Europe — EMA
Nitoman (Tetrabenazine)
GNH USA supplies Nitoman (Tetrabenazine), a VMAT2 inhibitor for Huntington's disease and tardive dyskinesia.
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What is Tetrabenazine?
Tetrabenazine, the active ingredient in Nitoman, is a VMAT2 inhibitor presented as an oral tablet for oral use. It is employed to reduce involuntary movements associated with Huntington’s disease and tardive dyskinesia in adult patients. By decreasing dopamine storage in presynaptic vesicles, it helps control chorea and dyskinetic movements, improving functional ability and quality of life.
GNH USA supplies Nitoman as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to EU quality standards and provides reliable sourcing for regulated markets.
What is Tetrabenazine used for?
Tetrabenazine is indicated for movement‑disorder conditions that involve excessive dopaminergic activity, where reduction of involuntary movements is clinically required.
- Huntington's disease: reduces chorea, improves motor coordination, may enhance daily functioning, and can decrease caregiver burden in patients with manifest disease. - Tardive dyskinesia: lessens involuntary facial, tongue, and limb movements that arise from chronic antipsychotic exposure, improves quality of life, and supports better adherence to psychiatric therapy. - Other choreiform disorders: may be used under specialist supervision to control involuntary movements in conditions such as Wilson disease or neuroacanthocytosis.
What are the side effects of Tetrabenazine?
Tetrabenazine may cause a range of adverse reactions, varying from mild to severe.
Common Side Effects: - Drowsiness: feeling of increased sleepiness or fatigue. - Nausea: mild to moderate stomach upset. - Depression: low mood that may require monitoring. - Weight loss: reduced appetite leading to decreased body weight. - Insomnia: difficulty falling or staying asleep. - Dry mouth: reduced salivation. - Dizziness: sensation of lightheadedness or unsteadiness.
Serious or Rare Side Effects: - Suicidal ideation: thoughts of self‑harm requiring immediate medical attention. - Severe depression: marked depressive episodes that may be life‑threatening. - QT prolongation: cardiac rhythm disturbance that can lead to arrhythmia. - Neuroleptic malignant‑like syndrome: rare hyperthermia and muscle rigidity.
What precautions apply to Tetrabenazine?
When prescribing Nitoman, clinicians should observe several safety measures.
- Monitor depression: assess patients regularly for mood changes and suicidal thoughts. - Avoid in severe hepatic impairment: dose adjustment or contraindication may be required. - Use caution with other CNS depressants: increased sedation risk. - Adjust dose in renal impairment: consider reduced dosing in moderate renal dysfunction. - Pregnancy and lactation: safety not established; avoid use unless benefit outweighs risk. - Store at below 25°C: keep in the original container, protect from moisture and light.
What does Tetrabenazine interact with?
Tetrabenazine interacts with several drug classes; awareness helps prevent adverse events.
Major Interactions (Avoid): - MAO inhibitors: risk of hypertensive crisis and severe serotonin syndrome. - QT‑prolonging agents: additive effect on cardiac repolarization increasing arrhythmia risk. - CNS depressants (e.g., opioids, benzodiazepines): may cause excessive sedation or respiratory depression.
Moderate Interactions (Monitor Closely): - Antidepressants (SSRIs, SNRIs): may enhance serotonergic effects. - Antihypertensives: tetrabenazine can potentiate blood pressure lowering. - Anticholinergic drugs: may increase anticholinergic burden and cognitive effects.
Frequently asked questions
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Product details
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