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TRIFLUOPERAZINE is a brand name for Trifluoperazine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Trifluoperazine is a tranquillizer of the phenothiazine group. In low doses, is indicated: 1. As adjunctive short-term treatment of anxiety states, depressive symptoms secondary to anxiety and agitation. 2. In the symptomatic treatment of nausea and vomiting. In high doses, is indicated: 3. In schizophrenia and in…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adult low dosage (anxiety, nausea, vomiting) 2-4mg daily in divided dosage, to maximum of 6mg daily. Adult high dosage (psychoses) Initial: 5 mg twice daily.
After 1 week:
May be increased to 15 mg daily. If necessary, for adequate control further increases of 5 mg daily may be made at 3 day intervals. When satisfactory control has been achieved dosage should be reduced gradually to an effective maintenance level.
Paediatric population Child low dosage (anxiety, nausea, vomiting) Age 3-5 Years Syrup dosage form recommended. 6-12 years Up to a maximum 4 mg daily in divided doses.
Child high dosage (psychoses) Age under 12 years:
Initially up to 5 mg daily in divided doses. Any increase should be given cautiously, not more often than every three days, and be adjusted according to age, body weight, and response. Use in the elderly Reduce starting dose in elderly or frail patients by at least half.
Method of administration Oral
Extrapyramidal 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.
Lassitude, drowsiness, transient restlessness, apathy, insomnia, dizziness, muscular weakness, dry mouth, blurred vision, mild postural hypotension, anorexia, skin reactions including photosensitivity reactions, weight gain, oedema, and confusion may occasionally present as side-effects.
Tachycardia, constipation, urinary hesitancy and retention and hyperpyrexia have been reported very rarely. Adverse reactions tend to be close related and to disappear. g. galactorrhoea, amenorrhoea and gynaecomastia; certain hormone-dependent breast neoplasms may be affected.
Phenothiazine can produce ECG changes with prolongation of the QT interval and T wave changes; serious ventricular arrhythmias (VF, VT (rare)), sudden unexplained death; cardiac arrest and Torsades de pointes have been reported. Such effects are rare with Trifluoperazine.
In some patients, especially non-psychotic patients, Trifluoperazine even at low dosage may cause unpleasant symptoms of being dulled or, paradoxically, of being agitated. May cause patient to feel mentally duller, or in some cases, agitated.
Tardive 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.
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.
Clinical improvement may not occur for several weeks after treatment has started. Similarly, there may be delay in recurrence of symptoms after treatment has stopped. 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. Phenothiazines may affect the body temperature control. 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 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.
1. • Antipsychotic drugs may be contraindicated in comatose state, particularly if associated with other central nervous system depressants. • CNS depression, phaeochromocytoma, existing blood dyscrasias and known liver damage. • Patients with uncontrolled cardiac decompensation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
The 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. Mild cholestatic jaundice, blood dyscrasias such as agranulocytosis, pancytopenia, leucopenia and thrombocytopenia, have been reported very rarely. Signs of persistent infection should be investigated.
Very rare cases of skin pigmentation, and lenticular opacities have been reported with Trifluoperazine. The 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 automatic instability.
6) -frequency not known. Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs- Frequency unknown 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.
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. 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 Tablets and preventive measures undertaken Acute withdrawal symptoms, including nausea, vomiting, 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, dystona 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.
Patients with known or with a family history of cardiovascular disease or QT prolongation should receive ECG screening, and monitoring and correction of electrolyte imbalance prior to considering treatment with trifluoperazine therapy.
Concomitant use of neuroleptics should be avoided. 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.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.