INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo STELAZINE TABLETS 5 MG
SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

STELAZINE TABLETS 5 MG

COMPOSITION:
Each tablet contains trifluoperazine 5 mg as the hydrochloride.

PHARMACOLOGICAL CLASSIFICATION:
A.2.6.1 Phenothiazines and derivatives.

PHARMACOLOGICAL ACTION:
'STELAZINE' is a piperazine phenothiazine tranquillizer with antipsychotic anxiolytic, and anti-emetic activity.

INDICATIONS:
For the management of manifestations of psychotic disorders, such as acute and chronic catatonic, hebephrenic and paranoid schizophrenia; psychosis due to organic brain damage and toxic psychosis. It is also indicated for the control of the manifestations of manic-depressive illness (manic phase).

CONTRA-INDICATIONS:
Greatly depressed states due to central nervous system depressants, and in cases of existing blood dyscrasias, bone marrow depression and pre-existing liver damage.
Closed-angle glaucoma, diabetes mellitus, hyperthyroidism, prostatic hypertrophy and hypersensitivity. Trifluoperazine is contra-indicated in comatose patients, particularly those under the influence of alcohol, barbiturates, narcotics and other CNS depressants, and in patients with bone-marrow depression. Trifluoperazine should be used with caution in patients with cardiovascular or respiratory disease, phaechromocytoma, or other conditions in which a sudden drop in blood pressure would be undesirable. It should be used with caution in patients with existing tachycardia or cardiac insufficiency and in patients with liver dysfunction or a history of jaundice.
Trifluoperazine should be used with care in patients with Parkinsonism.
Trifluoperazine should be given with caution in extremes of temperature owing to its impairment of the body's temperature-regulating mechanism.
Patients should be examined periodically for abnormal skin pigmentation or eye-changes.
Pregnancy and lactation.

DOSAGE AND DIRECTIONS FOR USE:
Dosage should be tailored to the individual response, carefully monitored and dosage adjusted accordingly.
Dosage should be increased more gradually in elderly patients. Because of the inherent long action of the drug, patients may be controlled on convenient twice daily administration.

ADULT DOSAGE:
ORAL:
Usual starting dosage is 2 mg to 5 mg twice daily. The recommended starting dosage for physically fit adults is 5 mg twice a day. Small or emaciated patients should always be started on a lower dosage.
After a week, this may be increased to 15 mg a day in divided doses. If necessary, further increases of 5 mg daily may be made at 9 day intervals, but not more often. Most patients will show optimum response on 15 to 20 mg daily, although a few will require more.
When satisfactory control has been achieved, dosage may be reduced gradually until an effective maintenance has been established.

DOSAGE FOR PSYCHOTIC CHILDREN (Ages 6 - 12)
ORAL:
The starting dosage is 1 mg twice daily. Any subsequent increase should be made with caution at intervals of not less than 3 days and taking into account age, body mass and severity of symptoms. It is usually not necessary to exceed dosages of 15 mg daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Drowsiness, dizziness, skin reactions, rash, dry mouth, amenorrhoea, fatigue, muscular weakness, lactation, blurred vision and neuromuscular (extrapyramidal) reactions can occur.
Neuromuscular (Extrapyramidal) Reactions:
These symptoms are seen in significant numbers of hospitalized mental patients. They may be characterised by motor restlessness, be of the dystonic type or they may resemble parkinsonism. The incidence is greater at higher dosages. Depending on the severity of symptoms, dosage should be reduced or discontinued. In mild cases, reassurance or a barbiturate is often sufficient. If greater control is needed, anti-parkinsonism agents, except levodopa, usually produce rapid control. Injectable diphenhydramine usually produces rapid reversal of dystonic signs.
Persistent Tardive Dyskinesia:
As with all antipsychotic agents, persistent tardive dyskinesia may occur in some patients on longterm therapy or may appear after drug therapy has been discontinued. The risk appears greater in elderly patients, especially females, on high-dose therapy. The syndrome is characterised by rhythmical involuntary movements of the facial muscles and sometimes of extremities. The symptoms may persist for many months or even years and while they gradually disappear in some patients, they appear to be irreversible in others.
There is no known effective treatment of tardive dyskinesia; anti-parkinsonism agents usually do not alleviate the symptoms of this syndrome. Gradual reduction of dosage to reveal persisting dyskinesia has been suggested so that treatment may be stopped if necessary.

PRECAUTIONS:
Cases of agranulocytosis, neutropenia, thrombocytopenia, anaemia, jaundice of the cholestatic type of hepatitis or liver damage have been reported.
Since certain phenothiazines have been reported to produce retinopathy, especially after long term treatment with high dosages, the drug should be discontinued if ophthalmoscopic examination or visual field studies should demonstrate retinal changes.
One result of therapy may be an increase in mental and physical activity. Therefore, angina pectoris patients should be observed carefully and, if an increase of pain is noted, the drug should be discontinued.
The anti-emetic effect of STELAZINE may mask signs of overdosage of toxic drugs or obscure the diagnosis of conditions such as intestinal obstruction and brain tumour.
If agents such as sedatives, narcotics, anaesthetics or alcohol are used simultaneously or successively with the drug, the possibility of an undesirable additive depressant effect should be considered.
Patients who drive motor vehicles or operate machinery should be warned of the possibility of drowsiness.
Neuroleptic drugs elevate prolactin levels; the elevation persists during chronic administration. Although disturbances such as galactorrhoea, amenorrhoea, gynaecomastia, and impotence have been reported, the clinical significance of elevated serum prolactin levels is unknown for most patients.
It should not be given in conjunction with medicines that might cause leucopenia such as phenylbutazone and the thiouracil derivatives.
The anti-parkinsonian actions of levodopa may be diminished with phenothiazines.
Phenothiazines enhance the activity of CNS depressants including alcohol, anaesthetics, hypnotics and narcotic analgesics and doses of these agents may need to be reduced.
The phenothiazines enhance the anticholinergic properties of tricyclic anti-depressants and atropine.
The anti-hypertensive action of guanethidine is reduced by phenothiazines.
It may raise blood-sugar concentrations which could affect diabetic control.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Signs and symptoms will be predominantly extrapyramidal. Treatment consists of gastic lavage together with supportive and symptomatic measures. Do not induce vomiting. Extrapyramidal symptoms may be treated with an anticholinergic antiparkinsonism drug. If hypotension occurs, noradrenaline or phenylephrine may be used, but adrenaline and other pressor agents are contra-indicated.

IDENTIFICATION:
Blue, round film-coated biconvex tablets.

PRESENTATION:
STELAZINE 5 mg tablets are available in containers containing 50 and 250 tablets.
STELAZINE is also available in 1 mg tablets and 2 mg 'Spansule' capsules.

STORAGE INSTRUCTIONS:
STELAZINE tablets should be stored below 25°C in a dry place, and dispensed in moisture-proof, light-resistant containers.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER:
B. 1032 (Act 101/1965).

NAME AND BUSINESS ADDRESS OF THE APPLICANT :
SmithKline Beecham Pharmaceuticals (Pty) Ltd
6 Carey Street
Wynberg Ext. 6
Johannesburg
2090

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
02.12.1969

LOGO
SmithKline Beecham
Pharmaceuticals (Pty) Ltd.
P2062

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