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 tablet for oral use. It is employed in the management of movement disorders such as Huntington’s disease chorea and tardive dyskinesia, targeting patients who require reduction of involuntary movements. The drug reduces dopamine and other monoamines in presynaptic neurons, helping to control excessive motor activity.

GNH India supplies Nitoman as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory documentation for global distribution.

Manufacturer / TM Owner

Bausch Health Ireland Limited

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Indications & Clinical Uses

Nitoman is a VMAT2 inhibitor used to treat hyperkinetic movement disorders.

  • Huntington’s disease chorea: reduces the severity and frequency of involuntary movements.
  • Tardive dyskinesia: alleviates persistent choreiform movements caused by long‑term antipsychotic therapy.
  • Other hyperkinetic movement disorders: may help control involuntary movements in various neurological conditions.

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 leads to depletion of these neurotransmitters in the neuronal cytoplasm, thereby reducing excessive dopaminergic stimulation that underlies chorea and dyskinesia.

Side Effects

Adverse reactions may occur with Nitoman use.

Common Side Effects

  • Fatigue: feeling unusually tired or weak.
  • Nausea: upset stomach often accompanied by vomiting.
  • Depression: low mood that may worsen existing depressive symptoms.
  • Sedation: drowsiness affecting daily activities.
  • Weight loss: unintended reduction in body weight.
  • Parkinsonism: stiffness or slowed movements resembling Parkinson disease.

Serious or Rare Side Effects

  • Suicidal ideation: thoughts of self‑harm requiring immediate evaluation.
  • Severe depression: marked mood disturbance that may need psychiatric intervention.
  • QT interval prolongation: cardiac rhythm changes that can lead to arrhythmia.
  • Hepatic dysfunction: abnormal liver enzymes indicating possible liver injury.

Precautions & Warnings

Before initiating Nitoman, several safety considerations are recommended.

  • Assess baseline mood: monitor patients for worsening depression or suicidal thoughts.
  • Evaluate liver function: avoid use in severe hepatic impairment and monitor enzymes regularly.
  • Check cardiac status: contraindicated in patients with known QT prolongation or significant arrhythmias.
  • Use caution in the elderly: increased risk of falls and sedation.
  • Avoid concomitant MAO inhibitors: risk of hypertensive crisis.
  • Store at ambient temperature: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Nitoman may interact with several drug classes; monitoring is essential.

Major Interactions (Avoid)

  • MAO inhibitors: can cause hypertensive crisis when combined.
  • Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): increase tetrabenazine plasma levels, raising toxicity risk.
  • Strong CYP2D6 inducers (e.g., rifampin): reduce efficacy by lowering drug concentrations.

Moderate Interactions (Monitor Closely)

  • Antihypertensive agents: additive blood pressure‑lowering effect may require dose adjustment.
  • Other dopamine‑depleting medications: may enhance motor side effects.
  • QT‑prolonging drugs (e.g., certain antiarrhythmics): monitor ECG for interval changes.

Frequently Asked Questions

Nitoman contains tetrabenazine, which is prescribed to manage hyperkinetic movement disorders. The primary approved uses are Huntington’s disease chorea and tardive dyskinesia, where it helps reduce involuntary, repetitive movements that interfere with daily activities.

Tetrabenazine blocks the vesicular monoamine transporter 2 (VMAT2) in nerve terminals, preventing dopamine and other monoamines from being stored in synaptic vesicles. This depletion lowers dopaminergic signaling in the brain, thereby diminishing the excessive motor activity that characterizes chorea and dyskinesia.

The dosage of Nitoman is individualized by the prescribing clinician based on the patient’s condition, response, and tolerability. The prescriber determines the starting dose, titration schedule, and maximum daily amount, following local regulatory guidelines and clinical judgment.

Safety data for tetrabenazine in pregnancy and lactation are limited. It is generally classified as contraindicated or to be used only if the potential benefit justifies the potential risk to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives with their healthcare provider.

To request Nitoman, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements), and necessary import documentation.

Nitoman (tetrabenazine) is the first‑generation VMAT2 inhibitor, whereas deutetrabenazine (Austedo) is a newer formulation with a longer half‑life and potentially fewer dosing adjustments. Both share the same mechanism, but deutetrabenazine may offer smoother plasma levels, reducing the frequency of dose titration for some patients.

Nitoman tablets should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture, and store it away from direct sunlight or heat sources to maintain potency throughout its shelf life.

Nitoman is taken orally as a tablet, usually with a full glass of water. The prescriber will advise whether the medication should be taken with food or on an empty stomach, and the dosing schedule (once daily or divided doses) will be individualized.

The most critical safety concerns include the potential for severe depression, suicidal thoughts or behavior, and cardiac QT‑interval prolongation, which can lead to arrhythmias. Patients should be monitored closely for mood changes and cardiac symptoms, and any concerning signs require immediate medical evaluation.

Nitoman is contraindicated in individuals with known QT prolongation, severe hepatic impairment, or those currently receiving monoamine oxidase (MAO) inhibitors. Caution is also advised for patients with a history of depression, suicidal ideation, or significant cardiac disease, and it should be avoided unless benefits outweigh risks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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