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 dose 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 also be delay before recurrence of symptoms after stopping treatment. Gradual withdrawal from high-dosage treatment is advisable.

Patients with hepatic impairment This tablet is not to be given in patients with patients with hepatic impairment.

Elderly:

Reduce starting dose in elderly or frail patients by at least half. Paediatric population This tablet presentation is unsuitable for children under 12 years, for whom a liquid presentation should be used. Method of administration For oral use

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). System organ class Frequency Undesirable effects Blood and lymphatic system disorders Very rare Blood dyscrasias6 such as agranulocytosis, pancytopenia, leucopenia and thrombocytopenia Endocrine disorders Not known Hyperprolactinaemia1, galactorrhoea1, amenorrhoea1, gynaecomastia1 Metabolism and nutrition disorders Not known Anorexia, weight gain Psychiatric disorders Not known Unpleasant symptoms2, Confusion Nervous system disorders Rare Extrapyramidal symptoms3, Neuroleptic malignant syndrome4 Not known Tardive dyskinesia5, drowsiness, dizziness, transient restlessness, insomnia Very rare Retinopathy, lenticular opacitiesEye disorders Not known Blurred vision Very rare TachycardiaCardiac disorders Rare Serious arrhythmias Vascular disorders Not known Mild postural hypotension, venous thromboembolism, pulmonary embolism, deep vein thrombosis Rare Extrapyramidal symptoms Not known Dry mouth Gastrointestinal disorders Very rare Constipation Hepatobiliary disorders Very rare Cholestatic jaundice Not known Photosensitivity reactionsSkin and subcutaneous tissue disorders Very rare Skin pigmentation 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 General disorders and administration site conditions Not known Lassitude, oedema, Withdrawal reactions 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.

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 the 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 with patients who have 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 antiemetic action of ‘trifluoperazine’ Acute withdrawal symptoms including nausea, vomiting and insomnia have been described after abrupt cessation of high doses 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, a gradual withdrawal is advisable. Phenothiazines should be used with care in extremes of temperature since they may affect body temperature control.

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