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Logo INTRAMED CHLORPROMAZINE INJECTION 25 mg
INTRAMED CHLORPROMAZINE INJECTION 50 mg

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

INTRAMED CHLORPROMAZINE INJECTION 25 mg
INTRAMED CHLORPROMAZINE INJECTION 50 mg

COMPOSITION:
Ampoules of one and two millilitres.
Each mL contains:
Chlorpromazine Hydrochloride 25 mg
Sodium Metabisulphite 0,1% m/v
Sodium Sulphite 0,1% m/v
Ascorbic Acid 0,2% m/v

PHARMACOLOGICAL CLASSIFICATION:
A2.6.1 Phenothiazines and derivatives

PHARMACOLOGICAL ACTION:
Chlorpromazine hydrochloride is 2–Chloro–10–(3-di-methylaminopropyl) phenothiazine Hydrochloride. It is primarily a central nervous system depressant. Phenothiazine demonstrate multiple autonomic nervous system effects, namely blockade of both nicotinic and muscarinic effects of acetylcholine and adrenergic alpha receptor blockade. They also possess antihistaminic and antiserotonin activity.

INDICATIONS:
The indications for chlorpromazine treatment are anxiety, tension and agitation in psychoneurotic and psychotic patients. Apprehension before anaesthesia induction. Conditions characterised by vomiting and nausea.
The sedative and antiemetic actions of chlorpromazine render acute alcoholism and delirium tremens indications for its use. Cases of severe and continuous pain are an important indication as chlorpromazine alters the patient's reaction by inducing a state of emotional indifference. Chlorpromazine is used in conjunction with pethidine for premedication in anaesthesia producing "potentiated anaesthesia" and thereby often reducing the dosage requirements of anaesthetics. Chlorpromazine is employed as adjunctive treatment for tetanus. It controls the convulsions, diminishes the pain and exhaustion and relieves the feeling of fear without significant effect on consciousness or respiration.

CONTRA-INDICATIONS:
Chlorpromazine may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillizers. It is contra-indicated in comas resulting from the above. It is also contra-indicated in patients with bone-marrow depression.
Chlorpromazine should not be given in conjunction with drugs that might cause leucopenia such as phenylbutazone and the thiouracil derivatives.
Dosage must be carefully adjusted when patients take drugs that may cause postural hypotension.

WARNINGS:
Chlorpromazine potentiates the action of hypnotics, analgesics, anaesthetics and granulocytopenic substances (e.g. diphenylbutazone) and should be used with great care in patients receiving any such above-mentioned substances. Contact with the skin should be avoided to minimise the risk of dermatitis.

DOSAGE AND DIRECTIONS FOR USE:
30 mg to 1,5 g per day at the physician's discretion depending upon the condition being treated.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The phenothiazines possess an anticholinergic activity and so enhance the anticholinergic properties of drugs such as atropine and tricyclic antidepressants. The antihypertensive action of guanethidine is reduced by chlorpromazine.

The side-effects include drowsiness, dryness of the mouth, pallor of the skin, postural hypotension, weakness, lowering of body temperature (occasionally pyrexia), tachycardia, arrhythmias, insomnia, depression or sometimes agitation, photosensitivity, and skin rashes. Patients should be examined periodically for abnormal skin pigmentation or eye damage, and chlorpromazine withheld if necessary.

The effect of chlorpromazine on thermo-regulatory mechanisms may result in patients likely to become hypothermic in cold weather and hyperpyrexic in warm weather.

Sensitivity reactions include urticaria, photosensitisation and on occasions exfoliative dermatitis. A lupus erythematous-like syndrome has been reported.

The administration of large doses of chlorpromazine 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. Jaundice of the obstructive type has occurred – it is usually readily reversible.

Chronic constipation and faecal impaction attributed to paralytic ileus as well as megacolon have also occurred.

Haemotological disorders include agranulocytosis (which has been fatal), leucopenia, leucocytosis and haemolytic anaemia. Most cases have occurred within 4-10 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.

Extrapyramidal disfunction is reversible or may be controlled with antiparkinsonian agents. However, persistent tardive dyskinesia has occurred and may be irreversible.

Chlorpromazine and other phenothiazines alter endocrine function. Amenorrhoea agents, galactorrhoea, gynaecomastia and mass gain as well as diabetes mellitis have been reported. There have been reports of raised serum-cholesterol concentrations.

Phenothiazines should be used with care in patients with parkinsonism.

Chlorpromazine should be used with caution in patients with existing tachycardia or cardiac insufficiency and in patients with liver dysfunction or a history of jaundice.

If it is used in obstetrics, it should not be given until labour is established and the cervix dilated. Withdrawal symptoms including nausea, vomiting, gastritis, and tremors may occur following the abrupt discontinuation of large doses.

Chlorpromazine should be used with care in the elderly and debilitated. Drowsiness is often experienced at the start of treatment and patients should be advised not to take charge of vehicles or other machinery during this period.

It may cause a pink or purple colouration of the urine, particularly in the presence of oxidising agents.

Irritation at the site of injection may occur. Pain may be reduced by the addition of a local anaesthetic.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In severe overdosage the stomach should be emptied by aspiration and lavage. Emetics should not be used. To counter the acute hypotension the patient should be placed in the head-down position and noradrenaline administered by intravenous infusion (the usual pressor amines including adrenaline should not be given). The central nervous depression should be dealt with on conservative symptomatic lines (analeptics should be avoided) and injections of penicillin given for prevention or treatment of pneumonia.
The low body temperature should be allowed to recover naturally unless the temperature falls below 30°C.
Severe extrapyramidal reactions should be treated with a slow intravenous injection of benztropine mesylate 1 to 2 mg, diphenhydramine hydrochloride 25 to 50 mg, or procyclidine hydrochloride 10 mg. Barbiturates might be effective if these fail.
Chlorpromazine is not effectively removed by haemodialysis.

IDENTIFICATION:
Clear solution in amber ampoules.

PRESENTATION:
25 mg in 1 mL ampoules –10's and 100's
50 mg in 2 mL amber ampoules –10's and 100's

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light.
Keep out of reach of children.

REGISTRATION NUMBER:
25 mg –B1449 (Act 101/1965).
50 mg –B1636 (Act 101/1965).

NAME AND BUSINESS ADDRESS OF APPLICANT:
INTRAMED (PTY) LTD.
6 Gibaud Road
PORT ELIZABETH 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
31 August 1987 12-114/5-93
  Tradepak P.E.

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