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TETRABENAZINE ARISTO is a brand name for Tetrabenazine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Tetrabenazine Aristo is indicated in: • hyperkinetic movement disorders in Huntington’s chorea • moderate to severe tardive dyskinesia, which has not responded to other therapeutic measures This medicine must only be used on prescription by a neurologist or paediatric neurologist who is familiar with the treatment of…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Hyperkinetic movement disorders in Huntington’s chorea Dosing and administration times are variable and must be individually adjusted according to the severity of the disease and response to treatment. The dose recommendation can therefore only serve as a guideline.
In general, however, the maximum daily dose of tetrabenazine should not be exceeded. An initial dose of 25 mg three times a day is recommended. This dose can be increased by 25 mg per day every three or four days until either satisfactory efficacy is achieved or until undesirable side effects occur (tolerance limit).
The dosage recommendation can therefore serve only as a guide. In general, however, the maximum daily dose of 200 mg tetrabenazine should not be exceeded. 5). If no improvement is seen after seven days of taking the maximum dose, this medicinal product is unlikely to benefit the patient, even if the dose is further increased or the duration of treatment prolonged.
Withdrawal of treatment with tetrabenazine should be considered. Discontinuation of treatment with tetrabenazine Discontinuation of tetrabenazine is associated with the return of chorea (without significant worsening compared to baseline).
Other adverse reactions to sudden treatment withdrawal are possible but unlikely and generally mild. 5 mg per day and is then increased depending on the patient’s response. This medicinal product should be discontinued if there is no clear improvement in the clinical picture or if the adverse reactions cannot be tolerated.
The maximum daily dose of 200 mg tetrabenazine should not be exceeded. Resumption of treatment Following treatment interruption of greater than 5 days or a treatment interruption occurring due to a change in the patient’s medical condition or medicinal products used concomitantly, tetrabenazine therapy should be retitrated when resumed.
5 mg per day. If adverse events such as akathisia, restlessness, parkinsonism, depression, insomnia, anxiety, or intolerable sedation occur, titration should be stopped and the dose should be reduced. Special populations Elderly patients No specific studies have yet been performed with patients of advancing age (> 65 years).
However, Tetrabenazine Aristo 25 mg has already been administered to elderly patients at the recommended adult dose and did not cause any discernible adverse effects. Paediatric Population No adequately controlled clinical studies have been performed in children.
The most common dose-dependent adverse reactions include drowsiness, depression (which in some cases was associated with suicidal thoughts and behaviour) and Parkinson’s symptoms. Other potential adverse reactions are listed in the table below.
The effects are generally reversible when treatment is discontinued. The frequency of adverse reactions is reported whenever known, but the frequency for some effects cannot be estimated from the available data. 000) Not known (frequency cannot be estimated based on available data) System organ class/ Frequency Very common Common Uncommon Rare Very rare Not known Infections and infestations Pneumonia Blood and lymphatic system disorders Leukopenia, Neutropenia Immune system disorders Hypersensitivity Metabolism and nutrition disorders Decreased appetite Dehydration Increased appetite Psychiatric disorders Depression, anxiety, restlessness, confusion Irritability, obsessive- compulsive disorder, agitation Aggression, anger, suicidal thoughts, suicide attempt, nervousness, sleep disorder Disorientation, nervousness, restlessness, sleep disorders Nervous system disorders Sedation/ somnolence/ drowsiness, extrapyramidal event, insomnia, akathisia Parkinsonism (may include balancing problems), gait imbalance/ balance difficulty, bradykinesia, dystonia, lethargy, dizziness, dysarthria, Neuroleptic malignant syndrome, ataxia, tremor, excess salivation Memory loss Eye disorders Blepharospasm Oculogyric crisis, photophobia Cardiac disorders Palpitations Bradycardia Vascular disorders Hypertension Orthostatic hypotension, hypertensive crisisRespiratory, thoracic and mediastinal disorders Upper respiratory tract infection Pneumonia, dyspnoea, bronchitis Cough, pneumonia aspiration Gastrointestinal disorders Nausea Diarrhoea, vomiting, constipation Dysphagia Dry mouth Epigastralgia Hepatobiliary disorders Increased ALT, increased AST Skin and subcutaneous tissue disorders Hyperhidrosis, rash, pruritus, urticaria Renal and urinary disorders Dysuria Urinary tract infection Reproductive system and breast disorders Irregular menstrual cycle/ amenorrhea/ menstrual disorders General disorders and administration site conditions Fatigue Ecchymosis Malaise, pyrexia, drug interaction Weakness, hypothermia Investigations Weight loss Weight increase Injury, poisoning and procedural complications Fall Laceration, inflicted injury Drug administration error Overdose Prolonged use may lead to an increase in the plasma prolactin level, which will decrease after discontinuation of treatment.
The appropriate dosage of tetrabenazine should be administered for each patient by titration. 2). 5). When first prescribed, the dose of tetrabenazine should be titrated up slowly over several weeks to find a dose that both reduces chorea symptoms and is well tolerated.
If side effects do not subside or become less severe, discontinuation of treatment with tetrabenazine should be considered. 5). 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 occurs, it may be controlled by reducing the dose of tetrabenazine and/or initiating antidepressant therapy.
If severe or persistent depression or suicidal ideation occurs, it may be controlled by reducing the dose of tetrabenazine and/or initiating antidepressant therapy. If depression or suicidal ideation is profound or persists, discontinuation of tetrabenazine and initiation of antidepressant therapy should be considered.
To avoid the risk of a potentially serious interaction, it must be ensured that at least 14 days elapse between the discontinuation of tetrabenazine and the start of treatment with a MAO inhibitor, as well as between the discontinuation of the MAO inhibitor and the start of treatment with tetrabenazine.
Anger and aggression In patients with depression or a history of other psychiatric illnesses taking tetrabenazine, there is a potential risk for the emergence or exacerbation of anger and aggressive behaviour. Parkinson’s symptoms Tetrabenazine can induce Parkinson’s symptoms and exacerbate pre-existing symptoms of Parkinson’s disease.
5); • patients with Parkinson’s syndrome and hypokinetic-rigid syndrome. Tetrabenazine Aristo must not be administered together with a monoamine oxidase inhibitor (MAO inhibitor).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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A dosage recommendation cannot be given. Limited clinical experience suggests that treatment be started at approximately half the daily dose for an adult and then to slowly and carefully adjust the dose, depending on tolerance and individual reaction Hepatic insufficiency, renal insufficiency In patients with impaired liver or kidney function, dose titration should be done slowly, lower daily doses may be required.
Patients taking CYP2D6 inhibitors The appropriate tetrabenazine dosage should be determined for each patient by titration. 2). 5). Method of administration Tetrabenazine Aristo is for oral use. The tablets should be taken with sufficient liquid (water or other non-alcoholic beverages) and should not be chewed.
As a result, galactorrhoea, absence of menstruation or cycle disorders, gynaecomastia, breast pain, breast enlargement, prolactinomas, orgasmic disorders and impotence may occur. 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 tetrabenazine dose must be adjusted according to clinical need, in order to minimise this adverse reaction. Dysphagia Dysphagia is a component of Huntington’s disease. However, medicinal products that reduce dopaminergic transmission have been associated with esophageal dysmotility and dysphagia.
Dysphagia may be associated with aspiration pneumonia. In clinical trials, some of the cases of dysphagia were associated with aspiration pneumonia. Whether these events were related to treatment is unknown. Tardive dyskinesia Tetrabenazine treatment may be considered if symptoms persist despite discontinuation of antipsychotic therapy or in cases where discontinuation of antipsychotic medication is not a suitable option.
This also applies if the symptoms persist despite reducing the dosage of antipsychotic medication or switching to atypical antipsychotic medication. However, tetrabenazine is a central transmitter-depleting active substance which can cause extrapyramidal symptoms and theoretically cause tardive dyskinesia in humans.
There have been cases of tardive dyskinesia with tetrabenazine reported in the literature and in post-marketing; therefore, physicians should be aware of the possible risk. If signs and symptoms of tardive dyskinesia appear in a patient treated with tetrabenazine, discontinuation of the medicinal product should be considered.
Neuroleptic malignant syndrome (NMS) In patients treated with tetrabenazine, onset of neuroleptic malignant syndrome has been reported in individual cases. It may occur shortly after the start of treatment, after dose modifications or after long-term treatment.
The clinical presentation of NMS includes hyperpyrexia, muscle stiffness, altered mental state and evidence of autonomic instability (irregular pulse or fluctuating blood pressure, tachycardia, diaphoresis and cardiac arrhythmias).
Other symptoms are elevated creatinine phosphokinase levels, myoglobinuria, rhabdomyolysis and acute renal failure. If neuroleptic malignant syndrome is suspected, tetrabenazine must be discontinued immediately and appropriate therapy initiated.
If the patient continues to require treatment with tetrabenazine after recovery from neuroleptic malignant syndrome, possible resumption of treatment with tetrabenazine should be carefully reviewed. The patient should be carefully monitored, as relapse of neuroleptic malignant syndrome has been reported.
QTc prolongation Tetrabenazine leads to a slight prolongation (approx. 8 msec) of the frequency- corrected QT interval. 5). Cardiac disease Tetrabenazine has not been studied in patients with a history of myocardial infarction or unstable cardiac disease.
Akathisia, restlessness and agitation Patients treated with tetrabenazine should be monitored for the presence of akathisia, as well as signs of restless and agitation, as these may be indicators of developing akathisia. If a patient develops akathisia, the tetrabenazine dose should be reduced.
In some patients, discontinuation of therapy may be required. Sedation and somnolence Sedation is the most common dose-limiting adverse reaction with tetrabenazine. Patients should be cautioned prior to performing activities that require […]