, the maximum daily dose is strictly capped (e.g., 50 mg/day) to prevent fatal toxic accumulation of the drug.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX WARNING (Depression & Suicidality): Tetrabenazine massively depletes monoamines (including serotonin), directly causing or worsening severe depression. It significantly increases the risk of suicidal thoughts and behavior, particularly in Huntington’s disease patients (who already have a high baseline suicide risk). It is strictly contraindicated in patients who are actively suicidal or have untreated/inadequately treated depression.
- Parkinsonism & Akathisia: By depleting dopamine, Tetrabenazine can induce severe, drug-induced Parkinson’s disease symptoms (rigidity, tremors, bradykinesia) and severe akathisia (an agonizing, unbearable inner restlessness).
- QTc Prolongation: The drug can prolong the QT interval on an ECG. It should be avoided in patients with congenital long QT syndrome or those taking other drugs known to prolong the QTc interval, due to the risk of fatal cardiac arrhythmias.
- MAOI Contraindication: Strictly contraindicated for use within 14 days of taking a Monoamine Oxidase Inhibitor (MAOI) antidepressant.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Neurological and Orphan Drug Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for movement disorder clinics in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Specialty Medicine Wholesaler receives WHO-GMP certified products at competitive rates.