GNH USA

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

What is Nitoman used for?+
Nitoman contains tetrabenazine, a medication indicated to treat involuntary movement disorders such as Huntington’s disease chorea and tardive dyskinesia. It works by reducing excess dopamine activity, thereby helping patients regain better motor control and improve daily functioning.
How does tetrabenazine work?+
Tetrabenazine reversibly inhibits the vesicular monoamine transporter 2 (VMAT2) on presynaptic neurons. This prevents dopamine and other monoamines from being stored in vesicles, leading to lower levels of these neurotransmitters in the synapse and a reduction in hyperkinetic movements.
What is the usual dose of Nitoman?+
The dose of Nitoman is individualized by the prescribing clinician based on the patient’s condition, response, and tolerability. Dosage adjustments are made according to clinical guidelines and patient-specific factors; no fixed regimen is provided in public information.
Is Nitoman safe during pregnancy or breastfeeding?+
Safety data for tetrabenazine in pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. It should only be used if the potential benefit justifies the potential risk to the fetus or infant, and under close medical supervision.
How do I order Nitoman from GNH USA?+
To order Nitoman, submit an enquiry on the product page at gnh-usa.com specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any required import documentation.
How does Nitoman compare with the main alternative drug or class?+
The primary alternative class for hyperkinetic movement disorders includes anticholinergic agents and dopamine‑depleting drugs such as deutetrabenazine. Compared with older anticholinergics, tetrabenazine offers more targeted VMAT2 inhibition, often resulting in better control of chorea but with a distinct side‑effect profile that requires careful monitoring.
How should Nitoman be stored and handled?+
Nitoman should be stored at temperatures below 25 °C, in its original packaging, and protected from moisture and direct light. Keep the product out of reach of children and avoid exposing it to excessive heat or humidity to maintain potency.
How is Nitoman administered?+
Nitoman is taken orally, usually as a tablet, with or without food as directed by the prescriber. The exact timing and frequency depend on the individualized dosing schedule set by the treating physician.
What are the most serious risks to watch for while using Nitoman?+
The most serious risks include the development of severe depression, suicidal thoughts or behaviors, and cardiac QT‑interval prolongation that can lead to arrhythmias. Patients should be monitored closely for mood changes and cardiac symptoms, and any concerning signs should prompt immediate medical evaluation.
Who should not use Nitoman?+
Nitoman is contraindicated in patients with known hypersensitivity to tetrabenazine or any component of the formulation, and it should be avoided in individuals with severe hepatic impairment, uncontrolled cardiac arrhythmias, or those taking prohibited major interacting drugs such as MAO inhibitors.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Tetrabenazine
Route
Oral Use
Manufacturer
Bausch Health Ireland Limited
Origin
EU

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