TRIFLUOPERAZINE

Posology Adults:

Low dosage: 2-4 mg a day given in divided doses, according to the severity of the patient's condition. If necessary, dosage may be increased to 6 mg a day, but above this level extrapyramidal symptoms are more likely to occur in some patients.

High dosage:

The recommended starting dosage for physically fit adults is 5 mg twice a day after a week this may be increased to 15 mg a day. If necessary, further increases of 5 mg may be made at three-day intervals, but not more often. When satisfactory control has been achieved, dosage should be reduced gradually until an effective maintenance level has been established.

As with all major tranquillisers, clinical improvement may not be evident for several weeks after starting treatment, and there may be delay before recurrence of symptoms after stopping treatment. Gradual withdrawal from high dosage treatment is advisable.

Paediatric population Low dosage:

For children 3-5 years, up to 1 mg a day given in divided doses. For children aged 6-12 years, the dosage may be increased to a maximum of 4 mg a day.

High dosage:

For children aged under 12 years, the initial oral dosage should not exceed 5 mg a day, given in divided doses. Any subsequent increase should be made with caution, at intervals of not less than three days, and taking into account age, body weight and severity of symptoms.

Elderly Reduce starting dose in elderly or frail patients by at least half.

Method of Administration:

Oral.

The following undesirable effects may occur with the use of Trifluoperazine in the following frequencies: Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000) Not known (cannot be estimated from the available data).

The following effects have been reported and are listed below by body system:

System organ class Frequency Undesirable effects Blood and lymphatic Very rare Blood dyscrasias6 such as system disorders agranulocytosis, pancytopenia, leucopenia and thrombocytopenia Endocrine disorders Not known Hyperprolactinaemia1, galactorrhoea1, amenorrhoea1, gynaecomastia1 Metabolism and nutrition Not known Anorexia, weight gain disorders Psychiatric disorders Not known Unpleasant symptoms2, Confusion, RareNervous system disorders Not known Extrapyramidal symptoms3, Neuroleptic malignant syndrome4, Tardive dyskinesia5, drowsiness, dizziness, transient restlessness, insomnia, Very rare Retinopathy, lenticular opacities Eye disorders Not known Blurred vision Very rare Tachycardia Rare Serious arrhythmias, sudden unexplained Cardiac disorders death, cardiac arrest Torsades de pointes Not known Mild postural hypotension, venous thromboembolism, pulmonary Vascular disorders embolism, deep vein thrombosis Rare Extrapyramidal symptoms Dry mouth Not known Constipation Very rare Gastrointestinal disorders Hepatobiliary disorders Very rare Cholestatic jaundice Skin and subcutaneous Not known Photosensitivity reactions, Musculoskeletal and connective tissue disorders Not known Muscular weakness Renal and urinary disorders Very rare Urinary hesitancy and retention Pregnancy, puerperium and perinatal conditions Not known Drug withdrawal syndrome neonatal Not known Lassitude, oedema, Withdrawal reactions General disorders and administration site conditions Very rare Hyperpyrexia Investigations Rare ECG changes with prolongation of the QT interval and T-wave changes Adverse reactions tend to be dose-related and to disappear.

1Hyperprolactinaemia may occur at higher dosages with associated effects such as galactorrhoea, amenorrhoea or gynaecomastia; certain hormone- dependent breast neoplasms may be affected. 2Trifluoperazine even at low dosage may cause unpleasant symptoms of being dulled or, paradoxically, of being agitated.

3Extrapyramidal symptoms are rare at daily oral dosages of 6 mg or less; they are considerably more common at higher dosage levels. These symptoms include parkinsonism; akathisia, with motor restlessness and difficulty in sitting still; and acute dystonia or dyskinesia, which may occur early in treatment and may present with torticollis, facial grimacing, trismus, tongue protrusion and abnormal eye movements including oculogyric crises.

These effects are likely to be particularly severe in children. Such reactions may often be controlled by reducing the dosage or by stopping medication. In more severe dystonic reactions, an anticholinergic antiparkinsonism drug should be given.

4The neuroleptic malignant syndrome is a rare but occasionally fatal complication of treatment with various neuroleptic drugs, and is characterised by hyperpyrexia, muscle rigidity, altered consciousness and autonomic instability. Intensive symptomatic treatment, following discontinuation of Trifluoperazine, should include cooling.

Intravenous dantrolene has been suggested for muscle rigidity. 5Tardive dyskinesia of the facial muscles, sometimes with involuntary movements of the extremities, has occurred in some patients on long-term high dosage and, more rarely, low dosage phenothiazine therapy, including Trifluoperazine.

Symptoms may appear for the first time either during or after a course of treatment; they may become worse when treatment is stopped. The symptoms may persist for many months or even years, and while they gradually disappear in some patients, they appear to be permanent in others.

Patients have most commonly been elderly, female, or with organic brain damage. Particular caution should be observed in treating such patients. Periodic gradual reduction of dosage to reveal persisting dyskinesia has been suggested, so that treatment may be stopped if necessary.

Anticholinergic antiparkinsonism agents may aggravate the condition. Since the occurrence of tardive dyskinesia may be related to length of treatment and total cumulative dosage, Trifluoperazine should be given for as short a time and at as low a dosage as possible.

6Signs of persistent infection should be investigated. 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.

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Trifluoperazine should be discontinued at the first sign of clinical symptoms of tardive dyskinesia and Neuroleptic Malignant Syndrome. Patients on long-term phenothiazine therapy require regular and careful surveillance with particular attention to tardive dyskinesia and possible eye changes, blood dyscrasias, liver dysfunction and myocardial conduction defects, particularly if other concurrently administered drugs have potential effects in these systems.

Care should be taken when treating elderly patients, and initial dosage should be reduced. Such patients can be especially sensitive, particularly to extrapyramidal and hypotensive effects. Patients with cardiovascular disease including arrhythmias should also be treated with caution.

Because Trifluoperazine may increase activity, care should be taken in patients with angina pectoris. If an increase in pain is noted, the drug should be discontinued. Patients who have demonstrated bone marrow suppression or jaundice with a phenothiazine should not be re-exposed to Trifluoperazine (or any trifluoperazine) unless in the judgement of the physician the potential benefits of treatment outweigh the possible hazard.

In patients with Parkinson's disease, symptoms may be worsened, and the effects of levodopa reversed. Since phenothiazines may lower the convulsive threshold, patients with epilepsy should be treated with caution, and metrizamide avoided.

Although Trifluoperazine has minimal anticholinergic activity, this should be borne in mind when treating patients with narrow angle glaucoma, myasthenia gravis or prostatic hypertrophy. Nausea and vomiting as a sign of organic disease may be masked by the anti-emetic action of Trifluoperazine.

An approximately 3-fold increased risk of cerebrovascular adverse events have been seen in randomised placebo controlled clinical trials in the dementia population with some atypical antipsychotics. The mechanism for this increased risk is not known.

Trifluoperazine should be used with caution in patients with risk factors for stroke. Caution should be used in patients with cardiovascular disease or family history of QT prolongation. Concomitant use of neuroleptics should be avoided.

Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Trifluoperazine and preventive measures undertaken Acute withdrawal symptoms, including nausea, vomitting, sweating, and insomnia have been described after abrupt cessation of antipsychotic drugs.

Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported. Therefore, gradual withdrawl is advisable. Phenothiazines should be used with care in extremes of temperature since they may affect body temperature control.

Increased Mortality in Elderly people with Dementia Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated.

There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known. Trifluoperazine is not licensed for the treatment of dementia-related behavioural disturbances.

e. essentially “sodium-free”. 5 mg/5 ml. 0 mg per 5 mL dose. This medicine contains Sorbitol, which is a sugar. If you have been told by your doctor that you are intolerant to some sugars, contact your doctor before taking this medicine.

Sorbitol can also cause stomach upset and diarrhoea in some patients.

1. o Do not use Trifluoperazine in comatose patients, particularly if associated with other central nervous system depressants. o Do not use Trifluoperazine in those with existing blood dyscrasias, or known liver damage. o Patients with uncontrolled cardiac decompensation should not be given Trifluoperazine.