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

Logo STELAZINE Tablets 1 mg
STELAZINE Spansule Capsules
SCHEDULING STATUS:
S5

PROPRIETARY NAMES
(and dosage form):

STELAZINE Tablets 1 mg
STELAZINE Spansule Capsules

COMPOSITION:
Tablets: Each tablet contains trifluoperazine 1 mg as the hydrochloride.
Spansule capsules: Each Stelazine capsule contains 2 mg trifluoperazine as the hydrochloride.
Contains TARTRAZINE.

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:
Stelazine is indicated in anxiety states. It is also indicated in the treatment or prevention of nausea and vomiting of various causes.

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 or other CNS depressants, and in patients with bone-marrow depression.
Trifluoperazine should be used with caution in patients with cardiovascular or respiratory disease, phaeochromocytoma, 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 lactaction.

WARNINGS:
Stelazine capsules contain FD and C Yellow No. 5 (Tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of Tartrazine sensitivity in the general population is currently thought to be low it is frequently seen in patients who also have aspirin sensitivity.

DOSAGE AND DIRECTIONS FOR USE:
Dosage should be tailored to the individual response, carefully monitored and adjusted accordingly. Because of the inherent long action of the drug, patients may be controlled on convenient twice daily administration.
Adult Dosage:
Oral: Usual dosage is 1 or 2 mg twice a day. 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.
Children Dosage:
Oral: For children 6 - 12 years of age, the dosage may be increased to a maximum of 4 mg a day according to body mass and general physical condition. Dosage is based on a rate of 1 mg per 20 kg body mass per day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The side-effects include drowsiness, dryness of the mouth, nasal congestion, postural hypotension, lowering of body temperature (occasionally pyrexia), tachycardia, arrhythmias, agitation, insomnia, depression, miosis and mydriasis, convulsions, photosensitivity, skin rashes, and inhibition of ejaculation.
Jaundice of the obstructive type, considered to be allergic in origin, has occurred in patients receiving chlorpromazine; it does not appear to be dose-related and is usually readily reversible. Chronic constipation and faecal impaction have also occurred. Urinary retention may also occasionally occur.
Various haematological disorders including agranulocytosis, leucopenia, leucocytosis, and haemolytic anaemia have occurred. Most cases of agranulocytosis have occurred within 4 to 10 weeks of starting treatment. It is advisable to beware of symptoms such as sore throat or fever and to institute white cell counts should they appear. Eosinophilia may also occur. Extrapyramidal dysfunction occurs in patients receiving phenothiazines and is largely reversible by lowering the dose, or discontinuing therapy. Extrapyramidal symptoms may also be reversed in emergency by anti-parkinsonian agents, but these do not alleviate or prevent the emergence of tardive dyskinesia on long-term administration, and may mask early symptoms, with eventual exacerbation of the syndrome.
Allergic reactions include urticaria, photosensitisation and on occasions exfoliative dermatitis. Contact dermatitis can occur in people handling the drug. A lupus erythematosus-like syndrome has been reported.
The administration of large doses for prolonged periods can lead to the development of a purplish pigmentation of exposed areas of the skin and, more frequently, to the deposition of pigment in the eyes. Corneal and lens opacities have been observed in some patients.
Trifluoperazine alters endocrine function. Patients have experienced amenorrhoea, galactorrhoea, gynaecomastia, and weight gain and there have been reports of hyperglycaemia and diabetes mellitus. There have also been reports of raised serum cholesterol concentrations.

Precautions:
Cases of agranulocytosis, neutropenia, thrombocytopenia, anaemia, jaundice of the cholestatic type of hepatitis or liver damage have been reported in patients receiving high doses of this drug. Therefore the possibility of this should be borne in mind by the physician.
Care should be exercised when treating elderly or debilitated patients as some appear more prone to neurological adverse reactions.
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 tumor.
If agents such as sedatives, narcotics, anaesthetics or alcohol are used either 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 by 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 antidepressants 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. Absorption of trifluoperazine from the 'Spansule' capsule is likely to be prolonged, and this should be borne in mind. Treatment consists of gastric lavage together with supportive and symptomatic measures. Do not induce vomiting.
Extrapyramidal symptoms may be treated with an anticholinergic anti-parkinsonian drug. If hypotension occurs, noradrenaline or phenylephrine may be used, but adrenaline and other pressor agents are contra-indicated.

IDENTIFICATION:
Tablets: Round, film-coated, light blue biconvex tablets.
Capsules: Hard gelatine capsules with opaque yellow cap and clear body, containing a mixture of white and pale blue spherical pellets with a SB monogram on body and cap.

PRESENTATION:
Stelazine 1 mg tablets are available in containers of 50 and 250 tablets
Stelazine capsules are available in containers of 50 'Spansule' capsules.

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

REFERENCE NUMBERS:
Stelazine tablets 1 mg: B.1031 (Act 101/1965)
Stelazine capsules: B.1024 (Act 101/1965)

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

DATE OF PUBLICATION OT THIS PACKAGE INSERT:
06.07.1990.

P2104

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