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  • Xenazine 25 mg
    / Neopharm

    Active Ingredient

    Status in Israel

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft


    112 X 25 mg

    partial basket chart 61821 24029

    Related information


    The tablets are for oral administration.
    Organic Central Nervous System Movement Disorders
    Adults: Dosage and administration are variable and only a guide is given. An initial starting dose of 25 mg three times a day is recommended. This can be increased by 25 mg a day every three or four days until 200 mg a day is being given or the limit of tolerance, as dictated by unwanted effects, is reached, whichever is the lower dose.
    If there is no improvement at the maximum dose in seven days, it is unlikely that the compound will be of benefit to the patient, either by increasing the dose or by extending the duration of treatment.
    Tardive Dyskinesia
    Recommended starting dose of 12.5 mg a day, subsequently titrated according to response.
    Medication should be discontinued if there is no clear benefit or if the side-effects cannot be tolerated.
    The elderly: No specific studies have been performed in the elderly, but tetrabenazine has been administered to elderly patients in standard dosage without apparent ill effect. Parkinson-like adverse reactions are quite common in these patients and could be doselimiting.
    Children: No adequate controlled studies have been performed in children. The treatment is not recommended in children.
    Patients with renal impairment: No studies have been performed in patients with renal impairment. Caution is advised in the treatment of these patients.


    Movement disorders, associated with organic central nervous system conditions, e.g. Huntington’s chorea, hemiballismus and senile chorea.
    Moderate to severe tardive dyskinesia, which is disabling and/or socially embarrassing. The condition should be persistent despite a switch to atypical
    antipsychotic medication and/or reduction in dosage of antipsychotic medication, when withdrawal of antipsychotic medication is not a realistic option.


    – Hypersensitivity to the active substance (tetrabenazine) or to any of the excipients.
    – Tetrabenazine is contraindicated during breast-feeding.
    – Tetrabenazine is contraindicated in patients with poorly controlled clinical depression.
    – Tetrabenazine should not be administered within two weeks of treatment together with a monoamine oxidase inhibitor (MAOI).
    – Use in patients in conjunction with reserpine
    – In patients with parkinsonism and hypokinetic-rigid syndrome (parkinsonism).
    – Active suicidality.
    – Impaired hepatic function, Child-Pugh class 5 to 9.
    – Pheochromocytoma
    – Pro-lactin-dependant tumours, e.g. pituitary or breast cancer.

    Special Precautions

    Tardive dyskinesia should be persistent despite withdrawal of antipsychotic therapy, or in cases where withdrawal of antipsychotic medicdbation is not a realistic option; also where the condition persists despite reduction in dosage of antipsychotic medicdbation or switching to atypical antipsychotic medicdbation. Patients should be advised that therapy may cause drowsiness and therefore may modify their performance at skilled tasks (driving abilitiy, operation of machinery, etc.) to a varying degree, depending on dose and individual susceptibility.
    See prescribing information for full details.

    Side Effects

    Side effects include drowsiness, depression (which has on occasion been reported to be associated with suicidal ideation and behaviour) and parkinsonism.
    See prescribing information for full details.

    Drug interactions

    Tetrabenazine inhibits the action of levodopa and thereby attenuates its effect.
    Tetrabenazine should not be administered in the presence of MAOIs because of the risk of possible severe adverse effects serious interactions resulting in hypertensive crisis.
    The possibility of additive sedative effects should be considered when tetrabenazine is used in conjunction with CNS depressants (including alcohol, neuroleptics, hypnotics and opioids).
    There is a potential for significant dopamine depletion when administering tetrabenazine concomitantly with neuroleptic agents (e.g., haloperidol, chlorpromazine, metoclopramide, etc.).
    The concurrent use of tetrabenazine with anti-hypertensive drugs and beta-blockers may increase the risk of orthostatic hypotension.
    Caution should be used when adding aCYP2D6 inhibitor (such as fluoxetine, paroxetine, quinidine, duloxetine, terbinafine, amiodarone, or sertraline) to a patient already receiving a stable dose of tetrabenazine.
    Tetrabenazine should be used with caution with drugs known to prolong QTc including antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin, moxifloxacin) and Class IA and III antiarrythmic medications (e.g., quinidine, procainamide, amiodarone, sotalol).
    Concomitant use of tetrabenazine and reserpine is contraindicated.
    See prescribing information for full details.

    Pregnancy and Lactation

    Pregnancy: There are no adequate and well controlled studies for the use of tetrabenazine in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Tetrabenazine is not recommended during pregnancy and in women of childbearing potential not using contraception. The effect of tetrabenazine on labour and delivery in humans is unknown.
    Lactation: It is unknown whether tetrabenazine or its metabolites are excreted in human milk. A risk to the suckling child cannot be excluded. Tetrabenazine is contraindicated during breast-feeding.


    Symptoms associated with overdoses of tetrabenazine may include: acute dystonia, oculogyric crisis, nausea, vomiting, diarrhoea, sweating, hypotension, hypothermia, confusion, hallucinations, sedation, rubor and tremor.
    Treatment should consist of those general measures employed in the management of overdosage with any CNS-active drug. General supportive and symptomatic measures are recommended. Cardiac rhythm and vital signs should be monitored. In managing overdosage, the possibility of multiple drug involvement should always be considered. The physician should consider contacting a poison control center on the treatment of any overdose.

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