NITOMAN

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.

5 mg (half a tablet) two to three times a day is recommended. 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 (see ADVERSE REACTIONS).

For some patients, a slower titration may be more appropriate (see Special Populations, CYP2D6 Poor Metabolizers, and Geriatrics below). 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. Special Populations Hepatic Impairment The use of NITOMAN in patients with liver disease is contraindicated (see CONTRAINDICATIONS and WARNINGS, Special Populations).

6-fold, respectively; see DRUG INTERACTIONS). Caution in dosing should be exercised (see WARNINGS, CYP2D6 Metabolizer Status). Geriatrics (> 65 years of age) The pharmacokinetics of tetrabenazine and its primary metabolites have not been systematically evaluated in geriatric subjects.

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. PrNITOMAN® Product Monograph Page 13 of 20 Pediatrics (< 18 years of age) No adequately controlled clinical studies have been performed in children.

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. 43 g/mol Physicochemical Properties Description: White to slightly yellow crystalline powder Composition Each NITOMAN tablet contains 25 mg Tetrabenazine, Corn Starch, Lactose, Talc, Magnesium Stearate and Iron Oxide.

Stability and Storage Recommendations NITOMAN tablets should be stored in well-closed containers. Store at 15-30°C. PrNITOMAN® Product Monograph Page 15 of 20 AVAILABILITY OF DOSAGE FORMS Round, yellowish-buff tablets with CL 25 imprinted across one face and a single break bar on the other, containing 25 mg tetrabenazine.