Product image of Nitoman (Tetrabenazine) supplied by GNH India

Nitoman

Active Ingredient:
Tetrabenazine
Origin:
EU

Nitoman (Tetrabenazine)

Tetrabenazine, the active ingredient in Nitoman, is a VMAT2 inhibitor presented as an oral dosage form for oral use. It is indicated for the management of movement disorders such as Huntington's disease chorea and tardive dyskinesia in adult patients.

GNH India supplies Nitoman as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Bausch Health Ireland Limited

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Indications & Clinical Uses

Nitoman (tetrabenazine) acts on the vesicular monoamine transporter 2 pathway to treat specific movement disorders.

  • Huntington's disease (chorea): reduces the frequency and severity of involuntary choreiform movements, helping to improve overall motor function and patient quality of life.
  • Tardive dyskinesia: lessens repetitive, involuntary facial grimacing and limb motions, providing symptomatic relief for patients with medication‑induced movement disorders.

How It Works

  • Tetrabenazine selectively inhibits vesicular monoamine transporter 2 (VMAT2) in presynaptic neurons, preventing the uptake of dopamine, serotonin, norepinephrine and other monoamines into synaptic vesicles. This blockade reduces the amount of neurotransmitter released into the synaptic cleft, leading to decreased dopaminergic stimulation of postsynaptic receptors, which mitigates hyperkinetic movement symptoms associated with Huntington's disease and tardive dyskinesia.

Side Effects

Tetrabenazine may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Drowsiness: feeling unusually sleepy or sluggish.
  • Fatigue: persistent lack of energy affecting daily activities.
  • Nausea: upset stomach often accompanied by an urge to vomit.
  • Depression: low mood or loss of interest that may require monitoring.

Serious or Rare Side Effects

  • Neuroleptic malignant syndrome: rare but life‑threatening reaction with fever, muscle rigidity, and autonomic instability.
  • Suicidal thoughts: emergence or worsening of suicidal ideation requiring immediate medical attention.

Precautions & Warnings

When prescribing tetrabenazine, clinicians should observe several safety considerations.

  • Assess baseline mood: monitor for depression or suicidal thoughts before initiating therapy.
  • Evaluate liver function: check hepatic enzymes as tetrabenazine is metabolized hepatically.
  • Review concomitant medications: avoid drugs that prolong QT interval or affect CYP2D6 metabolism.
  • Adjust dose in renal impairment: consider lower starting dose for patients with reduced renal clearance.
  • Monitor cardiac status: obtain ECG if patient has cardiac risk factors or is on QT‑prolonging agents.
  • Store at ambient temperature: keep below 25 °C, in the original container, protected from moisture and light.

Avoid Interactions

Tetrabenazine interacts with several drug classes, requiring careful management to avoid adverse outcomes.

Major Interactions (Avoid)

  • Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine): can markedly increase tetrabenazine plasma levels, raising risk of toxicity.
  • QT‑prolonging agents (e.g., haloperidol, sotalol): combined use may exacerbate cardiac rhythm disturbances.

Moderate Interactions (Monitor Closely)

  • CYP2D6 substrates (e.g., codeine, tramadol): may have altered efficacy when co‑administered.
  • Antidepressants affecting serotonin (e.g., SSRIs): monitor for additive central nervous system depression.
  • Antipsychotics (e.g., risperidone): may require dose adjustments to balance therapeutic effects.

Frequently Asked Questions

Nitoman contains tetrabenazine and is prescribed for adult patients with Huntington's disease chorea and for those experiencing tardive dyskinesia, a medication‑induced movement disorder. Both conditions involve involuntary, repetitive movements that the drug helps to reduce.

Tetrabenazine blocks the vesicular monoamine transporter 2 (VMAT2) in presynaptic neurons, preventing dopamine and other monoamines from being stored in vesicles. This reduces the amount released into the synapse, lowering dopaminergic stimulation that drives hyperkinetic movements.

The dosing regimen for Nitoman is individualized. A qualified prescriber determines the starting dose and any titration based on the patient’s clinical condition, response, and tolerability, following local prescribing guidelines.

The pregnancy category for tetrabenazine is unknown, and limited data exist for use while breastfeeding. It should only be used if the potential benefit justifies the potential risk to the fetus or infant, and decisions should be made in consultation with a healthcare professional.

To order Nitoman, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Nitoman (tetrabenazine) is a VMAT2 inhibitor, whereas alternatives such as deutetrabenazine offer a similar mechanism with potentially longer dosing intervals. Antipsychotics and benzodiazepines may also be used but act through different pathways and often have distinct side‑effect profiles.

Nitoman should be stored at ambient temperature, preferably below 25 °C. Keep the tablets in the original packaging, protect them from moisture and direct light, and avoid storing in areas with high humidity or temperature fluctuations.

Nitoman is taken orally, usually as a tablet, with or without food as directed by the prescribing clinician. The exact timing and frequency depend on the individualized dosing schedule established by the healthcare provider.

Serious risks include the development of depression or suicidal thoughts, neuroleptic malignant syndrome, and cardiac complications such as QT‑interval prolongation. Patients should be monitored closely for mood changes, fever, muscle rigidity, or any cardiac symptoms.

Nitoman is contraindicated in individuals with known hypersensitivity to tetrabenazine, severe hepatic impairment, or those taking monoamine oxidase inhibitors (MAOIs). Caution is also advised for patients with pre‑existing cardiac arrhythmias or significant QT prolongation.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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