NITOMAN 25 MG — DIN 02199270

What is NITOMAN?

NITOMAN 25 MG contains TETRABENAZINE : 25 MG. It is listed in the Health Canada Drug Product Database under DIN 02199270, held by BAUSCH HEALTH, CANADA INC., supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 02-Oct-2020. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is NITOMAN used for?

NITOMAN (tetrabenazine) has been found useful in the treatment of hyperkinetic movement disorders such as Huntington's chorea, hemiballismus, senile chorea, tic and Gille's de la Tourette's syndrome and tardive dyskinesia. Tetrabenazine is not indicated for the treatment of levodopa-induced dyskinetic/choreiform movements.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

General: The initial dose should be low, and dosage should be titrated slowly according to the tolerance and responsiveness of the individual patient. Once a stable dose has been achieved, treatment should be reassessed periodically in the context of the patient's underlying condition and their concomitant medications. Adults: For most patients, an initial starting dose of 12.5 mg (half a tablet) two to three times a day is recommended. This can be increased slowly by 12.5 mg a day at weekly intervals, until the maximal tolerated and effective dose is reached for the individual and may have to be up/down titrated depending on individual tolerance. For some patients, a slower titration may be more appropriate. In most cases the maximal tolerated dose will be 25 mg t.i.d. In very rare cases, a 200 mg dose has been reached (the maximum recommended dose in some publications). If there is no improvement at the maximal tolerated dose in seven days, it is unlikely that NITOMAN will be of benefit to the patient, either by increasing the dose or by extending the duration of treatment. Re-initiation of NITOMAN After Treatment Interruption: Following treatment interruption of greater than five days, NITOMAN should be re-titrated when resumed. For short-term treatment interruption of less than five days, NITOMAN can be resumed at the previous maintenance dose without titration. Geriatrics (> 65 years of age): Clinical experience suggests that a reduced initial and maintenance dose should be used. Parkinsonian-like adverse reactions are relatively common in geriatric and debilitated patients and may be dose-limiting. Pediatrics (< 18 years of age): Limited clinical experience suggests that treatment should be started at approximately half the adult dose and titrated slowly and carefully according to tolerance and individual response.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

NITOMAN (tetrabenazine) is contraindicated: * in patients with a known hypersensitivity to the drug or to any of the components of the formulation. * in patients who are actively suicidal, or in patients with currently untreated or inadequately treated episodes of clinical depression. * in patients with a history of depression, including those with a current episode of depression being satisfactorily treated, unless the patient is under the care of a supervising psychiatrist experienced with the patient's disorder and tetrabenazine's pharmacology. * in patients taking a monoamine oxidase inhibitor (MAOI). At least 14 days should elapse between the discontinuation of an MAOI and initiation of treatment with NITOMAN, as well as between the discontinuation of NITOMAN and the initiation of treatment with an MAOI. * in patients with impaired hepatic function. * in patients taking reserpine. At least 20 days should elapse after stopping reserpine before starting NITOMAN. * in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption because NITOMAN contains lactose.

Warnings and precautions

Depression and Suicidality: NITOMAN (tetrabenazine) can increase the risk of depression and suicidal thoughts and behavior (suicidality). Close observation of patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior should accompany therapy. Patients, their caregivers, and families should be informed of the risk and instructed to report behaviors of concern promptly. Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation. NITOMAN is contraindicated in patients who are actively suicidal, in patients with currently untreated or inadequately treated depression. Clinical Worsening and Adverse Effects: Huntington's disease is a progressive disorder. NITOMAN was also shown to cause slight worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for NITOMAN by assessing the effect on chorea and possible adverse effects, including depression and suicidality, cognitive decline, parkinsonism, dysphagia, sedation/somnolence, akathisia, restlessness, and disability. Parkinsonism: NITOMAN can induce symptoms of parkinsonism, which are seen more frequently in the elderly and at relatively low doses. If a patient develops parkinsonism, dose reduction should be considered; in some patients, discontinuation of therapy may be necessary. Levodopa-induced dyskinetic/choreiform movements should be treated by reducing the dose of levodopa, and not by giving NITOMAN. Neuroleptic Malignant Syndrome (NMS): NMS is a rare and potentially fatal symptom complex that has been reported in association with drugs that reduce dopaminergic transmission, including tetrabenazine. Management of NMS should include immediate discontinuation of tetrabenazine and other drugs not essential to concurrent therapy, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems. If the patient requires treatment with tetrabenazine after recovery from NMS, reintroduction of therapy should be carefully considered, and slow titration initiated if required. Akathisia, Restlessness, and Agitation: NITOMAN may increase the risk of akathisia, restlessness an agitation. Patients receiving NITOMAN should be monitored for the presence of akathisia, restlessness and agitation. If a patient develops akathisia, the NITOMAN dose should be reduced; however, some patients may require discontinuation of therapy. Sedation and Somnolence: Sedation is the most common dose-limiting adverse event of NITOMAN. Patients should not perform activities that require them to be alert such as driving a car or operating hazardous machinery, until they are on a maintenance dose of NITOMAN and know how the drug affects them.