TERRAZINE/TRIFLUOPERAZINE BP

ADULTS:

In the treatment of the symptoms of schizophrenia, paranoid psychosis and mania and hypomania, the recommended starting dose is 5 mg twice a day for physically fit adults. This dose may be increased after one week if necessary to 15 mg a day.

Further increases may be made of 5 mg at 3-day intervals; this is the minimum time that should be allowed to elapse. The dosage may be gradually reduced after satisfactory control has been achieved until an effective maintenance level is established.

When commencing treatment this should be undertaken under close supervision. Likewise, when it is necessary to increase dosage. Dosage requirement should always take into account the great variability of individual response. After commencing treatment it may take several weeks for clinical improvement to become evident.

There may be a delay before relapse after stopping treatment. It is essential that withdrawal from treatment should be gradual. The recommended dosage when Terra-zine is used as an adjunct to the short- term management of anxiety, severe psychomotor agitation, excitement, violent or dangerously impulsive behaviour is: 2-4 mg a day in divided doses.

This dosage may be increased to a maximum of 6 mg per day in divided doses. Treatment should be commenced under close supervision as should any increase in dosage. Likewise the variability of individual response and dosage requirement must be borne in mind.

ELDERLY:

A quarter or half the normal starting dose may be sufficient for therapeutic response in the elderly.

CHILDREN:

Not recommended for use in children.

GENERAL:

Terra-zine should always be used for the minimum possible time at the minimal effective dosage level except where it is established that long-term administration for conditions such as schizophrenia is required. Route of administration: oral.

Drowsiness, sedation, dry mouth and nasal stuffiness may occur, particularly with high dosage and at the start of treatment. Dose-related postural hypotension may occur, particularly in the elderly and after intramuscular Injections.

Other dose-related anticholinergic-type side effects include blurring of vision, tachycardia, constipation and urinary hesitancy or retention. Terra-zine may impair alertness, especially at the start of treatment. These effects may be potentiated by alcohol.

Extrapyramidal reactions are common and sometimes occur at low dosage. Acute dystonias may occur early in treatment. Parkinsonian rigidity, tremor, akathisia tend to appear less rapidly. Oculogyric crises have been reported. Anti-Parkinson agents should not be prescribed routinely, because of the possible risks of aggravating anticholinergic side effects of Terra-zine, of precipitating toxic-confusional states or of impairing its therapeutic efficacy.

They should only be given as required. Tardive dyskinesia is a syndrome of irregularly repetitive involuntary movement, which may occur during administration or after withdrawal of Terra-zine and other neuroleptic drugs. It is characterised by abnormal writhing movements or protrusions of the tongue with lip-smacking, puckering and chewing movements and facial grimaces.

Choreoathetoid movements of the extremities, or repetitive movements of the neck or trunk may accompany the orofacial dyskinesia or can occur alone. The syndrome is common among patients treated with moderate to high doses of antipsychotic drugs for prolonged periods of time and may prove irreversible, particularly in patients over the age of 50.

It is unlikely to occur in the short term when low or moderate doses are used as recommended, but tardive dyskinesia has been reported even when low doses of Terra-zine have been used for a few months. Since its occurrence may be related to duration of treatment as well as daily dose, Terra-zine should be given in the minimal effective dose for the minimum possible time, unless it is established that long-term administration for the treatment of schizophrenia is required.

The potential seriousness and unpredictability of tardive dyskinesia and the fact that it has occasionally been reported to occur when neuroleptic antipsychotic drugs have been prescribed for relatively short periods in low dosage means that the prescribing of such agents requires especially careful assessment of risks versus benefit.

Tardive dyskinesia can be precipitated or aggravated by anti-Parkinson drugs. Short-lived dyskinesias may occur after abrupt drug withdrawal. In schizophrenia, the response to antipsychotic drug treatment may be delayed. If drugs are withdrawn, recurrence of symptoms may not become apparent for several weeks or months.

Terra-zine, even in low dosage in susceptible (especially non-psychotic) individuals, may cause unpleasant subjective feelings of being mentally dulled or slowed down, nausea, dizziness, headache or paradoxical effects of excitement, agitation-or insomnia.

Confusional states or epileptic fits can occur. The elderly are more susceptible to the sedative and hypotensive effects. The effects of phenothiazines on the heart are dose-related. ECG changes, with prolongation of the QT interval and T-wave changes have been reported commonly in patients treated with moderate to high dosage; they are reversible on reducing the dose.

In a very small number of cases, they have been reported to precede serious arrhythmias, including ventricular tachycardia and fibrillation, which have also occurred after overdosage. Hormonal effects of antipsychotic neuroleptic drugs include hyperprolactinaemia, which may cause galactorrhoea, gynaecomastia and oligo-or amenorrhoea.

Sexual function, including erection and ejaculation is sometimes impaired by Terra- zine. Weight gain may occur. 6), Frequency: not known. Oedema has been reported with phenothiazine medication. These effects may be prevented by reduction in dosage.

Raised serum cholesterol and, rarely, hyperglycaemia have been reported in association with phenothiazines.

Blood Dyscrasias:

Agranulocytosis has been reported very rarely, most commonly in the first three months of treatment, but occasionally later. Blood counts should be performed if the patient develops signs of a persistent infection. Transient leucopenia can also occur.

Terra-zine, rarely, causes increased susceptibility to sunburn and patients should be warned to avoid excessive exposure. Skin rashes have occurred rarely. The occurrence of lenticular opacities has been reported. Terra-zine may impair body temperature-regulation and cases of severe hypothermia or hyperpyrexia have been reported, usually in association with moderate or high dosage of phenothiazines.

The elderly or hypothyroid patient may be particularly susceptible to hypothermia. The hazard of hyperthermia may be increased by especially hot or humid weather or by drugs, such as anti-Parkinson agents, which impair sweating. Terra-zine can, very rarely, cause obstructive jaundice associated with stasis in billiary canaliculi.

It has been thought to be a hypersensitivity reaction. Transient abnormalities of liver function tests may occur in the absence of jaundice. Neuroleptic malignant syndrome is a rare but occasionally fatal complication of treatment with various neuroleptic drugs and is characterized 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. With long-term usage, very rarely Terra-zine can cause increased melanin pigmentation of the skin, which eventually may develop a bluish-grey colouration.

Pigment deposits also occur in the eye and other tissues. Permanent deposits, leading to […]

g. alcohol withdrawal or brain damage); Parkinson's disease; patients who have shown hypersensitivity to other phenothiazines; personal or family history of narrow angle glaucoma - in very hot weather; the elderly, particularly if frail or at risk of hypothermia; hypothyroidism; depression; myasthenia gravis; phaeochromocytoma; prostatic hypertrophy; patients with a history of jaundice; blood dyscrasias.

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.

Terra-Zine is not licensed for the treatment of dementia-related behavioural disturbances. 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.

Terra-zine should not be used in comatose patients.