Trifluoperazine Abbreviated Prescribing Information

Abbreviated Prescribing Information: Trifluoperazine 5mg/5ml Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: Oral solution containing 5mg trifluoperazine per 5ml. Therapeutic Indications: Low dosage: Adjunct in the short-term management of anxiety states, depressive symptoms secondary to anxiety, and agitation. Symptomatic treatment of nausea and vomiting. High Dosage: treatment of symptoms and prevention of relapse in schizophrenia and in other psychoses (especially of the paranoid type, but not in depressive psychoses). Adjunct in the short-term management of severe psychomotor agitation and of dangerously impulsive behaviour. Posology and Method of Administration: Low Dosage: 2- 4 mg a day given in divided doses. May be increased to 6mg a day. High dosage: Starting dose for physically fit adults is 5mg twice a day; after a week this may be increased to 15mg a day. Further increases of 5mg at three-day intervals and then reduced gradually until an effective maintenance level has been established. Reduce initial dose in elderly by at least half. Paediatric population: Low dosage: 3-5 years up to 1mg/day, 5-12 years up to 4mg/day in divided doses. High dosage: under 12 years – the initial oral dosage should not exceed 5mg a day, given in divided doses and any increase made with caution at intervals of not less than three days. For oral administration only. Contra-indications: Hypersensitivity to trifluoperazine or to any of the excipients. Comatose patients, or in those with existing blood dyscrasias, or known liver damage. Patients with uncontrolled cardiac decompensation. Special warnings and Precautions for use: Trifluoperazine should be discontinued at the first sign of clinical symptoms of tardive dyskinesia and Neuroleptic Malignant Syndrome. Patients on long term therapy require regular and careful surveillance especially for tardive dyskinesia and possible eye changes, blood dyscrasias, liver dysfunction and myocardial conduction defects. Care should be taken when treating elderly patients, and initial dosage should be reduced. Patients with cardiovascular disease including arrhythmias and angina pectoris should also be treated with caution. Patients who have demonstrated bone marrow suppression or jaundice with a phenothiazine should not be re-exposed unless justified. In patients with Parkinson’s disease, symptoms may be worsened, and the effects of levodopa reversed. Patients with epilepsy should be treated with caution, and metrizamide avoided. Caution with patients with narrow angle glaucoma, myasthenia gravis or prostatic hypertrophy. Nausea and vomiting as a sign of organic disease may be masked. Caution in patients with risk factors for stroke, cardiovascular disease or family history of QT prolongation. Concomitant use of neuroleptics should be avoided. Venous thromboembolism (VTE) has been reported with antipsychotic drugs. All possible risk factors for VTE should be identified before and during treatment and preventive measures undertaken. Gradual withdrawal is advisable. Care should be used in extremes of temperature. Increased Mortality in Elderly people with Dementia. Trifluoperazine is not licensed for the treatment of dementia-related behavioural disturbances. Any warning from the MC, CHM CSM or MHRA. No. Black Triangle notice: Not applicable. Legal Category: POM. The reported adverse reactions are: Blood dyscrasias such as Agranulocytosis, Pancytopenia, Leucopenia and Thrombocytopenia, Hyperprolactinaemia, Galactorrhoea, Amenorrhoea, Gynaecomastia, Anorexia, Weight gain, Unpleasant symptoms, Confusion, Extrapyramidal symptoms, Neuroleptic malignant syndrome, Tardive dyskinesia, Drowsiness, Dizziness, Transient restlessness, Insomnia, Retinopathy, Lenticular opacities, Blurred vision, Serious arrhythmias, Unexplained death, Cardiac arrest and Torsades de pointes, Tachycardia, Mild postural hypotension, Venous thromboembolism, Pulmonary embolism, Deep vein thrombosis, Constipation, Dry mouth, Cholestatic jaundice, Skin pigmentation, Photosensitivity reactions, Muscular weakness, Urinary hesitancy and retention, Drug withdrawal syndrome neonatal, Hyperpyrexia, Lassitude, Oedema, Withdrawal reactions, and ECG changes with prolongation of the QT interval and T-wave changes. . Pack Size and NHS Price: 150ml £56.19. Marketing Authorisation Number: PL 00427/0118. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: December 2022.