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TETRABENAZINE is a brand name for Tetrabenazine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Tetrabenazine is indicated for hyperkinetic motor disorders with Huntington’s chorea.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults Huntington's chorea Dosage and administration are individual in each patient and therefore only a guide is given. 5 mg/day one to three times a day is recommended. 5 mg until the optimal effect is observed or up to the occurrence of intolerance effects (sedation, Parkinsonism, depression).
The maximum daily dose is 200 mg a day. 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.
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 dose-limiting.
Paediatric population No adequate controlled studies have been performed in children. The treatment is not recommended in children. 2). Renal impairment No studies have been performed in patients with renal impairment. Caution is advised in the treatment of these patients.
Method of administration The tablets are for oral administration. The therapy should be supervised by a doctor experienced in treating hyperkinetic disorders.
The following undesirable effects are ranked according to system organ class and to their frequency: Very common (≥1/10) Common (≥1/100 and <1/10) Uncommon (≥1/1000 and <1/100) Rare (≥1/10,000 and <1/1000) Very rare (<1/10,000) Not known (it is not possible to estimate the incidence from available data).
4). This may occur soon after initiation of therapy, following changes in dosage or after prolonged treatment. The main symptoms are altered mental status, muscle rigidity, hyperthermia, autonomic dysfunction, elevated levels of creatinine phosphokinase.
4). To avoid the risk of potentially serious interactions that may occur in the form of hypertensive crisis, at least 14 days should elapse between discontinuation of treatment with an MAOI and initiation of treatment with tetrabenazine, as well as between discontinuation of treatment with tetrabenazine and initiation of treatment with the MAOI.
Cardiac abnormalities including QT prolongation and ventricular arrhythmias (including ventricular tachycardia and ventricular fibrillation) leading to cardiac arrest or sudden unexplained death have been reported during treatment with neuroleptics.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
The dose of tetrabenazine should be titrated to determine the most appropriate dose for each patient. 2). 5). When first prescribed, tetrabenazine therapy should be titrated slowly over several weeks to allow the identification of a dose that both reduces chorea and is well tolerated.
If the adverse effect does not resolve or decrease, consideration should be given to discontinuing tetrabenazine. 5). It is known that dose dependent adverse events such as sedation, depression and the occurrence of a hypokinetic-rigid-syndrome (Parkinsonism) are possible.
In such a case, the dose should be reduced and discontinuation of tetrabenazine be considered if events do not resolve. Depression/Suicidality Tetrabenazine may cause depression or worsen pre-existing depression. Cases of suicidal ideation and behaviour have been reported in patients taking the product.
3). Patients should be closely monitored for the emergence of such adverse events and patients and their caregivers should be informed of the risks and instructed to report any concerns to their doctor immediately. If depression or suicidal ideation occurs it may be controlled by reducing the dose of tetrabenazine and/or initiating antidepressant therapy.
If depression suicidal ideation is profound, or persists, discontinuation of tetrabenazine and initiation of antidepressant therapy should be considered. 8). Anger and aggression There is a potential risk of anger and aggressive behavior occurring or worsening in patients taking tetrabenazine with a history of depression or other psychiatric illnesses.
Parkinsonism Tetrabenazine can induce parkinsonism and exacerbate pre-existing symptoms of Parkinson's disease. The tetrabenazine dose should be adjusted as clinically indicated to minimise this side effect. Tardive dyskinesia Tetrabenazine is a central monoamine depleting agent which has can cause extrapyramidal symptoms and theoretically cause tardive dyskinesia in humans.
1. Tetrabenazine can block the action of reserpine. Thus these substances should not be taken concomitantly. Use of monoamine oxidase inhibitors– tetrabenazine should not be administered within two weeks after treatment with MAOIs Presence of a hypokinetic-rigid-syndrome (Parkinsonism) Untreated or inadequately treated depression.
Patients who are actively suicidal. g. 5)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Neuroleptic malignant syndrome Neuroleptic malignant syndrome (NMS) is a rare complication of tetrabenazine therapy. Neuroleptic malignant syndrome most often occurs early in treatment or in response to changes in dose or after prolonged treatment, and has also been described after abrupt withdrawal.
The main symptoms of this condition are mental changes, rigidity, hyperthermia, autonomic dysfunction (sweating and irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac arrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria, rhabdomyolysis, and acute renal failure.
If NMS is suspected tetrabenazine should be withdrawn immediately and appropriate treatment initiated. If the patient requires treatment with tetrabenazine after recovery from NMS, the potential reintroduction of therapy should be carefully considered.
The patient should be carefully monitored, since recurrences of NMS have been reported. QTc Tetrabenazine causes a small increase (up to 8msec) in the corrected QT interval. 5). Cardiac disease Tetrabenazine has not been evaluated in patients with a recent history of myocardial infarction or unstable heart disease.
Akathisia, restlessness, and agitation Patients taking tetrabenazine should be monitored for the presence of akathisia and also for signs and symptoms of restlessness and agitation, as these may be indicators of developing akathisia.
If a patient develops akathisia, the tetrabenazine dose should be reduced; however, some patients may require discontinuation of therapy. Sedation and somnolence Sedation is the most common dose-limiting adverse effect of tetrabenazine.
Patients should be cautioned about performing activities requiring mental alertness, such as operating a motor vehicle or operating hazardous machinery, until they are on a maintenance dose of tetrabenazine and know how the drug affects them.
Orthostatic hypotension Tetrabenazine may induce postural hypotension at therapeutic doses. This should be considered in patients who may be vulnerable to hypotension or its effects. Monitoring of vital signs on standing should be considered in patients who are vulnerable to hypotension.
Hyperprolactinemia Tetrabenazine elevates serum prolactin concentrations in humans. Following administration of 25 mg to healthy volunteers, peak plasma prolactin levels increased 4- to 5-fold. Tissue culture experiments indicate that approximately one third of human breast cancers are prolactin-dependent in vitro, a factor of potential importance if tetrabenazine is being considered for a patient with previously detected breast cancer.
Although amenorrhea, galactorrhea, gynecomastia and impotence can be caused by elevated serum concentrations, the clinical significance of elevated serum prolactin concentrations for most patients is unknown. Chronic increase in serum prolactin levels (although not evaluated in the […]