NITOMAN
As listed in the register: NITOMAN
25 mg · tablet
- Prescription only
- Pain, sleep, mood, epilepsy and the brain
- Active substance
- Tetrabenazine
- Made by
- Bausch Health, Canada Inc.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (Tetrabenazine). It describes the substance, not this exact product.
The precise mechanism by which tetrabenazine exerts its anti-chorea effects is unknown but is believed to be related to its effect as a reversible depletor of monoamines (such as dopamine, serotonin, norepinephrine, and histamine) from nerve terminals.
Tetrabenazine reversibly inhibits the human vesicular monoamine transporter type 2 (VMAT2) (K i ≈ 100 nM), resulting in decreased uptake of monoamines into synaptic vesicles and depletion of monoamine stores.
After oral administration, tetrabenazine is extensively hepatically metabolized, and the metabolites are primarily renally eliminated. α-HTBZ, β-HTBZ and 9-desmethyl-β-DHTBZ have half-lives of 7 hours, 5 hours and 12 hours respectively.
In a mass balance study in 6 healthy volunteers, approximately 75% of the dose was excreted in the urine, and fecal recovery accounted for approximately 7 to 16% of the dose.
Food Effects The effects of food on the bioavailability of tetrabenazine were studied in subjects administered a single dose with and without food.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-10-13
Safety of the active substance
From the US prescribing label for the same active substance (Tetrabenazine). It describes the substance, not this exact product.
WARNING: DEPRESSION AND SUICIDALITY Tetrabenazine can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease.
- Tetrabenazine tablets are contraindicated in patients: Who are actively suicidal, or in patients with untreated or inadequately treated depression [see Warnings and Precautions ( 5.1 )].
- With hepatic impairment [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )].
- Taking monoamine oxidase inhibitors (MAOIs).
- Tetrabenazine tablets should not be used in combination with an MAOI, or within a minimum of 14 days of discontinuing therapy with an MAOI [see Drug Interactions ( 7.3 )].
The most common adverse reactions (over 10%, and at least 5% greater than placebo) were sedation/somnolence, fatigue, insomnia, depression, akathisia, anxiety/anxiety aggravated, and nausea.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United States12 matching products
Spain4 matching products
Netherlands6 matching products
SwitzerlandNo exact match for this strength and form
Details
| Made by | Bausch Health, Canada Inc. |
|---|---|
| Active substance | Tetrabenazine |
| Used in | Pain, sleep, mood, epilepsy and the brain |
| Strength | 25 mg |
| Form | tablet |
| Classification | N07XX06 · Pain, sleep, mood, epilepsy and the brain |
| Route | oral |
| Dispensing (as stated by the register) | PRESCRIPTION |
| Status | Marketed |
| Marketed | Yes, according to the register |
| DIN | 02199270 |
| DPD drug code | 42959 |
Source: Drug Product Database · 2026-09-30 · not reviewed by a clinician
Contains information licensed under the Open Government Licence – Canada. Reuse terms: Open Government Licence – Canada.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.